Use of physical restraints in acute hospitals in Germany: A multi
Transcription
Use of physical restraints in acute hospitals in Germany: A multi
G Model NS-2226; No. of Pages 8 International Journal of Nursing Studies xxx (2013) xxx–xxx Contents lists available at SciVerse ScienceDirect International Journal of Nursing Studies journal homepage: www.elsevier.com/ijns Use of physical restraints in acute hospitals in Germany: A multi-centre cross-sectional study Cäcilia Krüger a, Herbert Mayer a, Burkhard Haastert b, Gabriele Meyer a,c,* a Faculty of Health, School of Nursing Science, Witten/Herdecke University, Witten, Germany mediStatistica, Neuenrade, Germany c Medical Faculty, Institute for Health and Nursing Science, Martin-Luther-University Halle-Wittenberg, Germany b A R T I C L E I N F O A B S T R A C T Article history: Received 18 July 2012 Received in revised form 6 May 2013 Accepted 7 May 2013 Background: Physical restraints are contrary to patients’ autonomy and freedom. Their justification for controlling psychomotor agitation and risk of falling is being questioned more and more often. Physical restraints are associated with many negative outcomes. The German law is explicit, allowing physical restraints in nursing only as an exception. Data on the use of physical restraints in acute hospitals in Germany are sparse. Objectives: To investigate the prevalence of physical restraints and characteristics associated with physical restraint use in acute hospitals. Design: Cross-sectional study. Participants and setting: 1276 patients (mean age 65 years, 45% women, 50% surgical) on 61 wards (n = 47 general; n = 14 intensive care) in four acute care hospitals in North RhineWestphalia, Germany. Methods: One investigator visited each hospital ward at three randomly allocated time slots on randomly selected days within a period of three months. A total of 3434 direct observations on physical restraint status were collected. The study period lasted from October 2008 to March 2009. For analysis, one time slot per patient room was randomly chosen in order to avoid repeated analysis of the same patient. Results: The prevalence of patients with at least one physical restraint was 11.8% (95%CI 7.8–15.7). The measures used most often were full bed rails (9.8%, 95%CI 6.5–13.1). There was pronounced prevalence variation throughout the wards (general wards: 0.0–31.3%; intensive care: 0.0–90.0%). The prevalence of physical restraints between hospitals ranged from 6.2 to 16.6%, the overall association with hospital was non-significant. Multivariate regression analysis revealed statistically significant characteristics for physical restraint use: age 80–99 years versus 18–54 years (adjusted odds ratio 4.34, 95%CI 2.18–8.64), feeding tube (2.70, 1.40–5.22), indwelling urinary catheter (6.52, 3.75–11.34), and staying in intensive care unit (3.39, 1.29–8.92). Sharing a multi-bed room (0.55, 0.35–0.89) and in situ central venous line were inversely associated (0.44, 0.19–0.98). Conclusions: Physical restraints are apparently standard care in German acute hospitals. However, variation between wards indicates that hospital care with only few physical restraints is feasible. Respecting patients’ dignity and integrity warrants intervention programmes aimed at decreasing practice variation towards a general reduction of physical restraints in acute hospitals in Germany. ß 2013 Elsevier Ltd. All rights reserved. Keywords: Epidemiology Hospitals Nursing Restraint Physical * Corresponding author at: Medical Faculty, Institute for Health and Nursing Science, Martin-Luther-University Halle-Wittenberg, Germany, Tel.: +49 345 557 4498; fax: +49 345 557 4471. E-mail address: Gabriele.Meyer@medizin.uni-halle.de (G. Meyer). 0020-7489/$ – see front matter ß 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijnurstu.2013.05.005 Please cite this article in press as: Krüger, C., et al., Use of physical restraints in acute hospitals in Germany: A multi-centre cross-sectional study. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.05.005 G Model NS-2226; No. of Pages 8 2 C. Krüger et al. / International Journal of Nursing Studies xxx (2013) xxx–xxx What is already known about the topic? Former international epidemiological studies indicate substantial use of physical restraints in the acute hospital setting. Data on the use of physical restraints in acute hospitals in Germany are sparse. What this paper adds Physical restraints are applied to approximately 12 out of 100 patients in German acute care hospitals. Restrictive bedrails are the physical restraint most often used. Variation of prevalence between wards is pronounced, but indicates that hospital care with only few physical restraints is feasible. 1. Background Physical restraints are common practice in the acute care setting (Demir, 2007; Martin and Mathisen, 2005; Minnick et al., 2007; Heinze et al., 2012). They are used to keep patients in bed, to prevent accidental falls or patients’ interference with therapy (Agens, 2010; Benbenbishty et al., 2010; Lane and Harrington, 2011), even though many negative outcomes are known such as decreasing mobility, increased risk of pressure sores or psychological problems (Agens, 2010). A restraint-free nursing care environment is called for as a high standard of care (RNAO, 2012). Physical restraints violate patients’ autonomy and freedom and their right to take risks (Sokol, 2010). Although not much research on patients’ perception of physical restraints has been done, existing evidence indicates that patients experience negative psychological impact and negative feelings such as anger and fear, and often they do not know why they are being restrained (Bower and McCullough, 2000; Strout, 2010). Nursing staff report feelings of guilt and embarrassment while using physical restraints (Janelli et al., 2006), but mistakenly overestimate the perceived benefits (Martin, 2002). Bed rails, belts and chairs with a table are the measures most often used (Minnick et al., 2007). A recently published secondary data analysis of perceptions by nurses on general wards in 15 German hospitals revealed a prevalence of 9.3% physical restraints in a sample of 2827 patients (Heinze et al., 2012). Prevalence of physical restraints in acute hospitals reported in international publications ranges between 3% and 25% (Evans et al., 2002; Agens, 2010). The variance can be explained by different definitions of physical restraints, different data collection techniques, the characteristics of the care settings and the case mix (Krüger et al., 2010). Legal regulations and tradition also determine the likelihood of physical restraint use (Bower et al., 2003). The German law is explicit, allowing physical restraints in acute hospitals only for circumscribed exceptions with judicial authorisation for people who could not consent, or for a short period of time in the case of an emergency (Fogel and Steinert, 2012). Data on the use of physical restraints in acute hospitals in Germany are sparse. High quality epidemiological data are the basis for the future development of interventions in order to achieve nursing care with a minimum of physical restraints. Therefore, we performed a cross-sectional study on the prevalence of physical restraints in acute care hospitals and investigated associations with restraint use. 2. Methods 2.1. Recruitment Recruitment took place in July 2008 in North RhineWestphalia, Germany. We invited a convenience sample of four large maximum-care hospitals to take part in our study. The hospitals were known from former research projects and belong to a collaborative network, initiated by Witten/Herdecke University, aimed at improving knowledge transfer from research to practice. None of the hospitals had previously given priority to the topic of physical restraints. All agreed to participate. Each hospital nominated a nurse as contact person for the researchers and all study-related issues on-site. The selection of participating wards was made by the contact nurse of the respective hospital, who was requested to select nearly the same number of surgical and internal medicine units as well as intensive care units. Paediatric and psychiatric wards as well as accident and emergency departments were excluded. The study population consisted of patients aged over 18 years, who were cared for on the participating wards at the time of data collection for the cross-sectional study. 2.2. Definition of physical restraints According to an established definition, physical restraints were defined as ‘‘any device, material or equipment attached to or near a person’s body and which cannot be controlled or easily removed by the person and which deliberately prevents or is deliberately intended to prevent a person’s free body movement to a position of choice and/or a person’s normal access to their body’’ (Evans et al., 2002). Physical restraints included restrictive bed rails, i.e. bilateral full bed rails or a full bed rail on one side of the bed with the other side next to the wall, belts in beds or chairs (wrist, elbow, ankle, abdominal), geriatric chairs with fixed tables and other measures. Other measures included tipping chairs, blankets or sheets, and manipulation of furniture, all of which were considered as eligible. These devices and techniques have been observed in nursing settings during our own previous data collections on physical restraints (Meyer et al., 2009; Köpke et al., 2012). 2.3. Data collection Nursing staff on the wards were generally informed about the upcoming data collection, but not about the date and time. The contact nurse of each hospital was the only person who was fully informed, but who was also requested to conceal the dates. In preparation of the data Please cite this article in press as: Krüger, C., et al., Use of physical restraints in acute hospitals in Germany: A multi-centre cross-sectional study. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.05.005 G Model NS-2226; No. of Pages 8 C. Krüger et al. / International Journal of Nursing Studies xxx (2013) xxx–xxx 3 The prevalence data collection sheet contained the options of physical restraints as defined in Section 2.2 and patient characteristics as displayed in Table 1. Patient characteristics were collected from observation and/or by nursing staff who assessed patient records. The data collection sheet was piloted for its feasibility and acceptability on two wards of a hospital not contributing to the main study. The investigator entered the patients’ rooms on her own. The company of a staff nurse was not mandatory, but optional, and generally took place in intensive care units. For ethical reasons, the investigator was not allowed to lift the blanket or actively search for physical restraints. Thus, only apparent physical restraints could be documented. If unsure whether a physical restraint was in place, a staff nurse was asked. Only patients present in their rooms or on the ward were included in the data collection. collection, the contact nurse distributed laminated information sheets for patients and next of kin at the participating wards to explain the upcoming in-house data collection. The sheets were positioned so that they were easily visible, or even fixed on the tables in the patients’ rooms. The data collection period throughout all the hospitals lasted six months (from October 2008 until March 2009). Data were collected by one external investigator (CK) who was temporarily employed by the hospitals without getting a salary. Each participating hospital ward was visited three times: in the morning (9:30 to 11:30 a.m.), in the afternoon (4:00 to 6:00 p.m.), and in the evening (7:30 to 9:30 p.m.). The time slots were determined not for feasibility only, but also for the protection of patients’ private sphere by trying to avoid disturbing them when sleeping or when using the bathroom, for instance. In order to avoid underestimation of physical restraint use due to projectable visits, the three visits per ward were randomly allocated to randomly selected days during a period of three months maximum per hospital. Random procedure was carried out by a researcher who was not engaged in the study and who picked labelled and sealed notes out of a container. 2.4. Sample size The outcome of the study was defined as patients with at least one physical restraint documented at the time of observation. Assuming a literature-based prevalence of 10% patients with restraint use (Krüger et al., 2010) and Table 1 Characteristics of the randomly selected population. Characteristic Total random sample (n = 1276)a Patients with physical restraints on general wards (n = 82) Patients with physical restraints on intensive care units (n = 68) Women Mean SD age, years Age group (age classes around quartiles of 54, 68, 78), years 18–54 55–69 70–79 80–99 Assisted breathingb Line or drainagec Feeding tube Indwelling urinary catheter Central venous line Peripheral line Arterial line Surgical patients Non-surgical patients Assessed for physical restraint use on weekdays (Monday to Friday) Assessed for physical restraint use in the Morning Afternoon Evening Admitted to a ward size of 20 beds >20 beds Admitted to a ward size of 30 beds >30 beds Placed in Multi-bed room Single-bed room Single occupancy in multi-bed room 577 (45) 65 18 49 (60) 79 13 24 (35) 62 20 (26) (29) (25) (21) (24) 4 10 18 50 32 (5) (12) (22) (61) (39) 19 17 20 12 59 (28) (25) (29) (18) (87) 126 (10) 328 (26) 241(19) 530 (42) 119 (9) 634 (50) 642 (50) 911 (71) 15 49 8 52 25 57 68 (18) (60) (10) (63) 44 64 54 12 48 41 27 45 (65) (94) (79) (18) (71) (60) (40) (66) 361 (28) 405 (32) 510 (40) 31 (38) 17 (21) 34 (41) 18 (26) 24 (35) 26 (38) 265 (21) 1011 (79) 9 (11) 73 (89) 53 (78) 15 (22) 578 (45) 698 (55) 29 (35) 53 (65) 64 (94) 4 (6) 981 (77) 146 (11) 149 (12) 57 (69) 8 (10) 17 (21) 32 (47) 25 (37) 11 (16) 329 369 313 265 307 (30) (70) (83) Note: Values are numbers (percentage) unless stated otherwise. a Selected population (1 daytime per room, randomly selected) out of the total number of observations (n = 3434). b Assisted breathing means both artificial ventilation or oxygenation. c Multiple answers possible; Missing values (n = 13). Please cite this article in press as: Krüger, C., et al., Use of physical restraints in acute hospitals in Germany: A multi-centre cross-sectional study. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.05.005 G Model NS-2226; No. of Pages 8 C. Krüger et al. / International Journal of Nursing Studies xxx (2013) xxx–xxx 4 taking into account 20% of unoccupied beds, we calculated a number of at least 1200 observations in four acute care hospitals in order to estimate a 95% confidence interval (CI) of the prevalence with a precision of 2% (i.e. 95%CI 8–12%). The calculation was not adjusted for cluster correlation. Additional cluster adjustment using the methods of Donner and Klar (2000) and assuming a design factor of 5 (as observed in the data, Table 2) would result in a larger 95%CI of 6–14% based on the same sample size. 2.5. Statistical methods Since each hospital ward was visited three times – in the morning, in the afternoon and in the evening – with time slots in random order and on randomly selected days within a period of three months maximum, it cannot be ruled out that some patients were included in the data collection more than once. Therefore, for statistical analysis one time slot per room was randomly chosen in order to avoid repeated analysis of the same patient. Selection of one time slot per ward would have been even more restrictive. However, we assumed that the probability of a patient moving to another room within the same ward and therefore being observed twice during our data collection to be very low. Baseline characteristics of the randomly selected population are described as mean values standard deviations and as numbers and percentages. The outcome analysis is adjusted for cluster correlation with hospital wards as cluster units. All the patients in a room are documented at a fixed time. Therefore, we assumed that the documented patients are all different individuals and no further adjustment for repeated measurement has to be considered. Assuming that cluster correlation is related to the ward level and not to the patient room level, no further cluster adjustment for patients’ rooms was taken into account. Prevalence of physical restraints was estimated including cluster adjusted 95% confidence intervals using cluster size weights as described by Donner and Klar (2000). The cluster correlation was estimated by the corresponding intracluster correlation coefficient. Associations of characteristics of patients and institutions with the use of physical restraints were investigated by multivariate logistic regression analysis adjusted for cluster correlation using generalised linear mixed models (Brown and Prescott, 2006). The dependent variable was the use of physical restraints. Selected characteristics of patients and institutions were investigated as fixed effects. Hospital (n = 4) in particular are fixed effects. Clusters (wards) are random effects. The Satterthwaite method was used to calculate denominator degrees of freedom for the tests of fixed effects. Variable selection of the fixed effect was performed in two steps. First, univariate models were built-in. All variables with a p < 0.20 (testing the corresponding odds ratio) were selected for the final multiple model. Performing stepwise or backward variable selection in multiple regression cut-points for p-values of 0.10–0.15 is common (Le, 2003). The higher cut-point of 0.20 should help to avoid undetected associations due to confounding factors. Also for this reason, an additional model was integrated using all variables mentioned above (data not shown). Age was analysed in the models using four classes corresponding to rounded quartiles (18–54, 55–69, 70–79, 80–99 years). Ward size was dichotomized around the mean [mean = 30; median = 33 (general ward (mean = 32; median = 34); intensive care units (mean = 20; median = 16)]. Interpretation of the results was much more difficult from a non-mathematical point of view when age and ward size were analysed as continuous variables. Statistical calculations were performed by SAS version 9.3 on Windows 7 64. Generalised mixed models were built-in using SAS PROC GLIMMIX. Further data analyses were performed by PASW Statistics (Version 18 and 20). Table 2 Prevalence of physical restraints in the randomly selected population (n = 1276). Patients with at least one physical restraintc Patients with observed application of Restrictive bedrails Unilateral wrist restraintd Bilateral wrist restraint Waist belt in bedd Chair with fixed tabled Cluster adjusted prevalence, % (95% confidence interval) ICCCa DFb 11.8 (7.8–15.7) 0.1751 5.064 0.1316 0.0343 0.2778 0.0380 0.0083 4.054 1.797 7.447 1.881 1.193 9.8 0.5 2.5 0.1 0.4 (6.5–13.1) (0.0–1.1) (0.2–4.9) (0.0–0.3) (0.0–0.8) a ICCC = Intracluster correlation coefficient. DF = Design factor. c General wards (n = 1089 patients): cluster adjusted prevalence of patients with at least one physical restraint 7.5% [(95%CI 5.3–9.7), ICCC = 0.0412, DF = 1.998], restrictive bedrails 7.1% [(95%CI 4.9–9.3), ICCC = 0.0436, DF = 2.056], unilateral wrist restraint 0.2% [n = 2, (95%CI 0.0–0.4), ICCC = 0.0000, DF = 1.000], bilateral wrist restraint 0.2% [n = 2, (95%CI 0.0–0.4), ICCC = 0.0005, DF = 1.011], waist belt in bed 0.1% [n = 1, (95%CI 0.0–0.3), ICCC = 0.0429, DF = 2.039], chair with fixed table 0.3% [n = 3, (95%CI 0.0–0.6), ICCC = 0.0000, DF = 1.000]; Intensive care units (n = 187 patients): cluster adjusted prevalence of patients with at least one physical restraint 36.4% [(95%CI 23.2–49.6), ICCC = 0.1501, DF = 3.592], restrictive bedrails 25.7% [(95%CI 13.1– 38.3), ICCC = 0.1719, DF = 3.969], unilateral wrist restraint 2.7% [(95%CI 0.1–5.2), ICCC = 0.0116, DF = 1.200], bilateral wrist restraint 16.0% [(95%CI 5.4– 26.7), ICCC = 0.1739, DF = 4.005], chair with fixed table 1.1% [n = 2, (95%CI 0.0–2.8), ICCC = 0.0166, DF = 1.287]. No waist belt in bed was observed at intensive care units. d Due to low prevalence of these physical restraints (less than 10 cases) the asymptotical estimation of cluster adjusted 95%CI, ICCC and DF should be interpreted with caution. b Please cite this article in press as: Krüger, C., et al., Use of physical restraints in acute hospitals in Germany: A multi-centre cross-sectional study. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.05.005 G Model NS-2226; No. of Pages 8 C. Krüger et al. / International Journal of Nursing Studies xxx (2013) xxx–xxx 2.6. Ethical approval The protocol was approved by the ethics committee of the School of Nursing Science at Witten/Herdecke University (June 2008). A waiver of consent from participating patients was obtained, a method that has been successfully applied in other own studies (Meyer et al., 2009; Köpke et al., 2012). Additional approval was obtained by the local ethical committees of the participating hospitals. Due to data protection regulations, we were not allowed to collect information about diagnoses, medication or cognitive status from patients’ records. All patientrelated data were de-identified. 3. Results Sixty-one wards were visited, 47 were general wards and 14 intensive care units. Wards caring only for surgical patients (n = 26) had a mean cluster size of 21.7 9.1, wards caring only for non-surgical patients (n = 30) of 19.6 7.5 and wards caring for surgical and non-surgical patients (n = 5) of 25.0 9.4 (separated for different patients: 14.0 4.3 surgical patients, 11.0 6.4 non-surgical patients). A total of 3434 observations were performed and made available for outcome analysis (general wards: n = 2909; intensive care units: n = 525). Half of the observations (n = 1775, 52%) were performed on non-surgical wards and half on surgical wards (n = 1659, 48%). Random selection of one time slot per room revealed a study population of 1276 patients. Mean age of the randomly selected patient population was 65 18 years, 45% were women; 26% had an indwelling urinary catheter and 42% an in situ peripheral line. Table 1 displays the sociodemographic and clinical characteristics of the randomly selected population. The prevalence of patients with at least one physical restraint was 11.8% (95% confidence interval (CI) 7.8– 15.7%). The measures most often observed were bed rails (9.8%, 95%CI 6.5–13.1), followed by bilateral wrist restraint (2.5%, 95%CI 0.2–4.9). Table 2 presents the data on the prevalence of the observed physical restraints. Centre variation across wards was pronounced; prevalence ranged from 0.0% to 31.3% on general wards and 0.0% to 90.0% in intensive care units. The prevalence of physical restraints between hospitals varied between 6.2% and 16.6%, the overall association with hospital was nonsignificant (multivariate logistic model: p = 0.065, Table 3). A set of 15 baseline variables were evaluated in univariate models. The variables ‘female’ and ‘assessed for physical restraint use in the afternoon’ were excluded for the multivariate model because the related p-value was above 0.20 (p = 0.46 and p = 0.34). The results of the cluster adjusted univariate and multivariate regression analyses are displayed in Table 3. Multivariate regression analysis revealed statistically significant positive associations with physical restraint use for age 80–99 years versus 18–54 years (adjusted odds ratio: AOR = 4.34, 95%CI = 2.18–8.64), in situ feeding tube (AOR = 2.70, 95%CI = 1.40–5.22), indwelling urinary catheter (AOR = 6.52, 95%CI = 3.75–11.34) and staying in an intensive care unit (AOR = 3.39, 95%CI = 1.29–8.92). The 5 hospital itself was not statistically significantly associated with the use of physical restraints. Inverse associations were found for sharing a multi-bed room (AOR = 0.55, 95%CI = 0.35–0.89) and in situ central venous line (AOR = 0.44, 95%CI = 0.19–0.98). The results from an additional model including all variables from univariate analyses were very similar (data not shown). 4. Discussion This cross-sectional study is the first in Germany that determines the prevalence of physical restraints in a large group of patients from four maximum-care hospitals by direct observation, which is undoubtedly the most valid and reliable method (Laurin et al., 2004). Although the hospitals were personally known from an already existing collaborative network, they do not represent a special selection. Physical restraints were not a topic the hospitals had focused on previous to our study. We found that 12 out of 100 patients were subject to at least one physical restraint, predominately restrictive bed rails. The prevalence found in our study is slightly higher as the prevalence of 9.3% reported by a recent secondary data analysis of a questionnaire-based survey (Heinze et al., 2012). Here, 2827 patients on general wards of 15 hospitals in Germany were analysed, where – contrary to our study – intensive care units were excluded from data collection. We found a lower prevalence of 7.5% (95%CI 5.3–9.7) on general wards, which might be due to different methodological procedures and characteristics of participating hospitals. Comparison to other studies is hardly feasible due to different definitions of physical restraints, varying data collection methods and the different settings and populations investigated (Krüger et al., 2010). In the USA, Minnick et al. (1998) used comparable data collection methods, but excluded bed rails. Data were presented as observation rate of physical restraint use. The results indicated 5.8% physical restraints out of 49,000 patient observations throughout general wards and intensive care units. The average use rate in intensive care units was much higher at 24.3%. Differences between wards were pronounced. Our study confirms this variation of the prevalence between wards of the same discipline. The reason is unclear. The finding corresponds not only with the early study by Minnick et al. (1998), but also with further research in the acute hospital setting (Healey et al., 2009; Minnick et al., 2007) and other nursing settings (Meyer et al., 2009; Feng et al., 2009). We also found that staying in an intensive care unit implies a higher likelihood of physical restraint use. A reason often given for more frequent restraint use in intensive care units is the intended protection of patients from self-initiated removal of indwelling devices (Benbenbishty et al., 2010; Turgay et al., 2009). In a recent study (Benbenbishty et al., 2010) the prevalence of physical restraints across all 566 patients from 34 intensive care units in nine European countries was 39%. This figure is quite comparable to our findings (Table 2: cluster adjusted prevalence 36.4%, 95%CI 23.2–49.6), although our intensive care unit sample comprised only 187 patients. The Please cite this article in press as: Krüger, C., et al., Use of physical restraints in acute hospitals in Germany: A multi-centre cross-sectional study. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.05.005 G Model NS-2226; No. of Pages 8 C. Krüger et al. / International Journal of Nursing Studies xxx (2013) xxx–xxx 6 Table 3 Results of the cluster adjusted logistic regression analyses in the randomly selected population (n = 1276). Characteristic Univariate analysis p-value AORb (95%CI) Female sex Age (ref.: 18–54) 55–69 70–79 80–99 Assisted breathing Feeding tube Indwelling urinary catheter Central venous line Peripheral line Arterial line Intensive care unit patient Surgical patient Assessed for physical restraint use at the weekend Assessed for physical restraint use in the afternoon (ref.: morning and evening) Ward size > 30 beds Multi-bed room (ref.: 1-bed room and single occupancy in multi-bed room) Hospital (ref.: A) B C D a b c p-value AORb (95%CI) 1.15 (0.79–1.68) 1.24 2.31 5.96 5.47 8.02 12.36 2.39 1.33 3.69 8.24 0.62 0.71 0.81 Multivariate analysisa (0.66–2.36) (1.24–4.31) (3.25–10.96) (3.51–8.53) (4.68–13.75)a (7.81–19.56)a (1.45–4.05)a (0.89–1.99)a (1.98–6.88)a (4.39–15.45) (0.33–1.19) (0.44–1.13) (0.53–1.24) 0.50 (0.24–1.03) 0.42 (0.28–0.63) 0.92 (0.26–3.22) 0.36 (0.10–1.24) 1.11 (0.30–4.12) 0.456 <0.001c 0.505 0.009 <0.001 <0.001 <0.001 <0.001 0.001 0.162 <0.001 <0.001 0.149 0.148 0.340 – 0.060 <0.001 1.11 (0.57–2.18) 0.55 (0.35–0.89) 0.750 0.015 1.21 (0.47–3.13) 0.49 (0.19–1.28) 1.25 (0.44–3.58) 0.065c 0.678 0.140 0.664 0.083c 0.897 0.104 0.876 1.10 1.86 4.34 1.67 2.70 6.52 0.44 1.20 0.79 3.39 0.67 0.78 – (0.55–2.20) (0.95–3.66) (2.18–8.64) (0.93–3.00) (1.40–5.22) (3.75–11.34) (0.19–0.98) (0.71–2.02) (0.34–1.83) (1.29–8.92) (0.38–1.20) (0.46–1.31) – <0.001c 0.791 0.072 <0.001 0.088 0.003 <0.001 0.045 0.500 0.584 0.014 0.175 0.342 – Missing values (n = 13). AOR = Adjusted odds ratio. Overall type 3 test. European comparative study (Benbenbishty et al., 2010) revealed a country variation between 0.0% and 100%. However, the result must be interpreted with caution, since the country-related sample sizes differed from 15 to 319 patients. Attitudes and beliefs of nursing staff seem to be decisive factors for restraint use (Werner and Mendelsson, 2001; Hamers and Huizing, 2005; Goethals et al., 2012). A recent synthesis of qualitative evidence (Goethals et al., 2012) indicates the complexity of the decision-making process on appropriate use of physical restraints, which is influenced by context and nurse-related factors. As also pointed out in earlier work (e.g. Karlsson et al., 1998; Meyers et al., 2001), the priority is on safety, giving higher preference to physical restraint use rather than to autonomy and freedom from restraints accompanied by the risk of a patient falling or removing medical devices (Goethals et al., 2012). Legal regulation has certainly an impact on physical restraint use in nursing. For instance, the introduction of the US American Omnibus Budget Reconciliation Act in 1987 resulted in a relevant decrease of physical restraints in nursing homes (Castle and Mor, 1998). However, even strict legal regulations do not appear to adequately protect nursing care recipients from physical restraints. German law clearly directs that patients in acute nursing care settings have free body movement. Physical restraints should always be the last resort after all other alternatives have been tested. Use of physical restraints in German acute hospitals requires either the patient’s written consent or judicial authorisation if the person is not able to consent. Physical restraints are permitted as an exception in the case of an emergency, if contractually incapable, aggressive or violent persons show dangerous behaviour that could not be otherwise controlled, or for unconscious and sedated patients at intensive care units who should be prevented from self-inflicted activities (Fogel and Steinert, 2012). In our present study, we were not able to collect information on judicial authorisation and other justifications of physical restraints, since the participating hospitals denied access to the data. It is unknown whether acute care hospitals in Germany adhere to the legal requirements of physical restraint use. With regard to German nursing homes we know from our own recent study (Köpke et al., 2012) that nowadays the majority of physical restraints are authorised. However, this finding could not be transferred to acute hospital care. Physical restraints in German nursing homes and especially the legal issues have been a matter of debate for a long time, quite contrary to the acute hospital setting. Our regression analysis indicates the already known positive associations between the use of physical restraints and high age, indwelling catheter, and in situ feeding tube, respectively (Heinze et al., 2012; Hamers and Huizing, 2005; Demir, 2007; Minnick et al., 2007). We also add some new insights to the current knowledge on the use of physical restraints in acute hospitals. The in situ central venous line was inversely associated with the use of physical restraints, a surprising result without self-evident explanation. Sharing a multi-bed room was also inversely associated with physical restraints. Again, the rationale remains unclear. It may be that patients in single rooms differ from patients in multi-bed rooms. Another explanation could be that nurses expect relatively healthy roommates to control the behaviour of patients with an increased risk of physical restraint use. Please cite this article in press as: Krüger, C., et al., Use of physical restraints in acute hospitals in Germany: A multi-centre cross-sectional study. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.05.005 G Model NS-2226; No. of Pages 8 C. Krüger et al. / International Journal of Nursing Studies xxx (2013) xxx–xxx We could not find an association between gender and the use of physical restraints as indicated by former studies (Minnick et al., 1998, 2007). Our study has its strong points: a large sample size was investigated, both general wards and intensive care units were included, the analysis took cluster correlation into account and nursing staff were not aware of the date and time of the visits. We can certainly not rule out that the contact nurses informed the nursing staff in spite of promising not to do so. The information sheets for patients and next of kin distributed on the wards might have influenced the frequency of physical restraints. However, both potential limitations would have led to an underestimation of physical restraint use. Our study has other limitations. We were not allowed to collect information on diagnosis, medication or cognitive status from patients’ records because of data protection issues. The selection of participating wards was made by the contact nurse at the respective hospital. We could therefore not completely rule out selection bias due to a non-representative sample of wards. Our study did not explore reasons for the use of physical restraints because nurses are very likely to come up with socially desired answers. Former studies (e.g. Hamers and Huizing, 2005; Minnick et al., 1998, 2007) found fall prevention, disruption of therapy or keeping patients from wandering as the most important reasons for using physical restraints. Future research should reflect variation between wards. For the development of interventional programmes aimed at reducing physical restraints in acute hospitals, careful exploration of practices used by centres with low prevalence of physical restraints seems worthwhile. International guidelines suggest alternatives for physical restraints in acute care settings (Park and Tang, 2007; Bray et al., 2004; Maccioli et al., 2003; RNAO, 2012) and all agree that physical restraints should be used only as the last resort after detailed assessment of the patient’s status, the situation and the environment. The efforts should be embedded in an extensive physical restraint reduction approach comprising administrative support, interdisciplinary collaboration and staff education. This is a clear challenge for all acute hospitals, not only in Germany, because of the increasing number of admissions of patients with dementia, reduced patients’ length of hospital stay, and reduced nursing staff level (Rechel et al., 2009). Acknowledgements We thank the nurses and the participating patients of the four hospitals in North Rhine-Westphalia. We also thank Antonie Haut, MScN, Pia von Lützau, MScN, and Britta Blotenberg, BScN, University of Witten/Herdecke, for random selection of visits and data entry. The study was conducted without external financial support. Conflict of interest: None declared. Funding: None. 7 Ethical approval: The protocol was approved by the local ethical committee of the Department of Nursing Science at Witten/Herdecke University (available on request) and the local ethical committees of the participating hospitals. Appendix A. 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Please cite this article in press as: Krüger, C., et al., Use of physical restraints in acute hospitals in Germany: A multi-centre cross-sectional study. Int. J. Nurs. Stud. (2013), http://dx.doi.org/10.1016/j.ijnurstu.2013.05.005