The design and rationale of a multicenter real-world trial: The Southeastern Collaboration to Improve Blood Pressure Control in the US Black Belt - Addressing the Triple Threat.

Lynn Andreae, Andrea L Cherrington, James Tillman, Orysya Soroka, Erica Richman, Ethel Johnson, Debra Clark, Joanna Bryan, Elizabeth Baquero, Monika M Safford, Muna Anabtawi, Alyssa Adams, James Hollenberg, Suzanne Oparil, Joshua Richman, James M Shikany, Jacqueline Halladay, Doyle M Cummings

Journal: Contemporary clinical trials 2023;129():107183

PMID: 37061162

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Abstract

BACKGROUND

Impoverished African Americans (AA) with hypertension face poor health outcomes.

PURPOSE

To conduct a cluster-randomized trial testing two interventions, alone and in combination, to improve blood pressure (BP) control in AA with persistently uncontrolled hypertension.

METHODS

We engaged primary care practices serving rural Alabama and North Carolina residents, and in each practice we recruited approximately 25 AA adults with persistently uncontrolled hypertension (mean systolic BP >140 mmHg over the year prior to enrollment plus enrollment day BP assessed by research assistants ≥140/90 mmHg). Practices were randomized to peer coaching (PC), practice facilitation (PF), both PC and PF (PC + PF), or enhanced usual care (EUC). Coaches met with participants from PC and PC + PF practices weekly for 8 weeks then monthly over one year, discussing lifestyle changes, medication adherence, home monitoring, and communication with the healthcare team. Facilitators met with PF and PC + PF practices monthly to implement ≥1 quality improvement intervention in each of four domains. Data were collected at 0, 6, and 12 months.

RESULTS

We recruited 69 practices and 1596 participants; 18 practices (408 participants) were randomized to EUC, 16 (384 participants) to PF, 19 (424 participants) to PC, and 16 (380 participants) to PC + PF. Participants had mean age 57 years, 61% were women, and 56% reported annual income <$20,000.

LIMITATIONS

The PF intervention acts at the practice level, possibly missing intervention effects in trial participants. Neither PC nor PF currently has established clinical reimbursement mechanisms.

CONCLUSIONS

This trial will fill evidence gaps regarding practice-level vs. patient-level interventions for rural impoverished AA with uncontrolled hypertension.

Address: Department of Medicine, Weill Cornell Medical College of Cornell University, 1300 York Ave, New York, NY 10065, United States. Electronic address: [email protected].; Department of Family Medicine, East Carolina University, E 5th St, Greenville, NC 27858, United States.; Department of Family Medicine, University of North Carolina at Chapel Hill, 590 Manning Dr., Chapel Hill, NC 27514, United States.; Department of Medicine, University of Alabama at Birmingham, 1720 University Blvd, Birmingham, AL 35294, United States.; Department of Medicine, Weill Cornell Medical College of Cornell University, 1300 York Ave, New York, NY 10065, United States.; Health & Wellness Education, 1121 N Washington St, Livingston, AL 35470, United States.; West Central Alabama Community Health Improvement League of Camden, PO Box 219 Camden, AL 36726-0219, United States.; Open Water Coaching and Consulting, Cape Carteret, 300 Taylor Notion Rd, Cape Carteret, NC 28584, United States.

DOI: 10.1016/j.cct.2023.107183

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MeSH Terms: Adult, Female, Humans, Male, Middle Aged, Black or African American, Blood Pressure, Hypertension, Life Style, Medication Adherence, Alabama, North Carolina, Poverty