Abstract: Objective: To develop an evidence-based fall prevention management protocol for hospitalized patients based on the Comprehensive Unit-based Safety Program and evaluate its clinical effectiveness, and to provide references for improving the systematic management of falls in hospitalized patients. Methods: Based on literature review and expert consultation, an evidence-informed fall management protocol was developed. A stepped-wedge cluster randomized trial design with purposive sampling was employed. Nursing units with fall incidence rate higher than the hospital-wide average from 2020 to 2022 and their nurses were selected as participants. Intervention began in June 2023, the pre-intervention phases followed routine nursing practices with reference to the hospital-wide unified fall management documents, while the post-intervention phases implemented the evidence-informed fall management protocol. Outcomes included fall incidence, injury rates, and nurses' safety attitudes and safety culture cognition levels. Results: Eight nursing units and 158 nurses were included. After the intervention, the incidence (0.49‰) and injury rate (25.00%) of falls were lower than before (1.06‰ and 68.18%), nurses' safety attitude and safety culture cognition scores were higher than before, the differences were all statistically significant (P<0.05). Conclusion: The developed evidence-informed fall management protocol exhibits scientific rigor and practical applicability, reduces the incidence of falls and injury rate, and promotes nurses' safety attitude as well as safety culture cognition.

Key words: Comprehensive Unit-based Safety Program; fall; nursing; evidence-based management; protocol development