NIH, PCORI Seek Applications for Falls Prevention Clinical Trial

The National Institute on Aging (NIA) is seeking applications from researchers for a clinical trial to prevent serious injuries resulting from falls in older people.

The request, part of an initiative by the new Falls Injuries Prevention Partnership between NIA and the Patient Centered Outcomes Research Institute (PCORI), represents a unique collaboration joining scientists with clinicians and patients in pursuit of an effective strategy.

PCORI will commit up to $30 million to the effort, and NIA will administer the project, including the application process and peer review.

NIA is part of the National Institutes of Health, PCORI is authorized by Congress to fund research to provide information about the best available evidence to help patients and their health care providers make more informed decisions.

“Serious injuries from falls, such as broken bones or traumatic brain injury, are a major reason for the loss of independence among older people,” said NIA Director Richard J. Hodes, M.D.

Hodes continued, “This is a significant public health problem, greatly affecting older adults and their families - as well as the health care system. The clinical trial envisioned here seeks to test a comprehensive and practical approach that can make real progress in reducing these injuries.”

Falls resulting in serious injury depend on several factors, including an individual’s risk of falling, his or her physical and cognitive condition, the surrounding environment, and the ability to reduce risks.

The formal Request for Applications (RFA) asks for proposals that address these factors together, in a multifactorial approach.

Data are limited on reducing serious injuries through the use of multifactorial falls prevention strategies, with some trials finding favorable results.

More recent studies have aimed at decreasing serious injuries, beyond a focus on simply preventing falls. However, to date, definitive large-scale studies that can be broadly applied by clinicians and accepted by older adults have not been conducted.

Additionally, there is little evidence about the effectiveness of such strategies on other outcomes important to patients.

The RFA issued by the NIA outlines the rationale for the trial, along with the required elements of any proposal. A key element is the active involvement in the design and conduct of the study by older patients, family caregivers, health care professionals, and other stakeholders.

The ultimate goal of bringing together these interests is to help ensure that the strategy can be reliably replicated and used in at least one health care setting.

The strategy, NIA’s request says, should be designed to identify individuals at high risk for falling, assess them to define their specific risk factors, select interventions to address these factors, and monitor progress toward risk factor reduction.

“PCORI’s goal is to develop evidence and provide information on the best available evidence to help patients and their health care providers make better informed decisions,” said PCORI Executive Director Joe Selby, M.D., M.P.H.

Selby continued, “Finding a practical approach to preventing injuries from falls is one area where we think we can have a major impact, especially if we have active input from patients and other stakeholders from the very beginning of a study.”

Anyone interested in submitting a proposal is invited to consult the full RFA regarding submission policies, instructions, and requirements.

The RFA is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-14-009.html. Proposals are due on Nov. 13, 2013.