Shared Decision Making Between Patients and GPs in the Treatment of Type 2 Diabetes in Primary Care.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Background: Less than 20% of type 2 diabetes mellitus (T2DM) patients in different healthcare
      settings achieve all treatment goals to prevent cardiometabolic disease. A more personalised
      approach with shared decision making should increase that percentage. 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. The aim of the study was to evaluate whether such an
      approach increases the proportion of treatment goals that T2DM patients achieve.

      Methods: In a cluster-randomised trial in 40 primary care 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 shared decision making (SDM) was developed
      as well as a decision support tool to use during the consultation. These 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 (treatment-as-before). Follow-up: 24 months. The primary
      outcome is the proportion of patients who achieve all three treatment goals (HbA1c, blood
      pressure, total cholesterol) at 24 months. 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), 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 groups by
      estimating the relative risk of meeting the treatment targets. For the secondary outcomes
      mixed models will be used.

      Discussion: To achieve optimal diabetes care with a higher proportion of achieved
      individualised treatment goals, the SDM approach including a multi-faceted decision support
      tool might be useful. An intervention with such a support decision tool is designed.
    

Detailed description: 
      See brief summary
    

Intervention name(s): Shared decision making
Intervention type(s): Behavioral
Intervention description(s): In the intervention practices the SDM process is used. In the SDM proces the patient and GP use a decision aid to discuss the pros and cons of two evidence based treatment possibilities, according to the Dutch College of General Practitioners (NHG) versus the ADDITION guideline, and the patients' preferences for either of these treatments. Together they choose one of these treatments, and set the five treatment targets (blood pressure, cholesterol, HbA1c, smoking status and weight) in order of priority. Subsequent treatment will take place according to the priorities of these OPTIMAL treatment targets. The priorities will be evaluated every 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes treatment; personalized medicine; shared decision making; goal setting