BACKGROUND: Falls are the most frequent adverse events that are reported in hospitals. We examined the effectiveness of individualised falls-prevention education for patients, supported by training and feedback for staff, delivered as a ward-level programme. METHODS: Eight rehabilitation units in general hospitals in Australia participated in this stepped-wedge, cluster-randomised study, undertaken during a 50 week period. Units were randomly assigned to intervention or control groups by use of computer-generated, random allocation sequences. We included patients admitted to the unit during the study with a Mini-Mental State Examination (MMSE) score of more than 23/30 to receive individualised education that was based on principles of changes in health behaviour from a trained health professional, in addition to usual care. We provided information about patients' goals, feedback about the ward environment, and perceived barriers to engagement in falls-prevention strategies to staff who were trained to support the uptake of strategies by patients. The coprimary outcome measures were patient rate of falls per 1,000 patient-days and the proportion of patients who were fallers. All analyses were by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials registry, number ACTRN12612000877886). FINDINGS: Between Jan 13, and Dec 27, 2013, 3,606 patients were admitted to the eight units (n = 1,983 control period; n = 1,623 intervention period). There were fewer falls (n = 196, 7.80/1,000 patient-days versus n = 380, 13.78/1,000 patient-days, adjusted rate ratio 0.60 (robust 95% CI 0.42 to 0.94), p = 0.003), injurious falls (n = 66, 2.63/1,000 patient-days versus 131, 4.75/1,000 patient-days, 0.65 (robust 95% CI 0.42 to 0.88), p = 0.006), and fallers (n = 136 (8.38%) versus n = 248 (12.51%) adjusted odds ratio 0.55 (robust 95% CI 0.38 to 0.81), p = 0.003) in the intervention compared with the control group. There was no significant difference in length of stay (intervention median 11 days (IQR 7 to 19), control 10 days (6 to 18)). INTERPRETATION: Individualised patient education programmes combined with training and feedback to staff added to usual care reduces the rates of falls and injurious falls in older patients in rehabilitation hospital-units. FUNDING: State Health Research Advisory Council, Department of Health, Government of Western Australia.

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