The central objective of this proposal is to rigorously compare two strategies designed to improve blood pressure (BP) control in primary care practices serving rural Southeastern African Americans with low socioeconomic status living in the Black Belt. The Black Belt is in the heart of the Stroke Belt, a geographic area long recognized to have the highest cardiovascular disease mortality in the US. We draw on the growing evidence that practice facilitation (PF), a highly customized, staged approach to helping practices to implement process and structural changes, can enhance the quality of care and improve patient and staff satisfaction, but there is less evidence on its ability to improve outcomes such as BP control. An alternate approach to improving CVD risk factors that is more relationship-focused and with growing evidence of effectiveness involves the use of peer coaches. We and others have shown that peer coaches are effective in Black Belt communities, where mistrust of the healthcare system is common. Using well-established community-based partnerships and the RE-AIM implementation framework, our UH2 Specific Aims are: 1. Engage rural primary care practices, hypertension (HTN) patients, peer coaches, and Community Advisory Boards in AL and NC to collaboratively finalize a PF intervention and a peer coaching intervention, both designed to improve BP in African Americans. 2. Create the data systems for the trial. Our UH3 Specific Aims are: 3. Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled pragmatic implementation trial to compare the two multi- component, multi-level interventions finalized in the UH2 phase with enhanced usual care using a 2 x 2 factorial design. We hypothesize that both interventions will improve BP more than enhanced usual care, and that both interventions delivered together will result in greater improvements in BP than either intervention alone. While we aim to control BP in 75% of participating intervention patients overall, the trial is designed to detect >15% difference in BP control (primary outcome) between the combined intervention and the enhanced usual care arms. Secondary outcomes will include group mean BP differences between baseline and follow- up; quality of life; patient satisfaction; healthcare utilization; and provider and staff satisfaction. The study is designed to examine differences by sex, age, depression, and health literacy/numeracy.
Aim 4. Establish scalability of the intervention throughout the entire Black Belt region using extensive process data intended to facilitate future implementation, including practice characteristics, patient characteristics, intervention implementation variables and fidelity measures, as well as focus groups and interviews with patients, peer coaches, facilitators, practice staff, and clinicians. We have extensive experience with community-based peer coaching interventions; PF interventions; health disparities research in CVD; and large multi-site randomized controlled trials engaging real-world practices, assuring the success of the project.
High blood pressure is an important risk factor for stroke and heart disease, and affects African Americans more than others. African Americans who live in the rural impoverished 'Black Belt' region of the Southeast are especially hard hit, facing substantial barriers to getting their high blood pressure treated. We will use a stakeholder engaged research approach to finalize two interventions during a planning year, then carry out a 2 x 2 factorial, cluster-randomized trial comparing the practice facilitation and peer coaching interventions to usual care. We will test whether these interventions, alone and in combination, can improve blood pressure, quality of life and satisfaction with care. The trial will enroll 80 primary care practices and a total of 2000 adult African American Black Belt residents with uncontrolled high blood pressure. (End of Abstract)
