i-Matter: Investigating an mHealth texting tool for embedding patient-reported data into diabetes management

项目摘要：未控制的2型糖尿病(T2D)在美国是一个主要的健康问题，它构成了 发病率和死亡率的重要原因，特别是在继续遭受痛苦的弱势人群中 并发症的发生率高得不成比例。尽管T2D对身体和心理产生了重大影响 对患者的行为、功能和临床结果有影响；许多临床实践继续被忽视 患者对其T2D的看法偏向于疾病的生理方面。然而， 如果不将患者对其健康和功能状态的看法纳入糖尿病护理， 患者和初级保健提供者(PCP)所希望的结果将无法实现。至 为了解决这一差距，我们将使用技术接受模型和能力-机会-激励模型 评估基于技术的患者报告结果(PRO)系统的有效性的行为， 现代期刊系统，用于治疗T2D[MJS糖尿病]。MJS是一个创新的移动平台， 利用短信实时捕获专业数据，通过数据驱动增强患者参与度 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，并整合到电子健康记录(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- 以设计为中心的方法；以及2)临床疗效阶段。形成阶段将使用定性方法。 以：a)使MJS糖尿病适应PCP和T2D患者的需求；b)将MJS糖尿病纳入 电子病历系统、初级保健实践以及T2D患者的生活；以及c)评估 在T2D患者和PCP的子集中进行MJS糖尿病，以优化该工具的性能和 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疗效 282例T2D患者12个月时MJS糖尿病与常规护理(UC)对HbA1c降低的比较 在安全网实践中接受护理的人。被随机分配到干预组的患者将参加MJS。 他们将通过文本消息接收和回复专业人士，接收数据驱动的反馈，并 在这项为期12个月的研究中，基于他们的专业人士的模式和期刊报告的励志信息。PCP 将可以通过MJS-EHR界面访问患者PRO数据的报告，可以在 与患者一起访问或在两次访问之间同步跟踪患者的专业知识。患者被随机分配到UC ARM将接受由他们的初级保健计划确定的标准T2D治疗建议。主要结果是 HbA1c将从基线平均降低到12个月。次要成果将包括以下变化：a) 患者遵守自我护理行为(例如，生活方式和药物建议)；和b)理论上 糖尿病知识、自我效能、结果预期和患者-提供者沟通的中介。 无论分组情况如何，所有结果数据都将在基线、3-6个月、9个月和12个月进行评估。

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.