Despite unambiguous legal regulation and evidence for lack of effectiveness and safety, physical restraints are still frequently administered in nursing homes. To reduce physical restraint prevalence in nursing homes using a guideline- and theory-based multicomponent intervention. 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). 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. 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. 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. A guideline- and theory-based multicomponent intervention compared with standard information reduced physical restraint use in nursing homes. isrctn.org Identifier: ISRCTN34974819.
