Strategies to Reduce Injuries and Develop Confidence in Elders

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 4 years. Recruitment will take place over 20
months, with follow-up taking place for 20 months - 40 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 40 month study (20 months of recruitment and a minimum 20 month of
follow-up). For a 40 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.

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