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

Tracking Information

• First Submitted Date: June 1, 2015
• First Posted Date: June 19, 2015
• Results First Submitted Date: January 13, 2021
• Results First Posted Date: March 3, 2021
• Last Update Posted Date: March 3, 2021
• Actual Study Start Date: August 2015
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 2, 2021)

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.

Original Primary Outcome Measures (submitted: June 16, 2015)

Serious Fall-Related Injuries [ Time Frame: 1.5 to 3 years (average 2.25 years) ]

time to first serious fall-related injury

Current Secondary Outcome Measures (submitted: March 2, 2021)

• 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
• Time to Self-reported Falls [ Time Frame: these data were not collected ]
  ** data for this outcome was not collected
• 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
• 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
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: June 16, 2015)

• All Fall-Related Injuries [ Time Frame: 1.5 to 3 years (average 2.25 years) ]
  time to all fall-related injuries (serious and non-serious)
• All Falls [ Time Frame: 1.5 to 3 years (average 2.25 years) ]
  time to all falls
• Function, as measured by the Late Life Function and Disability Instrument [ Time Frame: Baseline, 12 months, 24 months ]
  self-report computer-adaptive measure of function
• Disability, as measured by the Late Life Function and Disability Instrument [ Time Frame: Baseline, 12 months, 24 months ]
  self-report computer-adaptive measure of disability
• Anxiety as measured by the Patient-reported Outcome Measure Information System (PROMIS) Anxiety Measure [ Time Frame: Baseline, 12 months, 24 months ]
  self-report measure of anxiety
• Depression as measured by the PROMIS Depression Measure [ Time Frame: Baseline, 12 months, 24 months ]
  self-report measure of depression
• Fear of falling as measured by the Falls Efficacy Scale [ Time Frame: Baseline, 12 months, 24 months ]
  self-report measure of fear of falling

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Strategies to Reduce Injuries and Develop Confidence in Elders
• Official Title: Randomized Trial of a Multifactorial Fall Injury Prevention Strategy
• 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.

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
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Accidental Falls
• Wounds and Injuries

Intervention

• Other: Evidence-based tailored fall prevention
• Other: Usual care

Study Arms

• 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
  Intervention: Other: Evidence-based tailored fall prevention
• Control
  Usual fall prevention care
  Intervention: Other: Usual care

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 4, 2017): 5451
• Original Estimated Enrollment (submitted: June 16, 2015): 6000
• Actual Study Completion Date: January 2020
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 70 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02475850
• Other Study ID Numbers: U01AG048270( U.S. NIH Grant/Contract ); 1U01AG048270-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Nancy Latham, Brigham and Women's Hospital
• Study 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)

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

• PRS Account: Brigham and Women's Hospital
• Verification Date: March 2021