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

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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.