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| Name | Class |
|---|---|
| Foundation for Informed Medical Decision Making | OTHER |
| Olmsted Medical Center | OTHER |
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Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. FRAX combined with a decision aid may promote a shared decision making approach with patients, allowing the clinician and patient to weigh potential fracture risk (without treatment), versus risk reduction with medication (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FRAX + Decision Aid | Experimental |
| |
| Usual care | No Intervention | ||
| FRAX estimated fracture risk | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FRAX + Decision Aid | Behavioral | Clinicians will present patient's with their individualized risk of osteoporotic fracture in 10 years, based on the FRAX risk calculator, as well as sharing a decision aid with them, which shows their risk of fracture, risk reduction on medications, as well as the downsides of the medications. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication start/stop, knowledge, and patient involvement. | Baseline and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decisional quality. | Baseline and at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor M. Montori, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55901 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26010755 | Derived | LeBlanc A, Wang AT, Wyatt K, Branda ME, Shah ND, Van Houten H, Pencille L, Wermers R, Montori VM. Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II. PLoS One. 2015 May 26;10(5):e0128063. doi: 10.1371/journal.pone.0128063. eCollection 2015. | |
| 25179289 |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| FRAX estimated fracture risk | Behavioral | The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX |
|
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| Rochester |
| Minnesota |
| 55902 |
| United States |
| Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81. |