Strategies to Reduce Injuries and Develop Confidence in Elders

NCT02475850 | Completed Phase 3 Results DMC

• 2 other identifiers: U01AG0482701U01AG048270-01
• Study Type: interventional
• Target: 5,451
• Locations: 1 country
• Sites: 10

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.

Conditions

Accidental Falls; Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• First Self-reported Fall-related Injury

  Enrollment through last completed follow-up or death interview (max 44 months)

• Time to Self-reported Falls

  these data were not collected

• Physical Function

  measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores

• Disability

  measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores

• Anxiety

  Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.

Study Arms (2)

Fall prevention standard of care

OTHER

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

OTHER

Usual fall prevention care

Other: Usual care

Interventions

Evidence-based tailored fall prevention OTHER

Fall prevention standard of care

Usual care OTHER

Control

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (10)

Healthcare Partners

Torrance, California, United States

Location

University of Iowa Health Alliance

Des Moines, Iowa, United States

Location

Johns Hopkins Medicine

Baltimore, Maryland, United States

Location

Partners Healthcare

Boston, Massachusetts, United States

Location

Reliant Medical Group

Worcester, Massachusetts, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

Essentia Health

Duluth, Minnesota, United States

Location

Mt Sinai Health System

New York, New York, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Location

Related Publications (10)

• 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.

  PMID: 38740298 DERIVED

• 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.

  PMID: 37533073 DERIVED

• 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.

  PMID: 35932279 DERIVED

• 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.

  PMID: 33678038 DERIVED

• 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.

  PMID: 33037632 DERIVED

• 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.

  PMID: 32640131 DERIVED

• 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.

  PMID: 32408769 DERIVED

• 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.

  PMID: 32212395 DERIVED

• 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.

  PMID: 31245263 DERIVED

• 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.

  PMID: 30020415 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Erich Greene PhD
• Organization: Yale University

erich.greene@yale.edu

203-737-3636

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Nancy Latham, PhD

  Brigham and Women's Hosptial

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 19, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 3, 2021
• Results First Posted: March 3, 2021

Record last verified: 2021-03

Locations

US (10)