Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE)

• ClinicalTrials.gov Identifier: NCT02475850
• Recruitment Status: Completed
• First Posted: June 19, 2015
• Results First Posted: March 3, 2021
• Last Update Posted: March 3, 2021
• Sponsor: Brigham and Women's Hospital
• Collaborators: Yale University; University of California, Los Angeles; Healthcare Partners; The University of Texas Medical Branch, Galveston; University of Pittsburgh Medical Center; Johns Hopkins University; Mt Sinai Health System; Reliant Medical Group; Partners HealthCare; University of Michigan; University of Iowa Health Alliance; Essentia Health; Wake Forest University; National Institute on Aging (NIA); Patient-Centered Outcomes Research Institute; National Institutes of Health (NIH)
• Information provided by (Responsible Party): Nancy Latham, Brigham and Women's Hospital

Study Description

Brief Summary:

The aim of this pragmatic cluster-randomized trial is to determine the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy in community dwelling older adults at risk of falls recruited from 86 primary care practices around the U.S.

Condition or disease	Intervention/treatment	Phase
Accidental Falls; Wounds and Injuries	Other: Evidence-based tailored fall prevention; Other: Usual care	Phase 3

Detailed Description:

Objective: To determine the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy implemented within primary care practices using usual health care resources

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5451 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Randomized Trial of a Multifactorial Fall Injury Prevention Strategy
• Actual Study Start Date: August 2015
• Actual Primary Completion Date: December 2019
• Actual Study Completion Date: January 2020

Arms and Interventions

Arm	Intervention/treatment
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	Other: Evidence-based tailored fall prevention
Control; Usual fall prevention care	Other: Usual care

Outcome Measures

Primary Outcome Measures :

1. First Adjudicated Serious Fall-Related Injury [ Time Frame: Enrollment through last completed follow-up or death interview (max 44 months) ]
   Number of first adjudicated serious fall-related injury serious fall-related injury events per 100 per years of follow-up.

Secondary Outcome Measures :

1. First Self-reported Fall-related Injury [ Time Frame: Enrollment through last completed follow-up or death interview (max 44 months) ]
   Number of first self-reported fall-related injuries per 100 per years of follow-up
2. Time to Self-reported Falls [ Time Frame: these data were not collected ]
   ** data for this outcome was not collected
3. Physical Function [ Time Frame: measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores ]
   Late Life Function and Disability Instrument (LL-FDI) function score. The scores are on a 0-100 scale, higher score = better function. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment
4. Disability [ Time Frame: measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores ]
   Late Life Function and Disability Instrument (LL-FDI) disability score. The scores are on a 0-100 scale, higher score = less disability. The measure reported is the mean of scores at the 12-month and 24-months follow-up assessment
5. Anxiety [ Time Frame: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores. ]
   Patient-reported Outcome Measure Information System (PROMIS) Anxiety subscale. Measured on a 8-40 Scale, higher score = more anxiety.
6. Depression [ Time Frame: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores. ]
   PROMIS depression subscale. Measured on a 8-40 Scale, higher score = more depression.
7. Fear of Falling [ Time Frame: Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores. ]
   Falls Efficacy Scale. Measured on a 10-40 Scale, higher score = more fear of falling.

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• The patient is at least 70 years of age.
• 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 is enrolled in hospice.
• 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

Contacts and Locations

Locations

United States, California

Healthcare Partners

Torrance, California, United States

United States, Iowa

University of Iowa Health Alliance

Des Moines, Iowa, United States

United States, Maryland

Johns Hopkins Medicine

Baltimore, Maryland, United States

United States, Massachusetts

Partners Healthcare

Boston, Massachusetts, United States

Reliant Medical Group

Worcester, Massachusetts, United States

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States

United States, Minnesota

Essentia Health

Duluth, Minnesota, United States

United States, New York

Mt Sinai Health System

New York, New York, United States

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

United States, Texas

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Sponsors and Collaborators

Brigham and Women's Hospital

Yale University

University of California, Los Angeles

Healthcare Partners

The University of Texas Medical Branch, Galveston

University of Pittsburgh Medical Center

Johns Hopkins University

Mt Sinai Health System

Reliant Medical Group

Partners HealthCare

University of Michigan

University of Iowa Health Alliance

Essentia Health

Wake Forest University

National Institute on Aging (NIA)

Patient-Centered Outcomes Research Institute

National Institutes of Health (NIH)

Investigators

• Principal Investigator: Shalender Bhasin, MD; Brigham and Women's Hospital
• Principal Investigator: Thomas Gill, MD; Yale University
• Principal Investigator: Dave Reuben, MD; University of California, Los Angeles
• Study Director: Nancy Latham, PhD; Brigham and Women's Hosptial

  Study Documents (Full-Text)

Documents provided by Nancy Latham, Brigham and Women's Hospital:

Statistical Analysis Plan  [PDF] November 25, 2019

Study Protocol  [PDF] December 31, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Nancy Latham, Study Director, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02475850
• Other Study ID Numbers: U01AG048270 ( U.S. NIH Grant/Contract ); 1U01AG048270-01 ( U.S. NIH Grant/Contract )
• First Posted: June 19, 2015
• Results First Posted: March 3, 2021
• Last Update Posted: March 3, 2021
• Last Verified: March 2021

Additional relevant MeSH terms:

Wounds and Injuries