In osteoporosis, bones develop into brittle and fragile, placing them at excessive threat of fractures or breaks. These “fragility fractures” could cause ache, struggling, incapacity and even dying, and sufferers have elevated dangers of repeat fractures. It’s estimated that one in two ladies and as much as one in 4 males expertise a fracture of their lifetime on account of osteoporosis.
Can an augmented well being care supply pathway scale back the possibilities of these future fractures and enhance outcomes which are essential to sufferers? Two College of Alabama at Birmingham researchers have been authorized for a $13.9 million funding award by the Affected person-Centered Outcomes Analysis Institute, or PCORI, to reply that query.
The five-year, multi-site research will enroll 2,634 adults age 50 or older who’ve had a fragility fracture -; damaged hip, femur, pelvis, spine, humerus or wrist -; within the final six months. The research, led by UAB researchers Kenneth Saag, M.D., and Maria Danila, M.D., will examine Augmented-Fracture Liaison Service Care versus Enhanced Ordinary Care.
A Fracture Liaison Service, or FLS, is a post-fracture care method that features affected person schooling on weight loss program and way of life to enhance bone well being, together with referral to a bone well being clinician to think about drugs to forestall future fractures. Regardless of its advantages, the FLS adoption in the US has been difficult because of the want for face-to-face FLS visits, variable entry to bone well being clinicians and ‘liaisons,’ and restricted sources for implementation.”
Kenneth Saag, M.D., professor within the UAB Division of Drugs and director of the Division of Scientific Immunology and Rheumatology
“Whereas most post-fracture sufferers obtain very restricted bone well being care, typical post-fracture care will be enhanced with affected person schooling and first care supplier activation, often called Enhanced Ordinary Care,” mentioned Danila, a professor within the UAB Division of Drugs Division of Scientific Immunology and Rheumatology and physician-scientist with the Birmingham/Atlanta VA Geriatrics Analysis Schooling Scientific Middle. “A research that compares the effectiveness of Enhanced Ordinary Care with a centralized model of FLS for sufferers with fragility fracture is critically wanted.”
The UAB-led research, referred to as RESTORE, would be the first to match the effectiveness of two post-fracture care pathways, say Saag and Danila. Simply over $7 million of the $13.9 million funding award will keep in UAB, Saag says.
Half of the sufferers within the research will obtain Enhanced Ordinary Care, and half will obtain a centralized model of FLS, often called Augmented-FLS care. The first measure of efficient affected person care would be the variety of subsequent fractures in every group. Researchers may even measure health-related high quality of life, bodily operate, participation in social roles and actions, ache interference, osteoporosis medicine use, and dying.
Augmented-FLS combines supply of affected person schooling by a affected person navigator by cellphone/video calls with appointments with a bone well being clinician, Saag and Danila say. The Enhanced Ordinary Care combines mailed affected person academic supplies urging follow-up with their main care supplier, with notification of the affected person’s main care supplier about their affected person’s excessive threat of a future fracture and an informational pamphlet on guideline-recommended osteoporotic fracture care.
“The research staff will proceed to have interaction key stakeholders, together with sufferers, caregivers, each basic drugs and specialty clinicians, and payers to help with creating affected person supplies and to advise on research procedures and dissemination of findings,” Danila mentioned. “This may assist guarantee this research is carried out in a extremely patient-centered trend.”
At UAB, Saag’s analysis focuses on comparative effectiveness and security of therapeutics, in addition to strategies to enhance high quality of care in osteoporosis. Danila is an implementation scientist and end result researcher, engaged on enhancing the standard, effectiveness and supply of medical take care of sufferers. Her analysis program focuses on the design and analysis of well being care interventions that enhance outcomes for sufferers with power situations, equivalent to osteoporosis, gout, rheumatoid arthritis and lupus.
The UAB-led research was chosen by a PCORI funding announcement particularly centered on multi-component approaches to forestall bone fractures in folks with osteoporosis and a historical past of fractures.
“This research was chosen for PCORI funding for its potential to offer real-world knowledge on the comparative effectiveness of mixtures or sequencing of therapies to forestall a subsequent fracture amongst folks residing with osteoporosis,” mentioned PCORI Government Director Nakela L. Prepare dinner, M.D. “We sit up for following the research’s progress and dealing with UAB to share the outcomes.”
UAB’s award has been authorized pending completion of a enterprise and programmatic evaluation by PCORI employees and issuance of a proper award contract.
College of Alabama at Birmingham