Strategies to Reduce Injuries and Develop Confidence in Elders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of a Multifactorial Fall Injury Prevention Strategy

Conditions
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Accidental Falls, Wounds and Injuries

Intervention / Treatment
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* Other: Evidence-based tailored fall prevention
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fall prevention standard of care<br>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<br> <br> |
| Other: Control<br>Usual fall prevention care | Other: Usual care<br> <br> |

What is the study measuring?
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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. |