American Osteopathic Association 16 National CME Sponsors Conference

American Osteopathic Association
16th National CME Sponsors Conference
How to Write a Grant – Completing a Grant
Submission
January 9, 2010
Jacqueline Mayhew
Jacqueline.mayhew@pfizer.com
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Objectives
After participating in this breakout, attendees should be able
to:
1. Complete the steps to apply for a grant from industry
2. Predict funding success based upon the depth of a needs
assessment
3. Explain the linkage between needs assessment, objectives,
educational design, and evaluation and outcome
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Agenda
 Warm Up Exercise
 Presentation
 Example Grants and Discussion
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AHRQ Review; Effectiveness of Continuing Medical
Education
 Multiple methods are better that single methods
 Interactive methods are better.
 Multiple interventions across time are better than single
interventions
 Simulation is better than other methods
 Related to life experience
 Includes support for self directed methods
 Reflection and feedback
 Role modeling by faculty
Marinopoulos SS, Dorman T, Ratanawongsa N, Wilson LM, Ashar BH, Magaziner JL, Miller
RG, Thomas PA, Prokopowicz GP, Qayyum R, Bass EB. Effectiveness of Continuing Medical
Education. Evidence Report/Technology Assessment No. 149 (Prepared by the Johns Hopkins
Evidence-based Practice Center, under Contract No. 290-02-0018.) AHRQ Publication No.
07-E006. Rockville, MD: Agency for Healthcare Research and Quality. January 2007.
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Disclaimer
While I am an employee of Pfizer, I am
speaking for myself today and do not
represent official Pfizer position or policy.
The strategies and tactics described herein are subject to legal
and regulatory approval prior to implementation. This document
provides an outline of a presentation and is incomplete
without the accompanying oral commentary and discussion.
Conclusions and/or potential strategies contained herein are NOT
necessarily endorsed by Pfizer management. Any implied
strategy herein would be subject to management, regulatory and
legal review and approval before implementation.
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External Med Ed Environment: Factors Affecting CME
Pay
-forPay-forPerformance
Performance
Regulations/
Regulations/
Compliance
Compliance
Senate
Senate Finance
Finance
Quality
Quality
Improvement
Improvement
Clinical
Clinical Practice
Practice
Guidelines/
Guidelines/ Measures
Measures
Committee/Aging
Committee/Aging
MED ED
ACCME/AOA
ACCME/AOA
Accreditation
Accreditation
Requirements
Requirements
Increasing
Increasing public
public
scrutiny
scrutiny
Physician
Physician Competence
Competence
Practice
Practice Based
Based
CPD/Performance
CPD/Performance
OCC,
OCC, MOC,
MOC, MOL
MOL
Learning
Learning
Improvement
Improvement
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A Perception of Satellite Symposia
“At major scientific meetings, there are often dozens of “satellite” symposia
sponsored by industry, advertised via slick, multi-color, glossy promotional
brochures. These meetings offer a sit-down dinner, followed by a series of
lectures by high profile and well-paid academic physicians. The content is
artfully organized by the communications company to subtly and not so subtly
promote the sponsoring company’s products. If you don’t attend national
meetings, you can obtain the same content via web-based education, which is
professionally produced and skillfully displayed. The communications
companies that produce these materials often charge industry hundreds of
thousands of dollars for a single event or webcast.”
Testimony to the Senate Committee on Aging, Steven E. Nissen, M.D.
Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic, Past
President of the American
College of Cardiology (ACC).
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Why Quality Medical Education Matters
Increases
Increases
Physician
Physician
Competence
Competence
Addresses
Addresses
Local
Local Needs
Needs
Impacts
Impacts
Population
Population
Health
Health
 Educates physicians on evolving science and medical
innovations.
 Increases quality of patient care by helping
healthcare providers know when and how to treat
patients.
 Provides physicians with implementation strategies
and/or approaches to overcome barriers to adoption
of new science.
 Improves quality of physician-patient interaction
based on an understanding of multicultural, gender,
age, and/or socio-economic factors.
 Addresses healthcare challenges in patient
populations and other national/global healthcare
priorities.
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CME to CPD
Traditional
Traditional CME
CME

 Relied
Relied on
on didactic,
didactic, large-audience
large-audience
lectures
lectures –– often
often in
in locations
locations
offering
offering entertainment.
entertainment.

 Emphasized
Emphasized knowledge
knowledge transfer
transfer
with
with little
little focus
focus on
on
implementation.
implementation.

 Measured
Measured effectiveness
effectiveness by
by
attendance
attendance and
and ifif physicians
physicians liked
liked
the
the program.
program.








Continuing
Continuing Professional
Professional
Development
Development
Emphasizes
Emphasizes Evidence
Evidence Based
Based
Medicine
Medicine (EBM),
(EBM), knowing
knowing the
the
science
science and
and how
how itit has
has been
been used
used
to
to determine
determine how
how best
best to
to improve
improve
patient
patient outcomes.
outcomes.
Includes
Includes Performance
Performance
Improvement
Improvement (PI)
(PI) to
to apply
apply what
what is
is
learned
learned in
in practice
practice to
to improve
improve
patient
patient outcomes.
outcomes.
Focuses
Focuses on
on learner
learner needs
needs and
and
innovative
innovative learning
learning designs
designs (e.g.,
(e.g.,
small
small group
group activities,
activities, online
online
material,
material, case
case studies).
studies).
Continues
Continues to
to use
use large
large group
group
presentations,
presentations, but
but also
also
emphasizes
emphasizes overcoming
overcoming barriers
barriers to
to
adoption.
adoption.
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Industry Stages of Change
Organizational Development Level
Pfizer
External
Relationship
Compliance

Effectiveness

1 Decentralized Brand Driven
2 Compliant Grant Administration
Pre 2006
Promotional
High Touch


2006
Confused


Grant Review
Assembly Line


3 Decentralized Process Driven Transactional
4 Centralized Process Driven Tactical
2006-2007
Education
Vendor


5 Centralized Education Driven Strategic
2007-2008
Education
Supporter


6 Center of Excellence for
Healthcare Provider Education
2008-2009
CPD
Supporter


PI Supporter


7 Center of Excellence for
Healthcare Quality &
Performance Improvement
2009-2010
Acknowledgement: Mike Saxton
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Goal Setting and Budgeting – one company’s approach
Goal Setting
Budgeting
 Educational goals are set and
evaluated quarterly based upon
assessment of external educational
needs and alignment with Pfizer
business priorities
 Goals should result in improved
patient-health status indicators or
improved patient safety
Overlapping
Zones of Mutual
Value
• Local / Regional needs
• National outreach
Patient Needs
Business
Needs
Healthcare System
Quality Gaps
Healthcare Provider
Performance Gaps
 MEG budget allocation to each
clinical area is set through a
dialogue with Medical Directors
and Education Director team
relative prioritization exercise
 Within each clinical area – budgets
are
apportioned to
 MEG clinical area budgets are also
allocated to
• Knowledge building (linked to early
commercial planning)
• Addressing clinical challenges and
overcoming barriers
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Alignment of Business and Educational Needs – OAB Example
Internal Team Identified
Gaps
Undiagnosed/
Undiagnosed/
Untreated
Untreated

Presentation often does not result
in diagnosis and Rx treatment.
Patient-driven, with multiple
office visits frequently required
before Rx.

Physicians encourage Rx
treatment only 45% of the time
patients bring up OAB.
Patient
Patient
Adherence
Adherence

Poor expectations setting causes
poor adherence
External Assessment of Educational Need
Overactive Bladder: An Integrated Assessment,
University of Cincinnati, IPMA, Healthcare Performance
Consulting, May 2008, available at www..ipmameded.org
• Incorporate tools and process changes that support proactive
screening of male and female patients for OAB and urinary
tract symptoms. Tools and processes should address the time
concerns felt within primary care practice settings
• Address patient/physician communication issues so that
symptoms of OAB are acknowledged as societal, quality of life
and heath concerns by physicians thereby encouraging
patients to provide a timely and accurate representation of
their symptoms
• Improve/refine physician evaluation skills to diagnose OAB
through physical examination and appropriate testing
• Acknowledge, accommodate and address the pitfalls of
diagnosing OAB through patient response to a trial dose of
appropriate pharmacotherapy
• Address physicians’ lack of knowledge and confidence around
integrated pharmacologic and behavioral therapy
• Incorporate new data on effective treatment regimens and
overall clinical management thereby accommodate high
physician value placed on new data and opportunities to
increase knowledge
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Strategy
An Education Framework
Establishing Needs
Expert Driven Methods
Predisposing
Update CME
Sample Methods
Needs Assessment
Performance Gap
Analysis
Change Readiness
Inventory
Outcome
Goal
Pilots
Lectures
Symposia
Seminars
Traditional
Web
Continuous
Assessment
Efficiency
Integrated Plan
Knowledge
Learner Driven Methods
Enabling
System Driven Methods
Reinforcing
Performance Improvement CME
Case Based
Workshops
QI Tools
Self Directed Methods
Barrier
Mitigation
Practice Based
Learning &
Improvement Stage
A&B
Effectiveness
Competence
Customize
Tools
PBLI Stage C
Quality
Improvement
Performance
* Model based on ACCME accreditation process, Roger’s work on Diffusion of Innovations and the
current literature on medical education effectiveness
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Comparative Grant Review Criteria
 Qualifications/Experience of Provider (Sponsor) and Educational Partners –
Competence/History in implementing high quality educational initiatives
 Needs assessment that underlie practice gaps of the target audience.
 Educational Objectives that are measurable and designed to change
competence, performance, or patient outcomes
 Educational design that incorporates multiple methods and is based on adult
learning principles, includes education strategy to address barriers to HCP
change
 Evaluation/Outcomes-plan to gather data to analyze changes in knowledge,
competence or performance of target audience and aims for higher level of
outcomes measurement than acquisition of knowledge/skills
 Quality-Is intervention likely to improve HCP knowledge, competence,
performance? Innovative concept? Cost effectiveness? Legacy aspect?
 Importance-Benefits to society? Will it enhance understanding for future ME?
Advance knowledge and understanding within the clinical area? Does it broaden
participation of underrepresented groups?
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Organizational Eligibility
 Accredited
 Represent patient care (hospitals, medical centers,
societies)
 Past grant reconciliation
 Compliance
 Joint sponsors
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Grant Eligibility
 Scope
• The grant request is not a medical education grant. For
example, it could be a fundraiser or sponsorship grant.
 Timing
• The start date of the proposed initiative (typically a live
event) is before the end of the application window or
shortly after.
 Alignment
• There is no alignment to any current clinical area of
interest.
• The objectives are not aligned with educational goals.
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Grant Compliance
Internal company policies
• Speakers
• Financial Dependence
Independence (ACCME, AOA)
• Content
• COI
External regulations (OIG, PHRMA, FDA)
• Kick-backs
• Off-label
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Traditional CME – compliance review
 Education time
 Entertainment
 Venue
 Certified for credit
 Commercial support
 Registration fee
 History
 Program control
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Organizational Assessment
 The requesting organization and its educational partners
should have the competence and demonstrated history of
implementing high quality educational initiatives.
Score 0
Average organization(s) that has not demonstrated superior
ability or leadership in CME or education community
Score 1
Organization has solid reputation in the clinical area of
interest or has previously demonstrated some level of
excellence in education
Score 2
Leading organization(s) with strong CME, educational, and
content leadership and expertise.
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Collaboration/Partnering
 Efficient
 Effective
 Mission-driven motivation
 Independence
 Credibility
 ACCME: The activity or educational intervention
should build bridges with other stakeholders
through collaboration and cooperation.
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Needs Assessment
 The grant application should incorporate educational needs (knowledge,
competence or performance) that underlie the professional practice gaps
of the target audience. It should include current references (1-3 years)
and be based upon a sufficient level of evidence. Needs assessments
should include multiple sources (quantitative/qualitative methods). Ideal
needs assessments include methods for continuous assessment
Score 0
The needs assessment is minimal or does not exist
Score 1
The needs assessment has an extensive literature review but does
not go beyond articulating the science area of need.
Score 2
The needs assessment includes multiple methods and shows
linkage between the identified practice gap and the need for
education
Score 3
The needs assessment has specific localized quantitative data
sources to document practice gaps and linkage to show how the
educational intervention proposed is likely to close the gaps.
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Objectives
 The educational objectives or stated purpose of the activity or
intervention should be clearly measurable and appropriate. Objectives
should be designed to change competence, performance, or patient
outcomes. Objectives should match the target audience's current or
potential scope of professional activities.
Score 0
Objectives are non-existent or so poorly written that they are not
measurable
Score 1
Objectives are knowledge based, focusing on cognitive domains
only
Score 2
Objectives are application based, focusing on making use of
knowledge (implement, improve, apply, prepare, report)
Score 3
Objectives are performance based, focusing on specific process or
outcomes measures that are linked to the identified performance
gap need
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Educational Design
 The activity or intervention should incorporate multiple methods and be based
upon adult learning principles. The design should be appropriate for the target
audience, objectives, and desired results.
 CME/CE should be integrated into a process for improving professional practice.
It should utilize non-education strategies to enhance change as an adjunct to its
activities/interventions (e.g. reminders, patient feedback)
 The activity or educational intervention should include educational strategies to
remove, overcome or address barriers to healthcare provider change.
Score 0
Score 1
Score 2
Score 3
Traditional education such as symposia or conference with no evidence of
innovation or incorporation of adult learning principles Pedagogically
driven didactic lectures where there is no pre-activity or follow-up.
Some element of the design is better than average such as the use of
interactive workshops and discussion sessions during a live conference.
Two or more innovative, original, or substantive elements. An example
may be the use of tools or re-enforced learning strategies following a
education intervention
Educational design truly based on actual needs and specific objectives or
goals. Incorporates additional elements of exemplary criteria such as
collaboration with others, quality improvement system methodology, or
use of non-educational interventions.
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Evaluation
 The grant application should include a plan to gather data or information
in order to analyze changes in the knowledge, competence, or
performance of the target audience.
 The plan should aim for higher levels of outcomes measurement beyond
just the acquisition of knowledge and skills. The plan should
demonstrate clarity and innovation
Score 0
Measurements limited to reach and satisfaction
Score 1
Measurements include acquisition of knowledge, skills and/or
intent to change
Score 2
Measurements include actual practice change through chart audit,
independent observation etc.
Score 3
Measurements include patient or population health outcomes.
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Example from CV of Educational Outcomes
Virginia Pilot Program
 Goals
• Improve physician identification of at-risk
patients
(9 ACC/AHA measures)
• Provide tools and resources needed to ensure
patients adhere to necessary treatment
protocols and comply with recommended
practice guidelines
Population Health
Patient Health
Performance
 Change Strategies
• 6 methods from group program to practice
based coaching with 95 physicians in 16
practices
 Results
• High customer satisfaction
• 80% improvement in closing lipid testing
performance gap
• 46% improvement in smoking cessation
counseling performance gap
• Multiple practice based PDSA cycle
“breakthroughs” to overcome barriers
Learning
Satisfaction
Participation
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Quality
 Assess the overall quality of the application. Things to
consider:
• To what extent is the proposed activity/intervention likely to improve
healthcare provider knowledge, competence, and performance?
• How well qualified is the requestor to conduct the activity or
educational intervention?
• To what extent does the proposed activity/intervention suggest and
explore creative and original concepts?
• How well conceived and organized is the proposed
activity/intervention?
• How cost effective is the proposed activity/intervention?
• Is there a legacy aspect to the program that is important to
recognize and continue to support?
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Importance
 Assess the overall importance of the proposed activity or
educational intervention. Things to consider:
• Will the results of the activity or educational intervention be
published in order to become intellectual property in the public
domain?
• To what extent will it enhance understanding for future medical
education?
• To what extent does the intervention represent an improvement or
advance for the requesting organization that should be recognized
and encouraged?
• How important is the proposed activity/intervention to advancing
knowledge and understanding within its own therapeutic area or
across different diseases?
• How well does the proposed activity/intervention broaden the
participation of (and reach to) underrepresented groups (e.g.,
gender, ethnicity, disability, geographic, etc.)?
• What may be the benefits of the proposed activity to society?
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Cost
 Total budget amount for the activity or initiative
 Amount requested
 Percent of the total budget that is listed as
educational (versus non-educational) costs
 Cost per learner
 “skin in the game”
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In summary – attributes of successful CME grants:
 grounded in adult learning principles
 based upon appropriate assessment of physician
knowledge and performance, healthcare quality and
patient safety
 altered formats and methods to better meet the
needs of individual, self-directed physician learners
 collaborative, involving others involved in training
physicians across the continuum of medical
education
 content reflects the changing realities of medicine
(e.g., aging population, gender issues, minority
patients, globalization, genetics)
 effective COI resolution processes
 diversified funding sources
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THANK YOU!
Questions?
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