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

Randomized Trial of a Multifactorial Fall Injury Prevention Strategy

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Accidental Falls
• Intervention / Treatment: Other: Usual care; Other: Evidence-based tailored fall prevention

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 Type: Interventional
• Enrollment (Actual): 5451
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States
      • HealthCare Partners
  • Iowa
    • Des Moines, Iowa, United States
      • University of Iowa Health Alliance
  • Maryland
    • Baltimore, Maryland, United States
      • Johns Hopkins Medicine
  • Massachusetts
    • Boston, Massachusetts, United States
      • Partners HealthCare
    • Worcester, Massachusetts, United States
      • Reliant Medical Group
  • Michigan
    • Ann Arbor, Michigan, United States
      • University of Michigan
  • Minnesota
    • Duluth, Minnesota, United States
      • Essentia Health
  • New York
    • New York, New York, United States
      • Mt Sinai Health System
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
      • University of Pittsburgh
  • Texas
    • Galveston, Texas, United States
      • University of Texas Medical Branch at Galveston

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: Control; Usual fall prevention care	Other: Usual care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Self-reported Fall-related Injury	Number of first self-reported fall-related injuries per 100 per years of follow-up	Enrollment through last completed follow-up or death interview (max 44 months)
Time to Self-reported Falls	** data for this outcome was not collected	these data were not collected
Physical Function	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	measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores
Disability	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	measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores
Anxiety	Patient-reported Outcome Measure Information System (PROMIS) Anxiety subscale. Measured on a 8-40 Scale, higher score = more anxiety.	Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.
Depression	PROMIS depression subscale. Measured on a 8-40 Scale, higher score = more depression.	Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.
Fear of Falling	Falls Efficacy Scale. Measured on a 10-40 Scale, higher score = more fear of falling.	Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Patient-Centered Outcomes Research Institute; Johns Hopkins University; University of California, Los Angeles; Yale University; University of Michigan; National Institutes of Health (NIH); National Institute on Aging (NIA); The University of Texas Medical Branch, Galveston; Partners HealthCare; University of Pittsburgh Medical Center; Essentia Health; Wake Forest University; Reliant Medical Group; Healthcare Partners; Mt Sinai Health System; University of Iowa Health Alliance
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: U01AG048270 (U.S. NIH Grant/Contract); 1U01AG048270-01 (U.S. NIH Grant/Contract)