Multifactorial Falls Prevention Programme Compared to Routine Care in Long Term Older Care Residents (FinCH): A Multi-Centre Cluster Randomised Controlled Trial with Economic Evaluation

Background: Falls are three times more common for care home residents than for similarly aged people living at home, often causing hospital admission and death. The Guide to Action for Care Homes (GtACH) is a multifactorial programme designed to prevent falls in care homes. Methods: A multi-centre, cluster (care home) randomised controlled trial to evaluate the clinical and cost-effectiveness of the GtACH programme compared to usual care. The primary health outcome was fall rate between 91 and 180 days from randomisation. Secondary outcomes included dependency (Barthel ADL Index) and activity (Physical Activity Measure – Residential Care Homes (PAM-RC)) at 90, 180, 270 and 360 days from randomisation. Cost effectiveness was estimated adopting a UK National Health Service and personal social services perspective, measuring health-related quality of life using quality adjusted life years (QALYs) derived from the EQ-5D-5L-Proxy and DEMQOL-Proxy-U until 12 months post-randomisation. Findings: 84 care homes were randomised (39 GtACH, 45 usual care). 1657 residents consented and provided baseline measures, mean age 85 years, 32% men. GtACH training was delivered to 1051 staff (71%). Primary RCT outcome data were available for 630 GtACH participants and 712 usual care participants. The unadjusted Incidence Rate Ratio for falls between 91-180 days was 0.57 (95% CI 0.45-0.71, p<0.01) in favour of the GtACH programme (GtACH: 6 falls/1000 residents versus 10.4/1000 in usual care). Barthel ADL Indices and PAM-RC scores were similar between groups at all-time points. The incremental cost was £108 (95% CI -271.06, 487.58), incremental QALYs gained were 0.024 (95% CI 0.004, 0.044) and 0.005 (95% CI -0.019, 0.03) for EQ-5D-5L-P and DEMQOL-P-U respectively. The incremental costs per EQ-5D-5L-P and DEMQOL-P-U based QALY were £4,544 and £20,889 respectively. Interpretation: The GtACH programme reduced the fall rate and was cost-effective, without reducing activity or increasing dependency. Trial Registration: Trial registration number: ISRCTN34353836. Protocol V6 14 November 2017 Funding: This work was funded by NIHR HTA (Project number 13/115/29). Declaration of Interest: Profs Logan, Armstrong, Gladman, Gordon, Leighton, Mountain, Sach have nothing to disclose. Drs Horne, Allen, Clark, Conroy, Darby, Fox, Irvine, McCartney, Robinson, Wilson, Sims, have nothing to disclose. Mrs Godfrey and Robertson have nothing to disclose. Ethical Approval: The trial was not initiated before the protocol, informed consent forms and participant information sheets received approval / favourable opinion from the Research Ethics Committee (REC), and the National Health Service (NHS) Research & Development (RD the principles of Good Clinical Practice, and the Department of Health Research Governance Framework for Health and Social care, 2005