Köpke 2012.

Study characteristics
Methods	Study design: cluster‐randomised controlled trial (ISRCTN34974819) Intervention period: 6 months Duration of follow‐up: 6 months (follow‐up data were assessed after the intervention period) Study period: February 2009 to April 2010
Participants	Country: Germany Setting: nursing homes in Hamburg (northern Germany) and the region of Witten (Western Germany) Participants/clusters: Inclusion criteria for clusters: self‐reported rate of at least 20% of residents with physical restraints. All residents in the included clusters were included. Residents admitted to the clusters during the study were also included. Number of participants randomised: 3771; intervention group: 1952 (18 clusters), control group: 1819 (18 clusters) Number of participants at follow‐up: intervention group: 1909 (18 clusters), control group: 1833 (18 clusters) Number of participants newly admitted to the clusters after baseline: intervention group 331; control group 347 Number of participants completing the study: intervention group: 1909 (18 clusters); control group: 1833 (18 clusters) Number of participants analysed: 4449; intervention group: 2283 (18 clusters), control group: 2166 (18 clusters) Baseline characteristics: Age (mean ± SD), years: intervention group 83 ± 10; control group 85 ± 9 Gender, female: intervention group 73%; control group 77% Cognitive status (percentage of participants with cognitive impairment): intervention group 64%; control group 63% Care dependency: None intervention group 8%, control group 6%; considerable intervention group 34%, control group: 36%; severe intervention group 39%, control group 40%; most severe intervention group 19%, control group 18%
Interventions	Intervention: multi‐component intervention (addressed main components: attitudes, subjective norms, and perceived behavioural control), full and concise versions of the guideline, education for all nursing staff, explicit endorsement of nursing home leaders, education and structured support of key nurses in each cluster, and support material Control: head nurses received written information about the use of physical restraints and methods to avoid physical restraints, using three 12‐ to 24‐page brochures; also the topic of physical restraints was discussed during a short presentation by one of the researchers.
Outcomes	Primary: percentage of residents with at least 1 physical restraint Secondary: Number of falls Number of fall‐related fractures Prescription of psychotropic medication Costs
Notes	Funding: grant from the German Federal Ministry of Education and Research within the Nursing Research Network Northern Germany (projects 01GT0606 and 01GT0608)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Computer‐generated randomization lists were used for allocation of clusters in blocks of 4, 6, and 8 nursing homes. Randomization was stratified by region, i.e. Hamburg and Witten."
Allocation concealment (selection bias)	Low risk	"Allocation of clusters was performed by an external person not involved in the study, who informed cluster representatives about group assignment."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding of personnel was not possible due to the nature of the study. Clusters were allocated to the study groups and there was no evidence for an increased risk of contamination of clusters in the control group. No information about blinding of the participants was reported, but the intervention was delivered to the nursing staff. We judged the risk for a performance bias to be low.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Data on the prevalence of physical restraint use at baseline were obtained by trained external investigators before randomization through direct observation at 3 time points during 1 day (morning, noon, evening)." "Data on prevalence of physical restraint use at the 3‐ and 6‐month follow‐ups were assessed similarly to baseline by external investigators blinded to cluster group allocation."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates were comparable between the study groups and reasons for attrition were reported.
Selective reporting (reporting bias)	Low risk	All outcomes were reported as planned.