BACKGROUND Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. METHODS This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability. DISCUSSION Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model. TRIAL REGISTRATION ClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.

中文翻译：

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投资于糖尿病研究方案：一项比较标准化和患者驱动的糖尿病共享医疗预约的集群随机实用试验。

背景技术共享医疗预约 (SMA) 已被证明是提供糖尿病自我管理教育和自我管理支持的有效策略。SMA 功能各不相同，不知道哪些功能对不同的患者和实践环境最有效。Invested in Diabetes 研究测试了有和没有多学科护理团队和患者主题选择的 SMA 在改善以患者为中心和与糖尿病相关的临床结果方面的比较有效性。方法 本研究比较了两种使用疾病管理目标培训 (TTIM) 课程的 SMA 方法的有效性。标准化 SMA 由具有固定 TTIM 主题顺序的健康教育者领导。以患者为导向的 SMA 由多学科护理团队（健康教育者、医疗提供者、行为健康提供者和同伴导师）；患者选择 TTIM 主题的顺序和重点。Invested in Diabetes 是一项整群随机实用试验，涉及约 1440 名成年 2 型糖尿病患者。二十个初级保健实践将被随机分配到标准化或患者驱动的 SMA。混合方法评估将包括定量（实践和患者层面的数据）和定性（实践和患者访谈、观察）部分。以患者为中心的主要结果是糖尿病困扰。次要结果包括自主支持、自我管理行为、临床结果、患者范围以及实践水平的价值和可持续性。讨论 实践和患者利益相关者输入指导协议开发，用于比较 SMA 方法的实用试验。来自增强的复制有效计划框架的实施策略将有助于确保实践保持对干预协议的忠诚度，同时根据其设置调整工作流程。投资于糖尿病将有助于使用 RE-AIM 模型进行慢性病管理和实施科学的文献。试验注册 ClinicalTrials.gov，NCT03590041。于 2018 年 7 月 5 日注册。