UMSN's Dr. Marita Titler Co-Leads Patient-Engagement Component of $30 Million National PCORI and NIH Study

 

Each year, one out of three adults over age 65 falls. A third of those falls result in moderate to severe injuries that can lead to further declines in health and loss of independence. Thousands of older adults die each year from such falls as well.

 

To find effective, evidence-based strategies to address the personal and public health burden of these falls, the National Institutes of Health (NIH) and the Patient-Centered Outcomes Research Institute (PCORI) have joined 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) of the NIH and funded by PCORI as part of the Falls Injuries Prevention Partnership of the two organizations, is expected to total some $30 million over the five-year project. The trial will be led by Shalender Bhasin, M.D., Brigham and Women’s Hospital, Harvard Medical School, Boston; Thomas Gill, M.D., Yale School of Medicine, New Haven, Connecticut; and David Reuben, M.D., David Geffen School of Medicine at the University of California, Los Angeles. First-year funding of $7.6 million was awarded on June 1, 2014.

 

Marita Titler, PhD, RN, FAAN, University of Michigan School of Nursing (UMSN) Department Chair, Systems Leadership and Effectiveness Science, will serve as a co-leader of the national patient/stakeholder engagement component of the study. Her co-leader is Maureen Fagan, DNP, FNP-BC, executive director of the Center for Patients and Families at Brigham and Women's Hospital in Boston. One of their roles is to operationalize methods for assuring that patients’ and stakeholders voices are elicited and communicated to the local and national investigative teams.

 

Each of the 10 clinical sites has a site primary investigator (PI). Neil Alexander, MD, professor of Internal Medicine, is the U-M site PI. Nurses will be utilized as falls managers at all of the sites. Nationwide, the study team will include more than 100 researchers—and stakeholders, patients and their representatives at the sites.

 

The study’s approach differs from others in that it will integrate proven falls reduction strategies into a cohesive intervention that can be adopted by many health care systems. “This collaboration with PCORI exemplifies our efforts to go beyond the norms to solve the nation’s health issues,” said NIH Director Francis S. Collins, MD, PhD. “The problems we face are complex and therefore require thoughtful and complex solutions. I am hopeful this initiative will greatly improve the lives of those most at risk for falls.”
 

"This is a large landmark study that addresses a very important health issue of older adults: preventing falls and injuries from falls," said UMSN's Dr. Titler. "As a co-investigator on the study and lead investigator for patients, caregivers and other stakeholder engagement, I am looking forward to working with this very talented interdisciplinary team of investigators from across the U.S. and assuring that the key stakeholders are integrated into the national and local investigative teams and decision-making about various aspects of the study. Participating as a co-investigator for this multi-site clinical trial, I will share expertise in fall prevention, implementation science, and engaging patients, communities, and practices as partners in research."

 

Previous studies have analyzed risk factors for falls and falls injuries, along with interventions to prevent them. But the best evidence about how to reduce falls has not been broadly applied. Attempts to change physician behavior about falls through conventional medical education channels and other methods have not been very effective. Patients and other stakeholders generally have not been partners in the research process and, as a result, not fully engaged.

 

Each person in the trial will be assessed for his or her risk of falling, and receive either the current standard of care—primarily information about preventing falls—or the experimental study intervention in which individualized care plans will be developed and administered. The plans will be presented to the participant’s primary care provider for review, modification, and approval and will include proven fall risk reduction interventions that can be implemented by the research team, health care providers, caregivers, and community-based organizations. The intervention centers around the concept of a falls care manager (predominantly nurses) working with each participant’s primary care provider to develop the plans and monitor success.

 

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 many aspects of the intervention will be tested with small numbers of people across 10 clinical sites. If the go-ahead is given by NIA and PCORI to proceed with the study after that, 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.