Practice Facilitation
OtherTailored interventions provided by a trained Practice Facilitator
NCT Number: NCT04755153
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.
Interested in participating?
Request Info18 year–89 year
All sexes
Interventional
Not applicable
Access Community Health Network, Chicago, Illinois, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tailored interventions provided by a trained Practice Facilitator
Implementation support without using Practice Facilitation
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
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.
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.
Contact information is provided by the study sponsor or research team.
Allison Carroll, PhD
CONTACT
Jennifer Heinrich, MHA
CONTACT
Northwestern University
Other
Acronym: CIRCL-Chicago
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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