Cardiovascular Disease (CVD) Clinical Trial
Official title:
Carolina Heart Alliance Networking for Greater Equity (CHANGE)
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.
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.
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