Summary
he high cost of treatment and large variation in the quality of patient care are major concerns in the treatment of type 2 diabetes mellitus. Increasing the degree of patient involvement in decisions related to treatment of their condition has been advocated in current T2DM guidelines and has been shown to improve the overall quality of care. This article presents preliminary results from the multicenter, cluster-randomized Diabetes Medication Choice Cards Trial in Greece [NCT01861756; EASD 2014 (poster 1077)] evaluating use of the Diabetes Medication Choice Decision Aids.
- Diabetes & Endocrinology Clinical Trials
- Nursing
- Diabetes Mellitus
- Diabetes & Endocrinology Clinical Trials
- Endocrinology
- Diabetes & Metabolic Syndrome
- Nursing
- Diabetes Mellitus
The high cost of treatment and large variation in the quality of patient care are major concerns in the treatment of type 2 diabetes mellitus (T2DM) [Halperin F et al. N Engl J Med. 2008]. Increasing the degree of patient involvement in decisions related to treatment of their condition has been advocated in current T2DM guidelines [Inzucchi SE et al. Diabetologia. 2012] and has been shown to improve the overall quality of care [Stacey D et al. Cochrane Database Syst Rev. 2014]. The increased cost of new treatments enables patient involvement, because decisions for optimal individualized treatment become less technical and more value based [Grant RW et al. Diabetes Care. 2007]. Tools known as decision aids (DAs) have emerged to facilitate a shared decision-making process between patient and physician [Stacey D et al. Cochrane Database Syst Rev. 2014].
Thomas Karagiannis, MD, Aristotle University of Thessaloniki, Thessaloniki, Greece, presented a poster with preliminary results from the multicenter, cluster-randomized Diabetes Medication Choice Cards Trial in Greece [NCT01861756; EASD 2014 (poster 1077)] evaluating use of the Diabetes Medication Choice DA, which consists of cards providing a comparison of commonly used antidiabetic medication classes among 7 domains: blood sugar, daily sugar testing, low blood sugar, daily routine, weight change, side effects, and cost.
The objective of the study was to implement the DA (originally developed by the Mayo Clinic), assess its efficacy in patients with T2DM in primary and secondary care practices throughout Greece, and compare it with usual care. Practices were matched based on type of setting (urban or rural) and level of care (primary or secondary) before randomization of patients to either use of the Diabetes Medication Choice DA or usual care.
Patients eligible for the study were adults who had been diagnosed with T2DM at least 1 year, had more than 1 treatment option available, and were able to both provide informed consent and participate in decision making for their treatment. Patient characteristics were balanced between the 2 treatment arms. A total of 5 practices with 101 patients were allocated to the DA, and 4 practices with 103 patients were allocated to usual care. The study consisted of an initial encounter and 2 follow-up visits at 12 and 24 weeks. The quality of the decision-making process was evaluated immediately after the initial encounter by means of a 13-item Decisional Conflict Scale (DCS). Transfer of knowledge to the patient about antidiabetic medications as well as the level of satisfaction of both the patient and clinician were also assessed.
None of the trial results reached statistical significance (Table 1). Although patients in the DA arm displayed lower levels of overall decisional conflict (mean difference, 7.0; 95% CI, −8.1 to 22.2; P = .31), knowledge transfer was high in both groups (mean difference, 2.4%; 95% CI, −16.0 to 20.7; P = .77), and patients allocated to the DA and usual care were equally satisfied.
In the majority of cases, clinicians who had used the DA said that they found the tool to be useful and that it was easy to use and to integrate within their clinical setting. These clinicians also said that they would be willing to use similar DAs for patients with other chronic diseases. The Greek researchers characterized their results as similar to findings from trials assessing the Diabetes Medication Choice DA in the United States, where promoting patient-centered care via the DA was also positively accepted by clinicians and patients. The authors said, however, that further research is needed to determine the impact of DAs on care experience and outcomes in patients with different background values and preferences.
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