Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor (PACESETTER)

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Racial and rural-urban disparities in stroke care and outcomes are most prominent in the Southeastern region of the US, where 3 states have long been recognized as representing the `buckle' of a `stroke belt', i.e. highly stroke-prone tri-state area within a broader region already more heavily burdened with stroke compared to the rest of the country. One of these 3 states is South Carolina (SC). Fortunately, stroke is eminently preventable and hypertension (HTN) is the premier modifiable risk factor for stroke, but fewer than one third of patients with a recent stroke have their blood pressure (BP) controlled ≥75% of the time and low consistency of BP control is linked to higher risk of future major vascular events. Key factors responsible for uncontrolled HTN in African Americans (AA) are medication non-adherence and failure to intensify therapy in a timely manner. As such, culturally-tailored, efficacious blood pressure control programs which are acceptable, feasible, timely, and sustainable are needed, especially among hypertensive stroke survivors who reside in the stroke buckle or who are AA. Mobile health (mHealth) technology offers a promising approach to address this need. The overall objective of the Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor (PACESETTER) study is to demonstrate that a theoretical-model- based, mHealth technology-centered, multi-level integrated approach can be effectively implemented to improve sustained BP control among stroke patients encountered in South Carolina (at least half of whom will be AA) within one month of stroke symptom onset. The primary aim is conduct an implementation trial (at the patient level) of the PACESETTER intervention [health technology (personalized phone text messaging and home BP monitoring)] vs. usual care in 200 recent stroke patients with hypertension recruited across the three main safety net hospitals in the state of SC (in the cities of Charleston, Columbia, and Greenville). Primary outcome will be achievement of guideline-recommended systolic blood pressure control at 12 months. We also aim to explore whether implementation of the PACESETTER intervention vs. standard care is associated with a reduction in subsequent cardiovascular event-related re-hospitalizations, shows a signal of potential efficacy in reducing actual vascular events, and has distinct effects on providers caring for patients with stroke. Altogether, the PACESETTER intervention, if proven effective and implementable, may eventually be exported to other medically underserved populations in the US beyond SC, as a feasible model of evidence-based post-stroke management.