Strategies to Reduce Injuries and Develop Confidence in Elders
NCT ID: NCT02475850
Last Updated: 2021-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
5451 participants
INTERVENTIONAL
2015-08-31
2020-01-31
Brief Summary
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Detailed Description
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Design: This study is a cluster randomized, parallel group superiority trial with practices stratified by healthcare system and patients nested within practices. The unit of randomization is the practice.
Study Duration: The total study duration is 5 years. Recruitment will take place over 20 months, with follow-up taking place for 24 months - 44 months depending on date of enrollment.
Trial Sites: 86 primary care practices that are part of 10 trial sites located around the U.S.: The Partners' Health Care System; Essentia; Hopkins Health Care System; HealthCare Partners; Reliant Health Care System; Mount Sinai Health Care System; University of Pittsburgh Health Care System; University of Texas Medical Branch Health Care System; University of Iowa Health Care System; University of Michigan Health Care System.
Number of Subjects: The original target sample size was 6,000 participants enrolled in 86 practices to provide 90% power to detect a 20% reduction in the rate of the primary outcome with intervention relative to control. The study was originally designed for a study duration of 36 months with 18 months of recruitment and a minimum of 18 months of follow-up. The study was extended to a 44 month study (20 months of recruitment and a minimum 24 month of follow-up). For a 44 month trial, it was estimated that a sample size of 5,322 subjects would provide 90% power to detect a 20% reduction in the rate of the primary outcome with the intervention relative to control.
Main Inclusion Criteria Community-living persons, 70 years or older, who are at increased risk for serious fall injuries.
Intervention: An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the Center for Disease Control's (CDC's) "STEADI" toolbox (Stopping Elderly Accidents, Disability and Injury) and the joint American Geriatrics Society/British Geriatrics Society guidelines, and Assessing Care of Vulnerable Elders (ACOVE) practice change approach. The fall prevention strategies will be systematically implemented into clinical practice using: delivery system design to improve quality (Co-management); decision support (algorithms); information systems (software); self-management support (patient/caregiver engagement and activation); and linkage to community-based resources.
Primary Outcome: The primary outcome is adjudicated serious fall injuries, operationalized as a fall resulting in: (1) (fracture other than thoracic/lumbar vertebral; joint dislocation; or cut requiring closure) AND any medical attention; OR (2) (head injury; sprain or strain; bruising or swelling; or other) requiring hospitalization.
Primary Analysis: The risk of any serious fall injury (i.e., time to first event) will be analyzed using a survival model that incorporates competing risks (due to death) and clustering. In this analysis, participants who are lost to follow-up without a prior serious fall-related injury will be censored at their date last seen. In a sensitivity analysis, the investigators will adjust for the pre-specified set of baseline covariates to examine their influence on the intervention effect.
Secondary Outcomes: All self-reported falls, all self-reported fall-related injuries, and measures of well-being.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Fall prevention standard of care
An evidence-based patient-centered intervention that will combine elements of a multifactorial, risk factor-based, standardly-tailored fall prevention strategy developed at Yale, practice guidelines offered by the CDC's "STEADI" toolbox and the joint American Geriatrics Society/British Geriatrics Society guidelines, and ACOVE practice change approach
Evidence-based tailored fall prevention
Control
Usual fall prevention care
Usual care
Interventions
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Evidence-based tailored fall prevention
Usual care
Eligibility Criteria
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Inclusion Criteria
* The patient must answer 'yes' to one or more of the following questions:
* Have you fallen and hurt yourself in the past year?
* Have you fallen 2 or more times in the past year?
* Are you afraid that you might fall because of balance or walking problems?
Exclusion Criteria
* The patient resides in a nursing home.
* The patient is not capable of providing informed consent (or assent), and a proxy is not available.
* The patient does not speak English or Spanish
70 Years
ALL
No
Sponsors
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Yale University
OTHER
University of California, Los Angeles
OTHER
Healthcare Partners
OTHER
The University of Texas Medical Branch, Galveston
OTHER
University of Pittsburgh Medical Center
OTHER
Johns Hopkins University
OTHER
Sinai Health System
OTHER
Reliant Medical Group
OTHER
Partners HealthCare
OTHER
University of Michigan
OTHER
University of Iowa
OTHER
Essentia Health
OTHER
Wake Forest University
OTHER
National Institute on Aging (NIA)
NIH
Patient-Centered Outcomes Research Institute
OTHER
National Institutes of Health (NIH)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Nancy Latham
Study Director
Principal Investigators
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Shalender Bhasin, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Thomas Gill, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Dave Reuben, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Nancy Latham, PhD
Role: STUDY_DIRECTOR
Brigham and Women's Hosptial
Locations
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Healthcare Partners
Torrance, California, United States
University of Iowa Health Alliance
Des Moines, Iowa, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
Partners Healthcare
Boston, Massachusetts, United States
Reliant Medical Group
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Essentia Health
Duluth, Minnesota, United States
Mt Sinai Health System
New York, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Countries
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References
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Esserman D, Greene EJ, Latham NK, Kane M, Lu C, Peduzzi PN, Gill TM, Ganz DA. Assessing readiness to use electronic health record data for outcome ascertainment in clinical trials - A case study. Contemp Clin Trials. 2024 Jul;142:107572. doi: 10.1016/j.cct.2024.107572. Epub 2024 May 11.
Ganz DA, Gill TM, Reuben DB, Bhasin S, Latham NK, Peduzzi P, Greene EJ. Costs of fall injuries in the STRIDE study: an economic evaluation of healthcare system heterogeneity and heterogeneity of treatment effect. Cost Eff Resour Alloc. 2023 Aug 2;21(1):49. doi: 10.1186/s12962-023-00459-3.
Ganz DA, Yuan AH, Greene EJ, Latham NK, Araujo K, Siu AL, Magaziner J, Gurwitz JH, Wu AW, Alexander NB, Wallace RB, Greenspan SL, Rich J, Volpi E, Waring SC, Dykes PC, Ko F, Resnick NM, McMahon SK, Basaria S, Wang R, Lu C, Esserman D, Dziura J, Miller ME, Travison TG, Peduzzi P, Bhasin S, Reuben DB, Gill TM. Effect of the STRIDE fall injury prevention intervention on falls, fall injuries, and health-related quality of life. J Am Geriatr Soc. 2022 Nov;70(11):3221-3229. doi: 10.1111/jgs.17964. Epub 2022 Aug 6.
Esserman DA, Gill TM, Miller ME, Greene EJ, Dziura JD, Travison TG, Meng C, Peduzzi PN. A case study of ascertainment bias for the primary outcome in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial. Clin Trials. 2021 Apr;18(2):207-214. doi: 10.1177/1740774520980070. Epub 2021 Mar 7.
Gill TM, Bhasin S, Reuben DB, Latham NK, Araujo K, Ganz DA, Boult C, Wu AW, Magaziner J, Alexander N, Wallace RB, Miller ME, Travison TG, Greenspan SL, Gurwitz JH, Rich J, Volpi E, Waring SC, Manini TM, Min LC, Teresi J, Dykes PC, McMahon S, McGloin JM, Skokos EA, Charpentier P, Basaria S, Duncan PW, Storer TW, Gazarian P, Allore HG, Dziura J, Esserman D, Carnie MB, Hanson C, Ko F, Resnick NM, Wiggins J, Lu C, Meng C, Goehring L, Fagan M, Correa-de-Araujo R, Casteel C, Peduzzi P, Greene EJ. Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study. J Am Geriatr Soc. 2021 Jan;69(1):173-179. doi: 10.1111/jgs.16854. Epub 2020 Oct 9.
Bhasin S, Gill TM, Reuben DB, Latham NK, Ganz DA, Greene EJ, Dziura J, Basaria S, Gurwitz JH, Dykes PC, McMahon S, Storer TW, Gazarian P, Miller ME, Travison TG, Esserman D, Carnie MB, Goehring L, Fagan M, Greenspan SL, Alexander N, Wiggins J, Ko F, Siu AL, Volpi E, Wu AW, Rich J, Waring SC, Wallace RB, Casteel C, Resnick NM, Magaziner J, Charpentier P, Lu C, Araujo K, Rajeevan H, Meng C, Allore H, Brawley BF, Eder R, McGloin JM, Skokos EA, Duncan PW, Baker D, Boult C, Correa-de-Araujo R, Peduzzi P; STRIDE Trial Investigators. A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries. N Engl J Med. 2020 Jul 9;383(2):129-140. doi: 10.1056/NEJMoa2002183.
Esserman D. From screening to ascertainment of the primary outcome using electronic health records: Challenges in the STRIDE trial. Clin Trials. 2020 Aug;17(4):346-350. doi: 10.1177/1740774520920898. Epub 2020 May 14.
Gill TM, McGloin JM, Shelton A, Bianco LM, Skokos EA, Latham NK, Ganz DA, Nyquist LV, Wallace RB, Carnie MB, Dykes PC, Goehring LA, Doyle M, Charpentier PA, Greene EJ, Araujo KL. Optimizing Retention in a Pragmatic Trial of Community-Living Older Persons: The STRIDE Study. J Am Geriatr Soc. 2020 Jun;68(6):1242-1249. doi: 10.1111/jgs.16356. Epub 2020 Mar 25.
Ganz DA, Siu AL, Magaziner J, Latham NK, Travison TG, Lorenze NP, Lu C, Wang R, Greene EJ, Stowe CL, Harvin LN, Araujo KLB, Gurwitz JH, Agrawal Y, Correa-De-Araujo R, Peduzzi P, Gill TM; STRIDE Investigators. Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study. Inj Epidemiol. 2019 Apr 15;6:14. doi: 10.1186/s40621-019-0190-2. eCollection 2019.
Gill TM, McGloin JM, Latham NK, Charpentier PA, Araujo KL, Skokos EA, Lu C, Shelton A, Bhasin S, Bianco LM, Carnie MB, Covinsky KE, Dykes P, Esserman DA, Ganz DA, Gurwitz JH, Hanson C, Nyquist LV, Reuben DB, Wallace RB, Greene EJ. Screening, Recruitment, and Baseline Characteristics for the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) Study. J Gerontol A Biol Sci Med Sci. 2018 Oct 8;73(11):1495-1501. doi: 10.1093/gerona/gly076.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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