• JAMA · May 2012

    Randomized Controlled Trial Multicenter Study

    Effect of a guideline-based multicomponent intervention on use of physical restraints in nursing homes: a randomized controlled trial.

    • Sascha Köpke, Ingrid Mühlhauser, Anja Gerlach, Antonie Haut, Burkhard Haastert, Ralph Möhler, and Gabriele Meyer.
    • Unit of Health Sciences and Education, University ofHamburg, Hamburg, Germany. sascha.koepke@uksh.de
    • JAMA. 2012 May 23;307(20):2177-84.

    ContextDespite unambiguous legal regulation and evidence for lack of effectiveness and safety, physical restraints are still frequently administered in nursing homes.ObjectiveTo reduce physical restraint prevalence in nursing homes using a guideline- and theory-based multicomponent intervention.Design, Setting, And ParticipantsCluster 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).InterventionThe 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 MeasuresPrimary 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.ResultsAll 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.ConclusionA guideline- and theory-based multicomponent intervention compared with standard information reduced physical restraint use in nursing homes.Trial Registrationisrctn.org Identifier: ISRCTN34974819.

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