Community Intervention to Reduce CardiovascuLar Disease in Chicago (CIRCL-Chicago)

• ClinicalTrials.gov Identifier: NCT04755153
• Recruitment Status: Not yet recruiting
• First Posted: February 15, 2021
• Last Update Posted: October 13, 2021
• Sponsor: Northwestern University
• Collaborators: University of Utah; Pastors 4 PCOR
• Information provided by (Responsible Party): Justin D. Smith, Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Behavioral: Kaiser Bundle	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1250 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Community Intervention to Reduce CardiovascuLar Disease in Chicago
• Estimated Study Start Date: March 1, 2022
• Estimated Primary Completion Date: July 31, 2023
• Estimated Study Completion Date: June 30, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Kaiser Blood Pressure Control Bundle	Behavioral: Kaiser Bundle; 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.

Outcome Measures

Primary Outcome Measures :

1. Blood pressure [ Time Frame: 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 :

1. Feasibility of implementation [ Time Frame: 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.
2. Acceptability of Intervention Measure [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Justin D. Smith, Adjunct Associate Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT04755153
• Other Study ID Numbers: STU00212622
• First Posted: February 15, 2021
• Last Update Posted: October 13, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Available by request 1 year after completion of enrollment
• Time Frame: Available by request 1 year after completion of enrollment

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cardiovascular Diseases