Bone Loss, Age Related, Osteoporosis, Postmenopausal Bone Loss, Postmenopausal Osteoporosis
Conditions
Keywords
Osteoporosis, age-related, Osteoporosis, Postmenopausal, Bone Loss, Low Bone Density
Brief summary
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
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.
Interventions
BEHAVIORALOsteoporosis Choice Decision Aid
The provider will introduce the patient to the choice of bisphosphonates using the decision aid.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Evaluate ability to recruit participants and collect patient outcomes. | One year after start of study. |
Countries
United States
Outcome results
None listed