A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries

Abstract

Background: Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined.

Methods: We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group.

Results: The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups.

Conclusions: A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).

Figure 1. Cumulative Incidence of a First Adjudicated Serious Fall Injury and a First Participant-Reported Fall Injury.

The cumulative incidence curves are plotted to the last event time in each treatment group. The cumulative incidence of a first adjudicated serious fall injury over the course of 3.5 years was 15% in the intervention group (95% bootstrap CI, 13 to 16) and 19% in the control group (95% CI, 14 to 24) (Panel A). The cumulative incidence of a first participant-reported fall injury over the course of 3.5 years was 65% in the intervention group (99% CI, 53 to 80) and 63% in the control group (99% CI, 56 to 71) (Panel B).

Figure 2.. Prespecified Subgroup Analysis of the Primary Outcome.

The effect of the intervention on the first adjudicated serious fall injury was evaluated in five prespecified subgroups with the use of tests of interaction. Adjustment for multiple comparisons was made with the use of the Hochberg procedure to preserve an overall two-sided type 1 error rate at 0.05. The point estimates of the hazard ratio and the associated confidence intervals (95% for the overall analysis and 99% for each subgroup) are shown. Participants in the “Fear of falling only” subgroup had a negative response to all the fall-related screening questions except the question about whether they had a fear of falling. The dashed vertical line represents the hazard ratio for the overall intervention effect. The size of each black square is proportional to the total number of participants in the subgroup.