Clinical research study
Use of a Decision Aid to Improve Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial

https://doi.org/10.1016/j.amjmed.2011.01.013Get rights and content

Abstract

Objective

Poor adherence to therapy, perhaps related to unaddressed patient preferences, limits the effectiveness of osteoporosis treatment in at-risk women. A parallel patient-level randomized trial in primary care practices was performed.

Methods

Eligible postmenopausal women with bone mineral density T-scores less than −1.0 and not receiving bisphosphonate therapy were included. In addition to usual primary care, intervention patients received a decision aid (a tailored pictographic 10-year fracture risk estimate, absolute risk reduction with bisphosphonates, side effects, and out-of-pocket cost), and control patients received a standard brochure. Knowledge transfer, patient involvement in decision-making, and rates of bisphosphonate start and adherence were studied. Data came from medical records, post-visit written and 6-month phone surveys, video recordings of clinical encounters, and pharmacy prescription profiles.

Results

A total of 100 patients (range of 10-year fracture risk, 6%-60%) were allocated randomly to receive the decision aid (n = 52) or usual care (n = 48). Patients receiving the decision aid were 1.8 times more likely to correctly identify their 10-year fracture risk (49% vs 28%; 95% confidence interval [CI], 1.03-3.2) and 2.7 times more likely to identify their estimated risk reduction with bisphosphonates (43% vs 16%; 95% CI, 1.3-5.7). Patient involvement improved with the decision aid by 23% (95% CI, 13.6-31.4). Bisphosphonates were started by 44% of patients receiving the decision aid and 40% of patients receiving usual care. Adherence at 6 months was similarly high across both groups, but the proportion with more than 80% adherence was higher with the decision aid (n = 23 [100%] vs n = 14 [74%]; P = .009).

Conclusion

A decision aid improved the quality of clinical decisions about bisphosphonate therapy in at-risk postmenopausal women, did not affect start rates, and may have improved adherence.

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.

References (28)

  • I.B. Wilson et al.

    Physician-patient communication about prescription medication nonadherence: a 50-state study of America's seniors

    J Gen Intern Med

    (2007)
  • G. Guyatt et al.

    Patients at the center: in our practice, and in our use of language

    ACP J Club

    (2004)
  • A.M. O'Connor et al.

    Decision aids for people facing health treatment or screening decisions

    Cochrane Database Syst Rev

    (2009)
  • M.T. Cuddihy et al.

    A prospective clinical practice intervention to improve osteoporosis management following distal forearm fracture

    Osteoporos Int

    (2004)
  • Cited by (0)

    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

    View full text