Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women

Mayo Clinic100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

100

Conditions

Osteoporosis Bone Loss, Age Related Postmenopausal Bone Loss Postmenopausal Osteoporosis

Interventions

Osteoporosis Choice Decision AidBEHAVIORAL

The provider will introduce the patient to the choice of bisphosphonates using the decision aid.

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Directly following intervention.

Secondary Outcomes

Evaluate ability to recruit participants and collect patient outcomes.

Time frame: One year after start of study.

Data from ClinicalTrials.gov

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