title: Effect of a guideline-based multicomponent intervention on use of physical restraints in nursing homes: a randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  A guideline- and theory-based multicomponent intervention compared with standard information reduced physical restraint use in nursing homes.
  
  
  BACKGROUND
  isrctn.org Identifier: ISRCTN34974819.
authors.affiliation: Unit of Health Sciences and Education, University ofHamburg, Hamburg, Germany. sascha.koepke@uksh.de
authors.forename: Sascha
authors.initials: S
authors.lastname: Köpke
authors.forename: Ingrid
authors.initials: I
authors.lastname: Mühlhauser
authors.forename: Anja
authors.initials: A
authors.lastname: Gerlach
authors.forename: Antonie
authors.initials: A
authors.lastname: Haut
authors.forename: Burkhard
authors.initials: B
authors.lastname: Haastert
authors.forename: Ralph
authors.initials: R
authors.lastname: Möhler
authors.forename: Gabriele
authors.initials: G
authors.lastname: Meyer
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019317:Evidence-Based Medicine; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control; D005858:Germany; D019983:Guideline Adherence; D017408:Guidelines as Topic; D006801:Humans; D008297:Male; D008875:Middle Aged; D009735:Nursing Homes; D009740:Nursing Staff; D011619:Psychotropic Drugs / Q000627:therapeutic use; D012149:Restraint, Physical / Q000706:statistics & numerical data*
chemical_list: D011619:Psychotropic Drugs