Thomas M Gill1, Shalender Bhasin2, David B Reuben3, Nancy K Latham2, Katy Araujo4, David A Ganz3,5, Chad Boult6, Albert W Wu6, Jay Magaziner7, Neil Alexander8, Robert B Wallace9, Michael E Miller10, Thomas G Travison2,11, Susan L Greenspan12, Jerry H Gurwitz13, Jeremy Rich14, Elena Volpi15, Stephen C Waring16, Todd M Manini17, Lillian C Min8, Jeanne Teresi18, Patricia C Dykes19, Siobhan McMahon20, Joanne M McGloin1, Eleni A Skokos1, Peter Charpentier4, Shehzad Basaria2, Pamela W Duncan10, Thomas W Storer2, Priscilla Gazarian19,21, Heather G Allore4, James Dziura4, Denise Esserman4, Martha B Carnie19, Catherine Hanson22, Fred Ko23, Neil M Resnick12, Jocelyn Wiggins8, Charles Lu4, Can Meng4, Lori Goehring2, Maureen Fagan22, Rosaly Correa-de-Araujo24, Carri Casteel9, Peter Peduzzi4, Erich J Greene4. 1. Yale Claude D. Pepper Older Americans Independence Center, Yale University, New Haven, Connecticut, USA. 2. Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Boston, Massachusetts, USA. 3. Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA. 4. Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut, USA. 5. Geriatric Research, Education and Clinical Center; Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA. 6. Johns Hopkins University, Baltimore, Maryland, USA. 7. University of Maryland School of Medicine, Baltimore, Maryland, USA. 8. University of Michigan, Ann Arbor, Michigan, USA. 9. University of Iowa, Iowa City, Iowa, USA. 10. School of Medicine, Wake Forest University, Winston-Salem, North Carolina, USA. 11. Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, Massachusetts, USA. 12. Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. 13. Meyers Primary Care Institute, A Joint Endeavor of Reliant Medical Group, Fallon Health and University of Massachusetts Medical School, Worcester, Massachusetts, USA. 14. HealthCare Partners, El Segundo, California, USA. 15. University of Texas Medical Branch Claude D. Pepper Older Americans Independence Center; Sealy Center on Aging, The University of Texas Medical Branch, Galveston, Texas, USA. 16. Essentia Health, Duluth, Minnesota, USA. 17. Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida, USA. 18. Research Division, Hebrew Home at Riverdale, RiverSpring Health, Bronx, New York, USA. 19. Brigham and Women's Hospital, Boston, Massachusetts, USA. 20. School of Nursing, University of Minnesota, Minneapolis, Minnesota, USA. 21. University of Massachusetts, Boston, Massachusetts, USA. 22. University of Miami Health System, Miami, Florida, USA. 23. Icahn School of Medicine at Mount Sinai, New York, New York, USA. 24. National Institute on Aging, Bethesda, Maryland, USA.
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.
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.
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