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| ID | Type | Description | Link |
|---|---|---|---|
| OFP-2022C3-30386 | Other Grant/Funding Number | Patient Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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RESTORE tests whether Augmented-FLS, 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. We also aim 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care Arm | Active Comparator | Participants will be mailed education materials and encouraged to follow up with their primary care physician. |
|
| Augmented-Fracture Liaison Service Arm | Experimental | Participants will be mailed education materials. Participants will also be contacted by patient navigators who will guide participants through the process of getting a Bone Health Clinician appointment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented-Fracture Liaison Service Arm | Behavioral | Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of subsequent fracture | Incidence of fracture 24 months post randomization | 24 months post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth M Dye, MSN | Contact | 205-996-5025 | emmills@uabmc.edu | |
| Paolo Rusconi, PhD | Contact | 205-975-2405 | paolorusconi@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Saag, MD, MSc | University of Alabama at Birmingham | Principal Investigator |
| Maria Danila, MD, MSPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
Anonymized data will be made available upon request.
Study protocol, SAP, and ICF will be made available upon request at conclusion of the study and after study scientific reports (e.g. abstracts, journal articles) are published.
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| Enhanced Usual Care Arm | Behavioral | Patients will be mailed education materials and encouraged to follow up with their primary care physician. |
|
| Mayo Clinic Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| UAMS Health | Recruiting | North Little Rock | Arkansas | 72117 | United States |
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| University of Florida- Gainesville | Recruiting | Gainesville | Florida | 32611 | United States |
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| University of Florida- Jacksonville | Recruiting | Jacksonville | Florida | 32209 | United States |
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| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| University of Illinois Chicago (UIC), UI Health | Recruiting | Chicago | Illinois | 60612 | United States |
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| Loyola University Chicago | Recruiting | Maywood | Illinois | 60153 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Allina Health Orthopedics/NorthStar Trauma Network | Recruiting | Coon Rapids | Minnesota | 55433 | United States |
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| Missouri Orthopaedic Institute | Recruiting | Columbia | Missouri | 65212 | United States |
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| Washington University in St. Louis | Recruiting | St Louis | Missouri | 63110 | United States |
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| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 69198 | United States |
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| Dartmouth-Hitchcock Clinic | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
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| Montefiore Medical Center | Recruiting | The Bronx | New York | 104661 | United States |
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| The University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
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| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| UT Health Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D058866 | Osteoporotic Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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