Community Intervention to Reduce CardiovascuLar Disease in Chicago

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Other: Practice Facilitation; Other: Non-Practice Facilitation

• Registration Number: NCT04755153
• Lead Sponsor: Northwestern University

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-15
• Status Verified: 2025-01
• Study Start: 2025-01-07
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24
• Primary Completion: 2026-12-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5760

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Practice Facilitation	Practice Facilitation	Practice Facilitation to support implementation of the Kaiser Blood Pressure Control Bundle
Non-Practice Facilitation	Non-Practice Facilitation	implementation of the Kaiser Blood Pressure Control Bundle without Practice Facilitation

Primary Outcome Measures

Name	Time	Method
Blood pressure	3-6 months per patient	The investigators will examine change in systolic blood pressure measured via automatic and manual devices as a result of participating in the intervention

Secondary Outcome Measures

Name	Time	Method
Acceptability of Intervention Measure	2 years	The investigators will evaluate stakeholder perceptions of the acceptability of delivering the Kaiser BP Bundle after an iterative community-based adaptation process prior to and during the trial. This measure will use the validated Acceptability of Intervention Measure (AIM) (Weiner et al. 2017) which contains 3-items rated on a scale of 1-5 (range: 3-15) with higher scores indicating greater acceptability.
Feasibility of implementation	2 years	The investigators will evaluate stakeholder perceptions of the feasibility of the Kaiser BP Bundle and how it is being implemented after an iterative community-based adaptation process prior to and during the trial. This measure will use the validated Feasibility of Implementation (FIM) scale (Weiner et al. 2017) which contains 3-items rated on a scale of 1-5 (range: 3-15) with higher scores indicating greater feasibility.

Trial Locations

Locations (3)

Pastors4PCOR; 🇺🇸 Chicago, Illinois, United States

Access Community Health Network; 🇺🇸 Chicago, Illinois, United States

Advocate Aurora Health; 🇺🇸 Chicago, Illinois, United States