Process of Engaging Community and Scientific Partners in the Development of the CIRCL-Chicago Study Protocol.

Objectives: Hypertension affects 1 in 3 adults in the United States and disproportionately affects African Americans. Kaiser Permanente demonstrated that a "bundle" of evidence-based interventions significantly increased blood pressure control rates. This paper describes a multiyear process of developing the protocol for a trial of the Kaiser bundle for implementation in under-resourced urban communities experiencing cardiovascular health disparities during the planning phase of this biphasic award (UG3/UH3). Methods: The protocol was developed by a collaboration of faith-based community members, representatives from community health center practice-based research networks, and academic scientists with expertise in health disparities, implementation science, community-engaged research, social care interventions, and health informatics. Scientists from the National Institutes of Health and the other grantees of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Alliance also contributed to developing our protocol. Results: The protocol is a hybrid type 3 effectiveness-implementation study using a parallel cluster randomized trial to test the impact of practice facilitation on implementation of the Kaiser bundle in community health centers compared with implementation without facilitation. A central strategy to the Kaiser bundle is to coordinate implementation via faith-based and other community organizations for recruitment and navigation of resources for health-related social risks. Conclusions: The proposed research has the potential to improve identification, diagnosis, and control of blood pressure among under-resourced communities by connecting community entities and healthcare organizations in new ways. Faith-based organizations are a trusted voice in African American communities that could be instrumental for eliminating disparities.

Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial.

BACKGROUND: Over half of patients with elevated blood pressure require multi-drug treatment to achieve blood pressure control. However, multi-drug treatment may lead to lower adherence and more adverse drug effects compared with monotherapy. OBJECTIVE: The Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET) USA trial was designed to evaluate whether initiating treatment with ultra-low-dose quadruple-combination therapy will lower office blood pressure more effectively, and with fewer side effects, compared with initiating standard dose monotherapy in treatment naive patients with SBP < 180 and DBP < 110 mm Hg and patients on monotherapy with SBP < 160 and DBP < 100 mm Hg. METHODS/DESIGN: QUARTET USA was a prospective, randomized, double-blind trial (ClinicalTrials.gov NCT03640312) conducted in federally qualified health centers in a large city in the US. Patients were randomly assigned (1:1) to either ultra-low-dose quadruple combination therapy or standard dose monotherapy. The primary outcome was mean change from baseline in office systolic blood pressure at 12-weeks, adjusted for baseline values. Secondary outcomes included measures of blood pressure change and variability, medication adherence, and health related quality of life. Safety outcomes included occurrence of serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. A process evaluation aimed to understand provider experiences of implementation and participant experiences around side effects, adherence, and trust with clinical care. DISCUSSION: QUARTET USA was designed to evaluate whether a novel approach to blood pressure control would lower office blood pressure more effectively, and with fewer side effects, compared with standard dose monotherapy. QUARTET USA was conducted within a network of federally qualified healthcare centers with the aim of generating information on the safety and efficacy of ultra-low-dose quadruple-combination therapy in diverse groups that experience a high burden of hypertension.