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
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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DOI：
10.1186/s12875-015-0230-0
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发表时间：
2015-02-27
影响因子：
2.9
通讯作者：
Rutten, Guy E. H. M.
中科院分区：
文献类型：
--
作者：
den Ouden, Henk;Vos, Rimke C.;Rutten, Guy E. H. M.
背景资料：不超过10-15%的2型糖尿病（T2 DM）患者实现了关于血糖控制、血脂和血压的所有治疗目标。共享决策（SDM）应该会增加这一比例;然而，并非所有的辅助决策工具都是合适的。由于ADDITION-Europe研究证明了两种（几乎）同样有效的治疗方法，但强度略有不同，因此考虑到治疗强度，临床因素和患者的偏好，与患者讨论他们的糖尿病治疗可能是一个很好的起点。我们的目的是评估这种方法是否增加了患者的比例，实现所有三个treatment goals.Methods：在一个集群随机试验，包括40个一般的做法，参加，直到2009年在ADDITION研究，150 T2 DM患者60-80岁，已知T2 DM为8-15年，将被纳入。第二次对实践进行随机化，即ADDITION研究中的干预实践可以是当前研究中的对照实践，反之亦然。为干预组的全科医生制定了2小时的SDM培训以及在咨询期间使用的决策支持工具。全科医生计划与患者的首次就诊，以决定治疗的强度，个性化的目标和治疗的优先级。对照组将继续接受ADDITION研究中分配的治疗。随访：24个月。主要结局是实现所有三个治疗目标的患者比例。次要结局是达到5个治疗目标（HbA 1c、血压、总胆固醇、体重、不吸烟）的患者比例、SDM过程评价（SDM-Q9和CPS）、治疗满意度（DTSQ）、健康和生活质量（W-BQ 12、ADD QoL-19）、健康状况（SF-36、EQ-5D）和应对（DCMQ）。将比较两组之间达到治疗目标的比例。对于次要结局，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经批准了研究方案（方案编号：11-153）。讨论：本试验将提供证据，证明多方面决策支持工具的干预是否会增加2型糖尿病患者实现个性化目标的比例。
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.