Carolina Heart Alliance Networking for Greater Equity
Condition: Cardiovascular Disease (CVD)
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      In North Carolina, and nationally, cardiovascular disease (CVD) is the leading cause of death
      and disease among adults. North Carolina adults have high rates of CVD behavioral risk
      factors such as physical inactivity, unhealthy eating habits, smoking, and being overweight
      and obese. To help reduce these risks, researchers from the University of North Carolina at
      Chapel Hill Prevention Research Center (UNC PRC) will test the effectiveness and
      implementation of Carolina Heart Alliance Networking for Greater Equality (CHANGE).

      CHANGE is a health promotion strategy to link public health and clinical services through
      community health workers (CHWs). Primary care clinics, public health, and CHWs all have
      strengths in addressing chronic disease risk factors, but there is a widely recognized gap in
      the coordination among them. The CHANGE strategy will use CHWs as members of primary care and
      public health teams to distribute a behavioral change intervention called Heart-to-Health to
      a total of 480 clinic patients at risk for CVD. Heart-to-Health is an effective lifestyle and
      medication adherence intervention that includes a computerized decision aid to guide delivery
      of tailored counseling sessions. The counseling sessions are focused on diet, physical
      activity, tobacco cessation, and medication adherence and are facilitated by CHWs using
      tablet computers. The CHWs will use tablet computers to communicate with a medical home team
      about important patient health information to be acted on in real time. The CHWs also will
      link participants to public health and other community based resources to support behavior
      change. The CHANGE strategy will be tested in one underserved, rural community and then
      replicated in a second community.

      Researchers from the UNC PRC will examine whether CHANGE is effective at increasing the reach
      of clinic and public community services to at risk populations and at improving composite
      coronary heart disease risk.
    

Detailed description: 
      Cardiovascular disease (CVD) is the leading cause of mortality and morbidity among North
      Carolina (NC) and US adults, yet evidence-based CVD prevention interventions are often
      minimally implemented and poorly integrated across community and clinical settings. To
      address this gap, we will develop and test a multi-component strategy to help communities
      effectively implement evidence-based interventions (EBIs) to prevent CVD. We call our
      strategy the Carolina Heart Alliance Networking for Greater Equity (CHANGE) strategy. The
      CHANGE strategy will specifically address NC's large underserved, rural population, which is
      at increased risk for CVD due in part to behavioral risk factors, including physical
      inactivity, poor diet, and tobacco use.

      The CHANGE strategy is designed to improve the dissemination and implementation of CVD EBIs
      by strengthening clinical-community linkages. Clinics have strengths in identifying
      individuals at high risk for cardiovascular disease and prescribing medications and
      behavioral change to mitigate risk. However, clinics only reach those who seek care, and most
      clinics lack the capacity to deliver behavioral change EBIs. Public health has strengths in
      implementing behavioral and environmental change EBIs in the communities where people live.
      Therefore, the core focus of the CHANGE strategy is to create new structures to leverage the
      complementary strengths of clinics and public health departments, thereby expanding the reach
      and effectiveness of both clinic- and community-based EBIs. Because of their potential to
      reach underserved populations, community health workers (CHWs) are at the center of the
      CHANGE strategy. Working as part of a clinic/public health collaboration, CHWs will deliver a
      behavioral change EBI (Heart-to-Health). By linking and leveraging clinical and public health
      prevention activities, new opportunities for individuals and communities to reduce their risk
      for CVD will be created. CHWs will be equipped with tablet computers that provide decision
      support for delivering Heart-to-Health and facilitate linkages among clinics, public health,
      and community services. Linking services within complex systems is challenging, and many good
      ideas fall short at the level of implementation. Therefore, the study will apply an
      effectiveness-implementation hybrid design with a primary focus on the effective
      implementation of the CHANGE strategy and a secondary focus on its effectiveness at reducing
      CVD risk. With support and input from community stakeholders the investigators will refine
      the CHANGE strategy (Year 1), test it in one underserved, rural community (Years 2-3) and
      then replicate it in a second community (Years 4-5).

      Guided by key constructs from implementation science53 and the expanded Chronic Disease
      Model,54 the study's specific aims are as follows:

      Aim 1. Refine the CHANGE strategy through community-engaged formative research to:

      (a) identify existing CVD-related clinic and community services and barriers to their use,
      (b) engage stakeholders in designing the CHWs' roles and systems for integrating their work
      within clinical and public health practice, and (c) assess the tablet's usability for
      decision-support and data transfer.

      Aim 2. Assess the CHANGE strategy's implementation and effectiveness. Aim 2a. Use an
      explanatory sequential mixed-methods approach55 to assess the strategy's

      (1) Best processes for engaging partners and building capacity to plan and implement EBIs.
      (2) Effectiveness at increasing the reach of CVD-related public health EBIs.56 (3) Other
      Implementation outcomes (fidelity, cost, sustainability, acceptability, and feasibility).53

      Aim 2b. Use a pre-post comparison design to confirm the effectiveness of Heart-to-Health at
      improving composite coronary heart disease risk (primary outcome = Framingham Risk Score) and
      related risk factors: blood pressure, blood lipids, diet quality, physical activity, and
      tobacco use.

      Aim 2c. Use a matched control, pre-post comparison design to assess the overall CHANGE
      strategy's effects on the proportion of the clinic's total at-risk population that have
      cholesterol and blood pressure under control as compared to three matched comparison clinics.

      Aim 3. Plan for taking the CHANGE strategy to scale by replicating it in one additional
      community, identifying its core components,57, 58 creating and disseminating a replication
      toolkit, and promoting the strategy's adoption through NC's multiple clinical, public health,
      and research networks.

      The CHANGE Project seeks to recruit 380 adults who live or receive health care in Hertford
      County (Phase I) or Edgecombe/Nash Counties (Phase II) and are at risk of CVD. The
      investigators have completed enrollment in Herford County and are about to begin enrollment
      in Edgecombe/Nash. Through a series of 4 in-person and 3 phone sessions, 2 CHWs will meet
      with adults who are at risk of CVD to provide health information, support in setting
      behavioral goals and referrals to community resources. The CHWs' intervention activities are
      adapted from the evidence-based Heart-to-Health curriculum for individual behavior change.
      Outcomes will be measured using pre- post- data from all enrolled participants, including
      pre- post- CVD risk score (Framingham Risk Score (FRS) or the atherosclerotic cardiovascular
      disease (ASCVD)) data from a participant subgroup. Process outcomes will be assessed using a
      tracking tool designed specifically for this study to facilitate the CHWs' data collection,
      intervention delivery, and case management activities in the field. Interviews will be
      conducted with program participants within a month of the final study visit to better
      understand their experience with the CHANGE program.
    

Intervention name(s): CHANGE Study
Intervention type(s): Behavioral
Intervention description(s): The CHANGE strategy is designed to improve the dissemination and implementation of CVD EBIs by strengthening clinical-community linkages
Intervention model: Single Group Assignment
Intervention model description: The participants who are engaged with CHWs will be assessed in terms of weight and blood pressure compared to pre-intervention levels and will also complete pre and post dietary and physical activity questionnaires.
Masking: None (Open Label)
Primary purpose: Prevention