Evaluation of the Safe Recovery Program to reduce falls in older people in hospital: Protocol for a multicentre stepped-wedge cluster randomised trial.

Background Falls in hospitals are associated with injuries, deaths and poor patient outcomes. Although clinical guidelines recommend educating hospital patients about how to prevent falls, not all hospitals systematically deliver evidence-based patient falls education. The primary aim of this study is to implement and evaluate the effectiveness of delivering a research-informed education program called the Safe Recovery Program with ward support on rates of falls and falls-related injuries in hospitals. The secondary aims include measuring changes in patient and staff knowledge and awareness about falls prevention and identifying barriers and facilitators to staff and patients taking action to reduce hospital falls. Methods The trial will adhere to the Consolidated Standards of Reporting Trials guidelines. Twelve wards will be recruited from five Australian hospitals over a 65-week period. A stepped-wedge cluster randomised controlled trial design will be used with unidirectional crossover from control to experimental conditions together with randomisation of when each cluster makes the transition. The crossovers will occur at 12 timepoints, each five weeks apart. Alongside the trial, patients and staff on participating wards will be recruited for interviews and qualitative data analyses will be conducted to understand how to optimise implementation. The experimental condition involves usual care plus delivery of the Safe Recovery Program. For the Safe Recovery Program, supervised allied health assistants will deliver brief falls education programs to all suitable patients in designated wards, reinforced by all ward staff. Falls champions, who are registered nurses and allied health professionals, will provide Safe Recovery Program training for staff, using a train-the-trainer model. The ward staff will also be trained in how to support hospital patients to adopt safe behaviours. The primary outcome will be falls per 1000 patient bed days. The secondary outcomes will be: (i) injurious falls per 1000 patient bed days (ii) patient and staff changes in falls awareness, knowledge and motivation; and (iii) barriers and enablers to hospital staff engaging in behaviour change and program implementation. An economic evaluation will also be conducted to estimate the incremental cost effectiveness of implementing the Safe Recovery intervention. Ethics and Dissemination Ethics approvals have been obtained from The Royal Melbourne Hospital Human Research Ethics Committee (HREC/113864/MH-2024). The findings will be disseminated through peer-reviewed journals, workshops and conferences. Consumer team investigators will guide the communication of findings to the target audiences, including older patients, hospital staff, healthcare managers and policy makers. Trial Registration Number: ACTRN12624001469505