i-Matter: Investigating an mHealth texting tool for embedding patient-reported data into 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， 发病和死亡的重要原因，特别是继续遭受 不成比例的高并发症发生率。尽管T2 D对身体和心理社会有重大影响， 对患者的行为，功能和临床结果;许多临床实践继续忽视 患者对他们的T2 D的观点优先考虑疾病的生理方面。然而，在这方面， 如果不将患者对他们的健康和功能状态的观点结合到糖尿病护理中， 患者和初级保健提供者（PCP）所期望的结果的实现将是无法实现的。到 为了解决这一差距，我们将使用技术接受模型和能力-机会-动机模型 的行为，以评估基于技术的患者报告结果（PRO）系统的有效性， 现代期刊系统，用于T2 D管理[MJS糖尿病]。MJS是一个创新的移动的平台， 利用短信实时捕获PRO数据，通过数据驱动的 反馈和激励信息，并创建PRO数据的动态数据可视化， 通过打印报告共享，并集成到电子健康记录（EHR）中。使用混合方法 设计，我们将分两个阶段进行这项研究：1）形成阶段，使用基于证据的用户- 中心设计方法; 2）临床疗效阶段。形成阶段将使用定性方法 为了：a）使MJS糖尿病适应PCP和T2 D患者的需求; B）将MJS糖尿病纳入 EHR系统、初级保健实践以及T2 D患者的生活;以及c）评估 T2 D患者和PCP亚组中的MJS糖尿病，以优化工具的性能， 工作流集成对于临床疗效阶段，我们将在随机对照试验中评估 在282例T2 D患者中，MJS糖尿病与糖尿病护理（UC）在12个月时降低HbA 1c的比较 在安全网实践中接受护理的人。随机分配至干预组的患者将入组MJS 糖尿病患者，他们将通过短信接收和回复PRO，接收数据驱动的反馈， 基于PRO模式的激励信息，以及12个月研究期间的期刊报告。PCPs 将通过MJS-EHR界面访问患者的PRO数据报告，可以在 与患者一起进行访视或异步进行访视，以在访视之间跟踪患者PRO。随机分配至UC的患者 手臂将接受标准的T2 D治疗建议，由他们的PCP决定。主要结局 将是HbA 1c从基线至12个月的平均降低。次要结局将包括以下方面的变化：a） 患者对自我护理行为的坚持（例如，生活方式和药物建议）;和B）理论 糖尿病知识，自我效能，结果期望和患者-提供者沟通的调解人。 无论分组如何，将在基线、3- 6、9和12个月时评估所有结局数据。

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 vulnerable populations who continue to suffer disproportionately higher rates of complications. Despite the significant physical and psychosocial impact T2D has on patients' behavioral, functional and clinical outcomes; much of clinical practice continues to neglect patients' perspective of their T2D giving preference to the physiological aspects of the disease. However, without incorporation of patients' perspective of their health and functional status into diabetes care, achievement of the outcomes desired by patients and primary care providers (PCP) will be unattainable. To address this gap, we will use the Technology Acceptance Model and Capability-Opportunity-Motivation Model of Behavior to evaluate the efficacy of a technology-based patient-reported outcome (PRO) system, the Modern Journal System, for management of T2D [MJS DIABETES]. MJS is an innovative mobile platform that utilizes text-messaging to capture PRO data in real-time, enhance patient engagement through data-driven feedback and motivational messages, and creates dynamic data visualizations of the PRO data that can be shared through printed reports, and integrated into the electronic health record (EHR). Using a mixed-methods design, we will conduct this study in two phases: 1) A formative phase, using the evidence-based user- centered design approach; and 2) a clinical-efficacy phase. The formative phase will use qualitative methods to: a) adapt MJS DIABETES to the needs of PCP and patients with T2D; b) integrate MJS DIABETES into the EHR system, primary care practice as well as the lives of patients with T2D; and c) evaluate the usability of MJS DIABETES in a subset of T2D patients and PCPs in order to optimize the tool's performance and workflow integration. For the clinical efficacy phase, we will evaluate in a randomized control trial, the efficacy of MJS DIABETES versus Usual Care (UC) on reduction HbA1c at 12-months, among 282 patients with T2D who receive care in safety-net practices. Patients randomized to the intervention arm will be enrolled in MJS DIABETES where they will receive and respond to PROs via text message, receive data-driven feedback and motivational messages based on patterns of their PROs, and journal reports over the 12-month study. PCPs will have access to reports of patients' PRO data through the MJS-EHR interface, which can be viewed during visits with the patient or asynchronously to track patient PROs between visits. Patients randomized to the UC arm will receive standard T2D treatment recommendations, as determined by their PCP. The primary outcome will be mean reduction in HbA1c from baseline to 12 months. Secondary outcomes will include changes in: a) patient adherence to self-care behaviors (e.g., lifestyle and medication recommendations); and b) theoretical mediators of diabetes knowledge, self-efficacy, outcomes expectations, and patient-provider communication. Regardless of group assignment, all outcome data will be assessed at baseline, 3- 6-, 9- and 12-months.