Recruiting

Cardiovascular Disease

Sponsor:

Northwestern University

Code:

NCT04755153

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Practice Facilitation

Non-Practice Facilitation

Study Details

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 ID

NCT04755153

Start date

Jan 7, 2025

Status verified date

Aug, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Practice Facilitation

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

active comparator: Non-Practice Facilitation

implementation of the Kaiser Blood Pressure Control Bundle without Practice Facilitation

Interventions

Practice Facilitation

Tailored interventions provided by a trained Practice Facilitator

Non-Practice Facilitation

Implementation support without using Practice Facilitation

Primary outcome measure

  • Blood pressure [ Time Frame: 3-6 months per patient ]

Central Contacts and Locations

Locations

Pastors4PCOR

Recruiting

Chicago, Illinois, United States, 60643

Contacts

Access Community Health Network

Recruiting

Chicago, Illinois, United States, 60653

Contacts

Advocate Aurora Health

Recruiting

Chicago, Illinois, United States, 60657

Contacts

Rasha Khatib, PhD

Rasha.alkhatib@aah.org

More Information

Sponsor

Northwestern University

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2025-09-05.