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U-M among 10 clinical trial sites in country for major study on preventing fall injuries among elderly

U-M part of NIH, PCORI major award for large, multi-site, multi-intervention clinical trial to test new patient-centered strategies

An original version of this release was published by the National Institute of Aging

ANN ARBOR, Mich. – Each year, 1 out of 3 adults aged 65 and over 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.

Dr. Neil Alexander
Dr. Neil Alexander

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. The team will include more than 100 researchers, stakeholders, patients and their representatives at 10 clinical health system sites across the country. First-year funding of $7.6 million was awarded on June 1.

The University of Michigan was chosen as one of 10 trial sites in the country and only institution in Michigan to participate. U-M’s principal investigator is Neil Alexander, M.D., M.S., professor in the Division of Geriatrics and Palliative Medicine at the U-M Medical School and director of the Mobility Research Center at the Geriatrics Center. He is also the director of Geriatric Research, Education, and Clinical Center at the VA Ann Arbor Healthcare System.

The U-M site’s co-principal investigator is Jocelyn Wiggins, B.M., B.Ch. clinical associate professor of Internal Medicine at the U-M Medical School and associate division chief of Geriatric and Palliative Medicine.

“We are pleased to take part in this first-of-its-kind, large-scale collaborative study that addresses a critical public health problem on a national level,” says Alexander, who also runs a weekly Mobility Enhancement Clinic.

“Falls are the leading cause of both nonfatal and fatal injuries among our older adult community. This initiative will allow us to provide health care systems with a detailed look at how to successfully adopt fall reduction strategies and tailor them to individuals who are at highest risk.”
 
Marita Titler, Ph.D., R.N., FAAN, associate dean of clinical scholarship and practice development at the U-M School of Nursing, co-leads the patient/stakeholder engagement component of the study nationwide, which includes a National Patient and Stakeholder Council and local councils at each of the 10 clinical sites. The councils include older patients, caregivers, and other stakeholders who will provide ongoing feedback on the design and implementation of the study.

"This is a large landmark study that addresses a very important health issue of older adults: preventing falls and injuries from falls," says 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., assuring that the key stakeholders are integrated into the national and local investigative teams and decision-making about various aspects of the study.

Marita Titler
Dr. Marita Titler

“I will share expertise in fall prevention, implementation science, and engaging patients, communities, and practices as partners in research."

The co-leader of the national patient/stakeholder engagement component of the study is Maureen Fagan, DNP, FNP-BC, executive director of the Center for Patients and Families at Brigham and Women's Hospital in Boston.

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.

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. Enrollment will take place over the first 18 months of the study and participants will be followed for up to three years.

The primary trial outcome is reduction in serious fall injuries, including non-spinal fractures, joint dislocation, head injuries, lacerations, internal injuries, and hypothermia. Secondary outcomes include reduction in all falls that cause injuries; all falls regardless of injury; indicators of well-being, physical function and disability, and anxiety and depression.
 
Other trial sites include:

Essential Health, Duluth, Minnesota 
HealthCare Partners, Torrance, California 
Johns Hopkins Medicine, Baltimore 
Mount Sinai Health System, New York City 
Partners HealthCare, Waltham, Massachusetts 
Reliant Medical Group, Worcester, Massachusetts 
University of Iowa Health Alliance, Iowa City 
University of Pittsburgh Medical Center 
University of Texas Medical Branch, Galveston Health 
 
Data management and analysis will be coordinated by the Yale School of Public Health.
 
See the full release on this study at NIA’s website.

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