REducing future fractureS and improving ouTcOmes of fRagility fracturE (RESTORE)
Problem To Be Solved. With osteoporosis, bones become fragile and have a high risk of fracturing or breaking. These ‘fragility fractures’ are associated with considerable pain, suffering, disability or even death, and patients are at increased risk of a repeat fracture.
A Fracture Liaison Service (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 provider 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 providers and “liaisons” and limited resources for implementation. 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 (PCP) activation (Enhanced Usual Care). A study that compares the effectiveness of Enhanced Usual Care with a centralized version of FLS (Augmented-FLS) for patients with fragility fracture is critically needed. RESTORE will be the first study to compare the effectiveness of two post-fracture care pathways, Augmented-FLS and Enhanced Usual Care, to reduce the chance of future fractures and improve outcomes important to patients.
The Study Objective and Specific Aims. RESTORE tests whether an Augmented-FLS service, where patients are contacted by a patient navigator serving as the liaison and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. The study team also aims to determine the influence of age, race, ethnicity, sex, poverty level, geographic region and timing of entry into the trial after a fracture on the effectiveness of the two strategies.
Study Design. RESTORE will be conducted at multiple sites within PCORnet. Participants will be randomly assigned to one of two groups: Augmented-FLS or Enhanced Usual Care.
Who Can Use Results from This Study and How. RESTORE will address key gaps in secondary fracture prevention to enable U.S.-wide implementation of the most effective post-fracture care pathway. Beyond potential benefits to patients and knowledge gained by clinicians and health systems about what works best, the Centers for Medicare and Medicaid Services are considering creating a new reimbursement model for comprehensive post-fragility fracture care, and this study will inform healthcare policy.
Patient Population and Recruitment. RESTORE will recruit 2,634 adults (1,317 participants in each group) aged 50 and older with a fragility fracture in the last six months (e.g., broken hip, femur, pelvis, spine, humerus or wrist). Participants will not be enrolled if they have no PCP; received osteoporosis medication in the past 12 months; have severe kidney disease, other less common bone diseases, cancer or another serious illness limiting life expectancy to less than one year; or were unable to walk before their fracture.
Participants will be identified in four ways: 1) review of electronic health records, 2) referrals from clinicians who care for patients with fractures, 3) community emails/mass mailing or 4) patient self-referral on the study website.
Study Intervention and Comparators. Augmented-FLS combines delivery of patient education by a patient navigator by phone/video calls with appointments with a bone health provider. The Enhanced Usual Care combines mailed patient educational materials urging follow up with their PCP with notification of the patient’s PCP about their patient’s high risk of a future fracture and an informational pamphlet on guideline-recommended osteoporotic fracture care. Patient education materials, available in English or Spanish, will discuss approaches to reduce subsequent fracture risk, including exercise, healthy lifestyles, calcium and vitamin D supplementation, fall prevention and bone active medications.
Primary and Secondary Outcomes. The primary outcome is the incidence of subsequent fracture. Additional outcomes include health-related quality of life, physical function, participation in social roles and activities, pain interference, osteoporosis medication use and death. Study outcomes will come from medical records, billing data and surveys sent twice during the study period.
Stakeholder Engagement. 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. This will help ensure this study is conducted in a highly patient-centered fashion.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.