Evaluation of the guide to action care home fall prevention programme in care homes for older people: A multi-centre, single blinded, cluster randomised controlled trial (FINCH)

BackgroundFalls in care home residents are common, unpleasant, costly and difficult to prevent. Trial DesignThe objective was to evaluate the clinical and cost effectiveness of the Guide to Action for Falls Prevention Care Homes, GtACH) in which care home staff were trained and supported in the systematic use of a multi-domain decision support tool and identify issues affecting subsequent implementation. A two-arm parallel design, multi-centre, cluster randomised controlled trial of the GtACH programme and usual falls prevention in older care home residents was conducted with embedded process evaluation and economic evaluation. MethodThe study was conducted in care homes from ten UK sites. The primary trial outcome was the rate of falls per resident participant occurring during the 90-day period between 91 days and 180 days post-randomisation. The primary outcome for the cost effectiveness analysis was the cost per fall averted and for the cost utility analysis was the incremental cost per QALY. Secondary outcomes included the rate of falls over days 0-90 and 181-360 post randomisation, activity levels, dependency, and fractures. Care homes were randomised on a 1:1 basis to the GtACH programme or usual care, via a secure web-based randomisation service. Research assistants (RAs), resident participants and staff informants were blind to allocation at recruitment. RAs were blind to allocation at follow up. Data from NHS Digital were extracted blindly. The number of falls per resident was compared between groups using a negative binomial regression model (GEE).Results84 care homes were randomised, 39 to GtACH and 45 to usual care. 1657 residents consented and provided baseline measures, mean age 85 years, 32% men. GtACH training was delivered to 1051 staff (71% of eligible staff) over 146 group sessions. Primary RCT outcome data were available for 630 of the GtACH participants and 712 usual care participants. The primary RCT outcome result showed an unadjusted Incidence Rate Ratio (IRR) of 0.57 (95% CI 0.45-0.71, p