Abstract
BACKGROUND/OBJECTIVES: We investigated the impact of ceasing routine falls risk assessment tool (FRAT) completion and instead used clinical reasoning to select fall mitigation strategies. DESIGN: Two-group, multi-site cluster-randomized active-control non-inferiority trial. SETTING: Hospital wards. PARTICIPANTS: Adult inpatients admitted to participating hospitals (n = 10 hospitals, 123,176 bed days). INTERVENTION: Hospitals were randomly assigned (1:1) to a usual care control group that continued to use a historical FRAT to assign falls risk scores and accompanying mitigation strategies, or an experimental group whereby clinicians did not assign risk scores and instead used clinical reasoning to select fall mitigation strategies using a decision support list. MEASUREMENTS: The primary measure was between-group difference in mean fall rates (falls/1000 bed days). Falls were identified from incident reports supplemented by hand searches of medical records over three consecutive months at each hospital. The incidence rate ratio (IRR) of monthly falls rates in control versus experimental hospitals was also estimated. RESULTS: The experimental clinical reasoning approach was non-inferior to the usual care FRAT that assigned fall risk ratings when compared to a-priori stakeholder derived and sensitivity non-inferiority margins. The mean fall rates were 3.84 falls/1000 bed days for the FRAT continuing sites and 3.11 falls/1000 bed days for experimental sites. After adjusting for historical fall rates at each hospital, the IRR (95%CI) was 0.78 (0.64, 0.95), where IRR < 1.00 indicated fewer falls among the experimental group. There were 4 and 3 serious events in the control and experimental groups, respectively. CONCLUSION: Replacing a FRAT scoring system with clinical reasoning did not lead to inferior fall outcomes in the short term and may even reduce fall incidence.