Fall prevention interventions in primary care to reduce fractures and falls in people aged 70 years and over: the PreFIT three-arm cluster RCT

• Published in: Health technology assessment (Winchester, England) England), 2021-05, Vol.25 (34), p.1-114
• Main Authors: Bruce, Julie, Hossain, Anower, Lall, Ranjit, Withers, Emma J, Finnegan, Susanne, Underwood, Martin, Ji, Chen, Bojke, Chris, Longo, Roberta, Hulme, Claire, Hennings, Susie, Sheridan, Ray, Westacott, Katharine, Ralhan, Shvaita, Martin, Finbarr, Davison, John, Shaw, Fiona, Skelton, Dawn A, Treml, Jonathan, Willett, Keith, Lamb, Sarah E
• Format: Article
• Language: English
• Subjects: cluster randomised trial; economic evaluation; falls; falls prevention; fracture; primary care
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta25340

BACKGROUNDFalls and fractures are a major problem. OBJECTIVESTo investigate the clinical effectiveness and cost-effectiveness of alternative falls prevention interventions. DESIGNThree-arm, pragmatic, cluster randomised controlled trial with parallel economic analysis. The unit of randomisation was the general practice. SETTINGPrimary care. PARTICIPANTSPeople aged ≥ 70 years. INTERVENTIONSAll practices posted an advice leaflet to each participant. Practices randomised to active intervention arms (exercise and multifactorial falls prevention) screened participants for falls risk using a postal questionnaire. Active treatments were delivered to participants at higher risk of falling. MAIN OUTCOME MEASURESThe primary outcome was fracture rate over 18 months, captured from Hospital Episode Statistics, general practice records and self-report. Secondary outcomes were falls rate, health-related quality of life, mortality, frailty and health service resource use. Economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit. RESULTSBetween 2011 and 2014, we randomised 63 general practices (9803 participants): 21 practices (3223 participants) to advice only, 21 practices (3279 participants) to exercise and 21 practices (3301 participants) to multifactorial falls prevention. In the active intervention arms, 5779 out of 6580 (87.8%) participants responded to the postal fall risk screener, of whom 2153 (37.3%) were classed as being at higher risk of falling and invited for treatment. The rate of intervention uptake was 65% (697 out of 1079) in the exercise arm and 71% (762 out of 1074) in the multifactorial falls prevention arm. Overall, 379 out of 9803 (3.9%) participants sustained a fracture. There was no difference in the fracture rate between the advice and exercise arms (rate ratio 1.20, 95% confidence interval 0.91 to 1.59) or between the advice and multifactorial falls prevention arms (rate ratio 1.30, 95% confidence interval 0.99 to 1.71). There was no difference in falls rate over 18 months (exercise arm: rate ratio 0.99, 95% confidence interval 0.86 to 1.14; multifactorial falls prevention arm: rate ratio 1.13, 95% confidence interval 0.98 to 1.30). A lower rate of falls was observed in the exercise arm at 8 months (rate ratio 0.78, 95% confidence interval 0.64 to 0.96), but not at other time points. There were 289 (2.9%) deaths, with no differences by treatment arm. There was no evidence