Community intervention to reduce cardiovascular disease in Chicago (CIRCL-Chicago): protocol for a type 3 hybrid effectiveness-implementation study using a parallel cluster-randomized trial design

Justin Dean Smith*, Allison Jane Carroll, Yacob Ghirmatsion Tedla, Olutobi A. Sanuade, James L. Merle, Jennifer Heinrich, Jenn Bannon, Emily M. Abramsohn, Faraz Ahmad, Danielle Lazar, Stacy Tessler Lindau, Megan Colleen McHugh, Rasha Khatib, Ramona Donovan, Elizabeth A. Pinkerton, Linda L. Rosul, Theresa L. Walunas, Ricky Watson, Tejashri Ganbote, Namratha KandulaQuentin R. Youmans, Paris Davis, Abel N. Kho

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Hypertension affects nearly half of adults in the U.S., with African American and Black (AA/B) adults experiencing some of the highest rates domestically and globally. Despite improvements in blood pressure control in the general population, rates of control among AA/B adults have stagnated, contributing to significant health disparities in the prevalence of hypertension and its long-term health impacts. Systemic barriers, including poverty and historically earned distrust in healthcare, hinder patient and clinician adherence to best practices for hypertension management. Community-based interventions, particularly those involving faith-based organizations, show promise in improving blood pressure control among AA/B adults. Methods: The CIRCL-Chicago Implementation Research Center will test the effectiveness of a community-adapted hypertension control program, a “bundled” intervention developed by and tested in the Kaiser Permanente system, in South Side Chicago community health centers. A key partner for this trial, the Total Resource Community Development Organization, isa faith-based community outreach hub networked with faith-based organizations throughout Chicago’s South Side community. The study employs a type 3 hybrid effectiveness-implementation approach with a parallel cluster-randomized trial. Sixteen clinics will be randomized to implement a community-adapted Kaiser bundle with or without practice facilitation. We will recruit adults who live, work, or practice their faith in Chicago’s South Side community to populate a community-based hypertension registry (target n = 5,760 participants). The primary implementation outcome is the reach of the intervention, measured by the proportion of eligible patients in the registry who receive the adapted Kaiser bundle. Secondary outcomes include blood pressure control rates, assessed at 12 months post-enrollment. The study will use community-engaged adaptation, practice facilitation, and education and training strategies to support implementation. Discussion: The CIRCL-Chicago study aims to address cardiovascular health disparities by integrating clinical and community-based approaches to hypertension management. By leveraging trusted community settings and engaging local partners, the study seeks to enhance the reach and effectiveness of evidence-based hypertension interventions. The findings could inform scalable models for hypertension control in diverse urban communities, potentially reducing health disparities for AA/B adults. Trial registration: Clinicaltrials.gov NCT04755153 on 24 August 2023, https://www.centerwatch.com/clinical-trials/listings/NCT04755153/community-intervention-to-reduce-cardiovascular-disease-in-chicago

Original languageEnglish (US)
Article number19
JournalImplementation Science
Volume20
Issue number1
DOIs
StatePublished - Dec 2025

Funding

J.D. Smith is an Associate Editor of Implementatiosn Science. A.N. Kho discloses that he was founder and co-owner of HealthDataLink LLC, a company acquired in 2019 by Datavant, where he is currently an advisor and stockholder. S.T. Lindau discloses that she is founder and co-owner of NowPow LLC, a company acquired in 2021 by Unite Us LLC, where she is currently an advisor and stockholder. She is president of MAPSCorps, a 501c3 nonprofit organization, and serves on other nonprofit boards. Neither the University of Chicago nor the University of Chicago Medicine endorses or promotes any NowPow, Unite Us or MAPSCorps product or service. S.T. Lindau holds debt in Glenbervie Health LLC and owns health care\u2012related investments managed by third parties. S.T. Lindau is a contributor to UpToDate, Inc. The University of Chicago receives royalties from UpToDate, Inc. T.L. Walunas receives research funding from Gilead Sciences for work related to COVID in immunosuppressed populations. Q. R. Youmans has served on an advisory board for American Regent. This research was supported by grants UG3HL154297 and UH3HL154297 from the National Heart, Lung, and Blood Institute to A.N. Kho, J.D. Smith, and P. Davis. Additional support was provided by the Utah Clinical and Translational Science Institute (UM1TR004409) and Patient Centered Outcomes Research Institute Eugene Washington Award to Paris Davis. J.L. Merle was supported as a postdoctoral fellow by the National Library of Medicine T15 Training Program at the University of Utah (T15LM007124). A.J. Carroll was supported by National Heart, Lung, and Blood Institute grant K23HL168234. F.S. Ahmad was supported by National Heart, Lung, and Blood Institute grant K23HL155970 and American Heart Association grant 856917. O.A. Sanuade was supported by a University of Utah Vice President for Research Supplement to Promote a Diverse Research Community awarded to J.D. Smith. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, the National Library of Medicine, or the Patient Centered Outcomes Research Institute. As this study is funded under a cooperative agreement, scientists at the National Institutes of Health were involved in the design of the study; their role is described in detail in Smith et a., 2024, Ethn Dis. https://doi.org/10.1111/EthnDis-2023-26 .

ASJC Scopus subject areas

  • Health Policy
  • Health Informatics
  • Public Health, Environmental and Occupational Health

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