Evans 1997.

Study characteristics
Methods	Study design: cluster‐randomised controlled trial (not registered, no study protocol published) Intervention period: 6 months Duration of follow‐up: 12 months (follow‐up data were assessed six months after the intervention period) Study period: not reported
Participants	Country: USA Setting: three nursing homes (180 to 269 beds) in an urban region in the area of Philadelphia, geographically distant, comparable to the national profile in resident demographics and functional status, with comparable restraint policies Participants/clusters: Inclusion criteria: all residents in the participating nursing homes, ≥ 60 years, non‐comatose, conversant in English Number of participants randomised: 643 (no information about group allocation reported) Number of participants lost to follow‐up: 180 (no information about group allocation reported), survival rate did not differ between groups, mean attrition rate was 28%, main reasons: death or discharge Number of participants completing the study: 463; intervention group 1: 184, intervention group 2: 152, control group: 127 Baseline characteristics: Age (mean ± SD) years: intervention group 1: 83.8 ± 8.2, intervention group 2: 83.6 ± 7.1, control group: 83.0 ± 7.7 Gender, female: intervention group 1: 89%, intervention group 2: 83%, control group: 84% Cognitive status MMSE (mean ± SD): 14.7 ± 10.0 (not reported separately per group) Care dependency (Psychogeriatric Dependency Rating Scale, mean ± SD): intervention group 1: 18.4 ± 12.9, intervention group 2: 22.1 ± 13.6, control group: 24.7 ± 14.5 (scores ≥ 20 indicate moderate‐to‐severe functional impairment)
Interventions	Intervention 1: educational intervention plus consultation Intervention 2: educational intervention Control: usual care
Outcomes	No primary outcome defined Use of physical restraint Restraint intensity Falls Serious fall‐related injuries Psychotropic medications
Notes	Funding: grants from the National Institute on Aging (R01‐AG08324), the Alzheimer's Association, and the University of Pennsylvania Research Foundation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Following baseline data collection, interventions were randomized to site using the sealed envelope technique". Important differences between groups (intervention group 1 showed a statistically significant lower level of care dependency, control group had a statistically significant higher level of physical restraints at baseline), mainly due to chance since only one cluster was randomised to each group.
Allocation concealment (selection bias)	High risk	Allocation was not concealed.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding of personnel was not possible due to the nature of the study. Nursing homes 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	"Observer nurses were unaware of the exact study design, interventions, and nursing home's group assignment."
Incomplete outcome data (attrition bias) All outcomes	Low risk	"The sites did not differ in the sample proportion that survived (P = 0.14). Attrition (average 28%) mainly by death, reflects the populations advanced age and frailty."
Selective reporting (reporting bias)	Unclear risk	Not registered; no study protocol available. We had insufficient information to permit judgement of ‘low risk’ or ‘high risk'.