Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study

Abstract

Background/objectives: In the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, a multifactorial intervention was associated with a nonsignificant 8% reduction in time to first serious fall injury but a significant 10% reduction in time to first self-reported fall injury relative to enhanced usual care. The effect of the intervention on other outcomes important to patients has not yet been reported. We aimed to evaluate the effect of the intervention on patient well-being including concern about falling, anxiety, depression, physical function, and disability.

Design: Pragmatic cluster-randomized trial of 5,451 community-living persons at high risk for serious fall injuries.

Setting: A total of 86 primary care practices within 10 U.S. healthcare systems.

Participants: A random subsample of 743 persons aged 75 and older.

Measurements: The well-being measures, assessed at baseline, 12 months, and 24 months, included a modified version of the Fall Efficacy Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late-Life Function and Disability Instrument.

Results: Participants in the intervention (n = 384) and control groups (n = 359) were comparable in age: mean (standard deviation) of 81.9 (4.7) versus 81.8 (5.0) years. Mean scores were similar between groups at 12 and 24 months for concern about falling, physical function, and disability, whereas the intervention group's mean scores on anxiety and depression were .7 points lower (i.e., better) at 12 months and .6 to .8 points lower at 24 months. For each of these outcomes, differences between the groups' adjusted least square mean changes from baseline to 12 and 24 months, respectively, were quantitatively small. The overall difference in means between groups over 2 years was statistically significant only for depression, favoring the intervention: -1.19 (99% confidence interval, -2.36 to -.02), with 3.5 points representing a minimally important difference.

Conclusions: STRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.

Trial registration: ClinicalTrials.gov NCT02475850.

Keywords: fall injury prevention; older persons; pragmatic trials; well-being.

Conflict of interest statement

Conflict of Interest: The authors have declared no conflicts of interest for this article.

© 2020 The American Geriatrics Society.

Figures

Figure 1.

Adjusted least-squares mean changes from baseline at 12 months, 24 months, and overall for each of the well-being outcomes by treatment group. The I bars represent standard errors. Models were adjusted for baseline score, the practice-level randomization constraint variables (practice size, practice location [urban vs rural], and race of most of the persons in the practice [non-Hispanic White vs other]), and baseline covariates that were predictive of outcome-specific missingness (age at enrollment, use of outdoor mobility aid, history of congestive heart failure or myocardial infarction, number of positive responses to the serious fall injury screening questions, and poor self-reported health [for Concern about Falling, Anxiety and Depression], Hispanic ethnicity [for Anxiety, Depression, Physical Function, and Disability], ever married [for Physical Function and Disability], and consent provided by proxy/caregiver rather than participant [for Physical Function and Disability]). Differences were considered to be statistically significant if the 99% confidence interval did not include 0. Positive changes represent improvements for Concern About Falling and Physical Function, but worsening for Anxiety, Depression, and Disability.