The Tulane DECIPHeR Alliance study,
Community Health Worker-Led Church-Based Intervention for Eliminating Cardiovascular Health Disparities in African Americans, is led by Dr. Jiang He and Dr. Keith Ferdinand. The Tulane DECIPHeR study will focus on atherosclerotic cardiovascular disease (ASCVD) in New Orleans and Bogalusa, Louisiana. Louisiana residents, especially African Americans, bear a disproportionately high burden of atherosclerotic cardiovascular disease (ASCVD).
The Tulane DECIPHeR Alliance is creating the CHERISH (Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health) trial based on the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease that will be delivered in 42 black churches in New Orleans and Bogalusa, Louisiana.
The Tulane DECIPHeR Team is using the Exploration, Preparation, Implementation, Sustainment (EPIS) implementation framework. They are engaging variety of stakeholders including faith-based organizations, community-based organizations, governmental agencies, and community health workers. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE- AIM) evaluation framework will be used guided the development and evaluation of the multifaceted implementation strategy, which includes CHW-led health coaching on lifestyle changes and medication adherence; church-based exercise and weight loss programs; self-monitoring of physical activity, blood pressure (BP), and glucose; and provider education and engagement.
The Tulane DECIPHeR specific aims are:
Aim 1 (UG3 phase): Establish a community advisory board (CAB) including representative community members, church leaders, local public health agencies, CHWs, and healthcare providers and work with them to ensure the multifaceted implementation strategy is responsive to the needs of local African American communities and is culturally and socioeconomically tailored;
Aim 2 (UG3 phase): Develop partnerships with local churches, healthcare systems, public health agencies, and CHWs for continuous feedback on planning, conduct, dissemination, and scale-up of the proposed research;
Aim 3 (UG3 phase): Select 42 churches that primarily serve African American communities in New Orleans and Bogalusa, LA and are willing to be research partners;
Aim 4 (UG3 phase): Conduct a health needs assessment among church leaders, church members, other community members, CHWs, and providers on views about CHMs, healthcare access, and readiness for change;
Aim 5 (UG3 phase): Develop an implementation and sustainability plan that addresses RE-AIM elements, and develop and pilot test the study protocol, manual of procedures (MOP), and study forms;
Aim 6 (UG3 phase): Obtain approval of the study protocol from the NIH, Data and Safety Monitoring Board (DSMB), and IRB; and
Aim 7 (UG3 phase): Adapt implementation strategies to meet participants' needs and the context of each church, and recruit and train CHWs from local churches.
Aim 1 (UH3 phase): Recruit 1,050 African American participants (25 per church) aged ≥40 years who have <4 ideal CHMs from 42 churches and randomly assign 21 churches to the multifaceted intervention and 21 churches to the enhanced usual care stratified by New Orleans vs. Bogalusa;
Aim 2 (UH3 phase):.Implement the multifaceted intervention program in the intervention group and provide CVH education materials and health promotion sessions to the control group;
Aim 3 (UH3 phase): Keep a high retention and follow-up rate among all study participants;
Aim 4 (UH3 phase): Collect data on study outcomes (i.e., clinical outcome CHMs, implementation process measures, and costs) at baseline and follow-up visits at 6, 12, and 18 months from all participants;
Aim 5 (UH3 phase): Conduct a post-intervention 6-month follow-up study to evaluate the sustainability of the multifaceted implementation strategy from both participant and organizational perspectives;
Aim 6 (UH3 phase): Perform intention-to-treat analyses on the primary study outcomes and cost-effectiveness analysis; and
Aim 7 (UH3 phase): Comprehensively, effectively, and timely disseminate the study findings to influence public health policy and practice and plan to scale up the proven-effective implementation strategy in community settings in Louisiana and beyond.
Principal Investigator:
Jiang He, MD, PhD
Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, and Tulane University Translational Science Institute, New Orleans, LA, USA
Co-Principal Investigator:
Keith C. Ferdinand, MD, FACC, FAHA, FASPC, FNLA
Tulane University School of Medicine, New Orleans, LA, USA
Grant number: UG3 HL151309