Community Intervention to Reduce CardiovascuLar Disease in Chicago
CIRCL-Chicago
1 other identifier
interventional
2,000
1 country
3
Brief Summary
Hypertension affects 1 in every 3 adults in the US and contributes to 410,000 deaths annually. Hypertension and its associated complications disproportionately affect minority populations living in urban areas. In Chicago, health status indicators show worsening disparities between black and white residents, with the highest rates of hypertension, heart disease, and stroke clustering in the predominantly black South and West Sides. Kaiser Permanente demonstrated that a bundle of evidence-based interventions implemented within a large, integrated health system in Northern California significantly increased blood pressure control rates. However, it is unclear whether a health system centered intervention can be adapted to other settings, particularly under-resourced urban communities. Therefore, the overall goal is to support a community-centered design and adaptation of the Kaiser bundle. The investigative team will adapt the delivery model of the Kaiser bundle to be centered within churches within the South Side of Chicago, one of the most medically underserved communities in the United States. The proposed interventions are the same as in the Kaiser bundle (e.g., registry/audit and feedback, simplified treatment regimens, accurate Blood Pressure measurement) but implementation of the components of the bundle will be adapted for delivery in the community. The intervention will be carried out by local community health workers and ministry facilitators, with health clinics and hospitals in the community as support, all connected through a common data platform. Thus, the proposed project will identify the best strategies to support adoption, implementation with fidelity, and sustainability of the Kaiser bundle in the community setting. The proposed study will follow the Exploration, Preparation, Implementation and Sustainment (EPIS) process model and implementation is rigorously evaluated using a multimethod approach to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) evaluation framework. The specific aims are: Aim 1: Convene community stakeholders in order to adapt implementation strategies using the Dynamic Adaptation Process model. Aim 2: Design, implement, and evaluate pilot projects in order to optimize implementation strategies within the target community. Aim 3: Implement, test and evaluate an adapted implementation strategy to control hypertension through faith-based organizations in the South Side of Chicago. The study uses a hybrid Type 3 effectiveness-implementation design based within one primary community area (South Side Chicago) and in two settings (church and clinic). The overall study outcomes reach (implementation) and blood pressure (clinical effectiveness). Aim 4: Disseminate findings internally to community stakeholders and externally through creation of community implementation toolkits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Jan 2025
Typical duration for not_applicable hypertension
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedStudy Start
First participant enrolled
January 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
September 5, 2025
August 1, 2025
2.8 years
February 3, 2021
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Blood pressure
The investigators will examine change in systolic blood pressure measured via automatic and manual devices as a result of participating in the intervention
3-6 months per patient
Secondary Outcomes (2)
Feasibility of implementation
2 years
Acceptability of Intervention Measure
2 years
Study Arms (2)
Practice Facilitation
EXPERIMENTALPractice Facilitation to support implementation of the Kaiser Blood Pressure Control Bundle
Non-Practice Facilitation
ACTIVE COMPARATORimplementation of the Kaiser Blood Pressure Control Bundle without Practice Facilitation
Interventions
Tailored interventions provided by a trained Practice Facilitator
Implementation support without using Practice Facilitation
Eligibility Criteria
You may qualify if:
- Community: patients w/in participating clinics (by clinic location in community) OR within participating churches (by location in community)
- Age: adults (18-89 y/o)
You may not qualify if:
- Children less that 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- University of Utahcollaborator
- Pastors 4 PCORcollaborator
Study Sites (3)
Pastors4PCOR
Chicago, Illinois, 60643, United States
Access Community Health Network
Chicago, Illinois, 60653, United States
Advocate Aurora Health
Chicago, Illinois, 60657, United States
Related Publications (1)
Smith JD, Carroll AJ, Tedla YG, Sanuade OA, Merle JL, Heinrich J, Bannon J, Abramsohn EM, Ahmad FS, Lazar D, Lindau ST, McHugh MC, Khatib R, Donovan R, Pinkerton EA, Rosul LL, Walunas TL, Watson R, Ganbote T, Kandula N, Youmans QR, Davis P, Kho AN. 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. Implement Sci. 2025 May 5;20(1):19. doi: 10.1186/s13012-025-01431-w.
PMID: 40325453DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Associate Professor
Study Record Dates
First Submitted
February 3, 2021
First Posted
February 15, 2021
Study Start
January 7, 2025
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
September 5, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Available by request 1 year after completion of enrollment
Available by request 1 year after completion of enrollment