Community Intervention to Reduce CardiovascuLar Disease in Chicago

Hypertension Clinical Trial

— CIRCL-Chicago  

Official title:

Community Intervention to Reduce CardiovascuLar Disease in Chicago

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04755153
• Other study ID #: STU00212622
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Jennifer Heinrich, MHA
• Phone: 312-503-5477
• Email: jennifer.heinrich[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5760
• Est. completion date: August 31, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

Other:
• Practice Facilitation
Tailored interventions provided by a trained Practice Facilitator
• Non-Practice Facilitation
Implementation support without using Practice Facilitation

Locations

Country	Name	City	State
United States	Access Community Health Network	Chicago	Illinois
United States	Advocate Aurora Health	Chicago	Illinois
United States	Pastors4PCOR	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Pastors 4 PCOR, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of implementation	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.	2 years
Secondary	Acceptability of Intervention Measure	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.	2 years