Study Under Way to Evaluate New Approach to Prevent Fall-Related Injuries among the Elderly

It’s an all-too-common story. An older woman, otherwise able to care for herself, falls and suffers injuries that rob her of her independence. In fact, falls are the No. 1 cause of injury among older adults, with the Centers for Disease Control and Prevention estimating that one in three adults age 65 and older suffers a fall each year, and 30 percent of falls result in severe injuries. In 2010, almost 22,000 older adults died due to fall-related injuries.

The burden of these injuries on patients, families, and the healthcare system as a whole is enormous—and likely to become more so as our population ages. But the Fall Injuries Prevention Partnership, a recent joint effort by PCORI and the National Institute on Aging (NIA) of the National Institutes of Health, is sponsoring a study testing the effectiveness of a potential solution to this major public health issue. The study, called STRIDE (Strategies to Reduce Injuries and Develop Confidence in Elders), has made good progress in its first seven months.

The five-year, $30 million national randomized clinical trial will test the effectiveness of a comprehensive strategy to prevent serious injuries from falls in the elderly. Under this approach, nurses trained as falls care managers will work with each patient’s primary care provider on a four-stage approach to preventing injuries from falls.

The research has begun with a pilot project that will involve about 15 to 20 patients at each of 10 primary care sites to test out various components of the future trial, in preparation for its launch scheduled for next June. The investigators have selected the pilot project sites, hired and trained 12 falls care managers, and screened more than 1,000 potential participants for this stage of the study. As of January 7, 2015, the study had enrolled 164 participants in the pilot, meeting its target, and falls care managers had begun assessing enrollees.

Evaluating a Comprehensive Care Plan

Despite evidence that certain interventions can effectively prevent falls and the injuries they cause, the new trial is the first to look for the best mix of risk assessment, intervention, and delivery strategies to meet participants’ individual preferences and needs. Older Americans who have previously experienced a fall, their caregivers, nurses, and other key stakeholders will contribute to the planning and conduct of the study.

The research team is led by several of the country’s top geriatric researchers—three directors of the Claude D. Pepper Older Americans Independence Centers (OAICs), which are NIA-funded centers of research expertise on complex geriatric conditions. These joint principal investigators are Shalender Bhasin, MD, of Brigham and Women’s Hospital, Harvard Medical School; Thomas M. Gill, MD, of Yale School of Medicine; and David B. Reuben, MD, of the David Geffen School of Medicine at the University of California, Los Angeles.

The full trial will recruit 6,000 community-dwelling individuals, age 75 and older with one or more risk factors for falls, representing diverse populations from 80 community-based primary care practices affiliated with 10 healthcare delivery systems. These practices represent diverse geographic locations and healthcare contexts—they are located in urban, suburban, and rural communities in 12 states across the country, and include organizations reimbursed through Medicare and managed care, many of which are affiliated with Accountable Care Organizations. Study participants will represent a wide range of racial and ethnic populations. That diversity will broaden the applicability of findings so they can be used to help more patients and families.

Primary care practices participating in the study will be randomized to either provide participants with the study intervention or “usual care,” in which older adults will be assessed for their risk of falling and provided with information about preventing falls. The trial will compare rates of serious fall-related injuries in the two groups. Patients will be followed for up to three years to assess the effectiveness of the study intervention in reducing serious fall-related injuries.

Local and National Councils Ensure Engagement

To ensure systematic and robust engagement of patients and other stakeholders throughout all phases of the study, each of the 10 participating health systems is creating a local multi-stakeholder council. The National Patient and Stakeholder Council (NPSC) already established for the study has led the development of the local councils. Each local council and the NPSC includes patients who have a history of, or are at risk for, falls. They are joined by caregivers, clinicians, and representatives of advocacy and consumers groups and government agencies, among others.

This important new collaboration to prevent fall-related injuries capitalizes on PCORI’s expertise in supporting comparative clinical effectiveness research that engages patients and other stakeholders throughout the research process and NIA’s expertise in supporting and managing large, multi-center clinical trials in older adults. Working together, we hope this will be a landmark study that will make a real difference in improving the health and lives of older adults.