Community Intervention to Reduce CardiovascuLar Disease in Chicago

Conditions

• Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jan 7, 2025

Status verified

Aug 2025

Primary completion

Oct 31, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

2,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

Primary Outcome Measure

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

Central Contacts

• Jennifer Heinrich, MHA
  312-503-5477
  [email protected]
• Allison Carroll, PhD
  312-503-1631
  [email protected]

Locations (3)

Find similar trials in Chicago, IL

Related Studies

• A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
  PHASE3 · Enrolling By Invitation · United Therapeutics · Phoenix, Arizona
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Duke University · Phoenix, Arizona
• Church-based Intervention to Improve Blood Pressure in African Americans
  Recruiting · Rush University Medical Center · Chicago, Illinois
• Examining Digital Health Care Delivery Models Through Medicaid Collaborative
  Recruiting · OSF Healthcare System · Peoria, Illinois