title: Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial [ISRCTN34974819].
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN34974819.
authors.affiliation: University of Witten/Herdecke, Faculty for Medicine, Institute of Nursing Science, Stockumer Str. 12, 58453 Witten, Germany. Antonie.Haut@uni-wh.de
authors.forename: Antonie
authors.initials: A
authors.lastname: Haut
authors.forename: Sascha
authors.initials: S
authors.lastname: Köpke
authors.forename: Anja
authors.initials: A
authors.lastname: Gerlach
authors.forename: Ingrid
authors.initials: I
authors.lastname: Mühlhauser
authors.forename: Burkhard
authors.initials: B
authors.lastname: Haastert
authors.forename: Gabriele
authors.initials: G
authors.lastname: Meyer
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control; D000368:Aged; D016000:Cluster Analysis; D019317:Evidence-Based Medicine / Q000379:methods* / Q000592:standards; D015577:Geriatric Assessment / Q000379:methods; D005858:Germany / Q000453:epidemiology; D006707:Homes for the Aged / Q000592:standards*; D006801:Humans; D009735:Nursing Homes / Q000592:standards*; D011482:Protective Devices / Q000706:statistics & numerical data*; D012149:Restraint, Physical / Q000706:statistics & numerical data