Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00578981

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Bone Loss, Age Related Postmenopausal Bone Loss Postmenopausal Osteoporosis	Behavioral: Osteoporosis Choice Decision Aid	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Official Title:

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.

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Behavioral: Osteoporosis Choice Decision Aid The provider will introduce the patient to the choice of bisphosphonates using the decision aid.
No Intervention: Arm 2

Arm

Intervention/Treatment

Experimental: Arm 1

Behavioral: Osteoporosis Choice Decision Aid

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

No Intervention: Arm 2

Outcome Measures

Primary Outcome Measures

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

Evaluate ability to recruit participants and collect patient outcomes. [One year after start of study.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts 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.