Clinical trial NCT04755153: Community Intervention to Reduce CardiovascuLar Disease in Chicago
Official title: Community Intervention to Reduce CardiovascuLar Disease in Chicago
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Utah
name: Pastors 4 PCOR
First posted: 2021-02-15
Enrollment: 5760
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Blood pressure
timeFrame: 3-6 months per patient
Secondary outcomes:
measure: Feasibility of implementation
timeFrame: 2 years
measure: Acceptability of Intervention Measure
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Pastors4PCOR
state: Illinois
city: Chicago
country: United States
facility: Access Community Health Network
state: Illinois
city: Chicago
country: United States
facility: Advocate Aurora Health
state: Illinois
Study officials:
References: