Researchers Awarded $7.5 Million for Prevention of Bone Fracture Study

An interdisciplinary team of researchers from Duke, UNC, Harvard, Brown and the American Health Care Association Long-term Care Data Collaboratory have been awarded $7.5 million from the Patient-Centered Outcomes Research Institute (PCORI) to fund a study on models of post-acute care in complex older adults with fractures.

The study is one of the largest comparative effectiveness trials undertaken in skilled nursing facilities (SNF). Forty-two SNFs will be enrolled in the study.

The goal is to lay the groundwork for additional clinical trials in this vulnerable population that has been seriously underrepresented in research, said Cathleen Colón-Emeric, MD, MHS, chief of the division of Geriatrics and associate dean for research mentoring.

“We tell our older patients to think about a broken hip and other major osteoporotic fractures as having a ‘bone attack’ - it is just as serious as having a heart attack, with similar rates of death, disability, and future fractures,” Colón-Emeric said. “But while nearly all patients with a recent heart attack receive medications and other interventions to reduce their risks, fewer than 20% of patients with a recent osteoporotic fracture receive the evidence-based care that prevents deaths and additional serious injuries.”

The study will help patients and families make personalized choices about starting medications to prevent more broken bones, stopping risky medications that cause falls, or both based on their individual goals and preferences. It will also prepare physicians to spread effective care delivery models to health systems so that all patients can receive high-quality care after a broken bone, Colón-Emeric added.

The Duke investigator team includes three researchers from the division of Geriatrics, Milta Little, DO, Cara McDermott, PhD, and Ken Lyles, MD, and Richard Lee, MD, in the division of Endocrinology, Metabolism, and Nutrition, along with faculty from the Duke University School of Nursing, Eleanor McConnell, PhD, and Michael Cary, PhD, RN. Other Duke stakeholders include Lisa Gwyther, MSW, Rowena Dolor, MD, MHS, and Susan Spratt, MD.

The study will compare two care models that have previously been shown to improve care in SNFs. One model is a Fracture Liaison Service, in which recommendations are given to manage osteoporosis with medications. The second model is a Deprescribing Care Model, which helps patients reduce medications that cause falls.

The Duke study team will in random order provide the Fracture Liaison Service care model for six months, the Deprescribing care model for six months, or both models simultaneously for six months. Patients will be followed for two years using information that is already in their electronic health record and from Medicare to see if they have fewer injuries from falls compared to similar patients in facilities that don’t offer the care models. 

Patients or caregivers will also be asked to complete a survey 90 days after admission to compare whether important symptoms like pain, anxiety, sleep, and medication side effects are different in patients treated with the different care models. They will also look to see if the benefits vs. risks of starting osteoporosis medication or stopping medications that cause falls are different in patients depending on how long they are expected to live, or if they have dementia.

“This study was selected for PCORI funding for its potential to provide real-world data on the comparative effectiveness of combinations or sequencing of therapies to prevent a subsequent fracture among people living with osteoporosis,” said PCORI Executive Director Nakela L. Cook, MD, MPH.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better informed healthcare decisions.