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

1
Department of Clinical Research Center, Morehouse School of Medicine, 720 Westview Drive, SW, Atlanta, GA 30310, USA
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Department of Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine, 2400 Pratt St., Durham, NC 27705, USA
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Association of Black Cardiologists,2400 N Street, Suite 200, Washington, DC 20037, USA
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Department of Academic Affairs and Research, The Queen’s Medical Center, 1301 Punchbowl Street, Honolulu, HI 96813, USA
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Department of Medicine, Meharry Medical College,1818 Albion St, Nashville, TN 37208, USA
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RCMI Data Coordinating Center, Jackson State University, 1400 John R. Lynch Street, Jackson, MS 39217, USA
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Department of Biostatistics, College of Pharmacy, Xavier University of Louisiana, 1 Drexel Drive, New Orleans, LA 70125, USA
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Department of Pharmacology and Toxicology, University of Puerto Rico Medical Sciences Campus, P.O. Box 365067, San Juan, PR 00936, Puerto Rico
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Department of Bioethics, Tuskegee University, 1200 W. Montgomery Rd., Tuskegee, AL 36088, USA
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Department of Medicine, College of Medicine of the University of Lagos, Private Mail Bag 12003, Idi Araba, Lagos, Nigeria
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Department of Pediatrics and Computational Health Informatics, Harvard Medical School, 300 Longwood Avenue, Boston, MA 02115, USA
*
Author to whom correspondence should be addressed.
Int. J. Environ. Res. Public Health 2019, 16(9), 1631; https://doi.org/10.3390/ijerph16091631
Received: 16 December 2018 / Revised: 14 February 2019 / Accepted: 28 February 2019 / Published: 10 May 2019
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. View Full-Text
Keywords: cardiovascular disease; registry; informatics; mobile health technology; quality care; clinical trials; post marketing surveillance cardiovascular disease; registry; informatics; mobile health technology; quality care; clinical trials; post marketing surveillance
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Ofili, E.O.; Schanberg, L.E.; Hutchinson, B.; Sogade, F.; Fergus, I.; Duncan, P.; Hargrove, J.; Artis, A.; Onyekwere, O.; Batchelor, W.; Williams, M.; Oduwole, A.; Onwuanyi, A.; Ojutalayo, F.; Cross, J.A.; Seto, T.B.; Okafor, H.; Pemu, P.; Immergluck, L.; Foreman, M.; Mensah, E.A.; Quarshie, A.; Mubasher, M.; Baker, A.; Ngare, A.; Dent, A.; Malouhi, M.; Tchounwou, P.; Lee, J.; Hayes, T.; Abdelrahim, M.; Sarpong, D.; Fernandez-Repollet, E.; Sodeke, S.O.; Hernandez, A.; Thomas, K.; Dennos, A.; Smith, D.; Gbadebo, D.; AJULUCHUKWU, J.; Kong, B.W.; McCollough, C.; Weiler, S.R.; Natter, M.D.; Mandl, K.D.; Murphy, S. The Association of Black Cardiologists (ABC) Cardiovascular Implementation Study (CVIS): A Research Registry Integrating Social Determinants to Support Care for Underserved Patients. Int. J. Environ. Res. Public Health 2019, 16, 1631.

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