1. 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.
- Author
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Safford MM, Cummings DM, Halladay J, Shikany JM, Richman J, Oparil S, Hollenberg J, Adams A, Anabtawi M, Andreae L, Baquero E, Bryan J, Clark D, Johnson E, Richman E, Soroka O, Tillman J, and Cherrington AL
- Subjects
- Adult, Female, Humans, Male, Middle Aged, Blood Pressure, Life Style, Medication Adherence, Alabama epidemiology, North Carolina epidemiology, Poverty, Black or African American, Hypertension complications, Hypertension drug therapy, Hypertension epidemiology, Hypertension ethnology
- 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., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Alyssa Adams - None. Muna Anabtawi, DDS – None. Lynn Andreae, PhD – None. Elizabeth Baquero, EDD – chair of education advisory board of MedExplain, Inc., a company commercializing a patient education platform based on the Patient Activated Learning System (palsforhealth.com). Joanna Bryan, MS – None. Andrea Cherrington, MD, MPH – None. Debra Clark, MPH – None. Doyle Cummings, PharmD – None. Jacqueline Halladay, MD, MPH - None. James Hollenberg, MD – None. Ethel Johnson – None. Suzanne Oparil – research funding from CinCor Pharma Inc. (site PI for a primary aldosterone study), George Clinical Pty (site PI for GMRx2 treatment of hypertension), and Higi (site PI for a blood pressure validation study); advisory roles for CinCor Pharma Inc. (Scientific Advisory Board for primary aldosteronism and hypertension) and Preventric Diagnostics, LLC (Chair of the Medical and Technology Committee, 2019–2022); and Editor-in-Chief of Current Hypertension Reports (Springer Science Business Media LLC) until 12/2023. Erica Richman, PhD - None. Joshua Richman, PhD, MD – None. Monika Safford, MD – owner of MedExplain, Inc., a company commercializing a patient education platform based on the Patient Activated Learning System (palsforhealth.com). James Shikany, Dr.P·H - None. Orysya Soroka, PhD – None. James Tillman – None., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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