PROTECT DC

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Inadequate control of vascular risk factors contributes to health disparities, particularly in secondary stroke prevention. PROTECT DC is a randomized phase II intervention clinical trial designed to determine whether hospital-based initiation of secondary prevention strategies coupled with community-based case management (via "stroke navigators") can improve secondary prevention measures in underserved patients. PROTECT DC is adapted from the Stroke PROTECT (Preventing Recurrence Of Thromboembolic Events through Coordinated Treatment) program, which systematically implements medication/behavioral secondary prevention measures. The general aim of this proposal is to prepare for a future Phase III trial of the PROTECT DC intervention: an in-hospital education coupled with community-based "stroke navigators" designed to reduce the rate of vascular events or death in a population of underserved stroke patients. The current proposed phase II study will employ surrogate measures of risk factor control to detect a signal of efficacy from the PROTECT DC intervention. The two specific aims are to: 1) assess the effect of PROTECT DC on four objective markers of secondary stroke risk factor control (antithrombotic therapy, antihypertensive therapy, lipid-lowering medication, and anti-diabetic medication) in patients randomized to PROTECT DC vs. those randomized to ah observational control, and 2) assess the contribution of health status, depression, cognition, socio-economic status, race and other factors to the incidence of barriers and the rate of response to the study interventions. A total of 250 primarily inner-city, underserved, ischemic stroke patients will be recruited from 2 DC hospitals: Howard University Hospital and Washington Hospital Center. Patients will be randomized to the PROTECT DC intervention (hospital based secondary prevention education plus community-based stroke navigators for one year) vs. standardized usual and customary care for one year. The primary endpoint is secondary stroke risk factor control for the 4 medication goals as determined by normalization of target laboratory values (systolic blood pressure, LDL, Hemoglobin A1c) or pill count for the antiplatelet goal. Secondary endpoints include rates of vascular events, functional status and a variety of disability, quality of life, and social participation measures. PROTECT DC intervention will be further refined by reviewing and adapting culturally sensitive educational materials for PROTECT DC; determining the frequency of modifiable and non-modifiable specific barriers to compliance; refining and standardizing strategies to overcome identified barriers to compliance; and refining materials and programs to train and supervise stroke navigators. The work proposed is expected to lead to a Phase III trial adequately powered to demonstrate the effectiveness of PROTECT DC in reducing recurrent vascular event rates in underserved populations.