In osteoporosis, bones become brittle and fragile, putting them at high risk of fractures or breaks. These "fragility fractures" can cause pain, suffering, disability and even death, and patients have increased risks of repeat fractures. It is estimated that one in two women and up to one in four men experience a fracture in their lifetime due to osteoporosis.
Can an augmented health care delivery pathway reduce the chances of those future fractures and improve outcomes that are important to patients? Two University of Alabama at Birmingham researchers have been approved for a $13.9 million funding award by the Patient-Centered Outcomes Research Institute, or PCORI, to answer that question.
The five-year, multi-site study will enroll 2,634 adults age 50 or older who have had a fragility fracture -; broken hip, femur, pelvis, spine, humerus or wrist -; in the last six months. The study, led by UAB researchers Kenneth Saag, M.D., and Maria Danila, M.D., will compare Augmented-Fracture Liaison Service Care versus Enhanced Usual Care.
A Fracture Liaison Service, or FLS, is a post-fracture care approach that includes patient education on diet and lifestyle to improve bone health, along with referral to a bone health clinician to consider medications to prevent future fractures. Despite its benefits, the FLS adoption in the United States has been challenging due to the need for face-to-face FLS visits, variable access to bone health clinicians and 'liaisons,' and limited resources for implementation."
Kenneth Saag, M.D., professor in the UAB Department of Medicine and director of the Division of Clinical Immunology and Rheumatology
"While most post-fracture patients receive very limited bone health care, usual post-fracture care can be enhanced with patient education and primary care provider activation, known as Enhanced Usual Care," said Danila, a professor in the UAB Department of Medicine Division of Clinical Immunology and Rheumatology and physician-scientist with the Birmingham/Atlanta VA Geriatrics Research Education Clinical Center. "A study that compares the effectiveness of Enhanced Usual Care with a centralized version of FLS for patients with fragility fracture is critically needed."
The UAB-led study, called RESTORE, will be the first to compare the effectiveness of two post-fracture care pathways, say Saag and Danila. Just over $7 million of the $13.9 million funding award will stay in UAB, Saag says.
Half of the patients in the study will receive Enhanced Usual Care, and half will receive a centralized version of FLS, known as Augmented-FLS care. The primary measure of effective patient care will be the number of subsequent fractures in each group. Researchers will also measure health-related quality of life, physical function, participation in social roles and activities, pain interference, osteoporosis medication use, and death.
Augmented-FLS combines delivery of patient education by a patient navigator by phone/video calls with appointments with a bone health clinician, Saag and Danila say. The Enhanced Usual Care combines mailed patient educational materials urging follow-up with their primary care provider, with notification of the patient's primary care provider about their patient's high risk of a future fracture and an informational pamphlet on guideline-recommended osteoporotic fracture care.
"The study team will continue to engage key stakeholders, including patients, caregivers, both general medicine and specialty clinicians, and payers to assist with developing patient materials and to advise on study procedures and dissemination of findings," Danila said. "This will help ensure this study is conducted in a highly patient-centered fashion."
At UAB, Saag's research focuses on comparative effectiveness and safety of therapeutics, as well as methods to improve quality of care in osteoporosis. Danila is an implementation scientist and outcome researcher, working on enhancing the quality, effectiveness and delivery of medical care for patients. Her research program focuses on the design and evaluation of health care interventions that improve outcomes for patients with chronic conditions, such as osteoporosis, gout, rheumatoid arthritis and lupus.
The UAB-led study was selected through a PCORI funding announcement specifically focused on multi-component approaches to prevent bone fractures in people with osteoporosis and a history of fractures.
"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, M.D. "We look forward to following the study's progress and working with UAB to share the results."
UAB's award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.