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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- The between groups difference in the proportion of patients which achieve the treatment goals for HbA1c, blood pressure, and total cholesterol
研究概览
简要总结
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.
详细描述
See brief summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two more or less comparable categories of patients are eligible:
- •if diagnosed with T2DM in 2002-2004 by screening, aged between 50-70 years at that time and having participated in the ADDITION-study that ended in 2009;
- •treated for their T2DM in a practice that participated in the ADDITION study, between 60 and 80 years in 2012-2014 and with a T2DM duration between 8 to 15 years.
排除标准
- •Patients will be excluded if they have a history of alcoholism, drug abuse, psychosis, personality disorder or another emotional, psychological or intellectual problem that is likely to invalidate informed consent, or limit the ability of the individual to comply with the protocol requirements and patients with a limited life expectancy.
研究组 & 干预措施
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.
干预措施: Shared decision making (Behavioral)
control group
Patients in the control practices will receive treatment-as-before, which means that the patients will not be offered the structured SDM process. So the GP will treat the former ADDITION patients as they were used during the period that followed after the ADDITION study (2009), either according to the national guidelines or to the ADDITION intensive treatment algorithm.
结局指标
主要结局
The between groups difference in the proportion of patients which achieve the treatment goals for HbA1c, blood pressure, and total cholesterol
时间窗: after 12 months
The proportions of achieved treatment goals of HbA1c, blood pressure, total cholesterol within each study group will by estimated by calculating relative risk. Intention-to-treat analyses (ITT) will be performed to examine between-group differences.
次要结局
- Characteristics of success for the SDM process in the patients in the intervention group.(after 24 months)
- The difference between groups in the proportion of patients which achieved the five treatment goals for HbA1c, blood pressure, total cholesterol, body weight, and smoking.(after 24 months)
- The difference in health status between both groups at 24 months as measured with the Short Form-36.(after 24 months)
- The difference in health related Quality of Life between both groups at 24 months as measured with the Audit of Diabetes Dependent Quality of Life and the European Quality of Life questionnaire.(after 24 months)
- The difference in well-being between baseline and 24 months within and between both groups as measured with the Well-Being Questionnaire.(after 24 months)
- The difference in wellbeing between baseline and 24 months within and between both groups as measured with the Well-Being Questionnaire.(after 24 months)
- The difference in coping style between baseline and 24 months within and between both groups as measured with the Diabetes Coping Measurement Questionnaire.(after 24 months)