NCT02285881

Shared Decision Making Between Patients and GPs in the Treatment of Type 2 Diabetes in Primary Care.

Shared Decision Making in Type 2 Diabetes With a Support Decision Tool That Takes Into Account Patient Preferences, Clinical Factors and the Intensity of Treatment: Design of a Cluster Randomised Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Shared decision making	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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-03-01
• Completion: 2016-02-01
• First posted: 2014-11-07
• Last updated: 2016-05-13

Locations

1 site across 1 country: Netherlands