The Association of Black Cardiologists (ABC) Cardiovascular Implementation Study (CVIS): A Research Registry Integrating Social Determinants to Support Care for Underserved Patients

Elizabeth O. Ofili, Laura E. Schanberg, Barbara Hutchinson, Felix Sogade, Icilma Fergus, Phillip Duncan, Joe Hargrove, Andre Artis, Osita Onyekwere, Wayne Batchelor, Marcus Williams, Adefisayo Oduwole, Anekwe Onwuanyi, Folake Ojutalayo, Jo Ann Cross, Todd B. Seto, Henry Okafor, Priscilla Pemu, Lilly Immergluck, Marilyn Foreman, Ernest Alema Mensah, Alexander Quarshie, Mohamed Mubasher, Almelida Baker, Alnida Ngare, Andrew Dent, Mohamad Malouhi, Paul Tchounwou, Jae Lee, Traci Hayes, Muna Abdelrahim, Daniel Sarpong, Emma Fernandez-Repollet, Stephen O. Sodeke, Adrian Hernandez, Kevin Thomas, Anne Dennos, David Smith, David Gbadebo, Janet Ajuluchukwu, B. Waine Kong, Cassandra McCollough, Sarah R. Weiler, Marc D. Natter, Kenneth D. Mandl and Shawn Murphy
Additional contact information
Elizabeth O. Ofili: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Laura E. Schanberg: Department of Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine, 2400 Pratt St., Durham, NC 27705, USA
Barbara Hutchinson: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Felix Sogade: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Icilma Fergus: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Phillip Duncan: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Joe Hargrove: Department of Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine, 2400 Pratt St., Durham, NC 27705, USA
Andre Artis: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Osita Onyekwere: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Wayne Batchelor: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Marcus Williams: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Adefisayo Oduwole: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Anekwe Onwuanyi: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Folake Ojutalayo: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Jo Ann Cross: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Todd B. Seto: Department of Academic Affairs and Research, The Queen’s Medical Center, 1301 Punchbowl Street, Honolulu, HI 96813, USA
Henry Okafor: Department of Medicine, Meharry Medical College,1818 Albion St, Nashville, TN 37208, USA
Priscilla Pemu: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Lilly Immergluck: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Marilyn Foreman: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Ernest Alema Mensah: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Alexander Quarshie: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Mohamed Mubasher: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Almelida Baker: Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
Alnida Ngare: RCMI Data Coordinating Center, Jackson State University, 1400 John R. Lynch Street, Jackson, MS 39217, USA
Andrew Dent: RCMI Data Coordinating Center, Jackson State University, 1400 John R. Lynch Street, Jackson, MS 39217, USA
Mohamad Malouhi: RCMI Data Coordinating Center, Jackson State University, 1400 John R. Lynch Street, Jackson, MS 39217, USA
Paul Tchounwou: RCMI Data Coordinating Center, Jackson State University, 1400 John R. Lynch Street, Jackson, MS 39217, USA
Jae Lee: RCMI Data Coordinating Center, Jackson State University, 1400 John R. Lynch Street, Jackson, MS 39217, USA
Traci Hayes: RCMI Data Coordinating Center, Jackson State University, 1400 John R. Lynch Street, Jackson, MS 39217, USA
Muna Abdelrahim: RCMI Data Coordinating Center, Jackson State University, 1400 John R. Lynch Street, Jackson, MS 39217, USA
Daniel Sarpong: Department of Biostatistics, College of Pharmacy, Xavier University of Louisiana, 1 Drexel Drive, New Orleans, LA 70125, USA
Emma Fernandez-Repollet: Department of Pharmacology and Toxicology, University of Puerto Rico Medical Sciences Campus, P.O. Box 365067, San Juan, PR 00936, Puerto Rico
Stephen O. Sodeke: Department of Bioethics, Tuskegee University, 1200 W. Montgomery Rd., Tuskegee, AL 36088, USA
Adrian Hernandez: Department of Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine, 2400 Pratt St., Durham, NC 27705, USA
Kevin Thomas: Department of Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine, 2400 Pratt St., Durham, NC 27705, USA
Anne Dennos: Department of Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine, 2400 Pratt St., Durham, NC 27705, USA
David Smith: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
David Gbadebo: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Janet Ajuluchukwu: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
B. Waine Kong: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Cassandra McCollough: Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
Sarah R. Weiler: Department of Pediatrics and Computational Health Informatics, Harvard Medical School, 300 Longwood Avenue, Boston, MA 02115, USA
Marc D. Natter: Department of Pediatrics and Computational Health Informatics, Harvard Medical School, 300 Longwood Avenue, Boston, MA 02115, USA
Kenneth D. Mandl: Department of Pediatrics and Computational Health Informatics, Harvard Medical School, 300 Longwood Avenue, Boston, MA 02115, USA
Shawn Murphy: Department of Pediatrics and Computational Health Informatics, Harvard Medical School, 300 Longwood Avenue, Boston, MA 02115, USA

IJERPH, 2019, vol. 16, issue 9, 1-16

Abstract: African Americans, other minorities and underserved populations are consistently under- represented in clinical trials. Such underrepresentation results in a gap in the evidence base, and health disparities. The ABC Cardiovascular Implementation Study (CVIS) is a comprehensive prospective cohort registry that integrates social determinants of health. ABC CVIS uses real world clinical practice data to address critical gaps in care by facilitating robust participation of African Americans and other minorities in clinical trials. ABC CVIS will include diverse patients from collaborating ABC member private practices, as well as patients from academic health centers and Federally Qualified Health Centers (FQHCs). This paper describes the rationale and design of the ABC CVIS Registry. The registry will: (1) prospectively collect socio-demographic, clinical and biospecimen data from enrolled adults, adolescents and children with prioritized cardiovascular diseases; (2) Evaluate the safety and clinical outcomes of new therapeutic agents, including post marketing surveillance and pharmacovigilance; (3) Support National Institutes of Health (NIH) and industry sponsored research; (4) Support Quality Measures standards from the Center for Medicare and Medicaid Services (CMS) and Commercial Health Plans. The registry will utilize novel data and technology tools to facilitate mobile health technology application programming interface (API) to health system or practice electronic health records (EHR). Long term, CVIS will become the most comprehensive patient registry for underserved diverse patients with cardiovascular disease (CVD) and co morbid conditions, providing real world data to address health disparities. At least 10,000 patients will be enrolled from 50 sites across the United States.

Keywords: cardiovascular disease; registry; informatics; mobile health technology; quality care; clinical trials; post marketing surveillance (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2019
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