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

Authors

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

Publication Date

6-1-2023

Journal

Contemporary Clinical Trials

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.

Keywords

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

Comments

Supplementary Materials

PMID: 37061162