Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women

Study Overview
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Brief Summary
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To develop a decision aid to support the decision to use (or not use) bisphosphonates in postmenopausal women at risk for osteoporotic fractures, and to assess the impact of the decision aid on start and six month adherence to bisphosphonates.

Detailed Description
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Bisphosphonates can reduce fracture risk in patients with osteoporosis. However, many patients may not start and adhere to bisphosphonates, consequently losing independence, quality, and length of life. We hypothesize that a decision aid that efficiently improves patient education and communication with their provider about fracture risk, and about using bisphosphonates to reduce that risk, will improve the quality of treatment decisions. We anticipate that patients will become more involved in the decision-making process and decisions will be more consistent with patients' values and health care goals. We expect this will lead to increased bisphosphonate start and adherence and improved patient outcomes.

Official Title
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Wiser Choices in Osteoporosis Trial: The OSTEOPOROSIS CHOICE Decision Aid to Support the Decision to Use or Not Use Bisphosphonates in Postmenopausal Women at Risk of Osteoporotic Fractures.

Conditions
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Osteoporosis, Bone Loss, Age Related, Postmenopausal Bone Loss, Postmenopausal Osteoporosis

Intervention / Treatment
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* Behavioral: Osteoporosis Choice Decision Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, post-menopausal women aged 50 to 90. Have a bone mineral density (BMD) evaluation resulting in a T-Score of <-1.0. Have a follow-up appointment with a provider in the areas of Family Medicine (FM), Primary Care Internal Medicine (PCIM), or POM. Have no major barriers (i.e., severe hearing impairment, dementia, require interpreter, etc.) to participation in shared decision-making (per provider's assessment) Enrollment is open to females of diverse racial backgrounds. Exclusion Criteria: Currently taking a bisphosphonate. Not available for 6 month follow-up phone call.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Behavioral: Osteoporosis Choice Decision Aid<br>* The provider will introduce the patient to the choice of bisphosphonates using the decision aid.<br>|
| No Intervention: Arm 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of success of decision aid to providers and patients, which leads to improved knowledge, reduced decisional conflict and enhanced satisfaction with the decision, and enhanced adherence to medication. |  | Directly following intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate ability to recruit participants and collect patient outcomes. |  | One year after start of study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, age-related, Osteoporosis, Postmenopausal, Bone Loss, Low Bone Density