EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) - When the self-management demands of chronic diseases like diabetes and hypertension exceed patients’ self-management capacity, poor control ensues. For many patients, clinic-based chronic disease care provides insufficient self-management support, resulting in clinic-refractory chronic diseases. As an example, 12% of all patients with type 2 diabetes maintain a hemoglobin A1c (HbA1c) ≥8.5% for ≥1 year despite clinic-based care; this is defined as ‘persistent poorly-controlled diabetes mellitus’ (PPDM). PPDM does not respond to clinic- based care because the factors that underlie PPDM are not well-addressed with the infrequent patient-provider contact achievable in clinic. Importantly, over 85% of patients with PPDM have comorbid hypertension, which further exacerbates outcomes in this high-risk group. Without better treatment options, patients with PPDM and hypertension will inevitably accrue preventable complications and costs. Telehealth has the potential to improve management of clinic-refractory chronic diseases relative to clinic- based care alone because it facilitates patient-provider contact and better supports self-management. Our prior work shows that nurse-delivered telehealth interventions incorporating telemonitoring, self-management support, and medication management can lower HbA1c even among clinic-refractory patients with PPDM. Excitingly, emerging mobile monitoring technologies could enhance telehealth for clinic-refractory chronic diseases, either by generating multiple streams of health data to facilitate patient self-management, or by integrating mobile monitoring data into a nurse-delivered telehealth intervention. However, key evidence gaps currently prevent use of mobile monitoring-enabled telehealth in clinical practice. The current proposal, EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) seeks to address current barriers and evidence gaps preventing practical use of mobile monitoring-enabled telehealth for clinic-refractory chronic disease, using PPDM with comorbid hypertension as the target condition. Because this population has already proven refractory to usual clinic care, this study proposes an active comparator randomized trial (N=220) comparing the effectiveness of two 12-month telehealth interventions: 1) EXTEND-Monitoring, or mobile monitoring alone; and 2) EXTEND-Nursing, a nurse-delivered intervention incorporating mobile monitoring, self-management support, and medication management. In order to guide further scaling and dissemination of the EXTEND interventions, a rigorous, multi-method evaluation will: (A) interview stakeholders regarding implementation barriers and facilitators; and (B) compare intervention costs against potential reimbursement mechanisms. Finally, the value of combining data from mobile monitoring and electronic health records to predict patient safety events will be examined in the cohort over 24 months. Clinic-refractory chronic diseases demand innovation to reduce preventable complications. This high- impact proposal will address an urgent clinical problem in a manner that is generalizable to other conditions.
