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Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians

Primary Purpose

Osteoporosis, Osteopenia, Fragility Fractures

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FRAX + Decision Aid

FRAX estimated fracture risk

About this trial

This is an interventional supportive care trial for Osteoporosis focused on measuring Decision Aid, Shared Decision Making, Shared Medical Decision Making

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Peri and Postmenopausal Caucasian, Black, Hispanic and Asian women, aged 50-90
Bone mineral density (BMD) T-Score < 1.0
Have appointment with clinician to discuss test results and treatment options
Patients with FRAX <20% risk who have taken a bisphosphonate for < 5 years.

Exclusion Criteria:

Unable to speak or read English

Sites / Locations

Mayo Clinic
Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

FRAX + Decision Aid

Usual care

FRAX estimated fracture risk

Arm Description

Outcomes

Primary Outcome Measures

Medication start/stop, knowledge, and patient involvement.

Secondary Outcome Measures

Decisional quality.

Full Information

NCT ID

NCT00949611

First Posted

July 28, 2009

Last Updated

February 1, 2016

Sponsor

Mayo Clinic

Collaborators

Foundation for Informed Medical Decision Making, Olmsted Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00949611

Brief Title

Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians

Official Title

Wiser Choices In Osteoporosis Choice II

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Foundation for Informed Medical Decision Making, Olmsted Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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: FRAX FRAX + decision aid Usual care (no decision aid and no FRAX given to clinician)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Osteopenia, Fragility Fractures

Keywords

Decision Aid, Shared Decision Making, Shared Medical Decision Making

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FRAX + Decision Aid

Arm Type

Experimental

Arm Title

Usual care

Arm Type

No Intervention

Arm Title

FRAX estimated fracture risk

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

FRAX + Decision Aid

Other Intervention Name(s)

Decision Support

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

FRAX estimated fracture risk

Other Intervention Name(s)

Risk estimate

Intervention Description

The clinician is provided with the patient's estimated risk of fracture as computed by the FRAX

Primary Outcome Measure Information:

Title

Medication start/stop, knowledge, and patient involvement.

Time Frame

Baseline and at 6 months

Secondary Outcome Measure Information:

Title

Decisional quality.

Time Frame

Baseline and at 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Peri and Postmenopausal Caucasian, Black, Hispanic and Asian women, aged 50-90 Bone mineral density (BMD) T-Score < 1.0 Have appointment with clinician to discuss test results and treatment options Patients with FRAX <20% risk who have taken a bisphosphonate for < 5 years. Exclusion Criteria: Unable to speak or read English

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victor M. Montori, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55901

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55902

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26010755

Citation

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.

Results Reference

derived

PubMed Identifier

25179289

Citation

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.

Results Reference

derived

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Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians

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