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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02475850
Recruitment Status : Active, not recruiting
First Posted : June 19, 2015
Last Update Posted : January 14, 2020
Sponsor:
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

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 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 secondary analysis, the investigators will adjust for the pre-specified set of baseline covariates to examine their influence on the intervention effect.

Secondary Outcomes: Number of falls, number of all fall-related injuries, and measures of well-being.

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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 : March 31, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

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



Primary Outcome Measures :
  1. Serious Fall-Related Injuries [ Time Frame: 24 months to 44 months ]
    time to first serious fall-related injury


Secondary Outcome Measures :
  1. All Fall-Related Injuries [ Time Frame: 24 months to 44 months ]
    time to all fall-related injuries (serious and non-serious)

  2. All Falls [ Time Frame: 24 months to 44 months ]
    time to all falls

  3. 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

  4. 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

  5. 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

  6. Depression as measured by the PROMIS Depression Measure [ Time Frame: Baseline, 12 months, 24 months ]
    self-report measure of depression

  7. Fear of falling as measured by the Falls Efficacy Scale [ Time Frame: Baseline, 12 months, 24 months ]
    self-report measure of fear of falling



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475850


Locations
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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
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Wounds and Injuries