Clinical research studyUse of a Decision Aid to Improve Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial
Section snippets
Design
To evaluate the decision aid, we conducted a multicenter randomized trial. All study procedures were approved by the Mayo Clinic Institutional Review Board. The protocol for this trial has been reported in full.19 A summary of our methods follows.
Setting and Participants
We conducted the trial in 10 general medicine and primary care practices affiliated with the Mayo Clinic and located within a 60-mile radius of Rochester, Minnesota. Eligible patients were postmenopausal women, age 50 years and more with bone mineral
Results
From August 2007 to July 2008, we randomized 100 patients into the study (Figure 2). All patients were followed for 6 months after the visit date, except for 7 who were lost to follow-up (decision aid, n = 5; control, n = 2). Table 1 describes the patients by study arm. Although 13 clinicians enrolled more than 1 patient, only 5 enrolled more than 2. Of the 70 patients with video analysis, the median (range) duration of osteoporosis discussions was 12.4 minutes (2.3-27.4) in the decision aid arm
Our Findings
In this trial, we found that the decision aid improved knowledge transfer and patient involvement in decision-making with adequate patient and clinician satisfaction, but with weak or no effect on medication start and adherence.
Limitations and Strengths
This was a small trial, rendered even smaller for the purposes of adherence analyses by the relatively low proportion of patients opting to take bisphosphonates. The decision aid itself seemed successful at improving knowledge transfer, but knowledge remained low in both
Conclusions
Our decision aid, Osteoporosis Choice, improves the quality of clinical decisions about bisphosphonate therapy in postmenopausal women at risk of osteoporotic fractures by improving knowledge transfer and patient involvement. However, medication start rates were similar across risk groups, and medication adherence results were mixed with a trend toward improved adherence in patients receiving the decision aid.
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Funding: The trial was funded by the Mayo Clinic Foundation for Medical Education and Research. The funding source had no role in the design, conduct, or decision to publish results of this trial.
Conflict of Interest: The authors of this article disclose no financial conflicts of interest pertinent to this trial. In particular, the decision aid described in this article is in the public domain and can be obtained from the authors without charge. The authors, their relatives, or other associates have not initiated any business to profit from this decision aid (or any other decision aid they have developed and studied) or the dissemination of the results of this trial, beyond the usual benefits of academic recognition. The authors or any member of the team who participated in the development or evaluation of the decision aid have not received financial support from pharmaceutical companies that market bisphosphonates or their competitors. The KER UNIT, a laboratory within the Mayo Clinic where the study was conceived, run, and analyzed, and this report was prepared, had explicit rules in place before, during, and at the time of writing this note against receiving any funding from for-profit pharmaceutical or device manufacturers.
Authorship: All authors had access to the data and played a role in writing this manuscript. VMM and BAS conceived and designed this study; other authors contributed to the conduct and analyses of the study.
Trial registration: Clinical Trials.gov Identifier: NCT00578981