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

Thomas M. Gill, Shalender Bhasin, David B. Reuben, Nancy K. Latham, Katy Araujo, David A. Ganz, Chad Boult, Albert W. Wu, Jay Magaziner, Neil Alexander, Robert B. Wallace, Michael E. Miller, Thomas G. Travison, Susan L. Greenspan, Jerry H. Gurwitz, Jeremy Rich, Elena Volpi, Stephen C. Waring, Todd M. Manini, Lillian C. MinJeanne Teresi, Patricia C. Dykes, Siobhan McMahon, Joanne M. McGloin, Eleni A. Skokos, Peter Charpentier, Shehzad Basaria, Pamela W. Duncan, Thomas W. Storer, Priscilla Gazarian, Heather G. Allore, James Dziura, Denise Esserman, Martha B. Carnie, Catherine Hanson, Fred Ko, Neil M. Resnick, Jocelyn Wiggins, Charles Lu, Can Meng, Lori Goehring, Maureen Fagan, Rosaly Correa-de-Araujo, Carri Casteel, Peter Peduzzi, Erich J. Greene

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)173-179
Number of pages7
JournalJournal of the American Geriatrics Society
Volume69
Issue number1
DOIs
StatePublished - Oct 9 2020

Bibliographical note

Funding Information:
The STRIDE study was funded primarily by the Patient‐Centered Outcomes Research Institute (PCORI), with additional support from the National Institute on Aging (NIA) at the National Institutes of Health (NIH). Funding is provided and the award managed through a cooperative agreement (5U01AG048270) between the NIA and the Brigham and Women's Hospital. The project is part of the Partnership for Fall Injuries Prevention between the NIA and PCORI. This research is partially supported by the Boston Claude D. Pepper Older Americans Independence Center at Brigham and Women's Hospital (P30AG013679) and Harvard Catalyst | The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, NIH Award No. UL1TR001102) and financial contributions from Harvard University and its affiliated academic healthcare centers. Support was also provided by the Claude D. Pepper Older Americans Independence Centers at the University of California, Los Angeles (P30AG028748), Yale (P30AG021342), Mt. Sinai (P30AG2874106), University of Texas Medical Branch (P30AG024832), University of Michigan (P30AG024824), and Wake Forest (P30AG021332). Mt. Sinai also received support through a grant from the New York Academy of Medicine. Additional support at Yale University was provided by the NIH/National Center for Advancing Translational Sciences Clinical and Translational Science Awards program (UL1TR000142) and an Academic Leadership Award (K07AG043587) to Thomas M. Gill from the NIA. Sioban McMahon was supported by Grant Nos. KL2TR000113 and UL1TR000114. The University of Michigan also received support from Michigan Medicine, its academic healthcare system. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Funding Information:
Supplementary Document S1 lists the members of the STRIDE study team and Data and Safety Monitoring Board. The STRIDE study was funded primarily by the Patient-Centered Outcomes Research Institute (PCORI), with additional support from the National Institute on Aging (NIA) at the National Institutes of Health (NIH). Funding is provided and the award managed through a cooperative agreement (5U01AG048270) between the NIA and the Brigham and Women's Hospital. The project is part of the Partnership for Fall Injuries Prevention between the NIA and PCORI. This research is partially supported by the Boston Claude D. Pepper Older Americans Independence Center at Brigham and Women's Hospital (P30AG013679) and Harvard Catalyst | The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, NIH Award No. UL1TR001102) and financial contributions from Harvard University and its affiliated academic healthcare centers. Support was also provided by the Claude D. Pepper Older Americans Independence Centers at the University of California, Los Angeles (P30AG028748), Yale (P30AG021342), Mt. Sinai (P30AG2874106), University of Texas Medical Branch (P30AG024832), University of Michigan (P30AG024824), and Wake Forest (P30AG021332). Mt. Sinai also received support through a grant from the New York Academy of Medicine. Additional support at Yale University was provided by the NIH/National Center for Advancing Translational Sciences Clinical and Translational Science Awards program (UL1TR000142) and an Academic Leadership Award (K07AG043587) to Thomas M. Gill from the NIA. Sioban McMahon was supported by Grant Nos. KL2TR000113 and UL1TR000114. The University of Michigan also received support from Michigan Medicine, its academic healthcare system. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The authors have declared no conflicts of interest for this article. Erich J. Greene and Thomas M. Gill had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors met the criteria for authorship stated in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Study concept and design: Gill, Bhasin, and Reuben. Acquisition of data: Gill, Araujo, and McGloin. Analysis and interpretation of data: Araujo, Gill, and Greene. Preparation of manuscript: Gill. Critical revision of the manuscript for important intellectual content: All authors. The organizations funding this study had no role in the design or conduct of the study; in the collection, management, analysis, or interpretation of the data; or in the preparation, review, or approval of the manuscript.

Publisher Copyright:
© 2020 The American Geriatrics Society

Keywords

  • fall injury prevention
  • older persons
  • pragmatic trials
  • well-being

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