Despite the availability of effective therapy, hypertension (HTN) remains a significant contributor to morbidity and mortality in the United States. Racial and ethnic disparities in HTN prevalence and control persist despite targeted initiatives to reduce disparities. HTN is also more prevalent among persons with less education and among rural residents. Barriers to reducing disparities in HTN care are complex and include factors related to patients and their families, healthcare providers, practice settings, communities, and policies. Few approaches to reducing HTN combine multi-level strategies into a pragmatic and sustainable plan; improve patient- centered outcomes in underserved communities; and explicitly address disparities. We will compare the effectiveness of clinic-based standard of care plus audit, feedback and education (SCP) to an intervention that uses a collaborative care team, a community health worker and specialist consultation to deliver contextualized, appropriately stepped care (CC/stepped care) for reducing disparities and improving patient-centered outcomes among patients with HTN, with or without other comorbidities. We will use patient and broad stakeholder engagement and apply principles of community-based participatory research to refine and adapt intervention protocols and materials to the needs of participating organizations, clinic sites, and populations. We hypothesize that CC/stepped care will be more effective than SCP at improving patient BP control and self-management behaviors, and that CC/stepped care will reduce racial/ethnic, socioeconomic, and rural/non-rural disparities to a greater extent than SCP. Thirty primary care clinics, including Federally Qualified Health Centers, across Maryland will recruit 63 patients each (total=1,890) into our large, prospective and pragmatic cluster randomized trial. We will have adequate statistical power to detect a difference in BP control rates of 13% between groups (assuming 20% attrition). In the UH3 period, every 6 months 3 cohorts of 10 clinics each will be randomized to receive SCP or CC/stepped care for 2 years. Eligible patients are ?18 years, non-Hispanic black, non-Hispanic white, or Hispanic, receive care at participating clinics, and have uncontrolled HTN with or without comorbidities such as diabetes, hyperlipidemia, or depression. The main patient-level analysis compares SCP to CC/stepped care, regressing percent with BP under control (<140/90 mm Hg), systolic BP, patient activation and chronic disease self management on time indicators (0/1), an intervention indicator, and interactions of time and intervention to assess whether the change over time in CC/stepped care is statistically better than SCP. Pre-specified subgroup analyses test for heterogeneity across race/ethnicity, rural/urban residence, Medicaid/ non-Medicaid status and across steps. The proposed Intervention, if effective, will have potential for sustainability and scalability in real-world prmary care practices, especially among safety-net health centers, due to its inclusion of stakeholders at all phases of the project.
This study will help to lower reduce blood pressure and heart disease risk among minority, low income, and rural populations, by comparing standard clinical performance feedback and education for providers and staff to a more comprehensive approach that includes workshops for health system leaders, a structured team approach to care, and access to subspecialists or community support as needed for patients with hypertension. Finding effective approaches for patients to achieve better heart health helps patients and doctors to make critical decisions on real-world care for high risk patients, and our study combines tested approaches with new ideas in an innovative program that treats patients as whole people, rather than as a disease. Carefully tested interventions that show promise in improving health outcomes will give doctors, insurers, and law makers the confidence to support the widespread use of similar programs in a variety of medical settings and among other at-risk populations. (End of Abstract)
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