Community Intervention to Reduce CardiovascuLar Disease in Chicago

NCT ID: NCT04755153

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-07
• Study Completion Date: 2028-03-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Practice Facilitation

Practice Facilitation to support implementation of the Kaiser Blood Pressure Control Bundle

Group Type: EXPERIMENTAL

Practice Facilitation

Intervention Type: OTHER

Tailored interventions provided by a trained Practice Facilitator

Non-Practice Facilitation

implementation of the Kaiser Blood Pressure Control Bundle without Practice Facilitation

Group Type: ACTIVE_COMPARATOR

Non-Practice Facilitation

Intervention Type: OTHER

Implementation support without using Practice Facilitation

Interventions

Practice Facilitation

Tailored interventions provided by a trained Practice Facilitator

Intervention Type: OTHER

Non-Practice Facilitation

Implementation support without using Practice Facilitation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Children less that 18 years of age

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

Pastors 4 PCOR

UNKNOWN

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Justin D. Smith

Adjunct Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pastors4PCOR

Chicago, Illinois, United States

Site Status: RECRUITING

Access Community Health Network

Chicago, Illinois, United States

Site Status: RECRUITING

Advocate Aurora Health

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Heinrich, MHA

Role: CONTACT

jennifer.heinrich@northwestern.edu

312-503-5477

Allison Carroll, PhD

Role: CONTACT

allison.carroll@northwestern.edu

312-503-1631

Facility Contacts

Paris Davis, PhD, MBA

Role: primary

drpdavis77@gmail.com

773-881-7710

Danielle Lazar, MS

Role: primary

Danielle.Lazar@achn.net

866-267-2353

Rasha Khatib, PhD

Role: primary

Rasha.alkhatib@aah.org

References

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.

Reference Type: DERIVED

PMID: 40325453 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00212622

Identifier Type: -

Identifier Source: org_study_id