IG-3721-16-0003 - UL Transaction Security
Transcription
IG-3721-16-0003 - UL Transaction Security
Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 2.2 Gap Certification The following identifies criterion or criteria certified via gap certification. (a)(1) (a)(19) §170.314 (d)(6) (a)(6) (a)(20) (d)(8) (a)(7) (b)(5)* (d)(9) (a)(17) (d)(1) (f)(1) (f)(7)* (a)(18) (d)(5) *Gap certification allowed for Inpatient setting only No gap certification (h)(1) (h)(2) 2.3 Inherited Certification The following identifies criterion or criteria certified via inherited certification. (a)(1) §170.314 (c)(2) (a)(16) Inpt. only (f)(2) (a)(2) (a)(17) Inpt. only (c)(3) (f)(3) (a)(3) (a)(18) (d)(1) (f)(4) Inpt. only (a)(4) (a)(19) (d)(2) (f)(5) Optional & Amb. only (a)(5) (a)(20) (d)(3) (f)(6) Optional & Amb. only (a)(6) (b)(1) (d)(4) (f)(7) Amb. only (a)(7) (b)(2) (d)(5) (g)(1) (a)(8) (b)(3) (d)(6) (g)(2) (a)(9) (b)(4) (d)(7) (g)(3) (a)(10) (b)(5) (d)(8) (g)(4) (a)(11) (b)(6) Inpt. only (d)(9) Optional (h)(1) (a)(12) (b)(7) (e)(1) (h)(2) (a)(13) (b)(8) (e)(2) Amb. only (h)(3) (a)(14) (b)(9) (e)(3) Amb. only (a)(15) (c)(1) (f)(1) No inherited certification ©2016 InfoGard. May be reproduced only in its original entirety, without revision 2 Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 3.2.2 Test Tools Test Tool Cypress ePrescribing Validation Tool HL7 CDA Cancer Registry Reporting Validation Tool HL7 v2 Electronic Laboratory Reporting (ELR) Validation Tool HL7 v2 Immunization Information System (IIS) Reporting Validation Tool HL7 v2 Laboratory Results Interface (LRI) Validation Tool HL7 v2 Syndromic Surveillance Reporting Validation Tool Transport Testing Tool Direct Certificate Discovery Tool Edge Testing Tool No test tools required Version 2.6.1 1.0.6 1.8.2 1.7.2 1.7.2 182 3.0.4 3.2.3 Test Data Alteration (customization) to the test data was necessary and is described in Appendix A No alteration (customization) to the test data was necessary 3.2.4 Standards 3.2.4.1 Multiple Standards Permitted The following identifies the standard(s) that has been successfully tested where more than one standard is permitted. Criterion # (a)(8)(ii)(A)(2) Standard Successfully Tested §170.204(b)(1) HL7 Version 3 Implementation Guide: URL‐Based Implementations of the Context‐Aware Information Retrieval (Infobutton) Domain (a)(13) §170.207(a)(3) IHTSDO SNOMED CT® International Release July 2012 and US Extension to SNOMED CT® March 2012 Release (a)(15)(i) §170.204(b)(1) HL7 Version 3 Implementation Guide: URL‐ Based Implementations of the Context‐Aware Information Retrieval (Infobutton) Domain (a)(16)(ii) §170.210(g) Network Time Protocol Version 3 (RFC 1305) (b)(2)(i)(A) §170.207(i) §170.204(b)(2) HL7 Version 3 Implementation Guide: Context‐ Aware Knowledge Retrieval (Infobutton) Service‐Oriented Architecture Implementation Guide §170.207(j) HL7 Version 3 Standard: Clinical Genomics; Pedigree §170.204(b)(2) HL7 Version 3 Implementation Guide: Context‐ Aware Knowledge Retrieval (Infobutton) Service‐Oriented Architecture Implementation Guide §170. 210(g) Network Time Protocol Version 4 (RFC 5905) §170.207(a)(3) The code set specified at 45 CFR 162.1002(c)(2) IHTSDO SNOMED CT® International Release (ICD‐10‐CM) for the indicated conditions July 2012 and US Extension to SNOMED CT® March 2012 Release ©2016 InfoGard. May be reproduced only in its original entirety, without revision 4 Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 Criterion # Standard Successfully Tested (b)(7)(i) §170.207(i) §170.207(a)(3) The code set specified at 45 CFR 162.1002(c)(2) IHTSDO SNOMED CT® International Release (ICD‐10‐CM) for the indicated conditions July 2012 and US Extension to SNOMED CT® March 2012 Release (e)(1)(i) Annex A of the FIPS Publication 140‐2 TLS RSA; CBC SHA 128 (e)(1)(ii)(A)(2) §170.210(g) Network Time Protocol Version 3 (RFC 1305) (e)(3)(ii) §170. 210(g) Network Time Protocol Version 4 (RFC 5905) Annex A of the FIPS Publication 140‐2 TLS RSA; CBC SHA 128 Common MU §170.207(a)(3) Data Set (15) IHTSDO SNOMED CT® International Release July 2012 and US Extension to SNOMED CT® March 2012 Release §170.207(b)(2) The code set specified at 45 CFR 162.1002(a)(5) (HCPCS and CPT‐4) None of the criteria and corresponding standards listed above are applicable 3.2.4.2 Newer Versions of Standards The following identifies the newer version of a minimum standard(s) that has been successfully tested. Newer Version Applicable Criteria No newer version of a minimum standard was tested 3.2.5 Optional Functionality Criterion # (a)(4)(iii) (b)(1)(i)(B) Optional Functionality Successfully Tested Plot and display growth charts Receive summary care record using the standards specified at §170.202(a) and (b) (Direct and XDM Validation) (b)(1)(i)(C) Receive summary care record using the standards specified at §170.202(b) and (c) (SOAP Protocols) (b)(2)(ii)(B) Transmit health information to a Third Party using the standards specified at §170.202(a) and (b) (Direct and XDM Validation) (b)(2)(ii)(C) Transmit health information to a Third Party using the standards specified at §170.202(b) and (c) (SOAP Protocols) (f)(3) Ambulatory only – Create syndrome‐based public health surveillance information for transmission using the standard specified at §170.205(d)(3) (urgent care visit scenario) Common MU Express Procedures according to the standard specified at §170.207(b)(3) (45 Data Set (15) CFR162.1002(a)(4): Code on Dental Procedures and Nomenclature) Common MU Express Procedures according to the standard specified at §170.207(b)(4) (45 Data Set (15) CFR162.1002(c)(3): ICD‐10‐PCS) No optional functionality tested ©2016 InfoGard. May be reproduced only in its original entirety, without revision 5 Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 3.2.6 2014 Edition Certification Criteria* Successfully Tested Criteria # (a)(1) (a)(2) (a)(3) (a)(4) (a)(5) (a)(6) (a)(7) (a)(8) (a)(9) (a)(10) (a)(11) (a)(12) (a)(13) (a)(14) (a)(15) (a)(16) Inpt. only (a)(17) Inpt. only (a)(18) (a)(19) (a)(20) (b)(1) (b)(2) (b)(3) (b)(4) (b)(5) (b)(6) Inpt. only (b)(7) (b)(8) (b)(9) Version TP** TD*** 1.2 1.2 1.4 1.4 1.3 1.3 1.2 1.3 1.3 1.2 1.2 1.5 1.4 1.3 1.3 1.3 1.4 1.7 1.4 1.4 1.3 1.4 1.4 1.6 1.2 1.4 1.7.2 1.5 1.7 Criteria # (c)(1) (c)(2) (c)(3) (d)(1) (d)(2) (d)(3) (d)(4) (d)(5) (d)(6) (d)(7) (d)(8) (d)(9) Optional (e)(1) (e)(2) Amb. only (e)(3) Amb. only (f)(1) (f)(2) (f)(3) (f)(4) Inpt. only (f)(5) Optional & Amb. only (f)(6) Optional & Amb. only (f)(7) Amb. only (g)(1) (g)(2) (g)(3) (g)(4) (h)(1) (h)(2) (h)(3) Version TP** TD*** 1.12 1.12 1.12 2.6.1 2.6.1 2.6.1 1.6 1.3 1.2 1.2 1.11 1.2 1.3 1.5 1.6 1.3 1.3 1.3.0 1.3.0 1.1 2.0 1.4 1.2 1.1 1.1 1.1 2.0 *For a list of the 2014 Edition Certification Criteria, please reference http://www.healthit.gov/certification (navigation: 2014 Edition Test Method) **Indicates the version number for the Test Procedure (TP) ***Indicates the version number for the Test Data (TD) ©2016 InfoGard. May be reproduced only in its original entirety, without revision 6 Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 3.2.7 2014 Clinical Quality Measures* Type of Clinical Quality Measures Successfully Tested: Ambulatory Inpatient No CQMs tested *For a list of the 2014 Clinical Quality Measures, please reference http://www.cms.gov (navigation: 2014 Clinical Quality Measures) CMS ID 2 22 50 52 56 61 62 64 65 66 68 69 74 75 77 82 Version v4 v3 v3 v4 v4 v4 v4 v3 v2 CMS ID 90 117 122 123 124 125 126 127 128 129 130 131 132 133 134 135 Ambulatory CQMs Version CMS ID 136 v3 137 138 v3 v3 139 v3 140 141 v3 142 143 v3 144 v4 145 146 v3 147 v3 148 149 v3 153 154 Version v3 v3 v3 v3 v4 v3 v4 CMS ID 155 156 157 158 159 160 161 163 164 165 166 167 169 177 179 182 Version v3 v3 v3 v3 v4 v3 v3 CMS ID 9 26 30 31 32 Version CMS ID 71 72 73 91 100 Inpatient CQMs Version CMS ID 107 108 109 110 111 Version CMS ID 172 178 185 188 190 Version 53 55 60 102 104 105 113 114 171 ©2016 InfoGard. May be reproduced only in its original entirety, without revision 7 Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 3.2.8 Automated Numerator Recording and Measure Calculation 3.2.8.1 Automated Numerator Recording (a)(1) (a)(3) (a)(4) (a)(5) (a)(6) (a)(7) Automated Numerator Recording Successfully Tested (a)(16) (a)(9) (a)(17) (a)(11) (b)(2) (a)(12) (b)(3) (a)(13) (a)(14) (a)(15) (b)(4) (b)(5) (b)(6) (e)(1) (e)(2) (e)(3) (b)(6) (e)(1) (e)(2) (e)(3) Automated Numerator Recording was not tested 3.2.8.2 Automated Measure Calculation (a)(1) (a)(3) (a)(4) (a)(5) (a)(6) (a)(7) Automated Numerator Recording Successfully Tested (a)(9) (a)(16) (a)(11) (a)(17) (a)(12) (b)(2) (a)(13) (b)(3) (a)(14) (b)(4) (a)(15) (b)(5) Automated Measure Calculation was not tested 3.2.9 Attestation Attestation Forms (as applicable) Safety‐Enhanced Design* Quality Management System** Privacy and Security Appendix B C D *Required if any of the following were tested: (a)(1), (a)(2), (a)(6), (a)(7), (a)(8), (a)(16), (b)(3), (b)(4) **Required for every EHR product ©2016 InfoGard. May be reproduced only in its original entirety, without revision 8 Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 Appendix A: Alteration of Test Data Criteria b7 e1 Explanation Determined that modified Test Data had equivalent level of robustness to NIST Test Data Determined that modified Test Data had equivalent level of robustness to NIST Test Data ©2016 InfoGard. May be reproduced only in its original entirety, without revision 9 Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 Appendix B: Safety Enhanced Design ©2016 InfoGard. May be reproduced only in its original entirety, without revision 10 User Centered Design Process Attestation EnableMyHealth EHR Safety-Enhanced Design 170.314(g)(3) Report based on ISO/IEC 25062:2006 Common Industry Format for Usability Test Reports Date of Usability Test: 15 AUG 2015 – 14 SEP 2015 Date of Report: 14 SEP 2015 Report Prepared By: Steve Rothschild 540.588.0016 steve@enabledoc.com EnableDoc LLC 7700 Falstaff Road McLean VA 22104 Table of Contents Enablemyhealth User Centered Design Process Attestation ........................................................................ 2 Summary ....................................................................................................................................................... 2 Intended Purpose of Document.................................................................................................................... 2 Overview ....................................................................................................................................................... 2 Usability Definition ....................................................................................................................................... 3 Enablemyhealth UCD Process ....................................................................................................................... 3 Organizational ............................................................................................................................................... 5 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 1 Enablemyhealth User Centered Design Process Attestation Summary EnableMyHealth attests to the use and implementation of a User Centered Design process in the ongoing development of its EHR software. Our process implements the process outlined in NISTIR 7741. Reference: National Institute of Standards and Technology. (2010). NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records (NISTIR 7741). Gaithersburg, MD. www.nist.gov/manuscript-publication-search.cfm?pub_id=907313 The details of the EnableMyHealth implementation of NISTIR 7741 are described in the remainder of this document. This UCD approach has been applied in the development and measurement of the 7 ambulatory EHR criteria described in 170.314(g)(3) Safety-enhanced design. Specifically these are: • CPOE (medications, labs and radiology orders) • Drug-drug, drug-allergy interaction checks • Medication list • Medication allergy list • Clinical decision support • Electronic prescribing • Clinical information reconciliation The primary artifacts demonstrating this process are the summative usability test reports describing in detail the usability testing conducted on the 7 safety enhanced design criteria. Intended Purpose of Document This document is to attest to the ONC that EnableMyHealth has applied a User Centered Design process in the development of our EHR offering. Overview An established UCD process ensures that designed EHRs are efficient, effective, and satisfying to the user. Such a process would also ensure an understanding of end user needs, workflows, and environments. Users are engaged early and often to provide guidance and understanding of their work, formative feedback during an iterative design and development process, and summative usability testing to assess if performance goals have been met. Usability is defined by the International Organization for Standardization (ISO) as “…the effectiveness, efficiency, and satisfaction with which the intended users can achieve their tasks in the intended context of product use.” This definition establishes a framework for setting usability goals and specific evaluation measures. For a given application, measures of these attributes enable comparing the application‘s progress over time. UCD is an iterative process that serves to continually improve the application. In each iteration, critical points Enabledoc LLC ©2015 Confidential and Proprietary Version 1 2 and issues are uncovered which can be improved upon and implemented in subsequent releases. Established UCD processes are followed by organizations that have a culture of usability. Usability testing is a core component of user-centered design. The point of doing a usability test is to improve the EHR whether that means its workflow, navigation, screen layout, interaction, visual design, etc. Early and frequent testing (formative) confirms or refutes design decisions at a time when they can still easily be changed. Usability testing also guides the development process, helping to avoid problems in the use of the final software such as elimination of critical user errors, excessive time spent on a task, or unsuccessful task completion. The EnableMyHealth UCD process can be described in the following graphic manner: IMAGE [From: NISTIR 7741. http://www.nist.gov/manuscript-publication-search.cfm?pub_id=907313] The remainder of this document will outline this process as implemented at EnableMyHealth. Usability Definition The term “usability” appears repeatedly in this document. Ensuring a common ground and understanding, “usability” is defined thusly: Effectiveness – the degree to which users are able to successfully accomplish their tasks and goals. This is measured via collection of task completion rate, types and numbers of errors, and deviations from optimal path. Efficiency – the time the task takes for successful completion. The desired or optimal time is either contained within predetermined usability goals or considered acceptable by end users. This is measured by collecting time on task. Satisfaction – the degree to which users are frustrated or pleased, how learnable they consider the system, and the perceived ease of use. This is measured primarily by the SUS Questionnaire and by a post task single ease of use question. Enablemyhealth UCD Process 1. Understand user needs, workflows, and environments a. This is accomplished in a variety of ways during the analysis and design stages of a feature or enhancement. EnableMyHealth regularly conducts field visits to end user clients to observe their work practices and conduct interviews to identify user needs and concerns. Competitive analysis is also an ongoing activity to identify areas of opportunity. EnableMyHealth also relies on internal subject matter experts who are able to inform the design process. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 3 b. EnableMyHealth has established several Physician Advisory Groups: one for clinicians that primarily use the EHR and one that focuses on the Practice Management component. All groups meet periodically to provide input and feedback on their work practices and how our software integrates with and facilitates those practices. Areas of improvement are also discussed. 2. Engage users early and often User reaction and feedback is regularly sought during the development phase of the software. A variety of methods are used including presentation and discussion of proposed designs (screen visual design as well as interaction model), formative usability testing, surveys, and discussion forums. EnableMyHealth is actively working to conduct these activities even earlier in the development process, specifically during the initial design phase of a project. 3. Set usability objectives As part of the process of starting work on a new feature or enhancement, a discussion occurs among Product Management, Sales, and User Experience/Development groups to establish desired usability goals and objectives. 4. Design from known behavior principles and UI patterns i. The User Experience group consists of two usability and design professionals that collectively encompass over 40 years of experience in the field. The skillsets comprise: healthcare work flow, computer science, technical writing, graphic design, and system architecture. ii. The UI group owns the user experience of the products and as such produces or reviews all aspects of the design of the user interface. As such the UI design process focuses on: 1. Speed of performing functionality with optimal number of steps 2. Screen and functional design consistency 3. Modern user controls 4. Windows/Web User Experience Guidelines 5. Obtain user feedback via formative usability studies User feedback, either from members of the advisory group or internal users is obtained from formative usability studies during the design and development phase of a feature. Currently this is typically done with demonstration of screens and functional work flow. We obtain input from tests of users and selective customers and industry experts. 6. Adapt and modify designs iteratively User feedback and other formative usability test results are presented and discussed with product teams. User experience and functionality is discussed and modified for optimal usability and speed. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 4 7. Measure performance against objectives Once a feature is sufficiently coded to the point where relevant usability metrics can be measured and collected, small user groups are conducted to assess performance and determine if the solution meets usability goals. The design is reassessed if there is significant deviation. Organizational 1. Data as a basis for decision As much as possible, EnableMyHealth relies on the data from both formative and comprehensive usability tests to base design decisions as opposed to only opinions. When competing design options arise, a quick small-scale usability study is conducted to inform the appropriate design direction. The specific type of study is determined by the research question. It may be as simple as a wording preference question or as involved and rigorous as a summative study. 2. Management support The User Experience group was founded approximately 4 years ago when EnableMyHealth had attained a software development maturity level where management recognized the strategic importance of usable products. Since then there has been a 150% growth in the size of the group as workload increased, due in no small part to management championship. EnableMyHealth was also acquired by a much larger corporation during this time period which already had user experience and software usability as an established component of the development process. 3. Design team The User Experience team consists of a Lead Developer who focuses on is responsible for the interaction model, screen layout, and both internal and external software behavior consistency, and a designer who has primary responsibility for color palette, iconography, visual language, and screen layout consistency. Our development is approximately 10 to 15 software developers and testers that have multiple roles and responsibilities. Product Management works closely with the User Experience team to ensure proper work flow, inputs and outputs and provides the subject matter expertise to ensure customer, regulatory, and legal requirements are met. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 5 EHR Usability Test Report of Enablemyhealth EHR Medication Allergy List Safety-Enhanced Design 170.314(g)(3) Report based on ISO/IEC 25062:2006 Common Industry Format for Usability Test Reports Date of Usability Test: 15 AUG 2015 – 14 SEP 2015 Date of Report: 14 SEP 2015 Report Prepared By: Stephen Rothschild 877.540.0933 steve@enabledoc.com EnableDoc LLC 7700 Falstaff Road McLean VA 22104 Table of Contents 1 Executive Summary ............................................................................................................................... 2 2 INTRODUCTION ..................................................................................................................................... 3 3 METHOD................................................................................................................................................ 4 4 5 3.1 PARTICIPANTS ............................................................................................................................... 4 3.2 STUDY DESIGN............................................................................................................................... 5 3.3 TASKS............................................................................................................................................. 5 3.4 PROCEDURES................................................................................................................................. 6 3.5 TEST LOCATION ............................................................................................................................. 7 3.6 TEST ENVIRONMENT ..................................................................................................................... 7 3.7 TEST FORMS AND TOOLS .............................................................................................................. 7 3.8 PARTICIPANT INSTRUCTIONS ........................................................................................................ 7 3.9 USABILITY METRICS ....................................................................................................................... 8 3.10 DATA SCORING .............................................................................................................................. 8 RESULTS .............................................................................................................................................. 10 4.1 DATA ANALYSIS AND REPORTING ............................................................................................... 10 4.2 DISCUSSION OF THE FINDINGS ................................................................................................... 10 4.3 EFFECTIVENESS ........................................................................................................................... 11 4.4 EFFICIENCY .................................................................................................................................. 11 4.5 SATISFACTION ............................................................................................................................. 11 4.6 MAJOR FINDINGS ........................................................................................................................ 11 4.7 AREAS FOR IMPROVEMENT ........................................................................................................ 11 APPENDICES ........................................................................................................................................ 12 Appendix 1: PARTICIPANT RECRUITING SCREENER ................................................................................ 12 Appendix 2: PARTICIPANT DEMOGRAPHICS ........................................................................................... 15 Appendix 3: Informed Consent Form...................................................................................................... 16 Appendix 4: Task Scenarios ..................................................................................................................... 17 Appendix 5: Usability Test Administration Moderator’s Guide .............................................................. 18 Appendix 6: Sample data collection form ............................................................................................... 20 Appendix 7: System Usability Scale Questionnaire ................................................................................ 21 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 1 1 Executive Summary A usability test of EnableMyHealth – 2014.1, an ambulatory EHR, was conducted on 15 Aug 2015 – 14 Sep 2015 in the McLean, VA and Rochester MN offices of EnableDoc LLC. The purpose of this test was to test and validate the usability of the current user interface for edication allergy list, and provide evidence of usability in the EHR Under Test (EHRUT). During the usability test, five healthcare providers and clinical staff matching the target demographic criteria served as participants and used the EHRUT in simulated, but representative tasks. This study collected performance data on 3 medication allergies and 2 modified medication allergies in an EHR where the user is required to: · · · Enter 3 medication allergies Modify 2 medication allergies Review allergy history All test participants conducted the test sessions remotely via on-line conferencing software. During the 15 minute one-on-one usability test, each participant was greeted by the administrator and asked to review and verbally acknowledge an informed consent/release form (included in Appendix 3); they were instructed that they could withdraw at any time. Participants had prior experience with the EHR as they are current users/customers. No additional training materials were provided other than that usually given to customers. The administrator introduced the test and instructed participants to complete a series of tasks (given one at a time) using Enablemyhealth. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. Participant screens and audio were recorded for subsequent analysis. The following types of data were collected for each participant: • Number of tasks successfully completed within the allotted time without assistance • Time to complete the tasks • Participant’s subjective assessment of the ease of each task • Number and types of errors • Path deviations • Participant’s verbalizations • Participant’s satisfaction ratings of the system All participant data was de-identified – no correspondence could be made from the identity of the participant to the data collected. Following the conclusion of the testing, participants were asked to complete a post-test questionnaire and were compensated with a $50 gift card for their time. Following the conclusion of the testing, participants were asked to complete a post-test SUS questionnaire. Various recommended metrics, in accordance with the examples set forth in the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, were used to evaluate the usability of the EHRUT. Result data matrix - refer to Appendix 4 for complete task descriptions Enabledoc LLC ©2015 Confidential and Proprietary Version 1 2 MEASURES TASKS Path Deviations (Observed / Task Optimal) Number Success Task Time Mean (SD) Task Time Task Deviations Ratings (Observed / 5=Easy Errors Optimal) Mean (SD) Mean (SD) Create 3 medication allergies 3 100.00 1.1 (21.3/19) 84 (2.8) 1.1 (289/275) 1.86 (1.1) 3.7 (0.5) Make inactive 2 medication allergies Review Medication Allergy List 2 1 100.00 100.00 1.1 (16.8/16) 2.1 (2.1/1) 75 (2.7) 14 (7.7) 1.3 (75/60) 1.2 (18/15) 0.57 (0.7) 0.43 (0.7) 4.1 (0.6) 4.7 (0) 100.00 1.4 (13.4/12) 57.7 (4.5) 1.2 (128/116) 1 (0.9) 4.2 (0.4) Mean across tasks The results from the System Usability Scale scored the subjective satisfaction with the system based on performance with these tasks to be: 81.4. In addition to the performance data, the following qualitative observations were made: Major findings · Issues with adding medication allergies: 1. Providers tend to just want to enter the allergies and not want to provide other information. 2. Editing allergies required existing allergies to be made inactive, which was more time consuming. Areas for improvement · · · 2 Allow edit of existing allergy without making inactive. Allow default setting for medication allergies. Use speech recognition and NLP to make entering data more natural. INTRODUCTION The EHRUT tested for this study was EnableMyHealth EHR4 Release, an ambulatory EHR. Designed to present medical information to healthcare providers in primarily group practices with a focus on family practice, surgery, eye, and PT/OT/Chiropractic medicine, the EHRUT consists of modules and features that include but not limited to support for tested functionality: · Patient demographics · Patient problem and allergy lists · Creating lab orders and receiving lab results · Immunization recording · Electronic prescribing · Drug-drug, drug-allergy, and drug-problem interaction checking · Clinical decision support Enabledoc LLC ©2015 Confidential and Proprietary Version 1 3 The EHRUT is used predominantly by physicians and clinical staff such as MA’s, RN’s, LPN’s, etc. The usability testing attempted to represent realistic exercises and conditions. The purpose of this study was to test and validate the usability of the current user interface, and provide evidence of usability of the entry and modification of electronic prescriptions, laboratory orders, and imaging orders in the EHR Under Test (EHRUT).To this end, measures of effectiveness, efficiency and user satisfaction, such as successful task completion rate, time on task, number and types of errors, and participant satisfaction were captured during the usability testing. 3 3.1 METHOD PARTICIPANTS A total of 7 participants were tested on the CPOE feature of the EHRUT. Participants in the test were physicians and clinical staff such as RNs and MAs. Participants were recruited by Enabledoc staff from existing customers and paid a $50 gift card for their help in testing. Participants had no direct connection to the development of or organization producing the EHRUT other than being current customers. Participants were not from the testing or supplier organization. Participants were actual end users and thus have the same orientation and level of training as other non-participant customers. For the test purposes, end-user characteristics were identified and translated into an internal recruitment screener used to solicit potential participants; an example of a screener is provided in Appendix [1]. Recruited participants had a mix of backgrounds and demographic characteristics conforming to the recruitment screener. The following is a table of participants by characteristics, including demographics, professional experience, computing experience and user needs for assistive technology. Participant names were replaced with Participant IDs so that an individual’s data cannot be tied back to individual identities. Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Age Occupation / role 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Product Experience (yrs) 3 3 4 3 3 3 1 Seven (7) participants (matching the demographics in the section on Participants) were recruited and all participated in the usability test. 3); they were instructed that they could withdraw at any time. Participants all had prior experience with the EHR. No participants failed to show for the study. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 4 Participants were scheduled for 15 minute sessions with 15 minutes in between each session for debrief by the administrator and data logger, and to reset systems to proper test conditions. All testing was performed over several days to allow the participants to schedule time at their convenience. A spreadsheet was used to keep track of the participant schedule. The administrator introduced the test, and instructed participants to complete a series of tasks (given one at a time) using the EHRUT. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. 3.2 STUDY DESIGN The objective of this test was to perform summative testing to measure the key usability metrics of effectiveness, efficiency, and user satisfaction. These metrics will uncover areas where the application performed well and areas where the application failed to meet the needs of the participants in achieving our internal usability goals. The data from this test may serve as a baseline for future tests with an updated version of the same EHR and/or comparison with other EHRs provided the same tasks are used. In short, this testing serves as both a means to record or benchmark current usability, but also to identify areas where improvements should be made. During the usability test, participants interacted exclusively with the EHRUT. Each participant used the system in their preferred location, and was provided with the same instructions. All sessions were conducted remotely with Join.Me conferencing software. Screens with associated interaction and the audio stream were recorded for later analysis. The system was evaluated for effectiveness, efficiency and satisfaction as defined by measures collected and analyzed for each participant: • Number of tasks successfully completed within the allotted time without assistance • Time to complete the tasks • Number and types of errors • Path deviations • Participant’s verbalizations (comments) • Participant’s satisfaction ratings of the system Additional information about the various measures can be found in Section 3.9 on Usability Metrics. 3.3 TASKS Tasks were constructed that would be realistic and representative of the kinds of activities a user might do with this EHR in the area of [describe feature under study] and heavily based on the CMS test scripts for Meaningful Use Phase 2. The tasks for this study included: · Enter 3 medication allergies · Modify 2 medication allergies · Review allergy history Task Selection and Priority Tasks were selected based on their frequency of use, criticality of function, and those that may be most troublesome for users. The tasks were directly modeled on the CMS Medication Allergy List test procedure §170.314(a)(7). Enabledoc LLC ©2015 Confidential and Proprietary Version 1 5 Tasks were ordered and prioritized based on their impact on patient safety, in which the tasks that had the greatest potential for patient harm due to critical errors were performed first. The task scenario document is contained in appendix 4. 3.4 PROCEDURES Just prior to the scheduled time, the test administrator started the join.me session and greeted the participant on arrival; their identity was verified and matched with a name on the participant schedule. Participants were then assigned a participant ID. Recording of the session was started using the join.me recording feature. Each participant reviewed and agreed to the informed consent and release form via verbal acknowledgment (See Appendix 3). A representative from the test team witnessed the participant’s verbal agreement. To ensure that the test ran smoothly, testing was performed remotely by an experienced usability practitioner with over 25 years of experience in healthcare user interface and workflow design. The administrator moderated the session including administering instructions and tasks. The administrator also monitored task times, obtained post-task rating data, took notes on participant comments, path deviations, number and type of errors, and comments. Participants were instructed to perform the tasks (see specific instructions below): · · · As quickly as possible making as few errors and deviations as possible. Without assistance; administrators were allowed to give immaterial guidance and clarification on tasks, but not instructions on use. Without using a think aloud technique. For each session, the participants were given an electronic copy of the tasks for that session. They were requested to not read the tasks prior to the session. Participants were asked to read the task aloud prior to each task; task timing began once the participant finished reading the question and verbally indicated they were starting the task. The task time was stopped once the participant indicated they had successfully completed the task. Scoring is discussed below in Section 3.9. Following the session, the administrator gave the participant the post-test questionnaire (the System Usability Scale, see Appendix 7), solicited any further comments, and thanked each individual for their participation. Participants' demographic information, task success rate, time on task, errors, deviations, verbal responses, and post-test questionnaire were recorded into a spreadsheet. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 6 3.5 TEST LOCATION 3.6 TEST ENVIRONMENT The test was conducted remotely through the use of Join.Me virtual conferencing and screen sharing software. Thus the actual test location was at the discretion of the test participants. The test administrator conducted the test from Enabledoc LLC offices in Rochester MN. The EHRUT would be typically be used in a healthcare office or facility. In this instance, the testing was conducted in healthcare office. For testing, the computer used a Windows laptop running Windows OS and Chrome browser. The participants used a mouse and keyboard when interacting with the EHRUT. The Enablemyhealth application was used on a 13 inch laptop with 1366 by 768 resolution and 32 bit color. The application was set up by the vendor according to the vendor’s documentation describing the system set-up and preparation. The application itself was running on a Windows 2012 Server using a test database on a WAN connection. Technically, the system performance (i.e., response time) was representative to what actual users would experience in a field implementation with a minor lag caused by video screen sharing and recording. Additionally, participants were instructed not to change any of the default system settings (such as control of font size). 3.7 TEST FORMS AND TOOLS During the usability test, various documents and instruments were used, including: • Informed Consent • Test task scenarios • Moderator’s Guide • Observer’s data collection template • Post-test SUS Questionnaire Examples of these documents can be found in Appendices 3 – 7 respectively. The participant’s interaction with the EHRUT was captured and recorded digitally using the screen recording capability of join.me running on the test machine. This recording included the audio stream of verbalizations. The test sessions were electronically transmitted to any additional observers who logged into the join.me session. 3.8 PARTICIPANT INSTRUCTIONS The administrator reads the following instructions aloud to the each participant (also see the full moderator’s guide in Appendix 5): Thank you for participating in this study. Your input is very important. Our session today will last about 15 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the Enabledoc LLC ©2015 Confidential and Proprietary Version 1 7 tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screen interaction of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. Following the procedural instructions, participants were started with a specific patient’s chart data. Prior to giving the participant mouse and keyboard control, the moderator gave the following instructions: For each task, I will ask you to read the task and indicate when you begin. At that point, please perform the task and say “Done” once you believe you have successfully completed the task. I would like to request that you not talk aloud or verbalize while you are doing the tasks. You may certainly ask questions if necessary and we may provide guidance or a hint, however we will not provide direct instruction during the tasks. I will ask you your impressions about the task once you are done. Participants were then given 4 tasks to complete. Tasks are listed in Appendix 4. 3.9 USABILITY METRICS According to the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, EHRs should support a process that provides a high level of usability for all users. The goal is for users to interact with the system effectively, efficiently, and with an acceptable level of satisfaction. To this end, metrics for effectiveness, efficiency and user satisfaction were captured during the usability testing. The goals of the test were to assess: 1. Effectiveness of ENABLEMYHEALTH EHR by measuring participant success rates and errors 2. Efficiency of ENABLEMYHEALTH EHR by measuring the average task time and path deviations 3. Satisfaction with ENABLEMYHEALTH EHR by measuring ease of use ratings 3.10 DATA SCORING The following table details how tasks were scored, errors evaluated, and the time data analyzed: Rationale and Scoring Measure Effectiveness: Task Success A task was counted as a “Success” if the participant was able to achieve the correct outcome, without assistance, within the overall time allotted for the entire set of tasks. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 8 The total number of successes were calculated for each task and then divided by the total number of times that task was attempted. The results are provided as a percentage. Task times were recorded for successes. Observed task times divided by the optimal time for each task is a measure of optimal efficiency. Due to the variability of multiple correct paths and a large variety of user settable preferences, all of which can affect time on task, optimal task times and deviations from these times were unrealistic to assess. All participants were trained on Enablemyhealth EHR and so the performance factor of 1.0 was use. The overall usability goal for any feature of the EHR is task time that is deemed acceptable by the end user with no critical errors. Thus, if expert, optimal performance on a task was [60] seconds then allotted task time performance was [60 * 1.0] seconds. This ratio is aggregated across tasks and reported with mean and variance scores. Effectiveness: Task Failures Efficiency: Task Deviations If the participant abandoned the task, did not reach the correct answer, performed it incorrectly, or was unsure if they had completed the task, the task was counted as a “Critical Failure.” No task times were taken for failed tasks. Minor errors were defined as an errant click, initial selection of an incorrect menu option, or incorrect entries that the participant noticed and corrected. The total number of errors was calculated for each task and then divided by the total number of times that task was attempted. Minor errors and deviations were noted but not counted as significant errors. This is expressed as the mean number of failed tasks per participant. The participant’s path (i.e., steps) through the application was recorded. Deviations occur if the participant, for example, went to a wrong screen, clicked on an incorrect menu item, followed an incorrect link, or interacted incorrectly with an on-screen control. These path deviations were included in the minor error count. The minor error count is expressed as an average across all participants. Efficiency: Task Time Satisfaction: Task Rating Each task was timed from when the participant indicated they were beginning the task until the participant said “Done.” If he or she failed to say “Done,” the time was stopped when the participant stopped performing the task. Only task times for tasks that were successfully completed were included in the average task time analysis. Average time per task was calculated for each task as was variance (standard deviation). Participant’s subjective impression of the ease of use of the application was measured by administering both a simple post-task question as well as a post-session questionnaire. After each task, the participant was asked to rate “Overall, this task was:” on a scale of 1 (Very Difficult) to 7 (Very Easy). Average difficulty ratings per task were calculated as was variance. Common convention is that average ratings for systems judged easy to use should be 3.3 or above. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 9 To measure participants’ confidence in and likeability of the ENABLEMYHEALTH EHR feature overall, the testing team administered the System Usability Scale (SUS) post-test questionnaire. Questions included, “I think I would like to use this system frequently,” “I thought the system was easy to use,” and “I would imagine that most people would learn to use this system very quickly.” See full System Usability Score questionnaire in Appendix 7. 4 4.1 RESULTS DATA ANALYSIS AND REPORTING The results of the usability test were calculated according to the methods specified in the Usability Metrics section above. Participants who failed to follow session and task instructions had their data excluded from the analyses, however there were no instances of this occurring. The usability testing results for the ENABLEMYHEALTH EHR are detailed below (Table 1). The results should be seen in light of the objectives and goals outlined in Section 3.2 Study Design. The data should yield actionable results that, if corrected, yield material, positive impact on user performance. Table 1 MEASURES TASKS Path Deviations (Observed / Task Optimal) Number Success Task Time Mean (SD) Task Time Task Deviations Ratings (Observed / 5=Easy Errors Optimal) Mean (SD) Mean (SD) Create 3 medication allergies 3 100.00 1.1 (21.3/19) 84 (2.8) 1.1 (289/275) 1.86 (1.1) 3.7 (0.5) Make inactive 2 medication allergies Review Medication Allergy List 2 1 100.00 100.00 1.1 (16.8/16) 2.1 (2.1/1) 75 (2.7) 14 (7.7) 1.3 (75/60) 1.2 (18/15) 0.57 (0.7) 0.43 (0.7) 4.1 (0.6) 4.7 (0) 100.00 1.4 (13.4/12) 57.7 (4.5) 1.2 (128/116) 1 (0.9) 4.2 (0.4) Mean across tasks The results from the SUS (System Usability Scale) scored the subjective satisfaction with the system based on performance with these tasks to be: 81.4. Broadly interpreted, this indicates above average usability, but with further room for improvement. 4.2 DISCUSSION OF THE FINDINGS Overall, the Medical Allergy feature of Enablemyhealth user experience exhibits good effectiveness, with no critical errors out of 42 attempted tasks, but there were 1 mean deviations errors across all tasks. This is within internal usability goal guidelines. Of the total 20 deviation errors, 13 were attributable to entering new medication allergies. Efficiency measures indicate that while acceptable, there is room for improvement, specifically in the editing of medication allergies. Adding medication allergies can only be expedited using defaulting field values. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 10 Satisfaction, measured by an SUS score of 81.4 is very good, but can be improved. Working to make the user experience more natural and intelligent will improve the overall user experience and help guide the novice and advanced users. 4.3 EFFECTIVENESS Based on the success rate, minor error rate, and critical error rate data, the medication allergies feature has an acceptable level of effectiveness. The usability test consisted of 35 tasks. Out of the 42 attempted tasks, there were no critical errors, giving a successful completion rate of 100%. The 20 deviation (minor) errors in the medication allergies were difficulties associated with selecting the correct data and editing then making allergies inactive. The deviation error mean of 1 is within the acceptable range of effectiveness. 4.4 EFFICIENCY Observation of task time is the primary area for improvement. The mean task time across all tasks is 57.7 seconds out of an optimal 53.6 was primary caused by searching for medications and selecting affects and severity. 4.5 SATISFACTION Based on task difficulty ratings and SUS results data, user satisfaction of the feature is considered favorable. Users perception of ease of use is considered easy, with a mean rating of 4.2 across all tasks (1=very difficult, 5=very easy). SUS scoring is very good with a score of 81.4. These scores accurately describe the average patient satisfaction with Enablemyhealth feature set. SUS Scoring Mean StDev 4.6 81.43 4.40 MAJOR FINDINGS The major usability problems encountered in this study were: · 4.7 Issues with adding medication allergies: 1. Providers tend to just want to enter the allergies and not want to provide other information. 2. Editing allergies required existing allergies to be made inactive, which was more time consuming. AREAS FOR IMPROVEMENT Entering medication allergy improvements: Enabledoc LLC ©2015 Confidential and Proprietary Version 1 11 · · · 5 Allow edit of existing allergy without making inactive. Allow default setting for medication allergies. Use speech recognition and NLP to make entering data more natural. APPENDICES The following appendices include supplemental data for this usability test report. Following is a list of the appendices provided: 1: Participant Recruiting Screener 2: Participant demographics 3: Informed Consent Form 4: Task Scenarios 5: Moderator’s Guide 6: Sample data collection form 7: System Usability Scale Questionnaire Appendix 1: PARTICIPANT RECRUITING SCREENER Introduction Hello, my name is __. Enabledoc is seeking doctors and clinicians who are users of • Medication list and medication allergy list management to take part in a usability study of that portion of the EnableMyHealth EHR. This study will assist us in designing and developing a solution that meets your needs. Your experiences in using this particular design will greatly help our designers and developers. The testing of our design will take place in your office using remote meeting technology, requiring only your time, thoughts, and suggestions. We expect the session to last approximately 45 minutes. Does this sound like something that interests you? Before I schedule you for a session, do you have a few moments to answer some questions? General Questions 1. Are you male or female? [Recruit a mix of participants] 2. Have you participated in a focus group or usability test in the past three months? [Note but do not terminate if yes] 3. Which of the following best describes your age? [25 or less; 26 to 39; 40 to 59; 60 to 74; 75 and older][Recruit a mix of ages] Enabledoc LLC ©2015 Confidential and Proprietary Version 1 12 Professional Demographics 4. What is your current position/role in your practice? 5. How long have you been in this role? 6. Do you currently perform e-prescribing? [computerized order entry, manage medication and medication allergy lists – pick appropriate for test][Terminate if no to specific task for test] How many prescriptions [or lab orders – use appropriate choice for test] do you write per day (or week if that is a better estimate)? 7. What year did you receive your medical degree? Computer Expertise 8. About how many hours per week do you spend on the computer that is medical practice related? [Recruit a range of use, e.g., 0 to 10, 11 to 25, 26+ hours per week][Terminate if less than 5] 9. Do you use a computer outside of your medical work? 10. If so, about how many hours per week do spend using a computer for non-work related endeavors? 11. Regarding your use of ADP Advancedmd Practice Manager & EHR, what percentage of time is spent in each product? (per day) Domain Knowledge · Rate your expertise or comfort in using ADP Advancedmd software on a scale of 1 to 5 (1=just starting, 5=expert) for § PM § EHR (overall) § EHR e-Prescribing [Terminate if 1 or 2] · If you have used similar or competing products, describe your level of expertise in those products [it is not necessary to name the product(s) unless they want to]. Contact Information [If the person matches your qualifications, ask for any info we do not have] May I have your contact information? · Name of participant: · Office Key: · Best phone number: · Email address: Those are all the questions I have for you. Your background matches the people we're looking for. Would you be able to participate on [date, time]? Alternative: select from a list of sessions [ideal approach] Alternative; What would be the best date and time for you? Before your session starts, we will ask you to verbally acknowledge a release form allowing us to record Enabledoc LLC ©2015 Confidential and Proprietary Version 1 13 your session. The recording will only be used internally for further study if needed and will never be used for advertising or marketing purposes. Also, you will not be personally identified with any recording. Will you consent to be recorded? [Terminate if no] This study will take place remotely via conferencing software, allowing you to participate in the session at the place of your choosing. I will confirm your appointment a couple of days before your session and provide you with any additional information. What is the best time to contact you? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 14 Appendix 2: PARTICIPANT DEMOGRAPHICS Following is a high-level overview of the participants in this study. Gender Men Women Total (participants) 2 5 7 Occupationan/Role RN/NP/MA Physician Total (participants) 4 3 7 Years of Experience (average) Professional EHR Product Use 23.71 2.86 Demographic detail Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Age Occupation / role 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Enabledoc LLC ©2015 Confidential and Proprietary Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Version 1 Product Experience (yrs) 3 3 4 3 3 3 1 15 Appendix 3: Informed Consent Form Enabledoc would like to thank you for participating in this study. The purpose of this study is to evaluate an electronic health records system. If you decide to participate, you will be asked to perform several tasks using the prototype and give your feedback. The study will last up to 60 minutes. Agreement I understand and agree that as a voluntary participant in the present study conducted by Enabledoc. I am free to withdraw consent or discontinue participation at any time. I understand and agree to participate in the study conducted by Enabledoc. I understand and consent to the use and release of the recording by Enabledoc. I understand that the information and recording is for research purposes only and that my name and image will not be used for any purpose other than research. I relinquish any rights to the recording and understand the recording may be copied and used by Enabledoc without further permission. I understand and agree that the purpose of this study is to make software applications more useful and usable in the future. I understand and agree that the data collected from this study will not be shared outside of Enabledoc I understand and agree that data confidentiality is assured, because only de-identified data – i.e., identification numbers not names – will be used in analysis and reporting of the results. I agree to immediately raise any concerns or areas of discomfort with the study administrator. I understand that I can leave at any time. Please check or verbally indicate one of the following: YES, I have read the above statement and agree to be a participant. NO, I choose not to participate in this study. Signature: _____________________________________ Date: ____________________ Enabledoc LLC ©2015 Confidential and Proprietary Version 1 16 Appendix 4: Task Scenarios Usability Task Scenarios – Medication Allergies Access the clinical information for Garth Brooks by clicking Patient Center, then click Open Note and perform these steps: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Click Allergies and select Sulfasalazine. Select wheezing. Select moderate severity and click Save. Review interaction guidance and click Close. Select Penicillin V. Select Dizziness. Select Severe and click Save. Select Carbamazepine. Select Rash. Select moderate and click Save. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 Modify medication allergies by performing these steps: 1. Click edit next to Penicillin V. 2. Select Penicillin G and click Save. 3. Click X next to Penicillin V. 4. Type wrong med and click Make inactive. 5. Click edit next to Carbamazepine. 6. Select Codeine and click Save. 7. Click X next to Carbamazepine. 8. Type wrong med and click Make inactive. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 View medication allergies history by performing these steps: 1. Click Allergy History. Overall, how difficult or easy did you find this task? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 17 Very Difficult 1 Very Easy 2 3 4 5 Appendix 5: Usability Test Administration Moderator’s Guide 1. Items often forgotten a. Stop watch for recording time on task b. Elapsed time timer to time code observations/comments in the recording 2. Office Key Setup a. Environment b. Obtain copy of user key database if required for test c. Any required feature access d. Create and enter any necessary test data e. Create Database / Office Key snapshot 3. Schedule Join.Me sessions 4. Schedule participants 5. Supply test participants with materials prior to test a. Join.Me access b. Task scenarios (be prepared to resend at the start of the test – do not assume the participant has multiple monitors, so they may also need to print the scenarios) c. Informed consent form (can be done verbally during the session) 6. Set up administrative / test PC a. Join.Me installed and up to date b. Shut down all programs not needed for the test – remember things like Communicator c. Turn off notifications – audible and screen – on any software that may be running during the test (e.g.: Outlook) d. Ensure the application installed and functional 7. Running a test session a. Ensure office key/database snapshot of base data exists b. Start EHR session on test PC and arrive at starting screen for test c. Select first patient if selection is not part of the task scenario d. Start Join.Me session e. Share appropriate screen f. Greet user g. Administer introductory materials to user (see below, following checklist) h. Start Join.Me recording i. Display informed consent form on shared screen j. Obtain consent via verbal acceptance k. Give mouse and keyboard control to ALL l. Have user work through tasks m. For each task, record i. Time on task Enabledoc LLC ©2015 Confidential and Proprietary Version 1 18 ii. Critical errors (anything that constitutes task failure) iii. Minor errors (anything the user detects and recovers) iv. Deviation(s) from optimal path v. Interesting comments (try to include recording time stamp for reference) n. After each task or task set (see specific scenarios) ask for response to single ease of use question o. Allow verbal response to any questions contained in task scenarios p. At end of all tasks, display SUS questionnaire and have the participant place an X in appropriate response to each statement i. Save SUS with participant code as part of file name q. Conduct debrief to solicit any additional feedback, comments, Q&A, etc Thank you for participating in this study. Your input is very important. Our session today will last about 55 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screenshots of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 19 Appendix 6: Sample data collection form Summative Usability Test Data Log Test type: Participant: Participant code: Session Date/start time: File name: Task 1: Critical Error count: Minor error count: Optimal path deviations: Time on task: SEoUQ response: Comments/observations: <repeat for each task> Enabledoc LLC ©2015 Confidential and Proprietary Version 1 20 Appendix 7: System Usability Scale Questionnaire In 1996, Brooke published a “low-cost usability scale that can be used for global assessments of systems usability” known as the System Usability Scale or SUS. Lewis and Sauro (2009) and others have elaborated on the SUS over the years. Computation of the SUS score can be found in Brooke’s paper, at http://www.usabilitynet.org/trump/documents/Suschapt.doc or in Tullis and Albert (2008). Strongly Disagree 1. I think that I would like to use this system frequently Strongly agree 1 2 3 4 Strongly Disagree 5 Strongly agree 2. I found the system necessarily complex 1 2 3 4 5 1 2 3 4 5 3. I thought the system was easy to use 4. I think that I would need the support of a technical person to be able to use this system 5. I found the various functions in this system were well integrated 6. I thought there was too much inconsistency in this system 7. I would imagine that most people would learn to use this system very quickly 8. I found the system very cumbersome to use Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 Version 1 21 9. I felt very confident using the system 10. I needed to learn a lot of things before I could get going with this system Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 Version 1 22 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 23 EHR Usability Test Report of Enablemyhealth EHR Clinical Information Reconciliation Safety-Enhanced Design 170.314(g)(3) Report based on ISO/IEC 25062:2006 Common Industry Format for Usability Test Reports Date of Usability Test: 15 AUG 2015 – 14 SEP 2015 Date of Report: 14 SEP 2015 Report Prepared By: Stephen Rothschild 877.540.0933 steve@enabledoc.com EnableDoc LLC 7700 Falstaff Road McLean VA 22104 Table of Contents 1 Executive Summary ............................................................................................................................... 2 2 INTRODUCTION ..................................................................................................................................... 3 3 METHOD................................................................................................................................................ 4 4 5 3.1 PARTICIPANTS ............................................................................................................................... 4 3.2 STUDY DESIGN............................................................................................................................... 5 3.3 TASKS............................................................................................................................................. 6 3.4 TEST LOCATION ............................................................................................................................. 7 3.5 TEST ENVIRONMENT ..................................................................................................................... 7 3.6 TEST FORMS AND TOOLS .............................................................................................................. 7 3.7 PARTICIPANT INSTRUCTIONS ........................................................................................................ 8 3.8 USABILITY METRICS ....................................................................................................................... 9 3.9 DATA SCORING .............................................................................................................................. 9 RESULTS .............................................................................................................................................. 11 4.1 DATA ANALYSIS AND REPORTING ............................................................................................... 11 4.2 DISCUSSION OF THE FINDINGS ................................................................................................... 11 4.3 EFFECTIVENESS ........................................................................................................................... 12 4.4 EFFICIENCY .................................................................................................................................. 12 4.5 SATISFACTION ............................................................................................................................. 12 4.6 MAJOR FINDINGS ........................................................................................................................ 12 4.7 AREAS FOR IMPROVEMENT ........................................................................................................ 13 APPENDICES ........................................................................................................................................ 14 Appendix 1: PARTICIPANT RECRUITING SCREENER ................................................................................ 15 Appendix 2: PARTICIPANT DEMOGRAPHICS ........................................................................................... 17 Appendix 3: Informed Consent Form...................................................................................................... 18 Appendix 4: Task Scenarios ..................................................................................................................... 19 Appendix 5: Usability Test Administration Moderator’s Guide .............................................................. 20 Appendix 6: Sample data collection form ............................................................................................... 23 Appendix 7: System Usability Scale Questionnaire ................................................................................ 24 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 1 1 Executive Summary A usability test of EnableMyHealth – 2014.1, an ambulatory EHR, was conducted on 15 Aug 2015 – 14 Sep 2015 in the McLean, VA and Rochester MN offices of EnableDoc LLC. The purpose of this test was to test and validate the usability of the current user interface for Clinical Information Reconciliation (CIR), and provide evidence of usability in the EHR Under Test (EHRUT). During the usability test, four healthcare providers and clinical staff matching the target demographic criteria served as participants and used Enablemyhealth EHR in simulated, but representative tasks. This study collected performance data on two Clinical Information Reconciliation tasks that enable accepting and merging incoming clinical information obtained from an external provider for a new or existing patient. In these tasks, an EHR user is required to: · · Locate the reconciliation feature, identify the correct incoming clinical record, and match the incoming record to the correct patient, if not properly mapped. Reconcile current medications, allergies and problem from current patient and CDA, then import and verify. All test participants conducted the test sessions remotely via on-line conferencing software. During the 15 minute one-on-one usability test, each participant was greeted by the administrator and asked to review and verbally acknowledge an informed consent/release form (included in Appendix 3); they were instructed that they could withdraw at any time. Participants had prior experience with the EHR as they are current users/customers. Participants had prior experience with the EHR as they are current customers with an average of 2.85 years of use. No additional training materials were provided other than that usually given to customers. The administrator introduced the test and instructed participants to complete a series of tasks (given one at a time) using Enablemyhealth. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. Participant screens and audio were recorded for subsequent analysis. The following types of data were collected for each participant: • Number of tasks successfully completed within the allotted time without assistance • Time to complete the tasks • Participant’s subjective assessment of the ease of each task • Number and types of errors • Path deviations • Participant’s verbalizations • Participant’s satisfaction ratings of the system All participant data was de-identified – no correspondence could be made from the identity of the participant to the data collected. Following the conclusion of the testing, participants were asked to complete a post-test questionnaire and were compensated with one $50 gift card as a gift for their participation. Following the conclusion of the testing, participants were asked to complete a post-test SUS questionnaire. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 2 Various recommended metrics, in accordance with the examples set forth in the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, were used to evaluate the usability of the EHRUT. Result data matrix - refer to Appendix 4 for complete task descriptions: TASKS Find CDA and check or map to patient Reconcile current medications, allergies, and problems list Number Errors Mean (SD) Task Ratings 5=Easy Mean (SD) Path Deviations (Observed / Optimal) Task Time Mean (SD) Task Time Deviations (Observed / Optimal) 1 100.00 1.15 (4.6/4) 22.6 (1.8) 1.1 (22.6/20) 1.86 (1.1) 4.6 (0.5) 1 100.00 1.18 (4.7/4) 12.3 (1.8) 1.2 (12.3/10) 0.57 (0.7) 4.7 (0.5) Task Succes s The results from the System Usability Scale scored the subjective satisfaction with the system based on performance with these tasks to be: 83.6. In addition to the performance data, the following qualitative observations were made: Every participant found the process of reconciling to be very easy and completed the process very quickly, but there is always room for improvement. The major usability difficulties encountered were: · · · 2 Knowing how to select individual medications, allergies or problems or all in each category appeared to be most confusing. Selecting an encounter was also confusing. One user clicked import by accident prior to being completed and went back and imported the rest. INTRODUCTION The EHRUT tested for this study was EnableMyHealth EHR4 Release, an ambulatory EHR. Designed to present medical information to healthcare providers in primarily group practices with a focus on family practice, surgery, eye, and PT/OT/Chiropractic medicine, the EHRUT consists of modules and features that include but not limited to support for: · Patient demographics · Patient problem and allergy lists · Patient encounter notes and charts · Patient clinical documents · Creating lab orders and receiving lab results · Growth charting · Immunization recording Enabledoc LLC ©2015 Confidential and Proprietary Version 1 3 · · · · · Electronic prescribing Drug-drug, drug-allergy, and drug-problem interaction checking Clinical decision support Quality reporting Patient population reporting The EHRUT is used predominantly by physicians and clinical staff such as MA’s, RN’s, LPN’s, etc. The usability testing attempted to represent realistic exercises and conditions. The purpose of this study was to test and validate the usability of the current user interface, and provide evidence of usability of the entry and modification of electronic prescriptions, laboratory orders, and imaging orders in the EHR Under Test (EHRUT).To this end, measures of effectiveness, efficiency and user satisfaction, such as successful task completion rate, time on task, number and types of errors, and participant satisfaction were captured during the usability testing. 3 3.1 METHOD PARTICIPANTS A total of 7 participants were tested on the CPOE feature of the EHRUT. Participants in the test were physicians and clinical staff such as RNs and MAs. Participants were recruited by Enabledoc staff from existing customers and paid a $50 gift card for their help in testing. Participants had no direct connection to the development of or organization producing the EHRUT other than being current customers. Participants were not from the testing or supplier organization. Participants were actual end users and thus have the same orientation and level of training as other non-participant customers. For the test purposes, end-user characteristics were identified and translated into an internal recruitment screener used to solicit potential participants; an example of a screener is provided in Appendix [1]. Recruited participants had a mix of backgrounds and demographic characteristics conforming to the recruitment screener. The following is a table of participants by characteristics, including demographics, professional experience, computing experience and user needs for assistive technology. Participant names were replaced with Participant IDs so that an individual’s data cannot be tied back to individual identities. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 4 Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Age Occupation / role 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Product Experience (yrs) 3 3 4 3 3 3 1 Seven (7) participants (matching the demographics in the section on Participants) were recruited and all participated in the usability test. 3); they were instructed that they could withdraw at any time. Participants all had prior experience with the EHR. No participants failed to show for the study. Participants were scheduled for150 minute sessions with 30 minutes in between each session for debrief by the administrator and data logger, and to reset systems to proper test conditions. All testing was performed over several days to allow the participants to schedule time at their convenience. A spreadsheet was used to keep track of the participant schedule. The administrator introduced the test, and instructed participants to complete a series of tasks (given one at a time) using the EHRUT. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. 3.2 STUDY DESIGN The objective of this test was to perform summative testing to measure the key usability metrics of effectiveness, efficiency, and user satisfaction. These metrics will uncover areas where the application performed well and areas where the application failed to meet the needs of the participants in achieving our internal usability goals. The data from this test may serve as a baseline for future tests with an updated version of the same EHR and/or comparison with other EHRs provided the same tasks are used. In short, this testing serves as both a means to record or benchmark current usability, but also to identify areas where improvements should be made. During the usability test, participants interacted exclusively with the EHRUT. Each participant used the system in their preferred location, and was provided with the same instructions. All sessions were conducted remotely with Join.Me conferencing software. Screens with associated interaction and the audio stream were recorded for later analysis. The system was evaluated for effectiveness, efficiency and satisfaction as defined by measures collected and analyzed for each participant: · · Number of tasks successfully completed within the allotted time without assistance Time to complete the tasks Enabledoc LLC ©2015 Confidential and Proprietary Version 1 5 · · · · Number and types of errors Path deviations Participant’s verbalizations (comments) Participant’s satisfaction ratings of the system Additional information about the various measures can be found in Section 3.9 on Usability Metrics. 3.3 TASKS Tasks were constructed that would be realistic and representative of the kinds of activities a user might do with this EHR in the area of Clinical Information Reconciliation of incoming clinical data and heavily based on the CMS test scripts for Meaningful Use Phase 2. The tasks for this study broadly included: · · Locate the reconciliation feature, identify the correct incoming clinical record, and verify patient is matched to the correct patient. Select the correct medications, allergies, and problems for that patient’s clinical record and click import. Task Selection and Priority Tasks were selected based on their frequency of use, criticality of function, and those that may be most troublesome for users. The tasks were directly modeled on the CMS Clinical Information Reconciliation test procedure [170.314(b)(4)]. Tasks were ordered and prioritized based on their impact on patient safety, in which the tasks that had the greatest potential for patient harm due to critical errors were performed first. CIR of patient records are accomplished with the use of the new “Incoming CDA” tool. The interactions to reconcile clinical information from the patient’s active medication list, active medication allergy list, and problem list are identical and all are included within the Wizard interaction sequence. Therefore, reconciliation of the individual areas was not broken out into separate tasks. Results can be generalized across these list types. These tasks assessed if and how the clinician participants reacted to the intervention alerts. In conjunction with this usability study were tasks relating to Clinical Decision Support. The results of that study are described in a separate report and not included here. The seven tasks of that study are included in the task scenario document contained in appendix 4 but are irrelevant to this report. During the time a participant was scheduled, an email was sent to the participant that: • Confirmed the time of the session • Provided Join.Me access codes • A copy of the informed consent form • A document containing the tasks for the test session Just prior to the scheduled time, the test administrator started the join.me session and greeted the participant on arrival; their identity was verified and matched with a name on the participant schedule. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 6 Participants were then assigned a participant ID. Recording of the session was started using the join.me recording feature. Each participant reviewed and agreed to the informed consent and release form via verbal acknowledgment (See Appendix 3). A representative from the test team witnessed the participant’s verbal agreement. To ensure that the test ran smoothly, testing was performed remotely by an experienced usability practitioner with over 25 years of experience in healthcare user interface and workflow design. The administrator moderated the session including administering instructions and tasks. The administrator also monitored task times, obtained post-task rating data, took notes on participant comments, path deviations, number and type of errors, and comments. Participants were instructed to perform the tasks (see specific instructions below): · · · As quickly as possible making as few errors and deviations as possible. Without assistance; administrators were allowed to give immaterial guidance and clarification on tasks, but not instructions on use. Without using a think aloud technique. For each session, the participants were given an electronic copy of the tasks for that session. They were requested to not read the tasks prior to the session. Participants were asked to read the task aloud prior to each task; task timing began once the participant finished reading the question and verbally indicated they were starting the task. The task time was stopped once the participant indicated they had successfully completed the task. Scoring is discussed below in Section 3.9. Following the session, the administrator gave the participant the post-test questionnaire (the System Usability Scale, see Appendix 7), solicited any further comments, and thanked each individual for their participation. Participants' demographic information, task success rate, time on task, errors, deviations, verbal responses, and post-test questionnaire were recorded into a spreadsheet. 3.4 TEST LOCATION 3.5 TEST ENVIRONMENT The test was conducted remotely through the use of Join.Me virtual conferencing and screen sharing software. Thus the actual test location was at the discretion of the test participants. The test administrator conducted the test from Enabledoc LLC offices in Rochester MN. The EHRUT would be typically be used in a healthcare office or facility. In this instance, the testing was conducted in healthcare office. For testing, the computer used a Windows laptop running Windows OS and Chrome browser. The participants used a mouse and keyboard when interacting with the EHRUT. The Enablemyhealth application was used on a 13 inch laptop with 1366 by 768 resolution and 32 bit color. The application was set up by the vendor according to the vendor’s documentation describing the Enabledoc LLC ©2015 Confidential and Proprietary Version 1 7 system set-up and preparation. The application itself was running on a Windows 2012 Server using a test database on a WAN connection. Technically, the system performance (i.e., response time) was representative to what actual users would experience in a field implementation with a minor lag caused by video screen sharing and recording. Additionally, participants were instructed not to change any of the default system settings (such as control of font size). 3.6 TEST FORMS AND TOOLS During the usability test, various documents and instruments were used, including: · · · · · Informed Consent Test task scenarios Moderator’s Guide Observer’s data collection template Post-test SUS Questionnaire Examples of these documents can be found in Appendices 3 – 7 respectively. The participant’s interaction with the EHRUT was captured and recorded digitally using the screen recording capability of join.me running on the test machine. This recording included the audio stream of verbalizations. The test sessions were electronically transmitted to any additional observers who logged into the join.me session. 3.7 PARTICIPANT INSTRUCTIONS The administrator reads the following instructions aloud to the each participant (also see the full moderator’s guide in Appendix 5): Thank you for participating in this study. Your input is very important. Our session today will last about 15 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screen interaction of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. In today’s session, we will be using some new features that are currently being developed. Let’s go over those now so you will have some familiarity. The first new feature is called the Infobutton, denoted by a small blue “i” icon that appears as necessary to provide additional clinical information. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 8 The second new feature is a tool to retrieve incoming clinical information for a patient that is sent electronically from another provider outside your practice. This tool is to resolve discrepancies or duplicate information between the incoming record and the clinical record that is in your EHR. [important: only ask the following question if they indicated that they review/read release notes, view training videos, etc. based on their earlier answer regarding how they find out about new features and how to use them. Be ready to display the help file.] Would you like to review the help topic for these features now? Following the procedural instructions, participants were started with a specific patient’s chart data. Prior to giving the participant mouse and keyboard control, the moderator gave the following instructions: For each task, I will ask you to read the task and indicate when you begin. At that point, please perform the task and say “Done” once you believe you have successfully completed the task. I would like to request that you not talk aloud or verbalize while you are doing the tasks. You may certainly ask questions if necessary and we may provide guidance or a hint, however we will not provide direct instruction during the tasks. I will ask you your impressions about the task once you are done. Participants were then given 4 tasks to complete. Tasks are listed in Appendix 4. 3.8 USABILITY METRICS According to the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, EHRs should support a process that provides a high level of usability for all users. The goal is for users to interact with the system effectively, efficiently, and with an acceptable level of satisfaction. To this end, metrics for effectiveness, efficiency and user satisfaction were captured during the usability testing. The goals of the test were to assess: 1. Effectiveness of ENABLEMYHEALTH EHR by measuring participant success rates and errors 2. Efficiency of ENABLEMYHEALTH EHR by measuring the average task time and path deviations 3. Satisfaction with ENABLEMYHEALTH EHR by measuring ease of use ratings 3.9 DATA SCORING The following table details how tasks were scored, errors evaluated, and the time data analyzed. Rationale and Scoring Measure Effectiveness: Task Success A task was counted as a “Success” if the participant was able to achieve the correct outcome, without assistance, within the overall time allotted for the entire set of tasks. The total number of successes were calculated for each task and then divided by the total number of times that task was attempted. The results are provided as a percentage. Task times were recorded for successes. Observed task times divided by the optimal time for each task is a measure of optimal efficiency. Due to the variability of multiple correct paths and a large variety of user settable Enabledoc LLC ©2015 Confidential and Proprietary Version 1 9 preferences, all of which can affect time on task, optimal task times and deviations from these times were unrealistic to assess. All participants were trained on Enablemyhealth EHR and so the performance factor of 1.0 was use. The overall usability goal for any feature of the EHR is task time that is deemed acceptable by the end user with no critical errors. Thus, if expert, optimal performance on a task was [60] seconds then allotted task time performance was [60 * 1.0] seconds. This ratio is aggregated across tasks and reported with mean and variance scores. Effectiveness: Task Failures Efficiency: Task Deviations If the participant abandoned the task, did not reach the correct answer, performed it incorrectly, or was unsure if they had completed the task, the task was counted as a “Critical Failure.” No task times were taken for failed tasks. Minor errors were defined as an errant click, initial selection of an incorrect menu option, or incorrect entries that the participant noticed and corrected. The total number of errors was calculated for each task and then divided by the total number of times that task was attempted. Minor errors and deviations were noted but not counted as significant errors. This is expressed as the mean number of failed tasks per participant. The participant’s path (i.e., steps) through the application was recorded. Deviations occur if the participant, for example, went to a wrong screen, clicked on an incorrect menu item, followed an incorrect link, or interacted incorrectly with an on-screen control. These path deviations were included in the minor error count. The minor error count is expressed as an average across all participants. Efficiency: Task Time Satisfaction: Task Rating Each task was timed from when the participant indicated they were beginning the task until the participant said “Done.” If he or she failed to say “Done,” the time was stopped when the participant stopped performing the task. Only task times for tasks that were successfully completed were included in the average task time analysis. Average time per task was calculated for each task as was variance (standard deviation). Participant’s subjective impression of the ease of use of the application was measured by administering both a simple post-task question as well as a post-session questionnaire. After each task, the participant was asked to rate “Overall, this task was:” on a scale of 1 (Very Difficult) to 7 (Very Easy). Average difficulty ratings per task were calculated as was variance. Common convention is that average ratings for systems judged easy to use should be 3.3 or above. To measure participants’ confidence in and likeability of the ENABLEMYHEALTH EHR feature overall, the testing team administered the System Usability Scale (SUS) post-test questionnaire. Questions included, “I think I would like to use this system frequently,” “I thought the system was easy to use,” and “I would imagine that most people would learn to use this Enabledoc LLC ©2015 Confidential and Proprietary Version 1 10 system very quickly.” See full System Usability Score questionnaire in Appendix 7. 4 4.1 RESULTS DATA ANALYSIS AND REPORTING The results of the usability test were calculated according to the methods specified in the Usability Metrics section above. Participants who failed to follow session and task instructions had their data excluded from the analyses, however there were no instances of this occurring. The usability testing results for the ENABLEMYHEALTH EHR are detailed below (Table [x]). The results should be seen in light of the objectives and goals outlined in Section 3.2 Study Design. The data should yield actionable results that, if corrected, yield material, positive impact on user performance. TASKS Find CDA and check or map to patient Reconcile current medications, allergies, and problems list Mean across tasks Number Errors Mean (SD) Task Ratings 5=Easy Mean (SD) Path Deviations (Observed / Optimal) Task Time Mean (SD) Task Time Deviations (Observed / Optimal) 1 100.00 1.15 (4.6/4) 22.6 (1.8) 1.1 (22.6/20) 1.86 (1.1) 4.6 (0.5) 1 100.00 1.18 (4.7/4) 12.3 (1.8) 1.2 (12.3/10) 0.57 (0.7) 4.7 (0.5) 100.00 1.16 (4.65/4) 17.45 (1.8) 1.2 (17.5/15) 1.2 (0.9) 4.7 (.5) Task Succes s The results from the SUS (System Usability Scale) scored the subjective satisfaction with the system based on performance with these tasks to be: 83.6. Broadly interpreted, this indicates above average usability, but with further room for improvement. 4.2 DISCUSSION OF THE FINDINGS Clinical Information Reconciliation is performed by using the “Import CDA” tool, which we call Referral. This feature allows: · Selection of an incoming clinical summary document from an external source. · Verifying or remapping the CDA to a patient in the EHRUT. · Ability to add a new patient and appointment. · Selecting the medications, medication allergies, and problems to consolidate into a patient’s clinical record. · A single click imports the data. · A single click opens the patient encounter/note. Since we implemented the CDA as a referral on the appointment calendar, it was easier for participants to understand how this feature worked. The automated mapping and use of one screen to reconcile Enabledoc LLC ©2015 Confidential and Proprietary Version 1 11 medications, allergies and problems made the entire process very easy to import. The minor error rate, which includes optimal path deviations, is acceptably low, with a consolidated mean of 1.2 and 0.9 standard deviation. The number of steps to perform all tasks is only 8. This can vary if individual medications, allergies and problems are selected instead of all, but we selected steps to add all since this is more a more common usage. The mean task difficulty was 4.6 out of a high of 5.0. Satisfaction, measured by an SUS score of 83.5 is very good. 4.3 EFFECTIVENESS Based on the success rate, minor error rate, and critical error rate data, the CIR has a high acceptable level of effectiveness after a short amount of training. We did not test use of this feature without training, but with only 8 steps the process is very easy. CIR exhibited 100% success with low error mean of 1.2 across all tasks. The usability test consisted of 2 tasks of which all 2 were successfully completed. One participant did not select all the problems because they inadvertently clicked import prior to being finished, so they then select the problems and reimported. 4.4 EFFICIENCY Observation of task time and minor errors, which include path deviations, indicates strong acceptance and efficiency. There is room for improvement by adding tool tips to provide more direction and show the patient and sending provider on the selection screen. The combined mean task time of 17.45 second with a standard deviation of 1.8 seconds, which is very close to the optimal time of 15 seconds to perform both tests. If more time is use to think about the medications, allergies and problems a patient has then the task time could increase substantially, but this is not on account of usability merely considering the implications of the information provided. 4.5 SATISFACTION Based on task difficulty ratings and SUS results data, user satisfaction of the feature is considered favorable. Users perception of ease of use is considered easy, with a mean rating of 4.04 across all tasks (1=very difficult, 5=very easy). SUS scoring is very good with a score of 83.6. These scores accurately describe the average patient satisfaction with Enablemyhealth feature set. SUS Scoring Mean StDev 4.6 83.57 5.80 MAJOR FINDINGS The major usability difficulties encountered were: · Knowing how to select individual medications, allergies or problems or all in each category appeared to be most confusing. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 12 · · 4.7 Participants were confused that they had to select an encounter to import the data into. One user clicked import by accident prior to being completed and went back and imported the rest. AREAS FOR IMPROVEMENT · · · · Display patient name and referring provider name on the table to make it easier to find CDA. Add Step text to help guide novice user. If Import button is clicked Ask first if user has selected the appropriate medications, allergies and problems to import. additional tool tips for more information and perhaps Make Open Encounter active only once import has been performed. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 13 5 APPENDICES The following appendices include supplemental data for this usability test report. Following is a list of the appendices provided: 1: Participant Recruiting Screener 2: Participant demographics 3: Informed Consent Form 4: Task Scenarios 5: Moderator’s Guide 6: Sample data collection form 7: System Usability Scale Questionnaire Enabledoc LLC ©2015 Confidential and Proprietary Version 1 14 Appendix 1: PARTICIPANT RECRUITING SCREENER Introduction Hello, my name is __. Enabledoc is seeking doctors and clinicians who are users of • Electronic prescribing software • Computerized order entry (such as labs and imaging) • Medication list and medication allergy list management to take part in a usability study of that portion of the EnableMyHealth EHR. This study will assist us in designing and developing a solution that meets your needs. Your experiences in using this particular design will greatly help our designers and developers. The testing of our design will take place in your office using remote meeting technology, requiring only your time, thoughts, and suggestions. We expect the session to last approximately 15 minutes. Does this sound like something that interests you? Before I schedule you for a session, do you have a few moments to answer some questions? General Questions 1. Are you male or female? [Recruit a mix of participants] 2. Have you participated in a focus group or usability test in the past three months? [Note but do not terminate if yes] 3. Which of the following best describes your age? [25 or less; 26 to 39; 40 to 59; 60 to 74; 75 and older][Recruit a mix of ages] Professional Demographics 4. What is your current position/role in your practice? 5. How long have you been in this role? 6. Do you currently perform e-prescribing? [computerized order entry, manage medication and medication allergy lists – pick appropriate for test][Terminate if no to specific task for test] How many prescriptions [or lab orders – use appropriate choice for test] do you write per day (or week if that is a better estimate)? 7. What year did you receive your medical degree? Computer Expertise 8. About how many hours per week do you spend on the computer that is medical practice related? [Recruit a range of use, e.g., 0 to 10, 11 to 25, 26+ hours per week][Terminate if less than 5] 9. Do you use a computer outside of your medical work? 10. If so, about how many hours per week do spend using a computer for non-work related endeavors? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 15 11. Regarding your use of EnableMyHealth Practice Manager & EHR, what percentage of time is spent in each product? (per day) Domain Knowledge · Rate your expertise or comfort in using EnableMyHealth software on a scale of 1 to 5 (1=just starting, 5=expert) for § PM § EHR (overall) § EHR e-Prescribing [Terminate if 1 or 2] · If you have used similar or competing products, describe your level of expertise in those products [it is not necessary to name the product(s) unless they want to]. Contact Information [If the person matches your qualifications, ask for any info we do not have] May I have your contact information? · Name of participant: · Office Key: · Best phone number: · Email address: Those are all the questions I have for you. Your background matches the people we're looking for. Would you be able to participate on [date, time]? Alternative: select from a list of sessions [ideal approach] Alternative; What would be the best date and time for you? Before your session starts, we will ask you to verbally acknowledge a release form allowing us to record your session. The recording will only be used internally for further study if needed and will never be used for advertising or marketing purposes. Also, you will not be personally identified with any recording. Will you consent to be recorded? [Terminate if no] This study will take place remotely via conferencing software, allowing you to participate in the session at the place of your choosing. I will confirm your appointment a couple of days before your session and provide you with any additional information. What is the best time to contact you? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 16 Appendix 2: PARTICIPANT DEMOGRAPHICS Following is a high-level overview of the participants in this study. Gender Men Women Total (participants) Occupationan/Role RN/NP/MA Physician Total (participants) Years of Experience (average) Professional EHR Product Use 2 5 7 4 3 7 23.71 2.86 Demographic detail Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Occupation / role Age 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Enabledoc LLC ©2015 Confidential and Proprietary Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Version 1 Product Experience (yrs) 3 3 4 3 3 3 1 17 Appendix 3: Informed Consent Form Enabledoc would like to thank you for participating in this study. The purpose of this study is to evaluate an electronic health records system. If you decide to participate, you will be asked to perform several tasks using the prototype and give your feedback. The study will last up to 60 minutes. Agreement I understand and agree that as a voluntary participant in the present study conducted by Enabledoc. I am free to withdraw consent or discontinue participation at any time. I understand and agree to participate in the study conducted by Enabledoc. I understand and consent to the use and release of the recording by Enabledoc. I understand that the information and recording is for research purposes only and that my name and image will not be used for any purpose other than research. I relinquish any rights to the recording and understand the recording may be copied and used by Enabledoc without further permission. I understand and agree that the purpose of this study is to make software applications more useful and usable in the future. I understand and agree that the data collected from this study will not be shared outside of Enabledoc I understand and agree that data confidentiality is assured, because only de-identified data – i.e., identification numbers not names – will be used in analysis and reporting of the results. I agree to immediately raise any concerns or areas of discomfort with the study administrator. I understand that I can leave at any time. Please check or verbally indicate one of the following: YES, I have read the above statement and agree to be a participant. NO, I choose not to participate in this study. Signature: _____________________________________ Date: ____________________ Enabledoc LLC ©2015 Confidential and Proprietary Version 1 18 Appendix 4: Task Scenarios Note: In conjunction with this usability study were tasks relating to Clinical Information Reconciliation. Usability Task Scenarios – Clinical Information Reconciliation Note: in all tasks, please complete only to the point where any new information is ready to be saved or signed. Please do not sign any prescriptions or perform the final completion step! 1. A new patient referral is received on the appointment calendar. The referring provider has electronically sent you this patient’s clinical information. Using a new feature, access this incoming patient’s information for Hilary Clinton. You realize you have already had receive a CDA for this patient from another provider that was already imported. Check that the system mapped to correct patient and select the encounter already created. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 2. The current medications in the system are displayed in the left list. The received medications appear in the center box. Click on the medications and the right arrow to add to the consolidated list or click the double right arrow to add all of them. Perform the same steps for allergies and problems, then click the Import Button. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 Enabledoc LLC ©2015 Confidential and Proprietary 4 Version 1 5 19 Appendix 5: Usability Test Administration Moderator’s Guide 1. Items often forgotten a. Stop watch for recording time on task b. Elapsed time timer to time code observations/comments in the recording 2. Office Key Setup a. Environment b. Obtain copy of user key database if required for test c. Any required feature access d. Create and enter any necessary test data e. Create Database / Office Key snapshot 3. Schedule Join.Me sessions 4. Schedule participants 5. Supply test participants with materials prior to test a. Join.Me access b. Task scenarios (be prepared to resend at the start of the test – do not assume the participant has multiple monitors, so they may also need to print the scenarios) c. Informed consent form (can be done verbally during the session) 6. Set up administrative / test PC a. Join.Me installed and up to date b. Shut down all programs not needed for the test – remember things like Communicator c. Turn off notifications – audible and screen – on any software that may be running during the test (e.g.: Outlook) d. Ensure the application installed and functional 7. Running a test session a. Ensure office key/database snapshot of base data exists b. Start EHR session on test PC and arrive at starting screen for test c. Select first patient if selection is not part of the task scenario d. Start Join.Me session e. Share appropriate screen f. Greet user g. Administer introductory materials to user (see below, following checklist) h. Start Join.Me recording i. Display informed consent form on shared screen j. Obtain consent via verbal acceptance k. Give mouse and keyboard control to ALL l. Have user work through tasks m. For each task, record i. Time on task ii. Critical errors (anything that constitutes task failure) iii. Minor errors (anything the user detects and recovers) iv. Deviation(s) from optimal path v. Interesting comments (try to include recording time stamp for reference) Enabledoc LLC ©2015 Confidential and Proprietary Version 1 20 n. After each task or task set (see specific scenarios) ask for response to single ease of use question o. Allow verbal response to any questions contained in task scenarios p. At end of all tasks, display SUS questionnaire and have the participant place an X in appropriate response to each statement i. Save SUS with participant code as part of file name q. Conduct debrief to solicit any additional feedback, comments, Q&A, etc. Thank you for participating in this study. Your input is very important. Our session today will last about 15 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screenshots of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. [Show informed consent document and get verbal acceptance] Do you have any questions or concerns before we begin? Let’s start with some basic information: What is your job title? How long have you been in this profession? What is your specialty? How long have you used the EHR? How do you learn about new features as they are added to the EHR? [if necessary, prompt about reading release notes, viewing training videos, using the help system, or do they just start using the feature] In today’s session, we will be using some new features that are currently being developed. Let’s go over those now so you will have some familiarity. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 21 The first new feature is called the Infobutton, denoted by a small blue “i” icon that appears as necessary to provide additional clinical information. The second new feature is a tool to retrieve incoming clinical information for a patient that is sent electronically from another provider outside your practice. This tool is to resolve discrepancies or duplicate information between the incoming record and the clinical record that is in your EHR. [important: only ask the following question if they indicated that they review/read release notes, view training videos, etc. based on their earlier answer regarding how they find out about new features and how to use them. Be ready to display the help file.] Would you like to review the help topic for this feature now? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 22 Appendix 6: Sample data collection form Summative Usability Test Data Log Test type: Participant: Participant code: Session Date/start time: File name: Task 1: · · · · · Critical Error count: Optimal path deviations (minor error): Time on task: SEoUQ response: Comments/observations: <repeat for each task> Enabledoc LLC ©2015 Confidential and Proprietary Version 1 23 Appendix 7: System Usability Scale Questionnaire In 1996, Brooke published a “low-cost usability scale that can be used for global assessments of systems usability” known as the System Usability Scale or SUS. Lewis and Sauro (2009) and others have elaborated on the SUS over the years. Computation of the SUS score can be found in Brooke’s paper, at http://www.usabilitynet.org/trump/documents/Suschapt.doc or in Tullis and Albert (2008). Strongly Disagree 1. I think that I would like to use this system frequently Strongly agree 1 2 3 4 Strongly Disagree 5 Strongly agree 2. I found the system unnecessarily complex 1 2 3 4 5 1 2 3 4 5 3. I thought the system was easy to use 4. I think that I would need the support of a technical person to be able to use this system 5. I found the various functions in this system were well integrated 6. I thought there was too much inconsistency in this system 7. I would imagine that most people would learn to use this system very quickly 8. I found the system very cumbersome to use Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 Version 1 24 9. I felt very confident using the system 10. I needed to learn a lot of things before I could get going with this system Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 Version 1 25 Usability Test Report of Enablemyhealth® EHR Safety Enhanced Design 93 Safety-Enhanced Design 170.314(g)(3) Report based on ISO/IEC 25062:2006 Common Industry Format for Usability Test Reports Date of Usability Test: 15 AUG 2015 – 14 SEP 2015 Date of Report: 14 SEP 2015 Report Prepared By: Stephen Rothschild 877.540.0933 steve@enabledoc.com EnableDoc LLC 7700 Falstaff Road McLean VA 22104 Table of Contents Table of Contents .......................................................................................................................................... 1 1 Executive Summary ............................................................................................................................... 2 2 INTRODUCTION ..................................................................................................................................... 4 3 METHOD................................................................................................................................................ 4 4 5 3.1 PARTICIPANTS ............................................................................................................................... 4 3.2 STUDY DESIGN............................................................................................................................... 5 3.3 TASKS............................................................................................................................................. 6 3.4 PROCEDURES................................................................................................................................. 6 3.5 TEST LOCATION ............................................................................................................................. 7 3.6 TEST ENVIRONMENT ..................................................................................................................... 7 3.7 TEST FORMS AND TOOLS .............................................................................................................. 8 3.8 PARTICIPANT INSTRUCTIONS ........................................................................................................ 8 3.9 USABILITY METRICS ....................................................................................................................... 9 3.10 DATA SCORING .............................................................................................................................. 9 RESULTS .............................................................................................................................................. 11 4.1 DATA ANALYSIS AND REPORTING ............................................................................................... 11 4.2 DISCUSSION OF THE FINDINGS ................................................................................................... 11 4.3 EFFECTIVENESS ........................................................................................................................... 12 4.4 EFFICIENCY .................................................................................................................................. 12 4.5 SATISFACTION ............................................................................................................................. 13 4.6 MAJOR FINDINGS ........................................................................................................................ 13 4.7 AREAS FOR IMPROVEMENT ........................................................................................................ 14 APPENDICES ........................................................................................................................................ 14 Appendix 1: PARTICIPANT RECRUITING SCREENER ................................................................................ 15 Appendix 2: PARTICIPANT DEMOGRAPHICS ........................................................................................... 17 Appendix 3: Informed Consent Form...................................................................................................... 18 Appendix 4: Task Scenarios ..................................................................................................................... 19 Appendix 5: Usability Test Administration Moderator’s Guide .............................................................. 22 Appendix 6: Sample data collection form ............................................................................................... 24 Appendix 7: System Usability Scale Questionnaire ................................................................................ 25 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 1 1 Executive Summary A usability test of EnableMyHealth version EMH4, an ambulatory EHR, was conducted between August 15, 2015 and September 14, 2015 in the Rochester MN. office of EnableDoc LLC, and each providers offices. The purpose of this test was to test and validate the usability of the current user interface for Computerized Provider Order Entry, and provide evidence of usability in the EHR Under Test (EHRUT). During the usability test, seven (7) healthcare providers and clinical staff that meet the target demographic and professional profile serve as participants and used Enablemyhealth EHR in simulated, but representative tasks. This study collected performance data on the following these four tasks typically conducted in an EHR: • Prescription entry and modifying prescriptions • Entry and modification of laboratory orders • Entry and modification of imaging orders • View prior orders All test participants conducted the test sessions remotely via on-line conferencing software. During the 30 minute one-on-one usability test, each participant was greeted by the administrator and asked to review and verbally acknowledge an informed consent/release form (included in Appendix 3); they were instructed that they could withdraw at any time. Participants had prior experience with the EHR as they are current users/customers. No additional training materials were provided other than that usually given to customers. The administrator introduced the test and instructed participants to complete a series of tasks (given one at a time) using Enablemyhealth. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. Participant screens and audio were recorded for subsequent analysis. The following types of data were collected for each participant: • Number of tasks successfully completed within the allotted time without assistance • Time to complete the tasks • Participant’s subjective assessment of the ease of each task • Number and types of errors • Path deviations • Participant’s verbalizations • Participant’s satisfaction ratings of the system All participant data was de-identified – no correspondence could be made from the identity of the participant to the data collected. Following the conclusion of the testing, participants were asked to complete a post-test questionnaire and were compensated with a $50 gift card for their time. Following the conclusion of the testing, participants were asked to complete a post-test SUS questionnaire. Various recommended metrics, in accordance with the examples set forth in the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, were used to evaluate the usability of the EHRUT. Result data matrix - refer to Appendix 4 for complete task descriptions Enabledoc LLC ©2015 Confidential and Proprietary Version 1 2 MEASURES TASKS Path Deviations Task (Observed / Number Success Optimal) Task Time Mean (SD) Task Time Task Deviations Ratings 5=Easy (Observed / Errors Optimal) Mean (SD) Mean (SD) Create 3 RX 3 100.00 1.06 (31.8/30) 117 (16.7) 1.3 (117/90) 1.86 (1.1) 3.7 (0.5) Create 3 Lab orders Create 2 imaging orders Modify Rx Modify lab order Modify image order View imaging order View prior Rx 3 2 1 1 1 1 1 100.00 1.05 (11.57/11) 100.00 1.05 (8.43/8) 100.00 1.04 (13.57/13) 100.00 1.05 (8.43/8) 100.00 1.00 (8/8) 100.00 1.05 (3.14/3) 100.00 1.00 (3/3) 75 (19) 44 (10.7) 32 (7.5) 36 (7.2) 32 (6.1) 13 (1.3) 12 (1.3) 1.4 (75/55) 1.5 (44/55) 1.1 (32/30) 1.4 (36/25) 1.3 (32/25) 1.3 (13/10) 1.2 (12/10) 0.57 (0.7) 0.43(0.7) 0.57(0.7) 0.43 (0.7) 0 (0) 0.14 (0.4) 0 (0) 4.1 (0.6) 4.6 (0.5) 3.6 (0.5) 3.9 (0.6) 4.1 (0.4) 4.1 (0.4) 4.1 (0.4) The results from the System Usability Scale scored the subjective satisfaction with the system based on performance with these tasks to be: 80 In addition to the performance data, the following qualitative observations were made: - Major findings Electronic prescribing difficulties: · · · · Providers tend to just want to write or dictate the script rather then select a frequency of use Medications other than tablets (e.g.: injectables, inhalers) presented the most serious challenges Most frequent challenge was determining units of medication when none is defaulted. Changing a prescription frequency of use was not easily understood and preference is just to modify the script directions Lab and imaging order difficulties: · · · Lab orders can be confusing because the descriptions and codes are specific to the lab company. These can be modified to improve usability. The user is required to know the structure/set-up to avoid excessive and confusing searching. Lab orders are associated with a lab order company. Further, groups of lab orders can be set up as lab order sets to simplify the process further. Search is not global across all lab companies, which would prevent having to select the lab. The lab name would need to be appended to the lab order filter. - Areas for improvement Electronic prescribing: · · · · Add default units for all prescriptions Provide aids in recommended dosage based on patient BSA, age, gender, and diagnosis. Provide ability to type or speak script and parse data to build the prescription script. Add a wizard for first time or novice users. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 3 Lab and imaging orders: · · · 2 Allow search for labs across lab companies with the lab company listed on the test order. Add a wizard for first time use or novice users. Add support for speech recognition searching INTRODUCTION The EHRUT tested for this study was EnableMyHealth EHR4 Release, an ambulatory EHR. Designed to present medical information to healthcare providers in primarily group practices with a focus on family practice, surgery, eye, and PT/OT/Chiropractic medicine, the EHRUT consists of modules and features that include but not limited to support for tested functionality: · Patient demographics · Patient problem and allergy lists · Creating lab orders and receiving lab results · Immunization recording · Electronic prescribing · Drug-drug, drug-allergy, and drug-problem interaction checking · Clinical decision support The EHRUT is used predominantly by physicians and clinical staff such as MA’s, RN’s, LPN’s, etc. The usability testing attempted to represent realistic exercises and conditions. The purpose of this study was to test and validate the usability of the current user interface, and provide evidence of usability of the entry and modification of electronic prescriptions, laboratory orders, and imaging orders in the EHR Under Test (EHRUT).To this end, measures of effectiveness, efficiency and user satisfaction, such as successful task completion rate, time on task, number and types of errors, and participant satisfaction were captured during the usability testing. 3 3.1 METHOD PARTICIPANTS A total of 7 participants were tested on the CPOE feature of the EHRUT. Participants in the test were physicians and clinical staff such as RNs and MAs. Participants were recruited by Enabledoc staff from existing customers and paid a $50 gift card for their help in testing. Participants had no direct connection to the development of or organization producing the EHRUT other than being current customers. Participants were not from the testing or supplier organization. Participants were actual end users and thus have the same orientation and level of training as other non-participant customers. For the test purposes, end-user characteristics were identified and translated into an internal recruitment screener used to solicit potential participants; an example of a screener is provided in Appendix [1]. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 4 Recruited participants had a mix of backgrounds and demographic characteristics conforming to the recruitment screener. The following is a table of participants by characteristics, including demographics, professional experience, computing experience and user needs for assistive technology. Participant names were replaced with Participant IDs so that an individual’s data cannot be tied back to individual identities. Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Occupation / role Age 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Product Experience (yrs) 3 3 4 3 3 3 1 Seven (7) participants (matching the demographics in the section on Participants) were recruited and all participated in the usability test. 3); they were instructed that they could withdraw at any time. Participants all had prior experience with the EHR. No participants failed to show for the study. Participants were scheduled for 30 minute sessions with 30 minutes in between each session for debrief by the administrator and data logger, and to reset systems to proper test conditions. All testing was performed over several days to allow the participants to schedule time at their convenience. A spreadsheet was used to keep track of the participant schedule. The administrator introduced the test, and instructed participants to complete a series of tasks (given one at a time) using the EHRUT. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. 3.2 STUDY DESIGN The objective of this test was to perform summative testing to measure the key usability metrics of effectiveness, efficiency, and user satisfaction. These metrics will uncover areas where the application performed well and areas where the application failed to meet the needs of the participants in achieving our internal usability goals. The data from this test may serve as a baseline for future tests with an updated version of the same EHR and/or comparison with other EHRs provided the same tasks are used. In short, this testing serves as both a means to record or benchmark current usability, but also to identify areas where improvements should be made. During the usability test, participants interacted exclusively with the EHRUT. Each participant used the system in their preferred location, and was provided with the same instructions. All sessions were Enabledoc LLC ©2015 Confidential and Proprietary Version 1 5 conducted remotely with Join.Me conferencing software. Screens with associated interaction and the audio stream were recorded for later analysis. The system was evaluated for effectiveness, efficiency and satisfaction as defined by measures collected and analyzed for each participant: • Number of tasks successfully completed within the allotted time without assistance • Time to complete the tasks • Number and types of errors • Path deviations • Participant’s verbalizations (comments) • Participant’s satisfaction ratings of the system Additional information about the various measures can be found in Section 3.9 on Usability Metrics. 3.3 TASKS Tasks were constructed that would be realistic and representative of the kinds of activities a user might do with this EHR in the area of CPOE and based on the CMS test scripts for Meaningful Use Phase 2. The tasks for this study broadly included: 1. Create 3 prescriptions 2. Create 3 lab orders 3. Create 2 imaging orders 4. Modify a prescription 5. Modify a lab order 6. Modify an image order 7. View an lab and an imaging order 8. View a prior prescription Task Selection and Priority Tasks were selected based on their frequency of use, criticality of function, and those that may be most troublesome for users. The tasks were directly modeled on the CMS CPOE test procedure [170.314(a)(1)]. Tasks were ordered and prioritized based on their impact on patient safety, in which the tasks that had the greatest potential for patient harm due to critical errors were performed first. Thus the creation tasks of prescriptions and lab orders were done first, followed by prescription and lab order modifications, and finally viewing orders and prescriptions. The task scenario document is contained in appendix 4. 3.4 PROCEDURES During the time a participant was scheduled, an email was sent to the participant that: • Confirmed the time of the session • Provided Join.Me access codes • A copy of the informed consent form • A document containing the tasks for the test session Enabledoc LLC ©2015 Confidential and Proprietary Version 1 6 Just prior to the scheduled time, the test administrator started the join.me session and greeted the participant on arrival; their identity was verified and matched with a name on the participant schedule. Participants were then assigned a participant ID. Recording of the session was started using the join.me recording feature. Each participant reviewed and agreed to the informed consent and release form via verbal acknowledgment (See Appendix 3). A representative from the test team witnessed the participant’s verbal agreement. To ensure that the test ran smoothly, testing was performed remotely by an experienced usability practitioner with over 25 years of experience in healthcare user interface and workflow design. The administrator moderated the session including administering instructions and tasks. The administrator also monitored task times, obtained post-task rating data, took notes on participant comments, path deviations, number and type of errors, and comments. Participants were instructed to perform the tasks (see specific instructions below): · · · As quickly as possible making as few errors and deviations as possible. Without assistance; administrators were allowed to give immaterial guidance and clarification on tasks, but not instructions on use. Without using a think aloud technique. For each session, the participants were given an electronic copy of the tasks for that session. They were requested to not read the tasks prior to the session. Participants were asked to read the task aloud prior to each task; task timing began once the participant finished reading the question and verbally indicated they were starting the task. The task time was stopped once the participant indicated they had successfully completed the task. Scoring is discussed below in Section 3.9. Following the session, the administrator gave the participant the post-test questionnaire (the System Usability Scale, see Appendix 7), solicited any further comments, and thanked each individual for their participation. Participants' demographic information, task success rate, time on task, errors, deviations, verbal responses, and post-test questionnaire were recorded into a spreadsheet. 3.5 TEST LOCATION 3.6 TEST ENVIRONMENT The test was conducted remotely through the use of Join.Me virtual conferencing and screen sharing software. Thus the actual test location was at the discretion of the test participants. The test administrator conducted the test from Enabledoc LLC offices in Rochester MN. The EHRUT would be typically be used in a healthcare office or facility. In this instance, the testing was conducted in healthcare office. For testing, the computer used a Windows laptop running Windows OS Enabledoc LLC ©2015 Confidential and Proprietary Version 1 7 and Chrome browser. The participants used a mouse and keyboard when interacting with the EHRUT. The Enablemyhealth application was used on a 13 inch laptop with 1366 by 768 resolution and 32 bit color. The application was set up by the vendor according to the vendor’s documentation describing the system set-up and preparation. The application itself was running on a Windows 2012 Server using a test database on a WAN connection. Technically, the system performance (i.e., response time) was representative to what actual users would experience in a field implementation with a minor lag caused by video screen sharing and recording. Additionally, participants were instructed not to change any of the default system settings (such as control of font size). 3.7 TEST FORMS AND TOOLS During the usability test, various documents and instruments were used, including: • Informed Consent • Test task scenarios • Moderator’s Guide • Observer’s data collection template • Post-test SUS Questionnaire Examples of these documents can be found in Appendices 3 – 7 respectively. The participant’s interaction with the EHRUT was captured and recorded digitally using the screen recording capability of join.me running on the test machine. This recording included the audio stream of verbalizations. The test sessions were electronically transmitted to any additional observers who logged into the Join.me session. 3.8 PARTICIPANT INSTRUCTIONS The administrator reads the following instructions aloud to the each participant (also see the full moderator’s guide in Appendix 5): Thank you for participating in this study. Your input is very important. Our session today will last about 30 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 8 We are recording the audio and screen interaction of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. Following the procedural instructions, participants were started with a specific patient’s chart data. Prior to giving the participant mouse and keyboard control, the moderator gave the following instructions: For each task, I will ask you to read the task and indicate when you begin. At that point, please perform the task and say “Done” once you believe you have successfully completed the task. I would like to request that you not talk aloud or verbalize while you are doing the tasks. You may certainly ask questions if necessary and we may provide guidance or a hint, however we will not provide direct instruction during the tasks. I will ask you your impressions about the task once you are done. Participants were then given 8 tasks to complete. Tasks are listed in Appendix 4. 3.9 USABILITY METRICS According to the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, EHRs should support a process that provides a high level of usability for all users. The goal is for users to interact with the system effectively, efficiently, and with an acceptable level of satisfaction. To this end, metrics for effectiveness, efficiency and user satisfaction were captured during the usability testing. The goals of the test were to assess: 1. Effectiveness of ENABLEMYHEALTH EHR by measuring participant success rates and errors 2. Efficiency of ENABLEMYHEALTH EHR by measuring the average task time and path deviations 3. Satisfaction with ENABLEMYHEALTH EHR by measuring ease of use ratings 3.10 DATA SCORING The following table details how tasks were scored, errors evaluated, and the time data analyzed: Rationale and Scoring Measure Effectiveness: Task Success A task was counted as a “Success” if the participant was able to achieve the correct outcome, without assistance, within the overall time allotted for the entire set of tasks. The total number of successes were calculated for each task and then divided by the total number of times that task was attempted. The results are provided as a percentage. Task times were recorded for successes. Observed task times divided by the Enabledoc LLC ©2015 Confidential and Proprietary Version 1 9 optimal time for each task is a measure of optimal efficiency. Due to the variability of multiple correct paths and a large variety of user settable preferences, all of which can affect time on task, optimal task times and deviations from these times were unrealistic to assess. All participants were trained on Enablemyhealth EHR and so the performance factor of 1.0 was use. The overall usability goal for any feature of the EHR is task time that is deemed acceptable by the end user with no critical errors. Thus, if expert, optimal performance on a task was [60] seconds then allotted task time performance was [60 * 1.0] seconds. This ratio is aggregated across tasks and reported with mean and variance scores. Effectiveness: Task Failures Efficiency: Task Deviations If the participant abandoned the task, did not reach the correct answer, performed it incorrectly, or was unsure if they had completed the task, the task was counted as a “Critical Failure.” No task times were taken for failed tasks. Minor errors were defined as an errant click, initial selection of an incorrect menu option, or incorrect entries that the participant noticed and corrected. The total number of errors was calculated for each task and then divided by the total number of times that task was attempted. Minor errors and deviations were noted but not counted as significant errors. This is expressed as the mean number of failed tasks per participant. The participant’s path (i.e., steps) through the application was recorded. Deviations occur if the participant, for example, went to a wrong screen, clicked on an incorrect menu item, followed an incorrect link, or interacted incorrectly with an on-screen control. These path deviations were included in the minor error count. The minor error count is expressed as an average across all participants. Efficiency: Task Time Satisfaction: Task Rating Each task was timed from when the participant indicated they were beginning the task until the participant said “Done.” If he or she failed to say “Done,” the time was stopped when the participant stopped performing the task. Only task times for tasks that were successfully completed were included in the average task time analysis. Average time per task was calculated for each task as was variance (standard deviation). Participant’s subjective impression of the ease of use of the application was measured by administering both a simple post-task question as well as a post-session questionnaire. After each task, the participant was asked to rate “Overall, this task was:” on a scale of 1 (Very Difficult) to 7 (Very Easy). Average difficulty ratings per task were calculated as was variance. Common convention is that average ratings for systems judged easy to use should be 3.3 or above. To measure participants’ confidence in and likeability of the ENABLEMYHEALTH EHR feature overall, the testing team administered the System Usability Scale (SUS) post-test questionnaire. Questions included, “I think I would like to use this system frequently,” “I thought the system was easy to use,” and “I would imagine that most people would learn to use this Enabledoc LLC ©2015 Confidential and Proprietary Version 1 10 system very quickly.” See full System Usability Score questionnaire in Appendix 7. 4 4.1 RESULTS DATA ANALYSIS AND REPORTING The results of the usability test were calculated according to the methods specified in the Usability Metrics section above. Participants who failed to follow session and task instructions had their data excluded from the analyses, however there were no instances of this occurring. The usability testing results for the ENABLEMYHEALTH EHR are detailed below (Table 1). The results should be seen in light of the objectives and goals outlined in Section 3.2 Study Design. The data yield actionable results that yield material, positive impact on user performance. Table 1 MEASURES TASKS Path Deviations Task (Observed / Number Success Optimal) Task Time Mean (SD) Task Time Task Deviations Ratings (Observed / Errors 5=Easy Optimal) Mean (SD) Mean (SD) Create 3 RX 3 100.00 1.06 (31.8/30) 117 (16.7) 1.3 (117/90) 1.86 (1.1) 3.7 (0.5) Create 3 Lab orders Create 2 imaging orders Modify Rx Modify lab order Modify image order View imaging order View prior Rx 3 2 1 1 1 1 1 100.00 1.05 (11.57/11) 100.00 1.05 (8.43/8) 100.00 1.04 (13.57/13) 100.00 1.05 (8.43/8) 100.00 1.00 (8/8) 100.00 1.05 (3.14/3) 100.00 1.00 (3/3) 75 (19) 44 (10.7) 32 (7.5) 36 (7.2) 32 (6.1) 13 (1.3) 12 (1.3) 1.4 (75/55) 1.5 (44/55) 1.1 (32/30) 1.4 (36/25) 1.3 (32/25) 1.3 (13/10) 1.2 (12/10) 0.57 (0.7) 0.43(0.7) 0.57(0.7) 0.43 (0.7) 0 (0) 0.14 (0.4) 0 (0) 4.1 (0.6) 4.6 (0.5) 3.6 (0.5) 3.9 (0.6) 4.1 (0.4) 4.1 (0.4) 4.1 (0.4) 100.00 45 (8.7) 1.3 (45/34) 0.5 (0.6) 4.0 (0.5) Mean across tasks 1.46 (11/10) The results from the SUS (System Usability Scale) scored the subjective satisfaction with the system based on performance with these tasks to be: 80.7. Broadly interpreted, this indicates above average usability, but with further room for improvement. 4.2 DISCUSSION OF THE FINDINGS The CPOE feature is a combination of electronic prescribing, lab order entry, and imaging order entry. As such there are two distinctly different user interfaces involved. Particularly noteworthy is that the participants were familiar with and had been using for up to the last 3 years prior to this study. Overall, the CPOE feature of Enablemyhealth user experience exhibits acceptable effectiveness, with an acceptably low critical error rate and minimal variance among users. The critical error rate is of greatest concern for an EHR and in the case of the EHRUT there were no task failures due to critical errors out of 91 attempted tasks, but there were 2 deviations from normal operations. This is within internal usability Enabledoc LLC ©2015 Confidential and Proprietary Version 1 11 goal guidelines. Of the deviation errors, 13 were attributable to electronic prescribing, which was primarily finding the correct prescription and dosage/form and a non defaulting measurement unit. Efficiency measures indicate that while acceptable, there is room for improvement, specifically in the electronic prescription interface, although searching for labs and radiology orders can also be difficult if the names of the tests do not match the terminology used by the participant. One older user took significantly longer time to perform every task, but this can also be attributed to nervousness and second guessing themselves. Satisfaction, measured by an SUS score of 80 is very good, but can be improved. Working to make the user experience more natural and intelligent will improve the overall user experience and help guide the novice and advanced users. 4.3 EFFECTIVENESS Based on the success rate, minor error rate, and critical error rate data, the CPOE feature has an acceptable level of effectiveness. The usability test consisted of 91 tasks of which 91 were attempted. Out of the 91 attempted tasks, there were no critical errors, giving a successful completion rate of 100%. The 13 deviation (minor) errors in the electronic prescriptions were difficulties associated non defaulting scripts that required making changes in each field to build the script. Lab errors were with selecting a lab and then find the lab. Clearly the shorter the lab test list, the easier the user experience. As our system can customize the lab and radiology order names, this allows the tests to be tailored to the user. Order sets were not used in this testing and can eliminate the problem of complex prescription and other types of orders. The deviation error mean of 1.86 is within the acceptable range of effectiveness, with the errors most often being finding the order by spelling it. 4.4 EFFICIENCY Observation of task time is the primary area for improvement. The mean task time for three prescription orders of 117.14 seconds is largely due to • time to find the correct prescription, dose and form • one complex prescription script • number of fields on the prescription screen Simple prescription tasks such as 1 tablet of a drug once per day by mouth for 30 days posed little difficulties and did not greatly affect task time. More complex prescriptions, such as those that required complex scripts, selection of measurement units, and detailed directions had increased the task time by 30%. We know that prescription ordersets addresses this issue, but we also know that there are of solutions to improving usability. Three lab orders had a mean entry time of 75 seconds with a standard deviation of 19 seconds, which was significantly impact by one participant that does not order labs and took more than twice as long as mean participant. None of the labs had Ask on Entry questions, which would have added significantly more time. Again, lab ordersets were not used and also simplify and speed the process. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 12 Two radiology orders had a mean entry time of 44 seconds with a standard deviation of 10.7 seconds. Again, one participant took more than twice as long as the mean participant. On average Lab orders took three seconds more than radiology orders per task. This was caused by confusion of selecting a lab to order from and not selecting a radiology group to order from. This perhaps is something we will change in our next usability testing to make consistent for both. 4.5 SATISFACTION Based on task difficulty ratings and SUS results data, user satisfaction of the feature is considered favorable. Users perception of ease of use is considered easy, with a mean rating of 4.04 across all tasks (1=very difficult, 5=very easy). SUS scoring is very good with a score of 80.7. These scores accurately describe the average patient satisfaction with Enablemyhealth feature set. SUS Scoring Mean StDev 4.6 80.71 4.57 MAJOR FINDINGS The major usability problems encountered in this study were: Electronic prescribing difficulties: • Time on task continues to be a serious problem, because there are so many fields to write a script. • Medications other than tablets (e.g.: injectables, inhalers) presented the most serious challenges • Non-tablet prescriptions consistently lower ease of use scores • Frequency was not easily understood and that this field, dose, days calculate the quantity and auto generate the directions. Lab and imaging order difficulties: • The concept of Lab Order Sets can be confusing for some • The user is required to know the structure/set-up to avoid excessive and confusing searching. Lab orders are associated with a lab order company. Further, groups of lab orders can be set up as lab order sets, but there is no easy way to determine the set membership of a given type of lab procedure • Search is not global across all lab companies. Searching is strictly within a single lab company, thus if a desired lab procedure is not within the selected company, search returns a null • Hidden search functionality – search is explicitly invoked in all other screens in the EHR except in the lab order search function where it is performed implicitly upon hitting the enter key • Only one user was able to search by lab order description successfully • Lab orders are arranged in a horizontal alphabetic layout which was unexpected and confusing • Required field(s) not indicated – the “facility” field is required and not indicated. Many users missed this, increasing the minor error rate Enabledoc LLC ©2015 Confidential and Proprietary Version 1 13 4.7 AREAS FOR IMPROVEMENT Electronic prescribing: 1. Always default a measurement unit for every prescription type. 2. Add speech recognition to allow prescription to be spoken and the script to be automatically filled in with natural language processing. 3. Add more intelligence to recommend prescriptions and scripts based on diagnosis and patient demographics. 4. Provide a wizard option that leads users through the prescription scripting process. Lab and imaging orders: 1. Improve the search function to allow labs orders to search across lab companies and not require a lab to be selected. 2. Make print also print for electronic labs 3. Add New button to clear the lab 4. Add speech recognition to allow lab/radiology orders to be spoken. 5. Add more intelligence to recommend lab and radiology test based on diagnosis and patient demographics. 6. Provide a wizard option that leads users through the order process. 5 APPENDICES The following appendices include supplemental data for this usability test report. Following is a list of the appendices provided: 1: Participant Recruiting Screener 2: Participant demographics 3: Informed Consent Form 4: Task Scenarios 5: Moderator’s Guide 6: Sample data collection form 7: System Usability Scale Questionnaire Enabledoc LLC ©2015 Confidential and Proprietary Version 1 14 Appendix 1: PARTICIPANT RECRUITING SCREENER Introduction Hello, my name is __. Enabledoc is seeking doctors and clinicians who are users of • Electronic prescribing software • Computerized order entry (such as labs and imaging) • Medication list and medication allergy list management to take part in a usability study of that portion of the EnableMyHealth EHR. This study will assist us in designing and developing a solution that meets your needs. Your experiences in using this particular design will greatly help our designers and developers. The testing of our design will take place in your office using remote meeting technology, requiring only your time, thoughts, and suggestions. We expect the session to last approximately 45 minutes. Does this sound like something that interests you? Before I schedule you for a session, do you have a few moments to answer some questions? General Questions 1. Are you male or female? [Recruit a mix of participants] 2. Have you participated in a focus group or usability test in the past three months? [Note but do not terminate if yes] 3. Which of the following best describes your age? [25 or less; 26 to 39; 40 to 59; 60 to 74; 75 and older][Recruit a mix of ages] Professional Demographics 4. What is your current position/role in your practice? 5. How long have you been in this role? 6. Do you currently perform e-prescribing? [computerized order entry, manage medication and medication allergy lists – pick appropriate for test][Terminate if no to specific task for test] How many prescriptions [or lab orders – use appropriate choice for test] do you write per day (or week if that is a better estimate)? 7. What year did you receive your medical degree? Computer Expertise 8. About how many hours per week do you spend on the computer that is medical practice related? [Recruit a range of use, e.g., 0 to 10, 11 to 25, 26+ hours per week][Terminate if less than 5] 9. Do you use a computer outside of your medical work? 10. If so, about how many hours per week do spend using a computer for non-work related endeavors? 11. Regarding your use of EnableMyHealth Practice Manager & EHR, what percentage of time is spent in each product? (per day) Enabledoc LLC ©2015 Confidential and Proprietary Version 1 15 Domain Knowledge · Rate your expertise or comfort in using EnableMyHealth software on a scale of 1 to 5 (1=just starting, 5=expert) for § PM § EHR (overall) § EHR e-Prescribing [Terminate if 1 or 2] · If you have used similar or competing products, describe your level of expertise in those products [it is not necessary to name the product(s) unless they want to]. Contact Information [If the person matches your qualifications, ask for any info we do not have] May I have your contact information? · Name of participant: · Office Key: · Best phone number: · Email address: Those are all the questions I have for you. Your background matches the people we're looking for. Would you be able to participate on [date, time]? Alternative: select from a list of sessions [ideal approach] Alternative; What would be the best date and time for you? Before your session starts, we will ask you to verbally acknowledge a release form allowing us to record your session. The recording will only be used internally for further study if needed and will never be used for advertising or marketing purposes. Also, you will not be personally identified with any recording. Will you consent to be recorded? [Terminate if no] This study will take place remotely via conferencing software, allowing you to participate in the session at the place of your choosing. I will confirm your appointment a couple of days before your session and provide you with any additional information. What is the best time to contact you? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 16 Appendix 2: PARTICIPANT DEMOGRAPHICS Following is a high-level overview of the participants in this study. Gender Men Women Total (participants) 2 5 7 Occupationan/Role RN/NP/MA Physician Total (participants) 4 3 7 Years of Experience (average) Professional EHR Product Use 23.71 2.86 Demographic detail Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Age Occupation / role 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Enabledoc LLC ©2015 Confidential and Proprietary Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Version 1 Product Experience (yrs) 3 3 4 3 3 3 1 17 Appendix 3: Informed Consent Form Enabledoc would like to thank you for participating in this study. The purpose of this study is to evaluate an electronic health records system. If you decide to participate, you will be asked to perform several tasks using the prototype and give your feedback. The study will last up to 60 minutes. Agreement I understand and agree that as a voluntary participant in the present study conducted by Enabledoc. I am free to withdraw consent or discontinue participation at any time. I understand and agree to participate in the study conducted by Enabledoc. I understand and consent to the use and release of the recording by Enabledoc. I understand that the information and recording is for research purposes only and that my name and image will not be used for any purpose other than research. I relinquish any rights to the recording and understand the recording may be copied and used by Enabledoc without further permission. I understand and agree that the purpose of this study is to make software applications more useful and usable in the future. I understand and agree that the data collected from this study will not be shared outside of Enabledoc I understand and agree that data confidentiality is assured, because only de-identified data – i.e., identification numbers not names – will be used in analysis and reporting of the results. I agree to immediately raise any concerns or areas of discomfort with the study administrator. I understand that I can leave at any time. Please check or verbally indicate one of the following: YES, I have read the above statement and agree to be a participant. NO, I choose not to participate in this study. Signature: _____________________________________ Date: ____________________ Enabledoc LLC ©2015 Confidential and Proprietary Version 1 18 Appendix 4: Task Scenarios Usability Task Scenarios – CPOE For CPOE test we will use Garth Brooks encounter date 7/15/2015 to create prescriptions, labs, and radiology orders, then modify them and view them. Create Orders 1. Medications – create and save the following 3 prescriptions. The pharmacy can use generics if they choose to do so. Do not sign these prescriptions. a. Simvastatin, 20 mg tablet by mouth once daily; dispense 30, 1 refill b. Lorazepam, 0.5 mg tablet by mouth three times daily; dispense 20, 1 refill c. Insulin Glargine, 10 units once daily; package of 5, 2 refills Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 Task Time : _____ seconds Comments: 2. Laboratory Orders – Click Orders on main menu then select Lab then select each lab order and save each one: a. Select: Creatinine 24H renal clearance panel and click save. b. Select Cholesterol in HDL in serum and click save. c. Select Fasting glucose in serum and click save. Overall, how difficult or easy did you find this task? Very Difficult 1 2 Task Time : _____ seconds Comments: Very Easy 3 4 5 3. Radiology Orders - Click Orders on main menu then select: a. Select Radiologic examination knee 3 views (cpt 73562) and click save b. Select CT head/brain w/o contrast material (cpt 70450) and slick save. Overall, how difficult or easy did you find this task? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 19 Very Difficult 1 Very Easy 2 3 4 5 Task Time : _____ seconds Comments: Modify Orders 4. Modify Prescription for Garth Brooks encounter 7/15/2015: Simvastatin 20 mg tablet by mouth once daily; dispense 30, 1 refill was changed to: Atorvastatin 20 mg tablet by mouth once daily; dispense 30, 2 refills Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 Task Time : _____ seconds Comments: 5. Modify Lab order: Cholesterol in HDL in serum or plasma was changed to: Cholesterol in LDL in serum or plasma by direct assay Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 Task Time : _____ seconds Comments: 6. Modify Radiology order: CT head/brain w/o contrast material was changed to: CT head/brain w/ contrast material (Computed tomography, head or brain; with contrast material) Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 Enabledoc LLC ©2015 Confidential and Proprietary 4 Version 1 5 20 Task Time : _____ seconds Comments: View Orders: 7. Find and view radiology orders for patient Garth Brooks on 7/15/2015 in Patient Center. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 Task Time : _____ seconds Comments: 7. Find and view prescription orders for patient Garth Brooks on 7/15/2015 in Patient Center. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 Task Time : _____ seconds Comments: Enabledoc LLC ©2015 Confidential and Proprietary Version 1 21 Appendix 5: Usability Test Administration Moderator’s Guide 1. Items often forgotten a. Stop watch for recording time on task b. Elapsed time timer to time code observations/comments in the recording 2. Office Key Setup a. Environment b. Obtain copy of user key database if required for test c. Any required feature access d. Create and enter any necessary test data e. Create Database / Office Key snapshot 3. Schedule Join.Me sessions 4. Schedule participants 5. Supply test participants with materials prior to test a. Join.Me access b. Task scenarios (be prepared to resend at the start of the test – do not assume the participant has multiple monitors, so they may also need to print the scenarios) c. Informed consent form (can be done verbally during the session) 6. Set up administrative / test PC a. Join.Me installed and up to date b. Shut down all programs not needed for the test – remember things like softphone c. Turn off notifications – audible and screen – on any software that may be running during the test e.g.: Outlook d. Ensure the application installed and functional 7. Running a test session a. Ensure office key/database snapshot of base data exists b. Start EHR session on test PC and arrive at starting screen for test c. Select first patient if selection is not part of the task scenario d. Start Join.Me session e. Share appropriate screen f. Greet user g. Administer introductory materials to user (see below, following checklist) h. Start Join.Me recording i. Display informed consent form on shared screen j. Obtain consent via verbal acceptance k. Give mouse and keyboard control to ALL l. Have user work through tasks m. For each task, record i. Time on task ii. Critical errors (anything that constitutes task failure) iii. Minor errors (anything the user detects and recovers) iv. Deviation(s) from optimal path v. Interesting comments (try to include recording time stamp for reference) n. After each task or task set (see specific scenarios) ask for response to single ease of use Enabledoc LLC ©2015 Confidential and Proprietary Version 1 22 question o. Allow verbal response to any questions contained in task scenarios p. At end of all tasks, display SUS questionnaire and have the participant place an X in appropriate response to each statement i. Save SUS with participant code as part of file name q. Conduct debrief to solicit any additional feedback, comments, Q&A, etc Thank you for participating in this study. Your input is very important. Our session today will last about 30 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use Enablemyhealth, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screenshots of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 23 Appendix 6: Sample data collection form Summative Usability Test Data Log Test type: Participant: Participant code: Session Date/start time: File name: Task 1: Critical Error count: Minor error count: Optimal path deviations: Time on task: SEoUQ response: Comments/observations: <repeat for each task> Enabledoc LLC ©2015 Confidential and Proprietary Version 1 24 Appendix 7: System Usability Scale Questionnaire In 1996, Brooke published a “low-cost usability scale that can be used for global assessments of systems usability” known as the System Usability Scale or SUS. Lewis and Sauro (2009) and others have elaborated on the SUS over the years. Computation of the SUS score can be found in Brooke’s paper, at http://www.usabilitynet.org/trump/documents/Suschapt.doc or in Tullis and Albert (2008). Strongly Disagree 1. I think that I would like to use this system frequently Strongly agree 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 2. I found the system necessarily complex 3. I thought the system was easy to use 4. I think that I would need the support of a technical person to be able to use this system 5. I found the various functions in this system were well integrated 6. I thought there was too much inconsistency in this system 7. I would imagine that most people would learn to use this system very quickly 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 8. I found the system very cumbersome to use Enabledoc LLC ©2015 Confidential and Proprietary Version 1 25 1 2 3 4 5 1 2 3 4 5 9. I felt very confident using the system 10. I needed to learn a lot of things before I could get going with this system 1 2 3 4 5 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 26 EHR Usability Test Report of Enablemyhealth EHR Clinical Decision Support Safety-Enhanced Design 170.314(g)(3) Report based on ISO/IEC 25062:2006 Common Industry Format for Usability Test Reports Date of Usability Test: 15 AUG 2015 – 14 SEP 2015 Date of Report: 14 SEP 2015 Report Prepared By: Stephen Rothschild 877.540.0933 steve@enabledoc.com EnableDoc LLC 7700 Falstaff Road McLean VA 22104 Table of Contents 1 Executive Summary ............................................................................................................................... 2 2 INTRODUCTION ..................................................................................................................................... 4 3 METHOD................................................................................................................................................ 4 4 5 3.1 PARTICIPANTS ............................................................................................................................... 4 3.2 STUDY DESIGN............................................................................................................................... 5 3.3 TASKS............................................................................................................................................. 6 3.4 PROCEDURES................................................................................................................................. 6 3.5 TEST LOCATION ............................................................................................................................. 7 3.6 TEST ENVIRONMENT ..................................................................................................................... 7 3.7 TEST FORMS AND TOOLS .............................................................................................................. 8 3.8 PARTICIPANT INSTRUCTIONS ........................................................................................................ 8 3.9 USABILITY METRICS ....................................................................................................................... 9 3.10 DATA SCORING .............................................................................................................................. 9 RESULTS .............................................................................................................................................. 10 4.1 DATA ANALYSIS AND REPORTING ............................................................................................... 11 4.2 DISCUSSION OF THE FINDINGS ................................................................................................... 11 4.3 EFFECTIVENESS ........................................................................................................................... 12 4.4 EFFICIENCY .................................................................................................................................. 12 4.5 SATISFACTION ............................................................................................................................. 12 4.6 MAJOR FINDINGS ........................................................................................................................ 12 4.7 AREAS FOR IMPROVEMENT ........................................................................................................ 13 APPENDICES ........................................................................................................................................ 13 Appendix 1: PARTICIPANT RECRUITING SCREENER ................................................................................ 14 Appendix 2: PARTICIPANT DEMOGRAPHICS ........................................................................................... 16 Appendix 3: Informed Consent Form...................................................................................................... 17 Appendix 4: Task Scenarios ..................................................................................................................... 18 Appendix 5: Usability Test Administration Moderator’s Guide .............................................................. 20 Appendix 6: Sample data collection form ............................................................................................... 23 Appendix 7: System Usability Scale Questionnaire ................................................................................ 24 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 1 1 Executive Summary A usability test of EnableMyHealth – 2014.1, an ambulatory EHR, was conducted on 15 Aug 2015 – 14 Sep 2015 in the McLean, VA and Rochester MN offices of EnableDoc LLC. The purpose of this test was to test and validate the usability of the current user interface for Clinical Decision Support (CDS), and provide evidence of usability in the EHR Under Test (EHRUT). During the usability test, four healthcare providers and clinical staff matching the target demographic criteria served as participants and used the EHRUT in simulated, but representative tasks. This study collected performance data on 7 clinical decision support tasks that trigger clinical intervention warnings, provide clinical reference information, and allow the CDS status to be updated in an EHR where the user is required to: · Trigger a problem intervention, click Infobutton, and change status to completed. · Trigger a medication intervention, click Infobutton, and change status to completed. · Trigger a medication allergy intervention, click Infobutton, and change status to completed. · Trigger a lab test and value intervention, click Infobutton, and change status to completed. · Trigger a vital intervention and change status to completed. · Trigger a demographic intervention, click Infobutton, and change status to completed. · Trigger a demographic with a problem intervention, click Infobutton, and change status to completed. All test participants conducted the test sessions remotely via on-line conferencing software. During the 30 minute one-on-one usability test, each participant was greeted by the administrator and asked to review and verbally acknowledge an informed consent/release form (included in Appendix 3); they were instructed that they could withdraw at any time. Participants had prior experience with the EHR as they are current users/customers. No additional training materials were provided other than that usually given to customers. The administrator introduced the test and instructed participants to complete a series of tasks (given one at a time) using Enablemyhealth. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. Participant screens and audio were recorded for subsequent analysis. The following types of data were collected for each participant: • Number of tasks successfully completed within the allotted time without assistance • Time to complete the tasks • Participant’s subjective assessment of the ease of each task • Number and types of errors • Path deviations • Participant’s verbalizations • Participant’s satisfaction ratings of the system All participant data was de-identified – no correspondence could be made from the identity of the participant to the data collected. Following the conclusion of the testing, participants were asked to complete a post-test questionnaire and were compensated with a $50 gift card for their time. Following the conclusion of the testing, participants were asked to complete a post-test SUS questionnaire. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 2 Various recommended metrics, in accordance with the examples set forth in the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, were used to evaluate the usability of the EHRUT. Result data matrix - refer to Appendix 4 for complete task descriptions: Table 1 TASKS Trigger a problem intervention Trigger a medication intervention Trigger a medication allergy intervention Trigger a lab test and value intervention Trigger a vital intervention Trigger a demographic intervention Trigger a demographic with a problem intervention Mean across tasks Path Deviations Task Time (Observed / Mean Task Optimal) (SD) Number Success 100.00 1.2 (10.6/9) 58.7(5.3) 1 100.00 1.1 (12/11) 1 58.6 (2) Task Time Deviations (Observed / Optimal) 1.2 (58.7/50) 1.1 '(58.6/55) Task Ratings Errors 5=Easy Mean (SD) Mean (SD) 1.9 (1.1) 4.1 (0.4) 0.6 (0.7) 4.3 (0.5) 1 100.00 1.1 (13.7/13) 61.9 (3.4) 1.1 (61.8/58) 0.4 (0.7) 4.6 (0.5) 1 1 1 100.00 100.00 100.00 1.0 (7.3/7) 1.1 (12/11) 1.0 (8/8) 32.7 (2.1) 44.3 (3.3) 31.9 (1.6) 1.1 (32.7/30) 1.1 (44.3/40) 1.1 (31.9/30) 0.6 (0.7) 0.4 (0.7) 0.00 4.6 (0.5) 4.7 (0.5) 5.0 (0) 1 100.00 1.1 (9.6/9) 53.6 (2.2) 1.1 (53.6/50) 0.1 (0.4) 4.9 (0.4) 100.00 1.1 (10.5/9.7) 48.8 (2.9) 1.1 (48.8/44.7) 0.6 (0.6) 4.6 (0.4) The results from the System Usability Scale scored the subjective satisfaction with the system based on performance with these tasks to be: 87.5. In addition to the performance data, the following qualitative observations were made: The CDS capability of the EHRUT exhibits high usability. The trigger functionality is automated. Most deviations were selecting wrong screen to enter data. Any longer task times were the participant being careful in their selection or selection of the incorrect screen. The major usability difficulties encountered were: · · Users were confused why they had to go to the Superbill to trigger the CDS alert. We explained that all providers go to the Superbill screen at some point in the clinical documentation process to document the diagnosis and billing codes. There was confusion concerning the infobutton and the value it provided and how this worked with Education Materials. Functionally it worked well, but some labs and problems did not have links in MedlinePlus. Areas for Improvement · · Provide more textual description on the CDS popup screen. Allow users to set which screens trigger decision support. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 3 2 INTRODUCTION The EHRUT tested for this study was EnableMyHealth, Fall 2013 Release, an ambulatory EHR. Designed to present medical information to healthcare providers in primarily small private practice facilities (1-5 providers) with a focus on family practice, Ob/GYN, Pediatrics and Internal Medicine, the EHRUT consists of modules and features that include but not limited to support for: · Patient demographics · Patient problem and allergy lists · Patient encounter notes and charts · Patient clinical documents · Creating lab orders and receiving lab results · Growth charting · Inoculation recording · Electronic prescribing · Drug-drug, drug-allergy, and drug-problem interaction checking · Clinical decision support · Quality reporting · Patient population reporting The EHRUT is used predominantly by physicians and clinical staff such as MA’s, RN’s, LPN’s, etc. The usability testing attempted to represent realistic exercises and conditions. The purpose of this study was to test and validate the usability of the current user interface, and provide evidence of usability of adding, modifying, and viewing a patient’s medication list in the EHR Under Test (EHRUT).To this end, measures of effectiveness, efficiency and user satisfaction, such as successful task completion rate, time on task, number and types of errors, and participant satisfaction were captured during the usability testing. 3 3.1 METHOD PARTICIPANTS A total of 7 participants were tested on the CPOE feature of the EHRUT. Participants in the test were physicians and clinical staff such as RNs and MAs. Participants were recruited by Enabledoc staff from existing customers and paid a $50 gift card for their help in testing. Participants had no direct connection to the development of or organization producing the EHRUT other than being current customers. Participants were not from the testing or supplier organization. Participants were actual end users and thus have the same orientation and level of training as other non-participant customers. For the test purposes, end-user characteristics were identified and translated into an internal recruitment screener used to solicit potential participants; an example of a screener is provided in Appendix [1]. Recruited participants had a mix of backgrounds and demographic characteristics conforming to the recruitment screener. The following is a table of participants by characteristics, including demographics, Enabledoc LLC ©2015 Confidential and Proprietary Version 1 4 professional experience, computing experience and user needs for assistive technology. Participant names were replaced with Participant IDs so that an individual’s data cannot be tied back to individual identities. Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Age Occupation / role 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Product Experience (yrs) 3 3 4 3 3 3 1 Seven (7) participants (matching the demographics in the section on Participants) were recruited and all participated in the usability test. 3); they were instructed that they could withdraw at any time. Participants all had prior experience with the EHR. No participants failed to show for the study. Participants were scheduled for 30 minute sessions with 30 minutes in between each session for debrief by the administrator and data logger, and to reset systems to proper test conditions. All testing was performed over several days to allow the participants to schedule time at their convenience. A spreadsheet was used to keep track of the participant schedule. The administrator introduced the test, and instructed participants to complete a series of tasks (given one at a time) using the EHRUT. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. 3.2 STUDY DESIGN The objective of this test was to perform summative testing to measure the key usability metrics of effectiveness, efficiency, and user satisfaction. These metrics will uncover areas where the application performed well and areas where the application failed to meet the needs of the participants in achieving our internal usability goals. The data from this test may serve as a baseline for future tests with an updated version of the same EHR and/or comparison with other EHRs provided the same tasks are used. In short, this testing serves as both a means to record or benchmark current usability, but also to identify areas where improvements should be made. During the usability test, participants interacted exclusively with the EHRUT. Each participant used the system in their preferred location, and was provided with the same instructions. All sessions were conducted remotely with join.me conferencing software. Screens with associated interaction and the audio stream were recorded for later analysis. The system was evaluated for effectiveness, efficiency and satisfaction as defined by measures collected and analyzed for each participant: Enabledoc LLC ©2015 Confidential and Proprietary Version 1 5 · · · · · · Number of tasks successfully completed within the allotted time without assistance Time to complete the tasks Number and types of errors Path deviations Participant’s verbalizations (comments) Participant’s satisfaction ratings of the system Additional information about the various measures can be found in Section 3.9 on Usability Metrics. 3.3 TASKS Tasks were constructed that would be realistic and representative of the kinds of activities a user might do with this EHR in the area of clinical decision support interventions and heavily based on the CMS test scripts for Meaningful Use Phase 2. The tasks for this study broadly included: · · · · · · · Trigger a problem intervention, click Infobutton, and change status to completed. Trigger a medication intervention, click Infobutton, and change status to completed. Trigger a medication allergy intervention, click Infobutton, and change status to completed. Trigger a lab test and value intervention, click Infobutton, and change status to completed. Trigger a vital intervention and change status to completed. Trigger a demographic intervention, click Infobutton, and change status to completed. Trigger a demographic with a problem intervention, click Infobutton, and change status to completed. Task Selection and Priority Tasks were selected based on their frequency of use, criticality of function, and those most troublesome to users. Tasks were directly modeled on the CMS Clinical Decision Support test procedure [170.314(a)(8)]. 3.4 PROCEDURES During the time a participant was scheduled, an email was sent to the participant that: • Confirmed the time of the session • Provided Join.Me access codes • A copy of the informed consent form • A document containing the tasks for the test session Just prior to the scheduled time, the test administrator started the join.me session and greeted the participant on arrival; their identity was verified and matched with a name on the participant schedule. Participants were then assigned a participant ID. Recording of the session was started using the join.me recording feature. Each participant reviewed and agreed to the informed consent and release form via verbal acknowledgment (See Appendix 3). A representative from the test team witnessed the participant’s verbal agreement. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 6 To ensure that the test ran smoothly, testing was performed remotely by an experienced usability practitioner with over 25 years of experience in healthcare user interface and workflow design. The administrator moderated the session including administering instructions and tasks. The administrator also monitored task times, obtained post-task rating data, took notes on participant comments, path deviations, number and type of errors, and comments. Participants were instructed to perform the tasks (see specific instructions below): · · · As quickly as possible making as few errors and deviations as possible. Without assistance; administrators were allowed to give immaterial guidance and clarification on tasks, but not instructions on use. Without using a think aloud technique. For each session, the participants were given an electronic copy of the tasks for that session. They were requested to not read the tasks prior to the session. Participants were asked to read the task aloud prior to each task; task timing began once the participant finished reading the question and verbally indicated they were starting the task. The task time was stopped once the participant indicated they had successfully completed the task. Scoring is discussed below in Section 3.9. Following the session, the administrator gave the participant the post-test questionnaire (the System Usability Scale, see Appendix 7), solicited any further comments, and thanked each individual for their participation. Participants' demographic information, task success rate, time on task, errors, deviations, verbal responses, and post-test questionnaire were recorded into a spreadsheet. 3.5 TEST LOCATION The test was conducted remotely through the use of Join.Me virtual conferencing and screen sharing software. Thus the actual test location was at the discretion of the test participants. The test administrator conducted the test from Enabledoc LLC offices in Rochester MN. 3.6 TEST ENVIRONMENT The EHRUT would be typically be used in a healthcare office or facility. In this instance, the testing was conducted in healthcare office. For testing, the computer used a Windows laptop running Windows OS and Chrome browser. The participants used a mouse and keyboard when interacting with the EHRUT. The Enablemyhealth application was used on a 13 inch laptop with 1366 by 768 resolution and 32 bit color. The application was set up by the vendor according to the vendor’s documentation describing the system set-up and preparation. The application itself was running on a Windows 2012 Server using a test database on a WAN connection. Technically, the system performance (i.e., response time) was representative to what actual users would experience in a field implementation with a minor lag caused by video screen sharing and recording. Additionally, participants were instructed not to change any of the default system settings (such as control of font size). Enabledoc LLC ©2015 Confidential and Proprietary Version 1 7 3.7 TEST FORMS AND TOOLS During the usability test, various documents and instruments were used, including: • Informed Consent • Test task scenarios • Moderator’s Guide • Observer’s data collection template • Post-test SUS Questionnaire Examples of these documents can be found in Appendices 3 – 7 respectively. The participant’s interaction with the EHRUT was captured and recorded digitally using the screen recording capability of join.me running on the test machine. This recording included the audio stream of verbalizations. The test sessions were electronically transmitted to any additional observers who logged into the Join.me session. 3.8 PARTICIPANT INSTRUCTIONS The administrator reads the following instructions aloud to the each participant (also see the full moderator’s guide in Appendix 5): Thank you for participating in this study. Your input is very important. Our session today will last about 30 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screen interaction of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. In today’s session, we will be using the decision support functionality that has added some new features. Let’s go over those now so you will have some familiarity. The first new feature is called the Infobutton, to provide additional clinical information from MedlinePlus. The second new feature are links to reference and diagnostic source resources. Lastly, CDS alerts have a status that is saved in the Patient Center screen for each patient to track when alerts are made and when the status of the alert is changed. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 8 [important: only ask the following question if they indicated that they review/read release notes, view training videos, etc. based on their earlier answer regarding how they find out about new features and how to use them. Be ready to display the help file.] Would you like to review the help topic for these features now? Following the procedural instructions, participants were started with a specific patient’s chart data. Prior to giving the participant mouse and keyboard control, the moderator gave the following instructions: For each task, I will ask you to read the task and indicate when you begin. At that point, please perform the task and say “Done” once you believe you have successfully completed the task. I would like to request that you not talk aloud or verbalize while you are doing the tasks. You may certainly ask questions if necessary and we may provide guidance or a hint, however we will not provide direct instruction during the tasks. I will ask you your impressions about the task once you are done. Participants were then given 4 tasks to complete. Tasks are listed in Appendix 4. 3.9 USABILITY METRICS According to the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, EHRs should support a process that provides a high level of usability for all users. The goal is for users to interact with the system effectively, efficiently, and with an acceptable level of satisfaction. To this end, metrics for effectiveness, efficiency and user satisfaction were captured during the usability testing. The goals of the test were to assess: 1. Effectiveness of ENABLEMYHEALTH EHR by measuring participant success rates and errors 2. Efficiency of ENABLEMYHEALTH EHR by measuring the average task time and path deviations 3. Satisfaction with ENABLEMYHEALTH EHR by measuring ease of use ratings 3.10 DATA SCORING The following table details how tasks were scored, errors evaluated, and the time data analyzed Rationale and Scoring Measure Effectiveness: Task Success A task was counted as a “Success” if the participant was able to achieve the correct outcome, without assistance, within the overall time allotted for the entire set of tasks. The total number of successes were calculated for each task and then divided by the total number of times that task was attempted. The results are provided as a percentage. Task times were recorded for successes. Observed task times divided by the optimal time for each task is a measure of optimal efficiency. Due to the variability of multiple correct paths and a large variety of user settable preferences, all of which can affect time on task, optimal task times and deviations from these times were unrealistic to assess. All participants were trained on Enablemyhealth EHR and so the performance factor of 1.0 was use. The overall usability goal for any feature of the EHR is task time that is deemed acceptable by the end user with no critical errors. Thus, if expert, Enabledoc LLC ©2015 Confidential and Proprietary Version 1 9 optimal performance on a task was [60] seconds then allotted task time performance was [60 * 1.0] seconds. This ratio is aggregated across tasks and reported with mean and variance scores. Effectiveness: Task Failures Efficiency: Task Deviations If the participant abandoned the task, did not reach the correct answer, performed it incorrectly, or was unsure if they had completed the task, the task was counted as a “Critical Failure.” No task times were taken for failed tasks. Minor errors were defined as an errant click, initial selection of an incorrect menu option, or incorrect entries that the participant noticed and corrected. The total number of errors was calculated for each task and then divided by the total number of times that task was attempted. Minor errors and deviations were noted but not counted as significant errors. This is expressed as the mean number of failed tasks per participant. The participant’s path (i.e., steps) through the application was recorded. Deviations occur if the participant, for example, went to a wrong screen, clicked on an incorrect menu item, followed an incorrect link, or interacted incorrectly with an on-screen control. These path deviations were included in the minor error count. The minor error count is expressed as an average across all participants. Efficiency: Task Time The participant’s path (i.e., steps) through the application was recorded. Deviations occur if the participant, for example, went to a wrong screen, clicked on an incorrect menu item, followed an incorrect link, or interacted incorrectly with an on-screen control. These path deviations were included in the minor error count. The minor error count is expressed as an average across all participants. Satisfaction: Task Rating Participant’s subjective impression of the ease of use of the application was measured by administering both a simple post-task question as well as a post-session questionnaire. After each task, the participant was asked to rate “Overall, this task was:” on a scale of 1 (Very Difficult) to 7 (Very Easy). Average difficulty ratings per task were calculated as was variance. Common convention is that average ratings for systems judged easy to use should be 3.3 or above. To measure participants’ confidence in and likeability of the ENABLEMYHEALTH EHR feature overall, the testing team administered the System Usability Scale (SUS) post-test questionnaire. Questions included, “I think I would like to use this system frequently,” “I thought the system was easy to use,” and “I would imagine that most people would learn to use this system very quickly.” See full System Usability Score questionnaire in Appendix 7. 4 RESULTS Enabledoc LLC ©2015 Confidential and Proprietary Version 1 10 4.1 DATA ANALYSIS AND REPORTING The results of the usability test were calculated according to the methods specified in the Usability Metrics section above. Participants who failed to follow session and task instructions had their data excluded from the analyses, however there were no instances of this occurring. The usability testing results for the ENABLEMYHEALTH EHR are detailed below (Table 1). The results should be seen in light of the objectives and goals outlined in Section 3.2 Study Design. The data should yield actionable results that, if corrected, yield material, positive impact on user performance. Table 1 TASKS Trigger a problem intervention Trigger a medication intervention Trigger a medication allergy intervention Trigger a lab test and value intervention Trigger a vital intervention Trigger a demographic intervention Trigger a demographic with a problem intervention Path Deviations Task Time Task (Observed / Mean Number Success Optimal) (SD) 58.7(5.3) 1 100.00 1.2 (10.6/9) 58.6 (2) 1.1 (12/11) 1 100.00 Task Time Deviations (Observed / Optimal) 1.2 (58.7/50) 1.1 '(58.6/55) Task Ratings Errors 5=Easy Mean Mean (SD) (SD) 1.9 (1.1) 4.1 (0.4) 0.6 (0.7) 4.3 (0.5) 1 100.00 1.1 (13.7/13) 61.9 (3.4) 1.1 (61.8/58) 0.4 (0.7) 4.6 (0.5) 1 1 1 100.00 100.00 100.00 1.0 (7.3/7) 1.1 (12/11) 1.0 (8/8) 32.7 (2.1) 44.3 (3.3) 31.9 (1.6) 1.1 (32.7/30) 1.1 (44.3/40) 1.1 (31.9/30) 0.6 (0.7) 0.4 (0.7) 0.00 4.6 (0.5) 4.7 (0.5) 5.0 (0) 1 100.00 1.1 (9.6/9) 53.6 (2.2) 1.1 (53.6/50) 0.1 (0.4) 4.9 (0.4) 100.00 1.1 (10.5/9.7) 48.8 (2.9) 1.1 (48.8/44.7) 0.6 (0.6) 4.6 (0.4) Mean across tasks The results from the SUS (System Usability Scale) scored the subjective satisfaction with the system based on performance with these tasks to be: 87.5. SUS is considered to be above average because its automated and simple alerts. 4.2 DISCUSSION OF THE FINDINGS Clinical Decision Support interventions are trigged when a patient meets the rule criteria and provider accesses the Superbill screen or Diagnosis or Orders screen. A CDS alert is triggered as a popup describing the alert, providing guidance source, displaying reference information and links, provides Infobutton links to Medlineplus, allows orderset to be selected, and the status of the alert to be changed. The rules that trigger CDA alerts are based on configurable criteria, such as encounter dates, lab test and values, vital signs, demographics, problem, current medications, and allergies. CDS has been available in Enablemyhealth since 2010, but new information is now presented to comply with the 2014 requirements. Since this is an automated feature, participants has no difficulty triggering the alerts, viewing the Infobutton links, and changing the status. Efficiency measures indicate that users had minor deviator from the optimal steps (average across taks of 1.1). The minor error rate, which includes optimal path deviations, is acceptably low, with an overall mean of 0.6. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 11 Satisfaction, measured by an SUS score of 87.5 is satisfactory. This score tended to be reduced by the participants value in CDS. Participant perception of difficulty is an acceptably high score, with a mean of 4.6 on a 1-5 scale across all tasks. 4.3 EFFECTIVENESS Based on the success rate, minor error rate, and critical error rate data, the interactions module has an acceptable level of effectiveness after sufficient training. Without training however, the CDS features exhibit unacceptably low usability, as demonstrated by a successful completion rate of less than 50%. The usability test consisted of 49 tasks across all participants of which 49 were attempted. During the test, one participant spent more time evaluating the information rather than focusing on completion of the task. Out of the 49 attempted tasks, the successful completion rate was 100%. On some tasks participants produced deviation error by mistakenly clicking the incorrect menu option. The minor error mean of 0.6 is well within the acceptable range of effectiveness. 4.4 EFFICIENCY Observation of task time and minor errors which include path deviations indicates acceptable performance. The mean task times compared to optimal were very consistent across all tasks. Some participants wanted to examine the information in the links and references. Each task had very few steps to trigger the alert, which reduces the time it took to perform the task, but more time was spent reviewing the information. 4.5 SATISFACTION Based on task difficulty ratings and SUS results data, user satisfaction of the feature is considered favorable. Users perception of ease of use is considered easy, with a mean rating of 4.04 across all tasks (1=very difficult, 5=very easy). SUS scoring is very good with a score of 87.5 These scores accurately describe the average patient satisfaction with Enablemyhealth feature set. SUS Scoring Mean StDev 4.6 84.64 4.90 MAJOR FINDINGS The major usability difficulties encountered were: Enabledoc LLC ©2015 Confidential and Proprietary Version 1 12 · · 4.7 AREAS FOR IMPROVEMENT · · 5 Users were confused why they had to go to the Superbill to trigger the CDS alert. We explained that all providers go to the Superbill screen at some point in the clinical documentation process to document the diagnosis and billing codes. There was confusion concerning the infobutton and the value it provided and how this worked with Education Materials. Functionally it worked well, but some labs and problems did not have links in MedlinePlus. Provide more textual description on the CDS popup screen. Allow users to set which screens trigger decision support. APPENDICES The following appendices include supplemental data for this usability test report. Following is a list of the appendices provided: 1: Participant Recruiting Screener 2: Participant demographics 3: Informed Consent Form 4: Task Scenarios 5: Moderator’s Guide 6: Sample data collection form 7: System Usability Scale Questionnaire Enabledoc LLC ©2015 Confidential and Proprietary Version 1 13 Appendix 1: PARTICIPANT RECRUITING SCREENER Introduction Hello, my name is __. Enabledoc is seeking doctors and clinicians who are users of • Electronic prescribing software • Computerized order entry (such as labs and imaging) • Medication list and medication allergy list management to take part in a usability study of that portion of the EnableMyHealth EHR. This study will assist us in designing and developing a solution that meets your needs. Your experiences in using this particular design will greatly help our designers and developers. The testing of our design will take place in your office using remote meeting technology, requiring only your time, thoughts, and suggestions. We expect the session to last approximately 45 minutes. Does this sound like something that interests you? Before I schedule you for a session, do you have a few moments to answer some questions? General Questions 1. Are you male or female? [Recruit a mix of participants] 2. Have you participated in a focus group or usability test in the past three months? [Note but do not terminate if yes] 3. Which of the following best describes your age? [25 or less; 26 to 39; 40 to 59; 60 to 74; 75 and older][Recruit a mix of ages] Professional Demographics 4. What is your current position/role in your practice? 5. How long have you been in this role? 6. Do you currently perform e-prescribing? [computerized order entry, manage medication and medication allergy lists – pick appropriate for test][Terminate if no to specific task for test] How many prescriptions [or lab orders – use appropriate choice for test] do you write per day (or week if that is a better estimate)? 7. What year did you receive your medical degree? Computer Expertise 8. About how many hours per week do you spend on the computer that is medical practice related? [Recruit a range of use, e.g., 0 to 10, 11 to 25, 26+ hours per week][Terminate if less than 5] 9. Do you use a computer outside of your medical work? 10. If so, about how many hours per week do spend using a computer for non-work related endeavors? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 14 11. Regarding your use of EnableMyHealth Practice Practice Manager & EHR, what percentage of time is spent in each product? (per day) Domain Knowledge · Rate your expertise or comfort in using EnableMyHealth software on a scale of 1 to 5 (1=just starting, 5=expert) for § PM § EHR (overall) § EHR e-Prescribing [Terminate if 1 or 2] · If you have used similar or competing products, describe your level of expertise in those products [it is not necessary to name the product(s) unless they want to]. Contact Information [If the person matches your qualifications, ask for any info we do not have] May I have your contact information? · Name of participant: · Office Key: · Best phone number: · Email address: Those are all the questions I have for you. Your background matches the people we're looking for. Would you be able to participate on [date, time]? Alternative: select from a list of sessions [ideal approach] Alternative; What would be the best date and time for you? Before your session starts, we will ask you to verbally acknowledge a release form allowing us to record your session. The recording will only be used internally for further study if needed and will never be used for advertising or marketing purposes. Also, you will not be personally identified with any recording. Will you consent to be recorded? [Terminate if no] This study will take place remotely via conferencing software, allowing you to participate in the session at the place of your choosing. I will confirm your appointment a couple of days before your session and provide you with any additional information. What is the best time to contact you? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 15 Appendix 2: PARTICIPANT DEMOGRAPHICS Following is a high-level overview of the participants in this study. Gender Men Women Total (participants) Occupationan/Role RN/NP/MA Physician Total (participants) Years of Experience (average) Professional EHR Product Use 2 5 7 4 3 7 23.71 2.86 Demographic detail Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Occupation / role Age 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Enabledoc LLC ©2015 Confidential and Proprietary Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Version 1 Product Experience (yrs) 3 3 4 3 3 3 1 16 Appendix 3: Informed Consent Form Enabledoc would like to thank you for participating in this study. The purpose of this study is to evaluate an electronic health records system. If you decide to participate, you will be asked to perform several tasks using the prototype and give your feedback. The study will last up to 60 minutes. Agreement I understand and agree that as a voluntary participant in the present study conducted by Enabledoc. I am free to withdraw consent or discontinue participation at any time. I understand and agree to participate in the study conducted by Enabledoc. I understand and consent to the use and release of the recording by Enabledoc. I understand that the information and recording is for research purposes only and that my name and image will not be used for any purpose other than research. I relinquish any rights to the recording and understand the recording may be copied and used by Enabledoc without further permission. I understand and agree that the purpose of this study is to make software applications more useful and usable in the future. I understand and agree that the data collected from this study will not be shared outside of Enabledoc I understand and agree that data confidentiality is assured, because only de-identified data – i.e., identification numbers not names – will be used in analysis and reporting of the results. I agree to immediately raise any concerns or areas of discomfort with the study administrator. I understand that I can leave at any time. Please check or verbally indicate one of the following: YES, I have read the above statement and agree to be a participant. NO, I choose not to participate in this study. Signature: _____________________________________ Date: ____________________ Enabledoc LLC ©2015 Confidential and Proprietary Version 1 17 Appendix 4: Task Scenarios Note: In conjunction with this usability study were tasks relating to Clinical Information Reconciliation. The results of that study are described in a separate report and not included here. The two tasks of that study (#8 & #9) are included in this task scenario document in light grey text and are irrelevant to this report. Usability Task Scenarios – CDS Note: in all tasks, please complete only to the point where any new information is ready to be saved or signed. Please do not sign any prescriptions or perform the final completion step! 1. Patient George Burns is coming in for diabetes checkup. After code E11.00 is selected. Click Superbill to trigger Diabetes Type II alert. Click information link at bottom of screen. Change status to completed. Overall, how difficult or easy did you find this task? Very Difficult 1 2 3 Very Easy 4 5 2. Patient Hally Clinton is taking Warfarin 10 mg oral tablet for 30days 1 tablet once a day. The current medication is entered and saved. Superbill is clicked and triggers an alert. Review the detailed information regarding warnings with Warfarin by clicking the medication link and change the status to Completed. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 3. Patient Jesus Trump has a severe allergy to aspirin and gets a rash that makes his complexion look Mexican. Select Aspiring as the allergy, select rash and select severe, then click Save. Click superbill to activate the alert. Click the information link to see more information about aspirin allergies, then click Completed. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 4. Patient Max Carson had a WBC lab test which returned a 10 Hemoglobin result. Click superbill triggers alert to check information on low Hemoglobin results, then click Completed. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 18 Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 5. Donald Obama has vitals entered for 6 feet and 250 pounds, which generates a BMI over 30. Click superbill to trigger an alert. Review the guidance and select Completed. 6. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 7. Sam Adams is now over 50 years old and has a physical. Click Superbill provides guidance on other tests Sam should have. Select Completed. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 8. Bo Hussien is over 50 years old and has straining on urination. Click superbill triggers guidance to have a PSA test performed to check for prostate cancer. Click information link to find out other possible diagnosis. Select completed. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 Enabledoc LLC ©2015 Confidential and Proprietary 4 Version 1 5 19 Appendix 5: Usability Test Administration Moderator’s Guide 1. Items often forgotten a. Stop watch for recording time on task b. Elapsed time timer to time code observations/comments in the recording 2. Office Key Setup a. Environment b. Obtain copy of user key database if required for test c. Any required feature access d. Create and enter any necessary test data e. Create Database / Office Key snapshot 3. Schedule Join.Me sessions 4. Schedule participants 5. Supply test participants with materials prior to test a. Join.Me access b. Task scenarios (be prepared to resend at the start of the test – do not assume the participant has multiple monitors, so they may also need to print the scenarios) c. Informed consent form (can be done verbally during the session) 6. Set up administrative / test PC a. Join.Me installed and up to date b. Shut down all programs not needed for the test – remember things like Communicator c. Turn off notifications – audible and screen – on any software that may be running during the test (e.g.: Outlook) d. Ensure the application installed and functional 7. Running a test session a. Ensure office key/database snapshot of base data exists b. Start EHR session on test PC and arrive at starting screen for test c. Select first patient if selection is not part of the task scenario d. Start Join.Me session e. Share appropriate screen f. Greet user g. Administer introductory materials to user (see below, following checklist) h. Start Join.Me recording i. Display informed consent form on shared screen j. Obtain consent via verbal acceptance k. Give mouse and keyboard control to ALL l. Have user work through tasks m. For each task, record i. Time on task ii. Critical errors (anything that constitutes task failure) iii. Minor errors (anything the user detects and recovers) iv. Deviation(s) from optimal path v. Interesting comments (try to include recording time stamp for reference) Enabledoc LLC ©2015 Confidential and Proprietary Version 1 20 n. After each task or task set (see specific scenarios) ask for response to single ease of use question o. Allow verbal response to any questions contained in task scenarios p. At end of all tasks, display SUS questionnaire and have the participant place an X in appropriate response to each statement i. Save SUS with participant code as part of file name q. Conduct debrief to solicit any additional feedback, comments, Q&A, etc. Introductory script: Thank you for participating in this study. Your input is very important. Our session today will last about 30 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screenshots of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. [Show informed consent document and get verbal acceptance] Do you have any questions or concerns before we begin? Let’s start with some basic information: What is your job title? How long have you been in this profession? What is your specialty? How long have you used the EHR? How do you learn about new features as they are added to the EHR? [if necessary, prompt about reading release notes, viewing training videos, using the help system, or do they just start using the feature] In today’s session, we will be using some new features that are currently being developed. Let’s go over those now so you will have some familiarity. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 21 The first new feature is called the Infobutton, denoted by a small blue “i” icon that appears as necessary to provide additional clinical information. The second new feature is a tool to retrieve incoming clinical information for a patient that is sent electronically from another provider outside your practice. This tool is to resolve discrepancies or duplicate information between the incoming record and the clinical record that is in your EHR. [important: only ask the following question if they indicated that they review/read release notes, view training videos, etc. based on their earlier answer regarding how they find out about new features and how to use them. Be ready to display the help file.] Would you like to review the help topic for this feature now? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 22 Appendix 6: Sample data collection form Summative Usability Test Data Log Test type: Participant: Participant code: Session Date/start time: File name: Task 1: · · · · · · Critical Error count: Minor error count: Optimal path deviations: Time on task: SEoUQ response: Comments/observations: <repeat for each task> Enabledoc LLC ©2015 Confidential and Proprietary Version 1 23 Appendix 7: System Usability Scale Questionnaire In 1996, Brooke published a “low-cost usability scale that can be used for global assessments of systems usability” known as the System Usability Scale or SUS. Lewis and Sauro (2009) and others have elaborated on the SUS over the years. Computation of the SUS score can be found in Brooke’s paper, at http://www.usabilitynet.org/trump/documents/Suschapt.doc or in Tullis and Albert (2008). Strongly Disagree 1. I think that I would like to use this system frequently Strongly agree 1 2 3 4 Strongly Disagree 5 Strongly agree 2. I found the system unnecessarily complex 1 2 3 4 5 1 2 3 4 5 3. I thought the system was easy to use 4. I think that I would need the support of a technical person to be able to use this system 5. I found the various functions in this system were well integrated 6. I thought there was too much inconsistency in this system 7. I would imagine that most people would learn to use this system very quickly 8. I found the system very cumbersome to use Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 Version 1 24 9. I felt very confident using the system 10. I needed to learn a lot of things before I could get going with this system Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 Version 1 25 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 26 EHR Usability Test Report of Enablemyhealth EHR Drug-Drug & DrugAllergy Interaction Checking Safety-Enhanced Design 170.314(g)(3) Report based on ISO/IEC 25062:2006 Common Industry Format for Usability Test Reports Date of Usability Test: 15 AUG 2015 – 14 SEP 2015 Date of Report: 14 SEP 2015 Report Prepared By: Stephen Rothschild 877.540.0933 steve@enabledoc.com EnableDoc LLC 7700 Falstaff Road McLean VA 22104 Table of Contents 1 Executive Summary ............................................................................................................................... 2 2 INTRODUCTION ..................................................................................................................................... 3 3 METHOD................................................................................................................................................ 4 4 5 3.1 PARTICIPANTS ............................................................................................................................... 4 3.2 STUDY DESIGN............................................................................................................................... 5 3.3 TASKS............................................................................................................................................. 5 3.4 PROCEDURES................................................................................................................................. 6 3.5 TEST LOCATION ............................................................................................................................. 7 3.6 TEST ENVIRONMENT ..................................................................................................................... 7 3.7 TEST FORMS AND TOOLS .............................................................................................................. 7 3.8 PARTICIPANT INSTRUCTIONS ........................................................................................................ 7 3.9 USABILITY METRICS ....................................................................................................................... 8 3.10 DATA SCORING .............................................................................................................................. 8 RESULTS .............................................................................................................................................. 10 4.1 DATA ANALYSIS AND REPORTING ............................................................................................... 10 4.2 DISCUSSION OF THE FINDINGS ................................................................................................... 10 4.3 EFFECTIVENESS ........................................................................................................................... 11 4.4 EFFICIENCY .................................................................................................................................. 11 4.5 SATISFACTION ............................................................................................................................. 11 4.6 MAJOR FINDINGS ........................................................................................................................ 11 4.7 AREAS FOR IMPROVEMENT ........................................................................................................ 12 APPENDICES ........................................................................................................................................ 12 Appendix 1: PARTICIPANT RECRUITING SCREENER ................................................................................ 12 Appendix 2: PARTICIPANT DEMOGRAPHICS ........................................................................................... 15 Appendix 3: Informed Consent Form...................................................................................................... 16 Appendix 4: Task Scenarios ..................................................................................................................... 17 Appendix 5: Usability Test Administration Moderator’s Guide .............................................................. 17 Appendix 6: Sample data collection form ............................................................................................... 20 Appendix 7: System Usability Scale Questionnaire ................................................................................ 21 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 1 1 Executive Summary A usability test of EnableMyHealth – 2014.1, an ambulatory EHR, was conducted on 15 Aug 2015 – 14 Sep 2015 in the McLean, VA and Rochester MN offices of EnableDoc LLC. The purpose of this test was to test and validate the usability of the current user interface for Drug-Drug &Drug-Allergy Interaction Checking, and provide evidence of usability in the EHR Under Test (EHRUT). During the usability test, five healthcare providers and clinical staff matching the target demographic criteria served as participants and used the EHRUT in simulated, but representative tasks. This study collected performance data on 2 electronic prescription tasks that trigger drug-drug or drugallergy interaction warnings in an EHR where the user is required to: · · Enter a Drug-Drug intervention notification Enter a Drug-Allergy Intervention notification All test participants conducted the test sessions remotely via on-line conferencing software. During the 15 minute one-on-one usability test, each participant was greeted by the administrator and asked to review and verbally acknowledge an informed consent/release form (included in Appendix 3); they were instructed that they could withdraw at any time. Participants had prior experience with the EHR as they are current users/customers. No additional training materials were provided other than that usually given to customers. The administrator introduced the test and instructed participants to complete a series of tasks (given one at a time) using Enablemyhealth. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. Participant screens and audio were recorded for subsequent analysis. The following types of data were collected for each participant: • Number of tasks successfully completed within the allotted time without assistance • Time to complete the tasks • Participant’s subjective assessment of the ease of each task • Number and types of errors • Path deviations • Participant’s verbalizations • Participant’s satisfaction ratings of the system All participant data was de-identified – no correspondence could be made from the identity of the participant to the data collected. Following the conclusion of the testing, participants were asked to complete a post-test questionnaire and were compensated with a $50 gift card for their time. Following the conclusion of the testing, participants were asked to complete a post-test SUS questionnaire. Various recommended metrics, in accordance with the examples set forth in the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, were used to evaluate the usability of the EHRUT. Result data matrix - refer to Appendix 4 for complete task descriptions Enabledoc LLC ©2015 Confidential and Proprietary Version 1 2 MEASURES TASKS Number Task Success Drug- Drug Interaction 6 100.00 Drug- Allergy Interaction 3 100.00 Mean across tasks 100.00 Path Deviations (Observed / Optimal) 1.1 (14.7/13) 1.1 (12.1/11) Task Time Mean (SD) 72 (3.5) 68.4 (3.3) Task Time Deviations (Observed / Optimal) 1.1 (72/65) 1.1 (68.4/60) 1.1 (13.4/12) 70 (3.4) 1.1 (70/62.5) Errors Mean Task Ratings 5=Easy (SD) Mean (SD) 3.7 (0.5) 1.86 (1.1) 4.1 (0.6) 0.57 (0.7) 1.2 (0.9) 3.9 (0.6) The results from the System Usability Scale scored the subjective satisfaction with the system based on performance with these tasks to be: 81. In addition to the performance data, the following qualitative observations were made: Major findings · · Same issues with adding CPOE prescriptions and medications: 1. Providers tend to just want to write or dictate the script rather then select a frequency of use 2. Medications other than tablets (e.g.: injectables, inhalers) presented the most serious challenges 3. Most frequent challenge was determining units of medication when none is defaulted. 4. Changing a prescription frequency of use was not easily understood and preference is just to modify the script directions Participants inquired why they had to over-ride the notifications with typing a reason. Areas for improvement · · · · · 2 Add default units for all prescriptions Provide aids in recommended dosage based on patient BSA, age, gender, and diagnosis. Provide ability to type or speak script and parse data to build the prescription script. Add a wizard for first time or novice users for adding prescriptions. Add a drop down of common override reasons and do not require the box to also be checked. INTRODUCTION The EHRUT tested for this study was EnableMyHealth EHR4 Release, an ambulatory EHR. Designed to present medical information to healthcare providers in primarily group practices with a focus on family practice, surgery, eye, and PT/OT/Chiropractic medicine, the EHRUT consists of modules and features that include but not limited to support for tested functionality: · Patient demographics · Patient problem and allergy lists · Creating lab orders and receiving lab results · Immunization recording Enabledoc LLC ©2015 Confidential and Proprietary Version 1 3 · · · Electronic prescribing Drug-drug, drug-allergy, and drug-problem interaction checking Clinical decision support The EHRUT is used predominantly by physicians and clinical staff such as MA’s, RN’s, LPN’s, etc. The usability testing attempted to represent realistic exercises and conditions. The purpose of this study was to test and validate the usability of the current user interface, and provide evidence of usability of the entry and modification of electronic prescriptions, laboratory orders, and imaging orders in the EHR Under Test (EHRUT).To this end, measures of effectiveness, efficiency and user satisfaction, such as successful task completion rate, time on task, number and types of errors, and participant satisfaction were captured during the usability testing. 3 3.1 METHOD PARTICIPANTS A total of 7 participants were tested on the CPOE feature of the EHRUT. Participants in the test were physicians and clinical staff such as RNs and MAs. Participants were recruited by Enabledoc staff from existing customers and paid a $50 gift card for their help in testing. Participants had no direct connection to the development of or organization producing the EHRUT other than being current customers. Participants were not from the testing or supplier organization. Participants were actual end users and thus have the same orientation and level of training as other non-participant customers. For the test purposes, end-user characteristics were identified and translated into an internal recruitment screener used to solicit potential participants; an example of a screener is provided in Appendix [1]. Recruited participants had a mix of backgrounds and demographic characteristics conforming to the recruitment screener. The following is a table of participants by characteristics, including demographics, professional experience, computing experience and user needs for assistive technology. Participant names were replaced with Participant IDs so that an individual’s data cannot be tied back to individual identities. Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Age Occupation / role 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Enabledoc LLC ©2015 Confidential and Proprietary Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Version 1 Product Experience (yrs) 3 3 4 3 3 3 1 4 Seven (7) participants (matching the demographics in the section on Participants) were recruited and all participated in the usability test. 3); they were instructed that they could withdraw at any time. Participants all had prior experience with the EHR. No participants failed to show for the study. Participants were scheduled for 15 minute sessions with 15 minutes in between each session for debrief by the administrator and data logger, and to reset systems to proper test conditions. All testing was performed over several days to allow the participants to schedule time at their convenience. A spreadsheet was used to keep track of the participant schedule. The administrator introduced the test, and instructed participants to complete a series of tasks (given one at a time) using the EHRUT. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. 3.2 STUDY DESIGN The objective of this test was to perform summative testing to measure the key usability metrics of effectiveness, efficiency, and user satisfaction. These metrics will uncover areas where the application performed well and areas where the application failed to meet the needs of the participants in achieving our internal usability goals. The data from this test may serve as a baseline for future tests with an updated version of the same EHR and/or comparison with other EHRs provided the same tasks are used. In short, this testing serves as both a means to record or benchmark current usability, but also to identify areas where improvements should be made. During the usability test, participants interacted exclusively with the EHRUT. Each participant used the system in their preferred location, and was provided with the same instructions. All sessions were conducted remotely with Join.Me conferencing software. Screens with associated interaction and the audio stream were recorded for later analysis. The system was evaluated for effectiveness, efficiency and satisfaction as defined by measures collected and analyzed for each participant: • Number of tasks successfully completed within the allotted time without assistance • Time to complete the tasks • Number and types of errors • Path deviations • Participant’s verbalizations (comments) • Participant’s satisfaction ratings of the system Additional information about the various measures can be found in Section 3.9 on Usability Metrics. 3.3 TASKS Tasks were constructed that would be realistic and representative of the kinds of activities a user might do with this EHR in the area of [describe feature under study] and heavily based on the CMS test scripts for Meaningful Use Phase 2. The tasks for this study included: • Create a prescription that triggers a drug-drug interaction check • Create a prescription that triggers a drug-allergy interaction check Task Selection and Priority Enabledoc LLC ©2015 Confidential and Proprietary Version 1 5 Tasks were selected based on their frequency of use, criticality of function, and those that may be most troublesome for users. The tasks were directly modeled on the CMS Drug-Drug/Drug-Allergy Interaction test procedure [170.314(a)(2)]. Tasks were ordered and prioritized based on their impact on patient safety, in which the tasks that had the greatest potential for patient harm due to critical errors were performed first. Thus the entry of prescriptions that triggered drug-drug or drug-allergy interaction checks were followed by modifying a prescription to a new drug that then triggered an interaction check. The task scenario document is contained in appendix 4. 3.4 PROCEDURES Just prior to the scheduled time, the test administrator started the join.me session and greeted the participant on arrival; their identity was verified and matched with a name on the participant schedule. Participants were then assigned a participant ID. Recording of the session was started using the join.me recording feature. Each participant reviewed and agreed to the informed consent and release form via verbal acknowledgment (See Appendix 3). A representative from the test team witnessed the participant’s verbal agreement. To ensure that the test ran smoothly, testing was performed remotely by an experienced usability practitioner with over 25 years of experience in healthcare user interface and workflow design. The administrator moderated the session including administering instructions and tasks. The administrator also monitored task times, obtained post-task rating data, took notes on participant comments, path deviations, number and type of errors, and comments. Participants were instructed to perform the tasks (see specific instructions below): · · · As quickly as possible making as few errors and deviations as possible. Without assistance; administrators were allowed to give immaterial guidance and clarification on tasks, but not instructions on use. Without using a think aloud technique. For each session, the participants were given an electronic copy of the tasks for that session. They were requested to not read the tasks prior to the session. Participants were asked to read the task aloud prior to each task; task timing began once the participant finished reading the question and verbally indicated they were starting the task. The task time was stopped once the participant indicated they had successfully completed the task. Scoring is discussed below in Section 3.9. Following the session, the administrator gave the participant the post-test questionnaire (the System Usability Scale, see Appendix 7), solicited any further comments, and thanked each individual for their participation. Participants' demographic information, task success rate, time on task, errors, deviations, verbal responses, and post-test questionnaire were recorded into a spreadsheet. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 6 3.5 TEST LOCATION 3.6 TEST ENVIRONMENT The test was conducted remotely through the use of Join.Me virtual conferencing and screen sharing software. Thus the actual test location was at the discretion of the test participants. The test administrator conducted the test from Enabledoc LLC offices in Rochester MN. The EHRUT would be typically be used in a healthcare office or facility. In this instance, the testing was conducted in healthcare office. For testing, the computer used a Windows laptop running Windows OS and Chrome browser. The participants used a mouse and keyboard when interacting with the EHRUT. The Enablemyhealth application was used on a 13 inch laptop with 1366 by 768 resolution and 32 bit color. The application was set up by the vendor according to the vendor’s documentation describing the system set-up and preparation. The application itself was running on a Windows 2012 Server using a test database on a WAN connection. Technically, the system performance (i.e., response time) was representative to what actual users would experience in a field implementation with a minor lag caused by video screen sharing and recording. Additionally, participants were instructed not to change any of the default system settings (such as control of font size). 3.7 TEST FORMS AND TOOLS During the usability test, various documents and instruments were used, including: • Informed Consent • Test task scenarios • Moderator’s Guide • Observer’s data collection template • Post-test SUS Questionnaire Examples of these documents can be found in Appendices 3 – 7 respectively. The participant’s interaction with the EHRUT was captured and recorded digitally using the screen recording capability of join.me running on the test machine. This recording included the audio stream of verbalizations. The test sessions were electronically transmitted to any additional observers who logged into the join.me session. 3.8 PARTICIPANT INSTRUCTIONS The administrator reads the following instructions aloud to the each participant (also see the full moderator’s guide in Appendix 5): Thank you for participating in this study. Your input is very important. Our session today will last about 15 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 7 I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screen interaction of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. Following the procedural instructions, participants were started with a specific patient’s chart data. Prior to giving the participant mouse and keyboard control, the moderator gave the following instructions: For each task, I will ask you to read the task and indicate when you begin. At that point, please perform the task and say “Done” once you believe you have successfully completed the task. I would like to request that you not talk aloud or verbalize while you are doing the tasks. You may certainly ask questions if necessary and we may provide guidance or a hint, however we will not provide direct instruction during the tasks. I will ask you your impressions about the task once you are done. Participants were then given 4 tasks to complete. Tasks are listed in Appendix 4. 3.9 USABILITY METRICS According to the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, EHRs should support a process that provides a high level of usability for all users. The goal is for users to interact with the system effectively, efficiently, and with an acceptable level of satisfaction. To this end, metrics for effectiveness, efficiency and user satisfaction were captured during the usability testing. The goals of the test were to assess: 1. Effectiveness of ENABLEMYHEALTH EHR by measuring participant success rates and errors 2. Efficiency of ENABLEMYHEALTH EHR by measuring the average task time and path deviations 3. Satisfaction with ENABLEMYHEALTH EHR by measuring ease of use ratings 3.10 DATA SCORING The following table details how tasks were scored, errors evaluated, and the time data analyzed: Rationale and Scoring Measure Effectiveness: A task was counted as a “Success” if the participant was able to achieve the Enabledoc LLC ©2015 Confidential and Proprietary Version 1 8 Task Success correct outcome, without assistance, within the overall time allotted for the entire set of tasks. The total number of successes were calculated for each task and then divided by the total number of times that task was attempted. The results are provided as a percentage. Task times were recorded for successes. Observed task times divided by the optimal time for each task is a measure of optimal efficiency. Due to the variability of multiple correct paths and a large variety of user settable preferences, all of which can affect time on task, optimal task times and deviations from these times were unrealistic to assess. All participants were trained on Enablemyhealth EHR and so the performance factor of 1.0 was use. The overall usability goal for any feature of the EHR is task time that is deemed acceptable by the end user with no critical errors. Thus, if expert, optimal performance on a task was [60] seconds then allotted task time performance was [60 * 1.0] seconds. This ratio is aggregated across tasks and reported with mean and variance scores. Effectiveness: Task Failures Efficiency: Task Deviations If the participant abandoned the task, did not reach the correct answer, performed it incorrectly, or was unsure if they had completed the task, the task was counted as a “Critical Failure.” No task times were taken for failed tasks. Minor errors were defined as an errant click, initial selection of an incorrect menu option, or incorrect entries that the participant noticed and corrected. The total number of errors was calculated for each task and then divided by the total number of times that task was attempted. Minor errors and deviations were noted but not counted as significant errors. This is expressed as the mean number of failed tasks per participant. The participant’s path (i.e., steps) through the application was recorded. Deviations occur if the participant, for example, went to a wrong screen, clicked on an incorrect menu item, followed an incorrect link, or interacted incorrectly with an on-screen control. These path deviations were included in the minor error count. The minor error count is expressed as an average across all participants. Efficiency: Task Time Satisfaction: Task Rating Each task was timed from when the participant indicated they were beginning the task until the participant said “Done.” If he or she failed to say “Done,” the time was stopped when the participant stopped performing the task. Only task times for tasks that were successfully completed were included in the average task time analysis. Average time per task was calculated for each task as was variance (standard deviation). Participant’s subjective impression of the ease of use of the application was measured by administering both a simple post-task question as well as a post-session questionnaire. After each task, the participant was asked to rate “Overall, this task was:” on a scale of 1 (Very Difficult) to 7 (Very Easy). Average difficulty ratings per task were calculated as was variance. Common convention is that average ratings for systems judged easy to use Enabledoc LLC ©2015 Confidential and Proprietary Version 1 9 should be 3.3 or above. To measure participants’ confidence in and likeability of the ENABLEMYHEALTH EHR feature overall, the testing team administered the System Usability Scale (SUS) post-test questionnaire. Questions included, “I think I would like to use this system frequently,” “I thought the system was easy to use,” and “I would imagine that most people would learn to use this system very quickly.” See full System Usability Score questionnaire in Appendix 7. 4 4.1 RESULTS DATA ANALYSIS AND REPORTING The results of the usability test were calculated according to the methods specified in the Usability Metrics section above. Participants who failed to follow session and task instructions had their data excluded from the analyses, however there were no instances of this occurring. The usability testing results for the ENABLEMYHEALTH EHR are detailed below (Table 1). The results should be seen in light of the objectives and goals outlined in Section 3.2 Study Design. The data should yield actionable results that, if corrected, yield material, positive impact on user performance. Table 1 MEASURES TASKS Number Task Success Drug- Drug Interaction 6 100.00 Drug- Allergy Interaction 3 100.00 Mean across tasks 100.00 Path Deviations (Observed / Optimal) 1.1 (14.7/13) 1.1 (12.1/11) Task Time Mean (SD) 72 (3.5) 68.4 (3.3) Task Time Deviations (Observed / Optimal) 1.1 (72/65) 1.1 (68.4/60) 1.1 (13.4/12) 70 (3.4) 1.1 (70/62.5) Errors Mean Task Ratings 5=Easy (SD) Mean (SD) 3.7 (0.5) 1.86 (1.1) 4.1 (0.6) 0.57 (0.7) 1.2 (0.9) 3.9 (0.6) The results from the SUS (System Usability Scale) scored the subjective satisfaction with the system based on performance with these tasks to be: 81. Broadly interpreted, this indicates above average usability, but with further room for improvement. 4.2 DISCUSSION OF THE FINDINGS Overall, the CPOE feature of Enablemyhealth user experience exhibits good effectiveness, with no critical errors out of 14 attempted tasks, but there were 1.2 mean deviations errors across all tasks. This is within internal usability goal guidelines. Of the total 17 deviation errors, 13 were attributable to electronic prescribing, which was primarily finding the correct prescription, dosage/form and measurement unit, which was consistent with the CPOE and eRx test results. Efficiency measures indicate that while acceptable, there is room for improvement, specifically in the electronic prescription interface, although searching for labs and radiology orders can also be difficult if the names of the tests do not match the terminology used by the participant. One older user took Enabledoc LLC ©2015 Confidential and Proprietary Version 1 10 significantly longer time to perform every task, but this can also be attributed to nervousness and second guessing themselves. Satisfaction, measured by an SUS score of 81 is very good, but can be improved. Working to make the user experience more natural and intelligent will improve the overall user experience and help guide the novice and advanced users. 4.3 EFFECTIVENESS Based on the success rate, minor error rate, and critical error rate data, the CPOE feature has an acceptable level of effectiveness. The usability test consisted of 14 tasks of which 14 were attempted. Out of the 14 attempted tasks, there were no critical errors, giving a successful completion rate of 100%. The 13 deviation (minor) errors in the electronic prescriptions were difficulties associated non defaulting scripts that required making changes in each field to build the script. Order sets were not used in this testing and can eliminate the problem of complex prescription and other types of orders. The deviation error mean of 1.2 is within the acceptable range of effectiveness, with the errors most often being finding the order by spelling it. 4.4 EFFICIENCY Observation of task time is the primary area for improvement. The mean task time across all tasks is 70.2 seconds out of an optimal 62.5 was primary caused by searching for medications and reading the interaction guidance. Drug-Drug interaction testing took 4 seconds longer to enter the medication than drug-allergy, but the results were just about 1 standard deviation apart. Overall, improving efficiency is really related to medication CPOE improvements. 4.5 SATISFACTION Based on task difficulty ratings and SUS results data, user satisfaction of the feature is considered favorable. Users perception of ease of use is considered easy, with a mean rating of 3.9 across all tasks (1=very difficult, 5=very easy). SUS scoring is very good with a score of 81. These scores accurately describe the average patient satisfaction with Enablemyhealth feature set. SUS Scoring Mean StDev 4.6 81.07 3.98 MAJOR FINDINGS The major usability problems encountered in this study were: · Same issues with adding CPOE prescriptions and medications: Enabledoc LLC ©2015 Confidential and Proprietary Version 1 11 · 4.7 1. Providers tend to just want to write or dictate the script rather then select a frequency of use 2. Medications other than tablets (e.g.: injectables, inhalers) presented the most serious challenges 3. Most frequent challenge was determining units of medication when none is defaulted. 4. Changing a prescription frequency of use was not easily understood and preference is just to modify the script directions Participants inquired why they had to over-ride the notifications with typing a reason. AREAS FOR IMPROVEMENT Electronic prescribing with alerts: · · · · · 5 Add default units for all prescriptions Provide aids in recommended dosage based on patient BSA, age, gender, and diagnosis. Provide ability to type or speak script and parse data to build the prescription script. Add a wizard for first time or novice users for adding prescriptions. Add a drop down of common override reasons and do not require the box to also be checked. APPENDICES The following appendices include supplemental data for this usability test report. Following is a list of the appendices provided: 1: Participant Recruiting Screener 2: Participant demographics 3: Informed Consent Form 4: Task Scenarios 5: Moderator’s Guide 6: Sample data collection form 7: System Usability Scale Questionnaire Appendix 1: PARTICIPANT RECRUITING SCREENER Introduction Hello, my name is __. Enabledoc is seeking doctors and clinicians who are users of • Electronic prescribing software • Computerized order entry (such as labs and imaging) • Medication list and medication allergy list management Enabledoc LLC ©2015 Confidential and Proprietary Version 1 12 to take part in a usability study of that portion of the EnableMyHealth EHR. This study will assist us in designing and developing a solution that meets your needs. Your experiences in using this particular design will greatly help our designers and developers. The testing of our design will take place in your office using remote meeting technology, requiring only your time, thoughts, and suggestions. We expect the session to last approximately 45 minutes. Does this sound like something that interests you? Before I schedule you for a session, do you have a few moments to answer some questions? General Questions 1. Are you male or female? [Recruit a mix of participants] 2. Have you participated in a focus group or usability test in the past three months? [Note but do not terminate if yes] 3. Which of the following best describes your age? [25 or less; 26 to 39; 40 to 59; 60 to 74; 75 and older][Recruit a mix of ages] Professional Demographics 4. What is your current position/role in your practice? 5. How long have you been in this role? 6. Do you currently perform e-prescribing? [computerized order entry, manage medication and medication allergy lists – pick appropriate for test][Terminate if no to specific task for test] How many prescriptions [or lab orders – use appropriate choice for test] do you write per day (or week if that is a better estimate)? 7. What year did you receive your medical degree? Computer Expertise 8. About how many hours per week do you spend on the computer that is medical practice related? [Recruit a range of use, e.g., 0 to 10, 11 to 25, 26+ hours per week][Terminate if less than 5] 9. Do you use a computer outside of your medical work? 10. If so, about how many hours per week do spend using a computer for non-work related endeavors? 11. Regarding your use of ADP Advancedmd Practice Manager & EHR, what percentage of time is spent in each product? (per day) Domain Knowledge · Rate your expertise or comfort in using ADP Advancedmd software on a scale of 1 to 5 (1=just starting, 5=expert) for § PM § EHR (overall) § EHR e-Prescribing [Terminate if 1 or 2] Enabledoc LLC ©2015 Confidential and Proprietary Version 1 13 · If you have used similar or competing products, describe your level of expertise in those products [it is not necessary to name the product(s) unless they want to]. Contact Information [If the person matches your qualifications, ask for any info we do not have] May I have your contact information? · Name of participant: · Office Key: · Best phone number: · Email address: Those are all the questions I have for you. Your background matches the people we're looking for. Would you be able to participate on [date, time]? Alternative: select from a list of sessions [ideal approach] Alternative; What would be the best date and time for you? Before your session starts, we will ask you to verbally acknowledge a release form allowing us to record your session. The recording will only be used internally for further study if needed and will never be used for advertising or marketing purposes. Also, you will not be personally identified with any recording. Will you consent to be recorded? [Terminate if no] This study will take place remotely via conferencing software, allowing you to participate in the session at the place of your choosing. I will confirm your appointment a couple of days before your session and provide you with any additional information. What is the best time to contact you? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 14 Appendix 2: PARTICIPANT DEMOGRAPHICS Following is a high-level overview of the participants in this study. Gender Men Women Total (participants) 2 5 7 Occupationan/Role RN/NP/MA Physician Total (participants) 4 3 7 Years of Experience (average) Professional EHR Product Use 23.71 2.86 Demographic detail Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Age Occupation / role 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Enabledoc LLC ©2015 Confidential and Proprietary Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Version 1 Product Experience (yrs) 3 3 4 3 3 3 1 15 Appendix 3: Informed Consent Form Enabledoc would like to thank you for participating in this study. The purpose of this study is to evaluate an electronic health records system. If you decide to participate, you will be asked to perform several tasks using the prototype and give your feedback. The study will last up to 60 minutes. Agreement I understand and agree that as a voluntary participant in the present study conducted by Enabledoc. I am free to withdraw consent or discontinue participation at any time. I understand and agree to participate in the study conducted by Enabledoc. I understand and consent to the use and release of the recording by Enabledoc. I understand that the information and recording is for research purposes only and that my name and image will not be used for any purpose other than research. I relinquish any rights to the recording and understand the recording may be copied and used by Enabledoc without further permission. I understand and agree that the purpose of this study is to make software applications more useful and usable in the future. I understand and agree that the data collected from this study will not be shared outside of Enabledoc I understand and agree that data confidentiality is assured, because only de-identified data – i.e., identification numbers not names – will be used in analysis and reporting of the results. I agree to immediately raise any concerns or areas of discomfort with the study administrator. I understand that I can leave at any time. Please check or verbally indicate one of the following: YES, I have read the above statement and agree to be a participant. NO, I choose not to participate in this study. Signature: _____________________________________ Date: ____________________ Enabledoc LLC ©2015 Confidential and Proprietary Version 1 16 Appendix 4: Task Scenarios Usability Task Scenarios – Drug – Drug and Drug – Allergy Interaction Participant account is set for Interaction of High, Medium and Low Severity. Access the clinical information for Garth Brooks by clicking Patient Center, then click Open Note and perform these steps to trigger Drug – Drug Notification: 1. Click Current Medications and select Warfarin 10 mg tablet and click Save. 2. Click Prescription tab and select aspirin 325 mg oral tablet and click Save. 3. Review interaction guidance and click Close. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 1. Click Allergies and select amoxicillin, select fever, select severe and click Save. 2. Click Prescription tab and select azithromycin 250 mg oral tablet, enter 1 for dosage, and 10 days and click Save. 3. Review interaction guidance and click Close. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 Appendix 5: Usability Test Administration Moderator’s Guide 1. Items often forgotten a. Stop watch for recording time on task b. Elapsed time timer to time code observations/comments in the recording 2. Office Key Setup a. Environment b. Obtain copy of user key database if required for test c. Any required feature access d. Create and enter any necessary test data e. Create Database / Office Key snapshot 3. Schedule Join.Me sessions Enabledoc LLC ©2015 Confidential and Proprietary Version 1 17 4. Schedule participants 5. Supply test participants with materials prior to test a. Join.Me access b. Task scenarios (be prepared to resend at the start of the test – do not assume the participant has multiple monitors, so they may also need to print the scenarios) c. Informed consent form (can be done verbally during the session) 6. Set up administrative / test PC a. Join.Me installed and up to date b. Shut down all programs not needed for the test – remember things like Communicator c. Turn off notifications – audible and screen – on any software that may be running during the test (e.g.: Outlook) d. Ensure the application installed and functional 7. Running a test session a. Ensure office key/database snapshot of base data exists b. Start EHR session on test PC and arrive at starting screen for test c. Select first patient if selection is not part of the task scenario d. Start Join.Me session e. Share appropriate screen f. Greet user g. Administer introductory materials to user (see below, following checklist) h. Start Join.Me recording i. Display informed consent form on shared screen j. Obtain consent via verbal acceptance k. Give mouse and keyboard control to ALL l. Have user work through tasks m. For each task, record i. Time on task ii. Critical errors (anything that constitutes task failure) iii. Minor errors (anything the user detects and recovers) iv. Deviation(s) from optimal path v. Interesting comments (try to include recording time stamp for reference) n. After each task or task set (see specific scenarios) ask for response to single ease of use question o. Allow verbal response to any questions contained in task scenarios p. At end of all tasks, display SUS questionnaire and have the participant place an X in appropriate response to each statement i. Save SUS with participant code as part of file name q. Conduct debrief to solicit any additional feedback, comments, Q&A, etc Thank you for participating in this study. Your input is very important. Our session today will last about 45 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 18 I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screenshots of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 19 Appendix 6: Sample data collection form Summative Usability Test Data Log Test type: Participant: Participant code: Session Date/start time: File name: Task 1: Critical Error count: Minor error count: Optimal path deviations: Time on task: SEoUQ response: Comments/observations: <repeat for each task> Enabledoc LLC ©2015 Confidential and Proprietary Version 1 20 Appendix 7: System Usability Scale Questionnaire In 1996, Brooke published a “low-cost usability scale that can be used for global assessments of systems usability” known as the System Usability Scale or SUS. Lewis and Sauro (2009) and others have elaborated on the SUS over the years. Computation of the SUS score can be found in Brooke’s paper, at http://www.usabilitynet.org/trump/documents/Suschapt.doc or in Tullis and Albert (2008). Strongly Disagree 1. I think that I would like to use this system frequently Strongly agree 1 2 3 4 Strongly Disagree 5 Strongly agree 2. I found the system necessarily complex 1 2 3 4 5 1 2 3 4 5 3. I thought the system was easy to use 4. I think that I would need the support of a technical person to be able to use this system 5. I found the various functions in this system were well integrated 6. I thought there was too much inconsistency in this system 7. I would imagine that most people would learn to use this system very quickly 8. I found the system very cumbersome to use Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 Version 1 21 9. I felt very confident using the system 10. I needed to learn a lot of things before I could get going with this system Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 Version 1 22 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 23 EHR Usability Test Report of EnableMyHealth EHR Electronic Prescribing Safety-Enhanced Design 170.314(g)(3) Report based on ISO/IEC 25062:2006 Common Industry Format for Usability Test Reports Date of Usability Test: 15 AUG 2015 – 14 SEP 2015 Date of Report: 14 SEP 2015 Report Prepared By: Stephen Rothschild 877.540.0933 steve@enabledoc.com EnableDoc LLC 7700 Falstaff Road McLean VA 22104 Table of Contents 1 Executive Summary ............................................................................................................................... 2 2 INTRODUCTION ..................................................................................................................................... 3 3 METHOD................................................................................................................................................ 4 4 5 3.1 PARTICIPANTS ............................................................................................................................... 4 3.2 STUDY DESIGN............................................................................................................................... 5 3.3 TASKS............................................................................................................................................. 6 3.4 PROCEDURES................................................................................................................................. 6 3.5 TEST LOCATION ............................................................................................................................. 7 3.6 TEST ENVIRONMENT ..................................................................................................................... 7 3.7 TEST FORMS AND TOOLS .............................................................................................................. 8 3.8 PARTICIPANT INSTRUCTIONS ........................................................................................................ 8 3.9 USABILITY METRICS ....................................................................................................................... 9 3.10 DATA SCORING .............................................................................................................................. 9 RESULTS .............................................................................................................................................. 10 4.1 DATA ANALYSIS AND REPORTING ............................................................................................... 10 4.2 DISCUSSION OF THE FINDINGS ................................................................................................... 11 4.3 EFFECTIVENESS ........................................................................................................................... 11 4.4 EFFICIENCY .................................................................................................................................. 12 4.5 SATISFACTION ............................................................................................................................. 12 4.6 MAJOR FINDINGS ........................................................................................................................ 12 4.7 AREAS FOR IMPROVEMENT ........................................................................................................ 13 APPENDICES ........................................................................................................................................ 13 Appendix 1: PARTICIPANT RECRUITING SCREENER ................................................................................ 13 Appendix 2: PARTICIPANT DEMOGRAPHICS ........................................................................................... 15 Appendix 3: Informed Consent Form...................................................................................................... 17 Appendix 4: Task Scenarios ..................................................................................................................... 18 5: Usability Test Administration Moderator’s Guide .............................................................................. 18 Appendix 6: Sample data collection form ............................................................................................... 21 Appendix 7: System Usability Scale Questionnaire ................................................................................ 22 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 1 1 Executive Summary A usability test of EnableMyHealth version EMH4, an ambulatory EHR, was conducted between August 15, 2015 and September 14, 2015 in the Rochester MN. office of EnableDoc LLC, and each providers offices. The purpose of this test was to test and validate the usability of the current user interface for Computerized Provider Order Entry, and provide evidence of usability in the EHR Under Test (EHRUT). During the usability test, seven (7) healthcare providers and clinical staff that meet the target demographic and professional profile serve as participants and used Enablemyhealth EHR in simulated, but representative tasks. This study collected performance data on the following these four tasks typically conducted in an EHR: · · · Enter and send one Prescription Enter and send a second Prescription Enter and send a third Prescription All test participants conducted the test sessions remotely via on-line conferencing software. During the 15 minute one-on-one usability test, each participant was greeted by the administrator and asked to review and verbally acknowledge an informed consent/release form (included in Appendix 3); they were instructed that they could withdraw at any time. Participants had prior experience with the EHR as they are current users/customers. No additional training materials were provided other than that usually given to customers. The administrator introduced the test and instructed participants to complete a series of tasks (given one at a time) using Enablemyhealth. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. Participant screens and audio were recorded for subsequent analysis. The following types of data were collected for each participant: • Number of tasks successfully completed within the allotted time without assistance • Time to complete the tasks • Participant’s subjective assessment of the ease of each task • Number and types of errors • Path deviations • Participant’s verbalizations • Participant’s satisfaction ratings of the system All participant data was de-identified – no correspondence could be made from the identity of the participant to the data collected. Following the conclusion of the testing, participants were asked to complete a post-test questionnaire and were compensated with a $50 gift card for their time. Following the conclusion of the testing, participants were asked to complete a post-test SUS questionnaire. Various recommended metrics, in accordance with the examples set forth in the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, were used to evaluate the usability of the EHRUT. Result data matrix - refer to Appendix 4 for complete task descriptions Enabledoc LLC ©2015 Confidential and Proprietary Version 1 2 MEASURES TASKS Send prescription 1 Send prescription 2 Send prescription 3 Number 1 1 1 Mean across tasks 1 Path Deviations Task (Observed / Success Optimal) 100.00 1.9 (12.9/11) 100.00 1.3 (13.1/12) 100.00 1.5 (18/17) 100.00 1.6 (14.7/13.3) Task Time Mean (SD) 96 (8.8)_ 92 (3.1) 90.1 (2.6) Task Time Deviations (Observed / Optimal) 1.2 (96/80) 1.1 (92/81) 1.0 (90.1/86) Errors Mean (SD) 1.9 (1.1) 0.6 (0.7) 0.4 (0.7) Task Ratings 5=Easy Mean (SD) 3.9 (0.6) 3.9 (0.6) 3.7 (0.7) 92.7 (4.8) 1.1 (92.7/82.3) 1 (0.9) 3.8 (0.7) The results from the System Usability Scale scored the subjective satisfaction with the system based on performance with these tasks to be: 79.6 In addition to the performance data, the following qualitative observations were made: - Major findings · · · · · Providers tend to just want to write or dictate the script rather then select a frequency of use Medications other than tablets (e.g.: injectables, inhalers) presented the most serious challenges Most frequent challenge was determining units of medication when none is defaulted. Changing a prescription frequency of use was not easily understood and preference is just to modify the script directions Finding a pharmacy took some time to search. - Areas for improvement · · · · · 2 Add default units for all prescriptions Provide aids in recommended dosage based on patient BSA, age, gender, and diagnosis. Provide ability to type or speak script and parse data to build the prescription script. Add a wizard for first time or novice users. Add a short list of common pharmacies they order from. INTRODUCTION The EHRUT tested for this study was EnableMyHealth EHR4 Release, an ambulatory EHR. Designed to present medical information to healthcare providers in primarily group practices with a focus on family practice, surgery, eye, and PT/OT/Chiropractic medicine, the EHRUT consists of modules and features that include but not limited to support for tested functionality: · Patient demographics · Patient problem and allergy lists · Creating lab orders and receiving lab results Enabledoc LLC ©2015 Confidential and Proprietary Version 1 3 · · · · Immunization recording Electronic prescribing Drug-drug, drug-allergy, and drug-problem interaction checking Clinical decision support The EHRUT is used predominantly by physicians and clinical staff such as MA’s, RN’s, LPN’s, etc. The usability testing attempted to represent realistic exercises and conditions. The purpose of this study was to test and validate the usability of the current user interface, and provide evidence of usability of the entry and modification of electronic prescriptions, laboratory orders, and imaging orders in the EHR Under Test (EHRUT).To this end, measures of effectiveness, efficiency and user satisfaction, such as successful task completion rate, time on task, number and types of errors, and participant satisfaction were captured during the usability testing. 3 3.1 METHOD PARTICIPANTS A total of 7 participants were tested on the CPOE feature of the EHRUT. Participants in the test were physicians and clinical staff such as RNs and MAs. Participants were recruited by Enabledoc staff from existing customers and paid a $50 gift card for their help in testing. Participants had no direct connection to the development of or organization producing the EHRUT other than being current customers. Participants were not from the testing or supplier organization. Participants were actual end users and thus have the same orientation and level of training as other non-participant customers. For the test purposes, end-user characteristics were identified and translated into an internal recruitment screener used to solicit potential participants; an example of a screener is provided in Appendix [1]. Recruited participants had a mix of backgrounds and demographic characteristics conforming to the recruitment screener. The following is a table of participants by characteristics, including demographics, professional experience, computing experience and user needs for assistive technology. Participant names were replaced with Participant IDs so that an individual’s data cannot be tied back to individual identities. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 4 Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Age Occupation / role 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Product Experience (yrs) 3 3 4 3 3 3 1 Seven (7) participants (matching the demographics in the section on Participants) were recruited and all participated in the usability test. 3); they were instructed that they could withdraw at any time. Participants all had prior experience with the EHR. No participants failed to show for the study. Participants were scheduled for 30 minute sessions with 30 minutes in between each session for debrief by the administrator and data logger, and to reset systems to proper test conditions. All testing was performed over several days to allow the participants to schedule time at their convenience. A spreadsheet was used to keep track of the participant schedule. The administrator introduced the test, and instructed participants to complete a series of tasks (given one at a time) using the EHRUT. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. 3.2 STUDY DESIGN The objective of this test was to perform summative testing to measure the key usability metrics of effectiveness, efficiency, and user satisfaction. These metrics will uncover areas where the application performed well and areas where the application failed to meet the needs of the participants in achieving our internal usability goals. The data from this test may serve as a baseline for future tests with an updated version of the same EHR and/or comparison with other EHRs provided the same tasks are used. In short, this testing serves as both a means to record or benchmark current usability, but also to identify areas where improvements should be made. During the usability test, participants interacted exclusively with the EHRUT. Each participant used the system in their preferred location, and was provided with the same instructions. All sessions were conducted remotely with Join.Me conferencing software. Screens with associated interaction and the audio stream were recorded for later analysis. The system was evaluated for effectiveness, efficiency and satisfaction as defined by measures collected and analyzed for each participant: • Number of tasks successfully completed within the allotted time without assistance • Time to complete the tasks Enabledoc LLC ©2015 Confidential and Proprietary Version 1 5 • Number and types of errors • Path deviations • Participant’s verbalizations (comments) • Participant’s satisfaction ratings of the system Additional information about the various measures can be found in Section 3.9 on Usability Metrics. 3.3 TASKS Tasks were constructed that would be realistic and representative of the kinds of activities a user might do with this EHR in the area of Electronic Prescribing and based on the CMS test scripts for Meaningful Use Phase 2. The tasks for this study broadly included: Create the following prescriptions · Enter one types of prescriptions using different script fields and Send it electronically · Enter second types of prescriptions using different script fields and Send it electronically · Enter third types of prescriptions using different script fields and Send it electronically Task Selection and Priority Tasks were selected based on their frequency of use, criticality of function, and those that may be most troublesome for users. The tasks were directly modeled on the CMS Electronic Prescribing test procedure [170.314(b)(3)]. Tasks were ordered and prioritized based on their impact on patient safety, in which the tasks that had the greatest potential for patient harm due to critical errors were performed first. Thus the creation tasks of prescriptions preceded those of prescription modifications. Within the prescription creation tasks, the first task was intentionally fairly simple as this was the first time users have seen the redesigned prescription user interface. Following the first prescription task were the more complex tasks where user errors could have a large potential impact on patient safety. Specifically, these were prescriptions involving pharmacy instructions, dosage calculations, patient instructions, and drug interaction warnings. The task scenario document is contained in appendix 4. 3.4 PROCEDURES During the time a participant was scheduled, an email was sent to the participant that: • Confirmed the time of the session • Provided Join.Me access codes • A copy of the informed consent form • A document containing the tasks for the test session Just prior to the scheduled time, the test administrator started the join.me session and greeted the participant on arrival; their identity was verified and matched with a name on the participant schedule. Participants were then assigned a participant ID. Recording of the session was started using the join.me recording feature. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 6 Each participant reviewed and agreed to the informed consent and release form via verbal acknowledgment (See Appendix 3). A representative from the test team witnessed the participant’s verbal agreement. To ensure that the test ran smoothly, testing was performed remotely by an experienced usability practitioner with over 25 years of experience in healthcare user interface and workflow design. The administrator moderated the session including administering instructions and tasks. The administrator also monitored task times, obtained post-task rating data, took notes on participant comments, path deviations, number and type of errors, and comments. Participants were instructed to perform the tasks (see specific instructions below): · · · As quickly as possible making as few errors and deviations as possible. Without assistance; administrators were allowed to give immaterial guidance and clarification on tasks, but not instructions on use. Without using a think aloud technique. For each session, the participants were given an electronic copy of the tasks for that session. They were requested to not read the tasks prior to the session. Participants were asked to read the task aloud prior to each task; task timing began once the participant finished reading the question and verbally indicated they were starting the task. The task time was stopped once the participant indicated they had successfully completed the task. Scoring is discussed below in Section 3.9. Following the session, the administrator gave the participant the post-test questionnaire (the System Usability Scale, see Appendix 7), solicited any further comments, and thanked each individual for their participation. Participants' demographic information, task success rate, time on task, errors, deviations, verbal responses, and post-test questionnaire were recorded into a spreadsheet. 3.5 TEST LOCATION 3.6 TEST ENVIRONMENT The test was conducted remotely through the use of Join.Me virtual conferencing and screen sharing software. Thus the actual test location was at the discretion of the test participants. The test administrator conducted the test from Enabledoc LLC offices in Rochester MN. The EHRUT would be typically be used in a healthcare office or facility. In this instance, the testing was conducted in healthcare office. For testing, the computer used a Windows laptop running Windows OS and Chrome browser. The participants used a mouse and keyboard when interacting with the EHRUT. The Enablemyhealth application was used on a 13 inch laptop with 1366 by 768 resolution and 32 bit color. The application was set up by the vendor according to the vendor’s documentation describing the system set-up and preparation. The application itself was running on a Windows 2012 Server using a test database on a WAN connection. Technically, the system performance (i.e., response time) was Enabledoc LLC ©2015 Confidential and Proprietary Version 1 7 representative to what actual users would experience in a field implementation with a minor lag caused by video screen sharing and recording. Additionally, participants were instructed not to change any of the default system settings (such as control of font size). 3.7 TEST FORMS AND TOOLS During the usability test, various documents and instruments were used, including: • Informed Consent • Test task scenarios • Moderator’s Guide • Observer’s data collection template • Post-test SUS Questionnaire Examples of these documents can be found in Appendices 3 – 7 respectively. The participant’s interaction with the EHRUT was captured and recorded digitally using the screen recording capability of join.me running on the test machine. This recording included the audio stream of verbalizations. The test sessions were electronically transmitted to any additional observers who logged into the Join.me session. 3.8 PARTICIPANT INSTRUCTIONS The administrator reads the following instructions aloud to the each participant (also see the full moderator’s guide in Appendix 5): Thank you for participating in this study. Your input is very important. Our session today will last about 15 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screen interaction of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. Following the procedural instructions, participants were started with a specific patient’s chart data. Prior to giving the participant mouse and keyboard control, the moderator gave the following instructions: Enabledoc LLC ©2015 Confidential and Proprietary Version 1 8 For each task, I will ask you to read the task and indicate when you begin. At that point, please perform the task and say “Done” once you believe you have successfully completed the task. I would like to request that you not talk aloud or verbalize while you are doing the tasks. You may certainly ask questions if necessary and we may provide guidance or a hint, however we will not provide direct instruction during the tasks. I will ask you your impressions about the task once you are done. Participants were then given 4 tasks to complete. Tasks are listed in Appendix 4. 3.9 USABILITY METRICS According to the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, EHRs should support a process that provides a high level of usability for all users. The goal is for users to interact with the system effectively, efficiently, and with an acceptable level of satisfaction. To this end, metrics for effectiveness, efficiency and user satisfaction were captured during the usability testing. The goals of the test were to assess: 1. Effectiveness of ENABLEMYHEALTH EHR by measuring participant success rates and errors 2. Efficiency of ENABLEMYHEALTH EHR by measuring the average task time and path deviations 3. Satisfaction with ENABLEMYHEALTH EHR by measuring ease of use ratings 3.10 DATA SCORING The following table details how tasks were scored, errors evaluated, and the time data analyzed: Rationale and Scoring Measure Effectiveness: Task Success A task was counted as a “Success” if the participant was able to achieve the correct outcome, without assistance, within the overall time allotted for the entire set of tasks. The total number of successes were calculated for each task and then divided by the total number of times that task was attempted. The results are provided as a percentage. Task times were recorded for successes. Observed task times divided by the optimal time for each task is a measure of optimal efficiency. Due to the variability of multiple correct paths and a large variety of user settable preferences, all of which can affect time on task, optimal task times and deviations from these times were unrealistic to assess. All participants were trained on Enablemyhealth EHR and so the performance factor of 1.0 was use. The overall usability goal for any feature of the EHR is task time that is deemed acceptable by the end user with no critical errors. Thus, if expert, optimal performance on a task was [60] seconds then allotted task time performance was [60 * 1.0] seconds. This ratio is aggregated across tasks and reported with mean and variance scores. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 9 Effectiveness: Task Failures Efficiency: Task Deviations If the participant abandoned the task, did not reach the correct answer, performed it incorrectly, or was unsure if they had completed the task, the task was counted as a “Critical Failure.” No task times were taken for failed tasks. Minor errors were defined as an errant click, initial selection of an incorrect menu option, or incorrect entries that the participant noticed and corrected. The total number of errors was calculated for each task and then divided by the total number of times that task was attempted. Minor errors and deviations were noted but not counted as significant errors. This is expressed as the mean number of failed tasks per participant. The participant’s path (i.e., steps) through the application was recorded. Deviations occur if the participant, for example, went to a wrong screen, clicked on an incorrect menu item, followed an incorrect link, or interacted incorrectly with an on-screen control. These path deviations were included in the minor error count. The minor error count is expressed as an average across all participants. Efficiency: Task Time Satisfaction: Task Rating Each task was timed from when the participant indicated they were beginning the task until the participant said “Done.” If he or she failed to say “Done,” the time was stopped when the participant stopped performing the task. Only task times for tasks that were successfully completed were included in the average task time analysis. Average time per task was calculated for each task as was variance (standard deviation). Participant’s subjective impression of the ease of use of the application was measured by administering both a simple post-task question as well as a post-session questionnaire. After each task, the participant was asked to rate “Overall, this task was:” on a scale of 1 (Very Difficult) to 7 (Very Easy). Average difficulty ratings per task were calculated as was variance. Common convention is that average ratings for systems judged easy to use should be 3.3 or above. To measure participants’ confidence in and likeability of the ENABLEMYHEALTH EHR feature overall, the testing team administered the System Usability Scale (SUS) post-test questionnaire. Questions included, “I think I would like to use this system frequently,” “I thought the system was easy to use,” and “I would imagine that most people would learn to use this system very quickly.” See full System Usability Score questionnaire in Appendix 7. 4 4.1 RESULTS DATA ANALYSIS AND REPORTING The results of the usability test were calculated according to the methods specified in the Usability Metrics section above. Participants who failed to follow session and task instructions had their data excluded from the analyses, however there were no instances of this occurring. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 10 The usability testing results for the ENABLEMYHEALTH EHR are detailed below (Table 1). The results should be seen in light of the objectives and goals outlined in Section 3.2 Study Design. The data should yield actionable results that, if corrected, yield material, positive impact on user performance. Table 1 MEASURES TASKS Send prescription 1 Send prescription 2 Send prescription 3 Mean across tasks Number 1 1 1 1 Path Deviations Task (Observed / Success Optimal) 100.00 1.9 (12.9/11) 100.00 1.3 (13.1/12) 100.00 1.5 (18/17) 100.00 1.6 (14.7/13.3) Task Time Mean (SD) 96 (8.8)_ 92 (3.1) 90.1 (2.6) Task Time Deviations (Observed / Optimal) 1.2 (96/80) 1.1 (92/81) 1.0 (90.1/86) Errors Mean (SD) 1.9 (1.1) 0.6 (0.7) 0.4 (0.7) Task Ratings 5=Easy Mean (SD) 3.9 (0.6) 3.9 (0.6) 3.7 (0.7) 92.7 (4.8) 1.1 (92.7/82.3) 1 (0.9) 3.8 (0.7) The results from the SUS (System Usability Scale) scored the subjective satisfaction with the system based on performance with these tasks to be: 79.6 with a standard deviation of 5.08. Broadly interpreted, this score is 0.04 from being considered above average. 4.2 DISCUSSION OF THE FINDINGS The eprescribe feature is a combination of electronic prescribing and Send screens. Particularly noteworthy is that the participants were familiar with and had been using for up to the last 3 years prior to this study. Overall, the CPOE feature of Enablemyhealth user experience exhibits acceptable effectiveness, with an acceptably low critical error rate and minimal variance among users. The critical error rate is of greatest concern for an EHR and in the case of the EHRUT there were no task failures due to critical errors out of 21 attempted tasks. Of the deviation errors, each prescription averaged 1.6 deviations per task, which was primarily finding the correct prescription and dosage/form and a non defaulting measurement unit. Efficiency measures indicate that while acceptable, there is room for improvement. One older user took significantly longer time to perform every task, but this can also be attributed to nervousness and second guessing themselves. Finding the pharmacy also increased the time. Satisfaction, measured by an SUS score of 79.6 is very good, but can be improved. Working to make the user experience more natural and intelligent will improve the overall user experience and help guide the novice and advanced users. 4.3 EFFECTIVENESS Enabledoc LLC ©2015 Confidential and Proprietary Version 1 11 Based on the success rate, minor error rate, and critical error rate data, the CPOE feature has an acceptable level of effectiveness. The usability test consisted of 21 tasks of which 21 were attempted. Out of the 21 attempted tasks, there were no critical errors, giving a successful completion rate of 100%. The deviation (minor) errors in the electronic prescriptions were difficulties associated non defaulting scripts that required making changes in each field to build the script and finding the pharmacy. 4 out the 7 users do not prescribe regularly, so we felt these results we very positive and users improved the more they performed the tasks. Order sets were not used in this testing and can eliminate the problem of complex prescription and other types of orders. The deviation error mean of 1.0 is within the acceptable range of effectiveness, with the errors most often being finding the order by spelling it. 4.4 EFFICIENCY Observation of task time is the primary area for improvement. The mean task time for three prescription orders of 92.7 seconds is largely due to • time to find the correct prescription, dose and form • one complex prescription script • number of fields on the prescription screen • time to find pharmacy Simple prescription tasks such as 1 tablet of a drug once per day by mouth for 30 days posed little difficulties and did not greatly affect task time. More complex prescriptions, such as those that required complex scripts, selection of measurement units, and detailed directions had increased the task time by 30%. We know that prescription ordersets addresses this issue, but we also know that there are of solutions to improving usability. 4.5 SATISFACTION Based on task difficulty ratings and SUS results data, user satisfaction of the feature is considered favorable. Users perception of ease of use is considered easy, with a mean rating of 3.8 across all tasks (1=very difficult, 5=very easy). SUS scoring is very good with a score of 79.6. These scores accurately describe the average patient satisfaction with Enablemyhealth feature set. SUS Scoring Mean StDev 4.6 79.64 5.08 MAJOR FINDINGS The major usability problems encountered in this study were: · Providers tend to just want to write or dictate the script rather then select a frequency of use Enabledoc LLC ©2015 Confidential and Proprietary Version 1 12 · · · · 4.7 AREAS FOR IMPROVEMENT · · · · · 5 Medications other than tablets (e.g.: injectables, inhalers) presented the most serious challenges Most frequent challenge was determining units of medication when none is defaulted. Changing a prescription frequency of use was not easily understood and preference is just to modify the script directions Finding a pharmacy took some time to search. Add default units for all prescriptions Provide aids in recommended dosage based on patient BSA, age, gender, and diagnosis. Provide ability to type or speak script and parse data to build the prescription script. Add a wizard for first time or novice users. Add a short list of common pharmacies they order from. APPENDICES The following appendices include supplemental data for this usability test report. Following is a list of the appendices provided: 1: Participant Recruiting Screener 2: Participant demographics 3: Informed Consent Form 4: Task Scenarios 5: Moderator’s Guide 6: Sample data collection form 7: System Usability Scale Questionnaire Appendix 1: PARTICIPANT RECRUITING SCREENER Introduction Hello, my name is __. Enabledoc is seeking doctors and clinicians who are users of • Electronic prescribing software • Computerized order entry (such as labs and imaging) • Medication list and medication allergy list management to take part in a usability study of that portion of the EnableMyHealth EHR. This study will assist us in designing and developing a solution that meets your needs. Your experiences in using this particular design will greatly help our designers and developers. The testing of our design will take place in your office using remote meeting technology, requiring only your time, thoughts, and suggestions. We expect the session to last approximately 45 minutes. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 13 Does this sound like something that interests you? Before I schedule you for a session, do you have a few moments to answer some questions? General Questions 1. Are you male or female? [Recruit a mix of participants] 2. Have you participated in a focus group or usability test in the past three months? [Note but do not terminate if yes] 3. Which of the following best describes your age? [25 or less; 26 to 39; 40 to 59; 60 to 74; 75 and older][Recruit a mix of ages] Professional Demographics 4. What is your current position/role in your practice? 5. How long have you been in this role? 6. Do you currently perform e-prescribing? [computerized order entry, manage medication and medication allergy lists – pick appropriate for test][Terminate if no to specific task for test] How many prescriptions [or lab orders – use appropriate choice for test] do you write per day (or week if that is a better estimate)? 7. What year did you receive your medical degree? Computer Expertise 8. About how many hours per week do you spend on the computer that is medical practice related? [Recruit a range of use, e.g., 0 to 10, 11 to 25, 26+ hours per week][Terminate if less than 5] 9. Do you use a computer outside of your medical work? 10. If so, about how many hours per week do spend using a computer for non-work related endeavors? 11. Regarding your use of EnableMyHealth Practice Manager & EHR, what percentage of time is spent in each product? (per day) Domain Knowledge · Rate your expertise or comfort in using EnableMyHealth software on a scale of 1 to 5 (1=just starting, 5=expert) for § PM § EHR (overall) § EHR e-Prescribing [Terminate if 1 or 2] · If you have used similar or competing products, describe your level of expertise in those products [it is not necessary to name the product(s) unless they want to]. Contact Information Enabledoc LLC ©2015 Confidential and Proprietary Version 1 14 [If the person matches your qualifications, ask for any info we do not have] May I have your contact information? · Name of participant: · Office Key: · Best phone number: · Email address: Those are all the questions I have for you. Your background matches the people we're looking for. Would you be able to participate on [date, time]? Alternative: select from a list of sessions [ideal approach] Alternative; What would be the best date and time for you? Before your session starts, we will ask you to verbally acknowledge a release form allowing us to record your session. The recording will only be used internally for further study if needed and will never be used for advertising or marketing purposes. Also, you will not be personally identified with any recording. Will you consent to be recorded? [Terminate if no] This study will take place remotely via conferencing software, allowing you to participate in the session at the place of your choosing. I will confirm your appointment a couple of days before your session and provide you with any additional information. What is the best time to contact you? Appendix 2: PARTICIPANT DEMOGRAPHICS Following is a high-level overview of the participants in this study. Gender Men Women Total (participants) Occupationan/Role RN/NP/MA Physician Total (participants) Years of Experience (average) Professional EHR Product Use 2 5 7 4 3 7 23.71 2.86 Demographic detail Enabledoc LLC ©2015 Confidential and Proprietary Version 1 15 Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Age Occupation / role 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Enabledoc LLC ©2015 Confidential and Proprietary Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Version 1 Product Experience (yrs) 3 3 4 3 3 3 1 16 Appendix 3: Informed Consent Form Enabledoc would like to thank you for participating in this study. The purpose of this study is to evaluate an electronic health records system. If you decide to participate, you will be asked to perform several tasks using the prototype and give your feedback. The study will last up to 60 minutes. Agreement I understand and agree that as a voluntary participant in the present study conducted by Enabledoc. I am free to withdraw consent or discontinue participation at any time. I understand and agree to participate in the study conducted by Enabledoc. I understand and consent to the use and release of the recording by Enabledoc. I understand that the information and recording is for research purposes only and that my name and image will not be used for any purpose other than research. I relinquish any rights to the recording and understand the recording may be copied and used by Enabledoc without further permission. I understand and agree that the purpose of this study is to make software applications more useful and usable in the future. I understand and agree that the data collected from this study will not be shared outside of Enabledoc I understand and agree that data confidentiality is assured, because only de-identified data – i.e., identification numbers not names – will be used in analysis and reporting of the results. I agree to immediately raise any concerns or areas of discomfort with the study administrator. I understand that I can leave at any time. Please check or verbally indicate one of the following: YES, I have read the above statement and agree to be a participant. NO, I choose not to participate in this study. Signature: _____________________________________ Date: ____________________ Enabledoc LLC ©2015 Confidential and Proprietary Version 1 17 Appendix 4: Task Scenarios Usability Task Scenarios – eRx Click Patient Center and select Garth Brooks, click the first encounter and Click Open Note button. Click New Prescriptions and enter these prescriptions: 1. Simvastatin, 20 mg tablet by mouth once daily; dispense 30, 1 refill, allow generic medications. Click Save, select a pharmacy Brian Testing, and then click Send. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 2. Azithromycin 500 mg tablet, 1 tablet by mouth once a day for 10 days, dispense 10, 1 refill, allow generic medications. Click Save, select a pharmacy Brian Testing, and then click Send. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 3. Insulin Glargine, 10 units once daily; package of 5, 2 refills, allow generic medications. Click Save, select a pharmacy Brian Testing, and then click Send. Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 5: Usability Test Administration Moderator’s Guide 1. Items often forgotten a. Stop watch for recording time on task b. Elapsed time timer to time code observations/comments in the recording 2. Office Key Setup a. Environment b. Obtain copy of user key database if required for test Enabledoc LLC ©2015 Confidential and Proprietary Version 1 18 c. Any required feature access d. Create and enter any necessary test data e. Create Database / Office Key snapshot 3. Schedule Join.Me sessions 4. Schedule participants 5. Supply test participants with materials prior to test a. Join.Me access b. Task scenarios (be prepared to resend at the start of the test – do not assume the participant has multiple monitors, so they may also need to print the scenarios) c. Informed consent form (can be done verbally during the session) 6. Set up administrative / test PC a. Join.Me installed and up to date b. Shut down all programs not needed for the test – remember things like Communicator c. Turn off notifications – audible and screen – on any software that may be running during the test (e.g.: Outlook) d. Ensure the application installed and functional 7. Running a test session a. Ensure office key/database snapshot of base data exists b. Start EHR session on test PC and arrive at starting screen for test c. Select first patient if selection is not part of the task scenario d. Start Join.Me session e. Share appropriate screen f. Greet user g. Administer introductory materials to user (see below, following checklist) h. Start Join.Me recording i. Display informed consent form on shared screen j. Obtain consent via verbal acceptance k. Give mouse and keyboard control to ALL l. Have user work through tasks m. For each task, record i. Time on task ii. Critical errors (anything that constitutes task failure) iii. Minor errors (anything the user detects and recovers) iv. Deviation(s) from optimal path v. Interesting comments (try to include recording time stamp for reference) n. After each task or task set (see specific scenarios) ask for response to single ease of use question o. Allow verbal response to any questions contained in task scenarios p. At end of all tasks, display SUS questionnaire and have the participant place an X in appropriate response to each statement i. Save SUS with participant code as part of file name q. Conduct debrief to solicit any additional feedback, comments, Q&A, etc. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 19 Thank you for participating in this study. Your input is very important. Our session today will last about 15 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screenshots of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 20 Appendix 6: Sample data collection form Summative Usability Test Data Log Test type: Participant: Participant code: Session Date/start time: File name: Task 1: · · · · · · Critical Error count: Minor error count: Optimal path deviations: Time on task: SEoUQ response: Comments/observations: <repeat for each task> Enabledoc LLC ©2015 Confidential and Proprietary Version 1 21 Appendix 7: System Usability Scale Questionnaire In 1996, Brooke published a “low-cost usability scale that can be used for global assessments of systems usability” known as the System Usability Scale or SUS. Lewis and Sauro (2009) and others have elaborated on the SUS over the years. Computation of the SUS score can be found in Brooke’s paper, at http://www.usabilitynet.org/trump/documents/Suschapt.doc or in Tullis and Albert (2008). Strongly Disagree 1. I think that I would like to use this system frequently Strongly agree 1 2 3 4 Strongly Disagree 5 Strongly agree 2. I found the system unnecessarily complex 1 2 3 4 5 1 2 3 4 5 3. I thought the system was easy to use 4. I think that I would need the support of a technical person to be able to use this system 5. I found the various functions in this system were well integrated 6. I thought there was too much inconsistency in this system 7. I would imagine that most people would learn to use this system very quickly 8. I found the system very cumbersome to use Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 Version 1 22 9. I felt very confident using the system 10. I needed to learn a lot of things before I could get going with this system Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 Version 1 23 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 24 EHR Usability Test Report of EnableMyHealth EHR Medication List Management Safety-Enhanced Design 170.314(g)(3) Report based on ISO/IEC 25062:2006 Common Industry Format for Usability Test Reports Date of Usability Test: 15 AUG 2015 – 14 SEP 2015 Date of Report: 14 SEP 2015 Report Prepared By: Stephen Rothschild 877.540.0933 steve@enabledoc.com EnableDoc LLC 7700 Falstaff Road McLean VA 22104 Table of Contents 1 Executive Summary ............................................................................................................................... 2 2 METHOD................................................................................................................................................ 4 3 4 2.1 PARTICIPANTS ............................................................................................................................... 4 2.2 STUDY DESIGN............................................................................................................................... 5 2.3 TASKS............................................................................................................................................. 5 2.4 PROCEDURES................................................................................................................................. 6 2.5 TEST LOCATION ............................................................................................................................. 7 2.6 TEST ENVIRONMENT ..................................................................................................................... 7 2.7 TEST FORMS AND TOOLS .............................................................................................................. 7 2.8 PARTICIPANT INSTRUCTIONS ........................................................................................................ 7 2.9 USABILITY METRICS ....................................................................................................................... 8 2.10 DATA SCORING .............................................................................................................................. 8 RESULTS .............................................................................................................................................. 10 3.1 DATA ANALYSIS AND REPORTING ............................................................................................... 10 3.2 DISCUSSION OF THE FINDINGS ................................................................................................... 10 3.3 EFFECTIVENESS ........................................................................................................................... 11 3.4 EFFICIENCY .................................................................................................................................. 11 3.5 SATISFACTION ............................................................................................................................. 11 3.6 MAJOR FINDINGS ........................................................................................................................ 12 3.7 AREAS FOR IMPROVEMENT ........................................................................................................ 12 APPENDICES ........................................................................................................................................ 12 Appendix 2: PARTICIPANT DEMOGRAPHICS ........................................................................................... 15 Appendix 3: Informed Consent Form...................................................................................................... 16 Appendix 4: Task Scenarios ..................................................................................................................... 17 Appendix 5: Usability Test Administration Moderator’s Guide .............................................................. 19 Appendix 6: Sample data collection form ............................................................................................... 21 Appendix 7: System Usability Scale Questionnaire ................................................................................ 22 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 1 1 Executive Summary A usability test of EnableMyHealth version EMH4, an ambulatory EHR, was conducted between August 15, 2015 and September 14, 2015 in the Rochester MN. office of EnableDoc LLC, and each providers offices. The purpose of this test was to test and validate the usability of the current user interface for Computerized Provider Order Entry, and provide evidence of usability in the EHR Under Test (EHRUT). During the usability test, seven (7) healthcare providers and clinical staff that meet the target demographic and professional profile serve as participants and used Enablemyhealth EHR in simulated, but representative tasks. This study collected performance data on the following these four tasks typically conducted in an EHR: · · · Enter current medications Modify or mark as inactive View current or historical medications All test participants conducted the test sessions remotely via on-line conferencing software. During the 15 one-on-one usability test, each participant was greeted by the administrator and asked to review and verbally acknowledge an informed consent/release form (included in Appendix 3); they were instructed that they could withdraw at any time. Participants had prior experience with the EHR as they are current users/customers. No additional training materials were provided other than that usually given to customers. The administrator introduced the test and instructed participants to complete a series of tasks (given one at a time) using the EHRUT. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. Participant screens and audio were recorded for subsequent analysis. The following types of data were collected for each participant: · Number of tasks successfully completed within the allotted time without assistance · Time to complete the tasks · Participant’s subjective assessment of the ease of each task · Number and types of errors · Path deviations · Participant’s verbalizations · Participant’s satisfaction ratings of the system All participant data was de-identified – no correspondence could be made from the identity of the participant to the data collected. Following the conclusion of the testing, participants were asked to complete a post-test SUS questionnaire. Various recommended metrics, in accordance with the examples set forth in the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, were used to evaluate the usability of the EHRUT. Result data matrix - refer to Appendix 4 for complete task descriptions Enabledoc LLC ©2015 Confidential and Proprietary Version 1 2 MEASURES TASKS Path Deviations Task (Observed / Optimal) Number Success Task Time Mean (SD) Task Time Task Deviations Ratings Errors (Observed / 5=Easy Optimal) Mean (SD) Mean (SD) Create 6 medications 6 100.00 1.1 (29.1/26) 289 (8) 1.1 (289/275) 1.86 (1.1) 3.7 (0.5) Modify 3 medications Review Current Meds and History 3 1 100.00 100.00 1.3 (11.6/9) 1.4 (2.9/2) 75 (19) 18 (6) 1.3 (75/60) 1.2 (18/15) 0.57 (0.7) 0.43 (0.7) 4.1 (0.6) 4.7 (0) 100.00 1.3 (14.5/12) 128 (11) 1.2 (128/116) 1 (0.9) 4.2 (0.4) Mean across tasks The results from the System Usability Scale scored the subjective satisfaction with the system based on performance with these tasks to be: 81.4. In addition to the performance data, the following qualitative observations were made: Major findings · · · · Providers tend to just want to write or dictate the script rather then select a frequency of use Medications other than tablets (e.g.: injectables, inhalers) presented the most serious challenges Most frequent challenge was determining units of medication when none is defaulted. Changing a prescription frequency of use was not easily understood and preference is just to modify the script directions Areas for improvement · Add default units for all prescriptions · Provide aids in recommended dosage based on patient BSA, age, gender, and diagnosis. · Provide ability to type or speak script and parse data to build the prescription script. · Add a wizard for first time or novice users. The EHRUT tested for this study was EnableMyHealth EHR4 Release, an ambulatory EHR. Designed to present medical information to healthcare providers in primarily group practices with a focus on family practice, surgery, eye, and PT/OT/Chiropractic medicine, the EHRUT consists of modules and features that include but not limited to support for tested functionality: · Patient demographics · Patient problem and allergy lists · Creating lab orders and receiving lab results · Immunization recording · Electronic prescribing · Drug-drug, drug-allergy, and drug-problem interaction checking · Clinical decision support The EHRUT is used predominantly by physicians and clinical staff such as MA’s, RN’s, LPN’s, etc. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 3 The usability testing attempted to represent realistic exercises and conditions. The purpose of this study was to test and validate the usability of the current user interface, and provide evidence of usability of the entry and modification of electronic prescriptions, laboratory orders, and imaging orders in the EHR Under Test (EHRUT).To this end, measures of effectiveness, efficiency and user satisfaction, such as successful task completion rate, time on task, number and types of errors, and participant satisfaction were captured during the usability testing. 2 2.1 METHOD PARTICIPANTS A total of 7 participants were tested on the CPOE feature of the EHRUT. Participants in the test were physicians and clinical staff such as RNs and MAs. Participants were recruited by Enabledoc staff from existing customers and paid a $50 gift card for their help in testing. Participants had no direct connection to the development of or organization producing the EHRUT other than being current customers. Participants were not from the testing or supplier organization. Participants were actual end users and thus have the same orientation and level of training as other non-participant customers. For the test purposes, end-user characteristics were identified and translated into an internal recruitment screener used to solicit potential participants; an example of a screener is provided in Appendix [1]. Recruited participants had a mix of backgrounds and demographic characteristics conforming to the recruitment screener. The following is a table of participants by characteristics, including demographics, professional experience, computing experience and user needs for assistive technology. Participant names were replaced with Participant IDs so that an individual’s data cannot be tied back to individual identities. Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Occupation / role Age 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Product Experience (yrs) 3 3 4 3 3 3 1 Seven (7) participants (matching the demographics in the section on Participants) were recruited and all participated in the usability test. 3); they were instructed that they could withdraw at any time. Participants all had prior experience with the EHR. No participants failed to show for the study. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 4 Participants were scheduled for 30 minute sessions with 30 minutes in between each session for debrief by the administrator and data logger, and to reset systems to proper test conditions. All testing was performed over several days to allow the participants to schedule time at their convenience. A spreadsheet was used to keep track of the participant schedule. The administrator introduced the test, and instructed participants to complete a series of tasks (given one at a time) using the EHRUT. During the testing, the administrator timed the test and, along with the data logger(s) recorded user performance data on paper and electronically. The administrator did not give the participant assistance in how to complete the task. 2.2 STUDY DESIGN The objective of this test was to perform summative testing to measure the key usability metrics of effectiveness, efficiency, and user satisfaction. These metrics will uncover areas where the application performed well and areas where the application failed to meet the needs of the participants in achieving our internal usability goals. The data from this test may serve as a baseline for future tests with an updated version of the same EHR and/or comparison with other EHRs provided the same tasks are used. In short, this testing serves as both a means to record or benchmark current usability, but also to identify areas where improvements should be made. During the usability test, participants interacted exclusively with the EHRUT. Each participant used the system in their preferred location, and was provided with the same instructions. All sessions were conducted remotely with Join.Me conferencing software. Screens with associated interaction and the audio stream were recorded for later analysis. The system was evaluated for effectiveness, efficiency and satisfaction as defined by measures collected and analyzed for each participant: · · · · · · Number of tasks successfully completed within the allotted time without assistance Time to complete the tasks Number and types of errors Path deviations Participant’s verbalizations (comments) Participant’s satisfaction ratings of the system Additional information about the various measures can be found in Section 3.9 on Usability Metrics. 2.3 TASKS Tasks were constructed that would be realistic and representative of the kinds of activities a user might do with this EHR in the area of Medication List Management and based on the CMS test scripts for Meaningful Use Phase 2. The tasks for this study broadly included: 1. Enter 6 current medications 2. Change 3 current medications 3. Review current medications and history for a patient Enabledoc LLC ©2015 Confidential and Proprietary Version 1 5 Task Selection and Priority Tasks were selected based on their frequency of use, criticality of function, and those that may be most troublesome for users. The tasks were directly modeled on the CMS Medication List test procedure [170.314(a)(6)]. Tasks were ordered and prioritized based on their impact on patient safety, in which the tasks that had the greatest potential for patient harm due to critical errors were performed first. Thus the entry of current medication allergies was followed by modifying some of the current allergies and finished with the reviews of current medications and then the reviewing medication history task. The task scenario document is contained in appendix 4. 2.4 PROCEDURES During the time a participant was scheduled, an email was sent to the participant that: · · · · Confirmed the time of the session Provided Join.Me access codes A copy of the informed consent form A document containing the tasks for the test session Just prior to the scheduled time, the test administrator started the join.me session and greeted the participant on arrival; their identity was verified and matched with a name on the participant schedule. Participants were then assigned a participant ID. Recording of the session was started using the join.me recording feature. Each participant reviewed and agreed to the informed consent and release form via verbal acknowledgment (See Appendix 3). A representative from the test team witnessed the participant’s verbal agreement. To ensure that the test ran smoothly, testing was performed remotely by an experienced usability practitioner with over 25 years of experience in healthcare user interface and workflow design. The administrator moderated the session including administering instructions and tasks. The administrator also monitored task times, obtained post-task rating data, took notes on participant comments, path deviations, number and type of errors, and comments. Participants were instructed to perform the tasks (see specific instructions below): · · · As quickly as possible making as few errors and deviations as possible. Without assistance; administrators were allowed to give immaterial guidance and clarification on tasks, but not instructions on use. Without using a think aloud technique. For each session, the participants were given an electronic copy of the tasks for that session. They were requested to not read the tasks prior to the session. Participants were asked to read the task aloud prior to each task; task timing began once the participant finished reading the question and verbally indicated Enabledoc LLC ©2015 Confidential and Proprietary Version 1 6 they were starting the task. The task time was stopped once the participant indicated they had successfully completed the task. Scoring is discussed below in Section 3.9. Following the session, the administrator gave the participant the post-test questionnaire (the System Usability Scale, see Appendix 7), solicited any further comments, and thanked each individual for their participation. Participants' demographic information, task success rate, time on task, errors, deviations, verbal responses, and post-test questionnaire were recorded into a spreadsheet. 2.5 TEST LOCATION The test was conducted remotely through the use of Join.Me virtual conferencing and screen sharing software. Thus the actual test location was at the discretion of the test participants. The test administrator conducted the test from Enabledoc LLC offices in Rochester MN. 2.6 TEST ENVIRONMENT The EHRUT would be typically be used in a healthcare office or facility. In this instance, the testing was conducted in healthcare office. For testing, the computer used a Windows laptop running Windows OS and Chrome browser. The participants used a mouse and keyboard when interacting with the EHRUT. The Enablemyhealth application was used on a 13 inch laptop with 1366 by 768 resolution and 32 bit color. The application was set up by the vendor according to the vendor’s documentation describing the system set-up and preparation. The application itself was running on a Windows 2012 Server using a test database on a WAN connection. Technically, the system performance (i.e., response time) was representative to what actual users would experience in a field implementation with a minor lag caused by video screen sharing and recording. Additionally, participants were instructed not to change any of the default system settings (such as control of font size). 2.7 TEST FORMS AND TOOLS During the usability test, various documents and instruments were used, including: · · · · · Informed Consent Test task scenarios Moderator’s Guide Observer’s data collection template Post-test SUS Questionnaire Examples of these documents can be found in Appendices 3 – 7 respectively. The participant’s interaction with the EHRUT was captured and recorded digitally using the screen recording capability of join.me running on the test machine. This recording included the audio stream of verbalizations. The test sessions were electronically transmitted to any additional observers who logged into the join.me session. 2.8 PARTICIPANT INSTRUCTIONS Enabledoc LLC ©2015 Confidential and Proprietary Version 1 7 The administrator reads the following instructions aloud to the each participant (also see the full moderator’s guide in Appendix 5): Thank you for participating in this study. Your input is very important. Our session today will last about 30 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screen interaction of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. Following the procedural instructions, participants were started with a specific patient’s chart data. Prior to giving the participant mouse and keyboard control, the moderator gave the following instructions: For each task, I will ask you to read the task and indicate when you begin. At that point, please perform the task and say “Done” once you believe you have successfully completed the task. I would like to request that you not talk aloud or verbalize while you are doing the tasks. You may certainly ask questions if necessary and we may provide guidance or a hint, however we will not provide direct instruction during the tasks. I will ask you your impressions about the task once you are done. Participants were then given 4 tasks to complete. Tasks are listed in Appendix 4. 2.9 USABILITY METRICS According to the NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records, EHRs should support a process that provides a high level of usability for all users. The goal is for users to interact with the system effectively, efficiently, and with an acceptable level of satisfaction. To this end, metrics for effectiveness, efficiency and user satisfaction were captured during the usability testing. The goals of the test were to assess: 1. Effectiveness of ENABLEMYHEALTH EHR by measuring participant success rates and errors 2. Efficiency of ENABLEMYHEALTH EHR by measuring the average task time and path deviations 3. Satisfaction with ENABLEMYHEALTH EHR by measuring ease of use ratings 2.10 DATA SCORING The following table details how tasks were scored, errors evaluated, and the time data analyzed Enabledoc LLC ©2015 Confidential and Proprietary Version 1 8 Rationale and Scoring Measure Effectiveness: Task Success A task was counted as a “Success” if the participant was able to achieve the correct outcome, without assistance, within the overall time allotted for the entire set of tasks. The total number of successes were calculated for each task and then divided by the total number of times that task was attempted. The results are provided as a percentage. Task times were recorded for successes. Observed task times divided by the optimal time for each task is a measure of optimal efficiency. Due to the variability of multiple correct paths and a large variety of user settable preferences, all of which can affect time on task, optimal task times and deviations from these times were unrealistic to assess. All participants were trained on Enablemyhealth EHR and so the performance factor of 1.0 was use. The overall usability goal for any feature of the EHR is task time that is deemed acceptable by the end user with no critical errors. Thus, if expert, optimal performance on a task was [60] seconds then allotted task time performance was [60 * 1.0] seconds. This ratio is aggregated across tasks and reported with mean and variance scores. Effectiveness: Task Failures Efficiency: Task Deviations If the participant abandoned the task, did not reach the correct answer, performed it incorrectly, or was unsure if they had completed the task, the task was counted as a “Critical Failure.” No task times were taken for failed tasks. Minor errors were defined as an errant click, initial selection of an incorrect menu option, or incorrect entries that the participant noticed and corrected. The total number of errors was calculated for each task and then divided by the total number of times that task was attempted. Minor errors and deviations were noted but not counted as significant errors. This is expressed as the mean number of failed tasks per participant. The participant’s path (i.e., steps) through the application was recorded. Deviations occur if the participant, for example, went to a wrong screen, clicked on an incorrect menu item, followed an incorrect link, or interacted incorrectly with an on-screen control. These path deviations were included in the minor error count. The minor error count is expressed as an average across all participants. Efficiency: Task Time Satisfaction: Task Rating Each task was timed from when the participant indicated they were beginning the task until the participant said “Done.” If he or she failed to say “Done,” the time was stopped when the participant stopped performing the task. Only task times for tasks that were successfully completed were included in the average task time analysis. Average time per task was calculated for each task as was variance (standard deviation). Participant’s subjective impression of the ease of use of the application was measured by administering both a simple post-task question as well as a post-session questionnaire. After each task, the participant was asked to rate “Overall, this task was:” on a scale of 1 (Very Difficult) to 7 (Very Easy). Enabledoc LLC ©2015 Confidential and Proprietary Version 1 9 Average difficulty ratings per task were calculated as was variance. Common convention is that average ratings for systems judged easy to use should be 3.3 or above. To measure participants’ confidence in and likeability of the ENABLEMYHEALTH EHR feature overall, the testing team administered the System Usability Scale (SUS) post-test questionnaire. Questions included, “I think I would like to use this system frequently,” “I thought the system was easy to use,” and “I would imagine that most people would learn to use this system very quickly.” See full System Usability Score questionnaire in Appendix 7. 3 3.1 RESULTS DATA ANALYSIS AND REPORTING The results of the usability test were calculated according to the methods specified in the Usability Metrics section above. Participants who failed to follow session and task instructions had their data excluded from the analyses, however there were no instances of this occurring. The usability testing results for the ENABLEMYHEALTH EHR are detailed below (Table 1). The results should be seen in light of the objectives and goals outlined in Section 3.2 Study Design. The data should yield actionable results that, if corrected, yield material, positive impact on user performance. Table 1 MEASURES TASKS Path Deviations Task (Observed / Optimal) Number Success Task Time Mean (SD) Task Time Task Deviations Ratings Errors (Observed / 5=Easy Optimal) Mean (SD) Mean (SD) Create 6 medications 6 100.00 1.1 (29.1/26) 289 (8) 1.1 (289/275) 1.86 (1.1) 3.7 (0.5) Modify 3 medications Review Current Meds and History 3 1 100.00 100.00 1.3 (11.6/9) 1.4 (2.9/2) 75 (19) 18 (6) 1.3 (75/60) 1.2 (18/15) 0.57 (0.7) 0.43 (0.7) 4.1 (0.6) 4.7 (0) 100.00 1.3 (14.5/12) 128 (11) 1.2 (128/116) 1 (0.9) 4.2 (0.4) Mean across tasks The results from the SUS (System Usability Scale) scored the subjective satisfaction with the system based on performance with these tasks to be: 81.4 with a standard deviation of 4.4. Broadly interpreted, this indicates above average usability, but with further room for improvement. 3.2 DISCUSSION OF THE FINDINGS Enabledoc LLC ©2015 Confidential and Proprietary Version 1 10 The Current Medication feature works similar to electronic prescribing for entering medication scripts. The findings and issues are identical to eprescribe. Particularly noteworthy is that the participants were familiar with this interface and some had been using for up to 3 years prior to this study. Overall the CPOE feature of Enablemyhealth user experience exhibits acceptable effectiveness, with an acceptably low critical error rate and minimal variance among users. The critical error rate is of greatest concern for an EHR and in the case of the EHRUT there were no task failures due to critical errors out of 91 attempted tasks, but there were 20 deviations from normal operations. This is within internal usability goal guidelines. Of the deviation errors, 13 were attributable to current medications, which was primarily finding the correct medication and dosage/form and a non defaulting measurement unit. Efficiency measures indicate that while acceptable, there is room for improvement, in time to enter medications. One older user took significantly longer time to perform every task, but this can also be attributed to nervousness and second guessing themselves. Satisfaction, measured by an SUS score of 81.4 is very good, but can be improved. Working to make the user experience more natural and intelligent will improve the overall user experience and help guide the novice and advanced users. 3.3 EFFECTIVENESS Based on the success rate, minor error rate, and critical error rate data, the medication list feature has an acceptable level of effectiveness. The usability test consisted of 70 tasks of which 70 were attempted. Out of the 70 attempted tasks, there were no critical errors, but there were 20 deviations from optimal operation. The minor error mean of 1.86 (1.1 standard deviation) is within the acceptable range of effectiveness, with the errors most often being associated with entry of medications. These numbers are consistent with prescriptions CPOE. 3.4 EFFICIENCY Observation of task time and minor errors which include path deviations indicates acceptable performance; however there is ample room for improvement to reduce time on task. The mean task time across all tasks is 127.6 seconds (11 second standard deviation), but the mean task time for entering the 6 medications was 289 seconds (8 second standard deviation). This is largely due to making sure all the medication field data was entered correctly. The average ERX took 39 seconds per prescription verses 48 seconds per current medication entered, but this is within one standard deviation. We had expected some improvement, but the time to enter medications varies depending on the complexity of the script. 3.5 SATISFACTION Based on task difficulty ratings and SUS results data, user satisfaction of the feature is considered favorable. Users perception of ease of use is considered easy, with a mean rating of 4.04 across all tasks (1=very difficult, 5=very easy). SUS scoring is very good with a score of 80.7. These scores accurately describe the average patient satisfaction with Enablemyhealth feature set. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 11 SUS Scoring Mean StDev 3.6 81.43 4.40 MAJOR FINDINGS The major usability problems encountered in this study were: Current Medications list difficulties: · · · · 3.7 Time on task continues to be a serious problem, because there are so many fields to write a script. Medications other than tablets (e.g.: injectables, inhalers) presented the most serious challenges Non-tablet prescriptions consistently lower ease of use scores Frequency was not easily understood and that this field, dose, days calculate the quantity and auto generate the directions. AREAS FOR IMPROVEMENT Current medications improvements: 1. Always default a measurement unit for every prescription type. 2. Add speech recognition to allow prescription to be spoken and the script to be automatically filled in with natural language processing. 3. Add more intelligence to recommend prescriptions and scripts based on diagnosis and patient demographics. 4. Provide a wizard option that leads users through the prescription scripting process. 4 APPENDICES The following appendices include supplemental data for this usability test report. Following is a list of the appendices provided: 1: Participant Recruiting Screener 2: Participant demographics 3: Informed Consent Form 4: Task Scenarios 5: Moderator’s Guide 6: Sample data collection form 7: System Usability Scale Questionnaire Appendix 1: PARTICIPANT RECRUITING SCREENER Enabledoc LLC ©2015 Confidential and Proprietary Version 1 12 Introduction Hello, my name is __. Enabledoc is seeking doctors and clinicians who are users of • Electronic prescribing software • Computerized order entry (such as labs and imaging) • Medication list and medication allergy list management to take part in a usability study of that portion of the EnableMyHealth EHR. This study will assist us in designing and developing a solution that meets your needs. Your experiences in using this particular design will greatly help our designers and developers. The testing of our design will take place in your office using remote meeting technology, requiring only your time, thoughts, and suggestions. We expect the session to last approximately 30 minutes. Does this sound like something that interests you? Before I schedule you for a session, do you have a few moments to answer some questions? General Questions 1. Are you male or female? [Recruit a mix of participants] 2. Have you participated in a focus group or usability test in the past three months? [Note but do not terminate if yes] 3. Which of the following best describes your age? [25 or less; 26 to 39; 40 to 59; 60 to 74; 75 and older][Recruit a mix of ages] Professional Demographics 4. What is your current position/role in your practice? 5. How long have you been in this role? 6. Do you currently perform e-prescribing? [computerized order entry, manage medication and medication allergy lists – pick appropriate for test][Terminate if no to specific task for test] How many prescriptions [or lab orders – use appropriate choice for test] do you write per day (or week if that is a better estimate)? 7. What year did you receive your medical degree? Computer Expertise 8. About how many hours per week do you spend on the computer that is medical practice related? [Recruit a range of use, e.g., 0 to 10, 11 to 25, 26+ hours per week][Terminate if less than 5] 9. Do you use a computer outside of your medical work? 10. If so, about how many hours per week do spend using a computer for non-work related endeavors? 11. Regarding your use of EnableMyHealth Practice Manager & EHR, what percentage of time is spent in each product? (per day) Enabledoc LLC ©2015 Confidential and Proprietary Version 1 13 Domain Knowledge · Rate your expertise or comfort in using EnableMyHealth software on a scale of 1 to 5 (1=just starting, 5=expert) for § PM § EHR (overall) § EHR e-Prescribing [Terminate if 1 or 2] · If you have used similar or competing products, describe your level of expertise in those products [it is not necessary to name the product(s) unless they want to]. Contact Information [If the person matches your qualifications, ask for any info we do not have] May I have your contact information? · Name of participant: · Office Key: · Best phone number: · Email address: Those are all the questions I have for you. Your background matches the people we're looking for. Would you be able to participate on [date, time]? Alternative: select from a list of sessions [ideal approach] Alternative; What would be the best date and time for you? Before your session starts, we will ask you to verbally acknowledge a release form allowing us to record your session. The recording will only be used internally for further study if needed and will never be used for advertising or marketing purposes. Also, you will not be personally identified with any recording. Will you consent to be recorded? [Terminate if no] This study will take place remotely via conferencing software, allowing you to participate in the session at the place of your choosing. I will confirm your appointment a couple of days before your session and provide you with any additional information. What is the best time to contact you? Enabledoc LLC ©2015 Confidential and Proprietary Version 1 14 Appendix 2: PARTICIPANT DEMOGRAPHICS Following is a high-level overview of the participants in this study. Gender Men Women Total (participants) Occupationan/Role RN/NP/MA Physician Total (participants) Years of Experience (average) Professional EHR Product Use 2 5 7 4 3 7 23.71 2.86 Demographic detail Participant ID C1 C2 C3 C4 C5 C6 C7 Gender M F F F F M F Occupation / role Age 48 MD 58 Medical Ass 38 Medical Ass 37 MD 74 MD 35 Medical Ass 25 Medical Ass Enabledoc LLC ©2015 Confidential and Proprietary Computer Experience Professional (intermediate, advanced, Experience expert) (yrs) 27 intermediate 35 intermediate 17 intermediate 16 intermediate 53 intermediate 14 intermediate 4 intermediate Version 1 Product Experience (yrs) 3 3 4 3 3 3 1 15 Appendix 3: Informed Consent Form Enabledoc would like to thank you for participating in this study. The purpose of this study is to evaluate an electronic health records system. If you decide to participate, you will be asked to perform several tasks using the prototype and give your feedback. The study will last up to 60 minutes. Agreement I understand and agree that as a voluntary participant in the present study conducted by Enabledoc. I am free to withdraw consent or discontinue participation at any time. I understand and agree to participate in the study conducted by Enabledoc. I understand and consent to the use and release of the recording by Enabledoc. I understand that the information and recording is for research purposes only and that my name and image will not be used for any purpose other than research. I relinquish any rights to the recording and understand the recording may be copied and used by Enabledoc without further permission. I understand and agree that the purpose of this study is to make software applications more useful and usable in the future. I understand and agree that the data collected from this study will not be shared outside of Enabledoc I understand and agree that data confidentiality is assured, because only de-identified data – i.e., identification numbers not names – will be used in analysis and reporting of the results. I agree to immediately raise any concerns or areas of discomfort with the study administrator. I understand that I can leave at any time. Please check or verbally indicate one of the following: YES, I have read the above statement and agree to be a participant. NO, I choose not to participate in this study. Signature: _____________________________________ Date: ____________________ Enabledoc LLC ©2015 Confidential and Proprietary Version 1 16 Appendix 4: Task Scenarios Usability Task Scenarios – Medication List Access the clinical information for a patient of your choice. Make note of the patient’s name as that will be required in later tasks 1: Record Patient Active Medication List -- this patient provides their current medications. Each one below is selected and modified then saved: Simvastatin 20 mg tablet by mouth once daily Lorazepam 0.5 mg tablet by mouth three times daily Insulin Glargine 10 units mL once daily for 10 days Metoprolol Tartrate 50 mg tablet by mouth once daily Warfarin 5 mg tablet by mouth once daily Monday, Wednesday, Friday, Sunday Warfarin 2.5 mg tablet by mouth once daily Tuesday, Thursday, Saturday Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 2: Change Patient Active Medication List – make the following changes to the patient’s medication list. Click Current Medications, then click Edit next to each one of the medications below and Update each one with these changes: · Simvastatin 20 mg tablet was discontinued (uncheck Taking box) and · The frequency of Lorazepam 0.5 mg tablet was changed from three times daily to every six hours (select Frequency) · The dose of Insulin Glargine was changed from 10 units to 20 units (make Dose amount 2) Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 4 5 3: Access Patient Active Medication List – retrieve the clinical records for patient Angelica C Taber and review their active medications with the usability session facilitator Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 Enabledoc LLC ©2015 Confidential and Proprietary 4 Version 1 5 17 4: Access Patient Medication History – Click Patient Center then click Medication tab and review the medications: · Simvastatin 20 mg tablet by mouth once daily - Discontinued · Lorazepam 0.5 mg tablet by mouth every six hours – Active · Insulin Glargine 20 units once daily - Active · Metoprolol Tartrate 50 mg tablet by mouth once daily - Active · Warfarin Sodium 5 mg tablet by mouth once daily Monday, Wednesday, Friday, Sunday - Active · Warfarin Sodium 2.5 mg tablet by mouth once daily Tuesday, Thursday, Saturday – Active Overall, how difficult or easy did you find this task? Very Difficult 1 Very Easy 2 3 Enabledoc LLC ©2015 Confidential and Proprietary 4 Version 1 5 18 Appendix 5: Usability Test Administration Moderator’s Guide 1. Items often forgotten a. Stop watch for recording time on task b. Elapsed time timer to time code observations/comments in the recording 2. Office Key Setup a. Environment b. Obtain copy of user key database if required for test c. Any required feature access d. Create and enter any necessary test data e. Create Database / Office Key snapshot 3. Schedule Join.Me sessions 4. Schedule participants 5. Supply test participants with materials prior to test a. Join.Me access b. Task scenarios (be prepared to resend at the start of the test – do not assume the participant has multiple monitors, so they may also need to print the scenarios) c. Informed consent form (can be done verbally during the session) 6. Set up administrative / test PC a. Join.Me installed and up to date b. Shut down all programs not needed for the test – remember things like Communicator c. Turn off notifications – audible and screen – on any software that may be running during the test (e.g.: Outlook) d. Ensure the application installed and functional 7. Running a test session a. Ensure office key/database snapshot of base data exists b. Start EHR session on test PC and arrive at starting screen for test c. Select first patient if selection is not part of the task scenario d. Start Join.Me session e. Share appropriate screen f. Greet user g. Administer introductory materials to user (see below, following checklist) h. Start Join.Me recording i. Display informed consent form on shared screen j. Obtain consent via verbal acceptance k. Give mouse and keyboard control to ALL l. Have user work through tasks m. For each task, record i. Time on task ii. Critical errors (anything that constitutes task failure) iii. Minor errors (anything the user detects and recovers) iv. Deviation(s) from optimal path v. Interesting comments (try to include recording time stamp for reference) n. After each task or task set (see specific scenarios) ask for response to single ease of use Enabledoc LLC ©2015 Confidential and Proprietary Version 1 19 question o. Allow verbal response to any questions contained in task scenarios p. At end of all tasks, display SUS questionnaire and have the participant place an X in appropriate response to each statement i. Save SUS with participant code as part of file name q. Conduct debrief to solicit any additional feedback, comments, Q&A, etc. Thank you for participating in this study. Your input is very important. Our session today will last about 45 minutes. During that time you will use a version of EnableMyHealth EHR and work with specific features. Our goal is to determine where there are areas of difficulty and design aspects that can be improved. I will ask you to complete a few tasks using this system and answer some questions. You should complete the tasks as quickly as possible making as few errors as possible. Please try to complete the tasks on your own following the instructions very closely. Please note that we are not testing you we are testing the system, therefore if you have difficulty all this means is that something needs to be improved in the system. There are no wrong answers! We will be here in case you need specific help, but we will not be able to instruct you or provide help in how to use the application, however we may provide specific hints as necessary. Overall, we are interested in how easy (or how difficult) this system is to use, and how we could improve it. I did not have any involvement in its creation, so please be honest with your opinions. We are recording the audio and screenshots of our session today. All of the information that you provide will be kept confidential and your name will not be associated with your comments at any time. Should you feel it necessary you are able to withdraw at any time during the testing for any reason. Enabledoc LLC ©2015 Confidential and Proprietary Version 1 20 Appendix 6: Sample data collection form Summative Usability Test Data Log Test type: Participant: Participant code: Session Date/start time: File name: Task 1: · · · · · · Critical Error count: Minor error count: Optimal path deviations: Time on task: SEoUQ response: Comments/observations: <repeat for each task> Enabledoc LLC ©2015 Confidential and Proprietary Version 1 21 Appendix 7: System Usability Scale Questionnaire In 1996, Brooke published a “low-cost usability scale that can be used for global assessments of systems usability” known as the System Usability Scale or SUS. Lewis and Sauro (2009) and others have elaborated on the SUS over the years. Computation of the SUS score can be found in Brooke’s paper, at http://www.usabilitynet.org/trump/documents/Suschapt.doc or in Tullis and Albert (2008). Strongly Disagree 1. I think that I would like to use this system frequently Strongly agree 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 2. I found the system unnecessarily complex 3. I thought the system was easy to use 4. I think that I would need the support of a technical person to be able to use this system 5. I found the various functions in this system were well integrated 6. I thought there was too much inconsistency in this system 7. I would imagine that most people would learn to use this system very quickly 8. I found the system very cumbersome to use Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 Version 1 22 9. I felt very confident using the system 10. I needed to learn a lot of things before I could get going with this system Enabledoc LLC ©2015 Confidential and Proprietary 1 2 3 4 5 1 2 3 4 5 Version 1 23 Enabledoc LLC ©2015 Confidential and Proprietary Version 1 24 Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 Appendix C: Quality Management System ©2016 InfoGard. May be reproduced only in its original entirety, without revision 11 Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 Appendix D: Privacy and Security ©2016 InfoGard. May be reproduced only in its original entirety, without revision 12 Test Results Summary for 2014 Edition EHR Certification 16‐3721‐R‐0003‐PRA V1.0, March 3, 2016 Test Results Summary Document History Version V1.0 Description of Change Initial release Date 3/03/2016 END OF DOCUMENT ©2016 InfoGard. May be reproduced only in its original entirety, without revision 13
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