Shared decision making in type 2 diabetes with a support decision tool that takes into account clinical factors, the intensity of treatment and patient preferences: Design of a cluster randomised (OPTIMAL) trial

Abstract

Background: No more than 10-15% of type 2 diabetes mellitus (T2DM) patients achieve all treatment goals regarding glycaemic control, lipids and blood pressure. Shared decision making (SDM) should increase that percentage; however, not all support decision tools are appropriate. Because the ADDITION-Europe study demonstrated two (almost) equally effective treatments but with slightly different intensities, it may be a good starting point to discuss with the patients their diabetes treatment, taking into account both the intensity of treatment, clinical factors and patients' preferences. We aim to evaluate whether such an approach increases the proportion of patients that achieve all three treatment goals. Methods: In a cluster-randomised trial including 40 general practices, that participated until 2009 in the ADDITION Study, 150 T2DM patients 60-80 years, known with T2DM for 8-15 years, will be included. Practices are randomised a second time, i.e. intervention practices in the ADDITION study could be control practices in the current study and vice versa. For the GPs from the intervention group a 2-hour training in SDM was developed as well as a decision support tool to be used during the consultation. GPs plan the first visit with the patients to decide on the intensity of the treatment, personalised targets and the priorities of treatment. The control group will continue with the treatment they were allocated to in the ADDITION study. Follow-up: 24 months. The primary outcome is the proportion of patients who achieve all three treatment goals. Secondary outcomes are the proportion of patients who achieve five treatment goals (HbA1c, blood pressure, total cholesterol, body weight, not smoking), evaluation of the SDM process (SDM-Q9 and CPS), satisfaction with the treatment (DTSQ), wellbeing and quality of life (W-BQ12, ADD QoL-19), health status (SF-36, EQ-5D) and coping (DCMQ). The proportions of achieved treatment goals will be compared between both groups. For the secondary outcomes mixed models will be used. The Medical Research Ethics Committee of the University Medical Centre Utrecht has approved the study protocol (Protocol number: 11-153). Discussion: This trial will provide evidence whether an intervention with a multi-faceted decision support tool increases the proportion of achieved personalised goals in type 2 diabetes patients. Trial registration: NCT02285881, November 4, 2014