Each year, one out of three adults aged 65 and over falls with a third of these falls resulting in moderate to severe injuries that can lead to further decline in health, loss of independence, and even death. NIH and the Patient-Centered Outcomes Research Institute (PCORI) have joined together to support a clinical trial to test individually tailored interventions to prevent fall-related injuries.
The award made by the National Institute on Aging (NIA) within NIH and funded by PCORI as part of the Falls Injuries Prevention Partnership between the two organizations is expected to total $30 million for the five year project. First year funding of $7.6 million was awarded on June 1, 2014.
The trial will be led by Shalender Bhasin M.D. at Brigham and Women’s Hospital, Thomas Gill, MD at the Yale School of Medicine, and David Reuben MD at the David Geffen School of Medicine at the University of California Los Angeles. The team will include more than 100 researchers, stakeholders, patients, and their representatives at ten clinical health system sites across the country.
Previous studies have analyzed risk factors for falls and injuries along with interventions to prevent them. However, the best evidence on how to reduce falls has not been broadly applied. Attempts to change physician behavior about falls through conventional medical education channels, plus using other methods has not been very effective. So far, patients and other stakeholders have not generally been partners in the research process and as a result, not fully engaged.
“We will be able to evaluate interventions on a comprehensive and very large scale”, said NIA Director Richard J. Hodes M.D. “This study will focus on people at increased risk for injuries from falls and the specific care plans that should be implemented. The study will include interventions tailored to individual patients and how physicians and others in healthcare and the community can be involved.”
The research team plans to enroll 6,000 adults age 75 and older living in the community with one or more modifiable risk factors for falls. The first year of the study is a pilot phase, during which the many aspects of the intervention will be tested with small numbers of people across ten clinical sites.
If the go ahead is given by NIA and PCORI to proceed with the study then enrollment for the full trial will start in year two and take place over 18 months. The participants will be followed for up to three years.
“With this team, we can put all the different pieces of the falls prevention puzzle together as this trial will focus on clinical practice redesign, while also using interventions tailored to individuals,” according to Dr. Bhasin.
Patients and other stakeholders will partner with the investigators in national and local councils throughout the study development process and will continue to be engaged during the trial at national and site levels.
For more information, go to www.nia.nih.gov.