iMatter2: An AI-driven approach to supercharge a novel digital patient-reported outcomes tool for diabetes management

项目概述：未控制的2型糖尿病（T2 D）是美国的一个主要健康问题， 发病率和死亡率的重要原因，特别是在继续遭受 不成比例的高并发症发生率。尽管初级保健做法在这方面发挥着重要作用， T2 D的管理，他们从来没有被设计，也不适合捕捉和解决复杂的 社会心理学（例如，压力）和行为因素（例如，坚持自我护理），这显著影响 血糖控制。然而，如果不将T2 D的心理和行为影响纳入临床研究， 决策，实现患者和初级保健提供者（PCP）所期望的结果将是 高不可攀将患者报告结局（PRO）应用于T2 D护理是一个理想的机会， 捕获T2 D患者的心理社会和行为对患者临床结局的影响。直接 对NOT-HS-16-015的回复，该更新申请基于我们的AHRQ资助的随机对照 一项评估创新的mHealth PRO工具的有效性的随机对照试验（RCT）将解决文献中的这一空白。 本研究以理论为主导，以使用者为中心的设计方法，分两个阶段进行： 形成阶段，以完善和用户测试iMatter 2在现实世界的设置;和2）临床试验阶段。的 形成阶段将使用混合方法来：a）将增强的功能集成到我们现有的 工具和电子健康记录（EHR）在一个多样化的网络初级保健实践服务的少数民族 B）评价iMatter 2在T2 D和PCP患者亚组中的可用性，以优化 工具的性能和工作流集成。对于临床试验阶段，我们将在混合型1中进行评估 RCT，在353例患者中比较iMatter 2与常规治疗（UC）在12个月时降低HbA 1c的有效性 未控制的T2 D（HbA 1c>7%）。使用扩展的RE-AIM框架，我们将应用权益透镜， 衡量iMatter 2的覆盖范围、采用率和实施情况。我们还将探讨 患者的PRO应答和HbA 1c降低。PCP将是随机化单位，所有患者均在 PCP的小组在同一组。随机分配至iMatter 2组的患者将接受个性化的 PRO通过短信，通过AI聊天机器人接收个性化的激励和教育信息; 访问交互式仪表板，可视化他们的每日PRO和HbA 1c数据。PCP随机分配至 iMatter 2将可以访问EHR集成的临床决策支持工具，以推动PCP查看PRO HbA 1c数据。随机分配至UC的患者将接受标准T2 D治疗建议 从他们的PCP; PCP将无法访问EHR报告。主要结局是HbA 1c的平均降低， 从家庭A1 c试剂盒中提取，从基线到12个月。次要结果是：1）公平地获得 iMatter 2跨设置和患者; 2）iMatter 2跨PCP和患者的公平采用;以及3） 在PCP和患者之间公平参与（实施）iMatter 2。

Project Summary: Uncontrolled type 2 diabetes (T2D) is a major health problem in the US that constitutes a significant cause of morbidity and mortality, particularly in minoritized populations who continue to suffer disproportionately higher rates of complications. Despite the significant role primary care practices play in the management of T2D, they were never designed nor ideally suited to capture and address the complex psychosocial (e.g., stress) and behavioral factors (e.g., adherence to self-care) that significantly impact glycemic control. However, without incorporating the psychosocial and behavioral impacts of T2D into clinical decision-making, achievement of the outcomes desired by patients and primary care providers (PCP) will be unattainable. Application of patient-reported outcomes (PROs) to T2D care represents an ideal opportunity to capture the psychosocial and behavioral impacts of living with T2D on patients' clinical outcomes. In direct response to NOT-HS-16-015, this renewal application, which builds on our AHRQ-funded randomized control trial (RCT) evaluating the efficacy of an innovative mHealth PRO tool, will address this gap in the literature. Using a theory-driven and user-centered design approach, we will conduct the study in two phases: 1) a formative phase to refine and user-test iMatter2 in real-world settings; and 2) a clinical trial phase. The formative phase will use a mixed-methods approach to: a) integrate enhanced functionalities into our existing tool and the electronic health record (EHR) in a diverse network of primary care practices serving minoritized populations; and b) evaluate the usability of iMatter2 in a subset of patients with T2D and PCPs to optimize the tool's performance and workflow integration. For the clinical trial phase, we will evaluate in a hybrid type 1 RCT, the effectiveness of iMatter2 vs usual care (UC) on HbA1c reduction at 12-months among 353 patients with uncontrolled T2D (HbA1c>7%). Using the extended RE-AIM framework, we will apply an equity lens to measure the reach, adoption, and implementation of iMatter2. We will also explore the associations between patient's PRO responses and HbA1c reduction. PCPs will be the unit of randomization with all patients within the PCP's panel in the same group. Patients randomized to iMatter2 will receive and respond to personalized PROs via text message, receive personalized motivational and educational messages via an AI chatbot; and have access to an interactive dashboard that visualizes their daily PRO and HbA1c data. PCPs randomized to iMatter2 will have access to EHR-integrated clinical decision support tools to nudge PCPs to view the PRO reports and HbA1c data. Patients randomized to UC will receive standard T2D treatment recommendations from their PCPs; PCPs will not have access to the EHR reports. Primary outcome is mean reduction in HbA1c, extracted from home A1c kits, from baseline to 12 months. Secondary outcomes are 1) equitable reach of iMatter2 across settings and patients; 2) equitable adoption of iMatter2 across PCPs and patients; and 3) equitable engagement (implementation) with iMatter2 across PCPs and patients.