Abraham 2019.

Study characteristics
Methods	Study design: cluster‐randomised controlled trial (NCT02341898) Intervention period: 12 months Duration of follow‐up: 12 months (follow‐up data were assessed after the study period) Study period: February 2015‐February 2017
Participants	Country: Germany Setting: nursing homes randomly selected from publicly available registers Participants/clusters: Inclusion criteria for participants: none (all residents living in a nursing home on the day of data collection were included; residents admitted during follow‐up were also included) Number of participants randomised (with baseline assessment of the primary outcome): 8800; intervention group 1: 2972 in 40 clusters; intervention group 2: 2523 in 39 clusters; control group: 3305 in 41 clusters Number of participants lost to follow‐up: no clusters were lost to follow‐up; intervention group 1: 1127 (n = 875 died, n = 221 moved, n = 31 unknown); intervention group 2: 973 (n = 739 died, n = 199 moved, n = 35 unknown); control group: 1251 (n = 1039 died, n = 208 moved, n = 4 unknown) Residents newly admitted to the clusters after baseline: intervention group 1: 1135; intervention group 2: 1015; control group: 1252 Number of participants completing the study: 8841; intervention group 1: 2984; intervention group 2: 2550; control group: 3307 Number of participants analysed: 12,245; intervention group 1: 4126; intervention group 2: 3547; control group: 4572 Baseline characteristics: Age (mean ± SD) years: intervention group 1: 83.7 ± 9.7, intervention group 2: 83.5 ± 10.0, control group: 82.5 ± 10.5 Gender, female: intervention group 1: 71%, intervention group 2: 77%, control group: 73% Cognitive status: residents with impairment (Dementia Screening Scale): intervention group 1: 60%; intervention group 2: 58%; control group: 61% Care dependency (%): None: intervention group 1: 1%, intervention group 2: 3%, control group: 1%; Level 0 intervention group 1: 4%, intervention group 2: 3%, control group: 3%; Level 1 (considerable): intervention group 1: 39%, intervention group 2: 37%, control group: 39%; Level 2 (severe): intervention group 1: 39%, intervention group 2: 37%, control group: 36%; Level 3 (most severe): intervention group 1: 17%, intervention group 2: 19%, control group: 20%
Interventions	Intervention 1: guideline‐based multi‐component intervention Intervention 2: concise version of the guideline‐based multi‐component intervention Control: optimised usual care (written study materials)
Outcomes	Primary: number of residents with at least one physical restraint Secondary: number of falls and fall‐related fractures, quality of life
Notes	Funding: grant from the German Federal Ministry of Education and Research within the Nursing Research Network Northern Germany (grant 01GT0606 and 01GT0608)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Clusters were randomly assigned to study groups (...) using a computer‐generated randomization list stratified by region with blocks of six, nine, and twelve nursing homes (generated by an independent external biometrician)".
Allocation concealment (selection bias)	Low risk	"Clusters were randomly assigned to study groups by a person affiliated to the study center in Hamburg, but not involved in the study (...)."
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 different study groups and there was no evidence for an increased risk of contamination of clusters in the control group. Residents were not informed about the study, but might be aware of the study. The intervention was delivered to the nursing staff rather than the residents. We judged the risk for a performance bias to be low.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Physical restraint use was assessed through direct observation (...) by raters blinded to 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 reported as planned