Community Intervention to Reduce CardiovascuLar Disease in Chicago

Last updated: January 23, 2025
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Vascular Diseases

Stress

Treatment

Kaiser Bundle

Non-Practice Facilitation

Practice Facilitation

Clinical Study ID

NCT04755153
STU00212622
  • Ages 18-89
  • All Genders

Study 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 2 effectiveness-implementation design based within one primary community area (South Side Chicago) and in two settings (church and clinic). The overall study outcome is the Public Health Impact metric (reach * effect size of the intervention). Aim 4: Disseminate findings internally to community stakeholders and externally through creation of community implementation toolkits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Community: patients w/in participating clinics (by clinic location in community) ORwithin participating churches (by location in community)

  • Age: adults (18-89 y/o)

Exclusion

Exclusion Criteria:

  • Children less that 18 years of age

Study Design

Total Participants: 5760
Treatment Group(s): 3
Primary Treatment: Kaiser Bundle
Phase:
Study Start date:
January 07, 2025
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • Access Community Health Network

    Chicago, Illinois 60653
    United States

    Active - Recruiting

  • Advocate Aurora Health

    Chicago, Illinois 60657
    United States

    Active - Recruiting

  • AllianceChicago

    Chicago, Illinois 60654
    United States

    Site Not Available

  • Pastors4PCOR

    Chicago, Illinois 60643
    United States

    Active - Recruiting

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