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CONTEXT: Despite unambiguous legal regulation and evidence for lack of effectiveness and safety, physical restraints are still frequently administered in nursing homes. OBJECTIVE: To reduce physical restraint prevalence in nursing homes using a guideline- and theory-based multicomponent intervention. DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized controlled trial of 6 months' duration conducted in 2 German cities between February 2009 and April 2010. Nursing homes were eligible if they had 20% or more residents with physical restraints. Using external concealed randomization, 18 nursing home clusters were included in the intervention group (2283 residents) and 18 in the control group (2166 residents). INTERVENTION: The intervention was based on a specifically developed evidence-based guideline and applied the theory of planned behavior. Components were group sessions for all nursing staff; additional training for nominated key nurses; and supportive material for nurses, residents, relatives, and legal guardians. Control group clusters received standard information. MAIN OUTCOMES MEASURES: Primary outcome was percentage of residents with physical restraints (bilateral bed rails, belts, fixed tables, and other measures limiting free body movement) at 6 months, assessed through direct unannounced observation by blinded investigators on 3 occasions during 1 day. Secondary outcomes included restraint use at 3 months, falls, fall-related fractures, and psychotropic medication prescriptions. RESULTS: All nursing homes completed the study and all residents were included in the analysis. At baseline, 30.6% of control group residents had physical restraints vs 31.5% of intervention group residents. At 6 months, rates were 29.1% vs 22.6%, respectively, a difference of 6.5% (95% CI, 0.6% to 12.4%; cluster-adjusted odds ratio, 0.71; 95% CI, 0.52 to 0.97; P = .03). All physical restraint measures were used less frequently in the intervention group. Rates were stable from 3 to 6 months. There were no statistically significant differences in falls, fall-related fractures, and psychotropic medication prescriptions. CONCLUSION: A guideline- and theory-based multicomponent intervention compared with standard information reduced physical restraint use in nursing homes. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN34974819.

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PURPOSE: Attitudes of nursing home staff, residents, and their relatives determine the decision-making process about the use of physical restraints. Knowledge of staffs' attitudes toward physical restraints is sparse; even less is known about relatives' attitudes. Therefore, we surveyed relatives' attitudes and opinions toward physical restraints and compared the results to a survey of nursing home staff. DESIGN: Cross-sectional survey comparing 177 nursing home residents' relatives from 13 German facilities in 2008 to 258 nursing home nurses from 25 German facilities in 2007. METHODS: The German version of the Maastricht Attitude Questionnaire was administered. Part I contains 22 items with three subscales (reasons, consequences, and appropriateness of restraints); Part II contains 16 items evaluating restrictiveness and discomfort of restraint measures, respectively. Descriptive and explorative inferential statistics were used for data analyses. FINDINGS: Response rate in both samples was above 90%. Mean age was 62 years (SD 12.60; range 24-93) in relatives and 44 years (SD 11.40; range 19-65) in nurses; 72% and 82% were female, respectively. Relatives assess physical restraints a little more positively compared to nurses, with an average of 3.40 (SD 0.60) versus 3.07 (SD 0.48) on a 5-point scale (5=strongly positive attitude). Relatives assess physical restraints as slightly less restrictive, with 2.11 (SD 0.33), and as less discomforting, with 2.10 (SD 0.38) points, compared to nursing staff, who assess the restraints' restrictiveness with 2.19 (SD 0.29) points and its discomfort with 2.17 (SD 0.32) on a 3-point scale (3=very restrictive/discomforting). Both groups consider wrist and ankle belts as most restrictive and uncomfortable, while sensor mats, infrared systems, and unilateral bedrails were rated as the lowest for restrictiveness and discomfort. CONCLUSIONS: Attitudes of nursing home residents' relatives toward physical restraints are rather positive and generally comparable with nursing home staffs' attitudes. CLINICAL RELEVANCE: Interventions aimed to reduce physical restraints need to include education of both staff and relatives of nursing home residents.

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BACKGROUND: Physical restraints are regularly applied in German nursing homes. Their frequency varies substantially between centres. Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects. We developed an evidence-based guidance on this topic. The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aimed to reduce physical restraints and minimise centre variations. METHODS/DESIGN: Cluster-randomised controlled trial with nursing homes randomised either to the intervention group or to the control group with standard information. The intervention comprises a structured information programme for nursing staff, information materials for legal guardians and residents' relatives and a one-day training workshop for nominated nurses. A total of 36 nursing home clusters including approximately 3000 residents will be recruited. Each cluster has to fulfil the inclusion criteria of at least 20% prevalence of physical restraints at baseline. The primary endpoint is the number of residents with at least one physical restraint at six months. Secondary outcome measures are the number of falls and fall-related fractures. DISCUSSION: If successful, the intervention should be implemented throughout Germany. In case the intervention does not succeed, a three-month pre-post-study with an optimised intervention programme within the control group will follow the randomised trial. TRIAL REGISTRATION: ISRCTN34974819.

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Physical restraints are routinely used in nursing home residents in Germany. Bedrails are applied to at least one of four residents. Belts, fixed tables and other measures are less frequent but are still used as routine measures. So far, beneficial effects of the use of physical restraints have not been shown, negative effects are likely. A recently completed observational study in 30 nursing homes in Hamburg showed great variations between centres concerning the frequency of restraint use. An evidence-based practice guideline could be the appropriate measure to reduce physical restraints and overcome centre variations. Currently, there are no evidence-based practice guidelines for the avoidance of physical restraints in nursing homes. This applies to nursing practice in Germany in general. The "German Network for Quality Development in Nursing (DNQP)" deliberately distinguishes their so-called "national expert standards" from "medical" practice guidelines. Funded by the German Ministry of Education and Science, a project aiming to develop an evidence-based practice guideline on the avoidance of physical restraints in nursing homes, for the first time applies internationally discussed methods to a nursing guideline in Germany. This article describes the methodological framework, instruments and processes of the guideline's development.

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Nurses' attitudes influence decisions on physical restraints. A literature analysis was conducted on nurses', patients', and their families' attitudes towards physical restraint use in the elderly. While nurses' attitudes are characterized by ambivalence, patients and their relatives express mainly negative feelings towards the use of physical restraints. Knowledge about nurses', patients', and their relatives' attitudes is indispensable for the development of alternative interventions. Patients' dignity as well as their right to freedom and movement must be respected and protected.

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