Randomized Trial of a Multifactorial Fall Injury Prevention Strategy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 5,451
- Locations
- 10
- Primary Endpoint
- First Adjudicated Serious Fall-Related Injury
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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: Evidence-based tailored fall prevention (Other)
Control
Usual fall prevention care
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Time to Self-reported Falls(these data were not collected)
- First Self-reported Fall-related Injury(Enrollment through last completed follow-up or death interview (max 44 months))
- Depression(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.)
- Disability(measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores)
- Fear of Falling(Measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores.)
- Physical Function(measured at 12-month and 24-month follow-up assessments, reported score is an average (mean) of the follow-up scores)
Investigators
Nancy Latham
Study Director
Brigham and Women's Hospital