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首页> 外文期刊>BMC Family Practice >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
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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

机译：使用支持决策工具在2型糖尿病中进行共同决策，该决策工具考虑了临床因素，治疗强度和患者喜好：一项整群随机（OPTIMAL）试验设计

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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
机译：背景2型糖尿病（T2DM）患者中，不超过10-15％的患者达到有关血糖控制，脂质和血压的所有治疗目标。共享决策（SDM）应该增加该百分比;但是，并非所有支持决策工具都适用。由于ADDITION-Europe的研究显示了两种（几乎）同样有效的治疗方法，但强度稍有不同，因此考虑到治疗强度，临床因素和患者的病情，这可能是与患者讨论他们的糖尿病治疗方法的良好起点。优先。我们旨在评估这种方法是否会增加实现全部三个治疗目标的患者比例。方法在一项包括40种常规方法的整群随机试验中，该试验一直持续到2009年，直到2009年才参加ADDITION研究，其中包括150名60-80岁的T2DM患者，已知其患有8-15年的T2DM。做法是第二次随机化，即，ADDITION研究中的干预措施可能是当前研究中的控制措施，反之亦然。对于来自干预组的全科医生，开发了2小时的SDM培训以及在咨询过程中使用的决策支持工具。全科医生计划与患者进行首次就诊，以决定治疗强度，个性化目标和治疗重点。对照组将继续进行他们在ADDITION研究中分配的治疗。随访：24个月。主要结局是达到全部三个治疗目标的患者比例。次要结果是达到五个治疗目标（HbA1c，血压，总胆固醇，体重，不吸烟），对SDM流程的评估（SDM-Q9和CPS），对治疗的满意度（DTSQ），幸福感的患者比例和生活质量（W-BQ12，ADD QoL-19），健康状况（SF-36，EQ-5D）和应对（DCMQ）。将在两组之间比较已达到的治疗目标的比例。对于次要结果，将使用混合模型。乌得勒支大学医学中心的医学研究伦理委员会已批准了研究方案（协议编号：11-153）。讨论该试验将提供证据，证明采用多方面决策支持工具进行的干预是否会增加2型糖尿病患者已实现个性化目标的比例。试用注册NCT02285881，2014年11月4日

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