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
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 mm Hg over the year prior to enrollment plus enrollment day BP assessed by research assistants ≥140/90 mm Hg). 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,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,596 participants or records.
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