Community screening and therapeutic prevention strategies may reduce the incidence of falls in older people. The effects of these measures on the incidence of fractures are unknown. The PreFIT trial aimed to estimate the effects of falls risk screening by mail followed by an exercise program or multifactorial intervention compared to no screening or exercise or intervention on the rate of fractures in community-dwelling older people.
This rigorously designed cluster randomised controlled trial was undertaken in general practices in rural and urban regions in England. Each practice recruited 150 to 250 people (randomly selected from patient registries) who were aged 70 years or older, were living in their own homes and gave consent to participate in the trial. Using a concealed process, practices were randomised to provide advice by mail and falls-risk screening and exercise based on the Otago Exercise Program for people at increased risk of falls, advice by mail and falls-risk screening and a multifactorial falls prevention program for people at increased risk of falls, or advice by mail alone. All exercise and multifactorial fall interventions were arranged through the participants usual National Health Service provider. The primary outcome was the rate of fractures per 100 person-years over the 18-month period after randomisation. Secondary outcomes included falls (per 100 person-years over the 18-month period after randomisation). There was also an economic evaluation. All staff collecting outcome data (including the primary outcome) were blinded to group allocation. Analysis was by intention-to-treat.
A total of 9,803 older people from 63 practices in seven regions in England participated in the trial. About one-third of participants had fallen in the previous year, about 20% were classified as frail and 53% were women. 3,279 participants were assigned to advice by mail and falls-risk screening and exercise (2,925 returned the falls-risk screening; 1,079 were at increased risk of falls and were offered exercise), 3,301 to advice by mail and falls-risk screening and multifactorial fall prevention (2,854 returned the falls-risk screening; 1,074 were at increased risk of falls and were offered multifactorial intervention), and 3,223 to advice by mail alone. Fracture data were available for 9,802 of the 9,803 participants.
Screening and targeted intervention did not result in lower fracture or fall rates compared to advice by mail alone. The rate ratio for fractures over 18 months was 1.20 (95% confidence interval (CI) 0.91 to 1.59 for exercise and 1.30 (95% CI 0.99 to 1.71) for multifactorial fall prevention. The rate ratio for falls over 18 months was 0.99 (95% confidence interval (CI) 0.86 to 1.14) for exercise and 1.13 (95% CI 0.98 to 1.30) for multifactorial fall prevention. However, a reduction in the rate of falls was observed during the period 4 to 8 months after randomisation (which coincided with the duration of the exercise program) for exercise vs. advice by mail alone (rate ratio 0.79, 95% CI 0.64 to 0.96). Exercise was associated with the lowest overall costs. The incremental net monetary benefit was GBP 135 (95% CI -359 to 625) for exercise and GBP -353 (95% CI -840 to 147) for multifactorial fall prevention.
The effects of exercise in PreFIT were smaller than reported for the original Otago Exercise Program for serious or moderate fall-related injuries (incidence rate ratio 0.65, 95% CI 0.53 to 0.81) and falls (incidence rate ratio 0.65, 95% CI 0.57 to 0.75). This difference could be explained by variances in delivery of the exercise programs. PreFIT involved at least 3 group or individual sessions while the original Otago program involved 4 to 5 home visits to teach a home exercise program.
When applied in real-world settings, advice by mail, screening for fall risk, and a targeted exercise or multifactorial intervention to prevent falls did not result in fewer fractures than advice by mail alone.
Lamb SE, et al. Screening and intervention to prevent falls and fractures in older people. N Engl J Med 2020;383(19):1848-59