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Contemp Clin Trials. 2016 Mar;47:101-8. doi: 10.1016/j.cct.2015.12.020. Epub 2015 Dec 30.

Determining the effects and challenges of incorporating genetic testing into primary care management of hypertensive patients with African ancestry.

Author information

1
Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY 10029, USA; Center for Health Equity and Community Engaged Research, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY, 10029, USA; The Charles Bronfman Institute for Personalized Medicine, Icahn School of Medicine at Mount Sinai, 1468 Madison Avenue, Annenberg Building, 18th Floor, Room 18-16, New York, NY 10029, USA. Electronic address: carol.horowitz@mssm.edu.
2
The Charles Bronfman Institute for Personalized Medicine, Icahn School of Medicine at Mount Sinai, 1468 Madison Avenue, Annenberg Building, 18th Floor, Room 18-16, New York, NY 10029, USA; Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1022, New York, NY 10029, USA. Electronic address: noura.abul-husn@mssm.edu.
3
The Charles Bronfman Institute for Personalized Medicine, Icahn School of Medicine at Mount Sinai, 1468 Madison Avenue, Annenberg Building, 18th Floor, Room 18-16, New York, NY 10029, USA. Electronic address: steve.ellis@mountsinai.org.
4
Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY 10029, USA; Center for Health Equity and Community Engaged Research, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY, 10029, USA. Electronic address: michelle.ramos@mountsinai.org.
5
Yale Institute for Network Science, Yale University, 17 Hillhouse Avenue, P.O. Box 208263, New Haven, CT 06520, USA. Electronic address: rennie.negron@yale.edu.
6
Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY 10029, USA. Electronic address: maria.suprun@mountsinai.org.
7
Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1022, New York, NY 10029, USA. Electronic address: randi.zinberg@mssm.edu.
8
Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY 10029, USA. Electronic address: tatiana.sabin@mountsinai.org.
9
Institute for Family Health, 16 East 16th Street, New York, NY 10003, USA. Electronic address: dhauser@institute.org.
10
Center for Health Equity and Community Engaged Research, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY, 10029, USA; Institute for Family Health, 16 East 16th Street, New York, NY 10003, USA. Electronic address: ncalman@institute.org.
11
Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY 10029, USA. Electronic address: emilia.bagiella@mssm.edu.
12
The Charles Bronfman Institute for Personalized Medicine, Icahn School of Medicine at Mount Sinai, 1468 Madison Avenue, Annenberg Building, 18th Floor, Room 18-16, New York, NY 10029, USA; Berlin Institute of Health, Berlin, Germany. Electronic address: erwin.bottinger@mssm.edu.

Abstract

People of African ancestry (Blacks) have increased risk of kidney failure due to numerous socioeconomic, environmental, and clinical factors. Two variants in the APOL1 gene are now thought to account for much of the racial disparity associated with hypertensive kidney failure in Blacks. However, this knowledge has not been translated into clinical care to help improve patient outcomes and address disparities. GUARDD is a randomized trial to evaluate the effects and challenges of incorporating genetic risk information into primary care. Hypertensive, non-diabetic, adults with self-reported African ancestry, without kidney dysfunction, are recruited from diverse clinical settings and randomized to undergo APOL1 genetic testing at baseline (intervention) or at one year (waitlist control). Providers are educated about genomics and APOL1. Guided by a genetic counselor, trained staff return APOL1 results to patients and provide low-literacy educational materials. Real-time clinical decision support tools alert clinicians of their patients' APOL1 results and associated risk status at the point of care. Our academic-community-clinical partnership designed a study to generate information about the impact of genetic risk information on patient care (blood pressure and renal surveillance) and on patient and provider knowledge, attitudes, beliefs, and behaviors. GUARDD will help establish the effective implementation of APOL1 risk-informed management of hypertensive patients at high risk of CKD, and will provide a robust framework for future endeavors to implement genomic medicine in diverse clinical practices. It will also add to the important dialog about factors that contribute to and may help eliminate racial disparities in kidney disease.

KEYWORDS:

African ancestry; Chronic kidney disease; Community-based research; Disparities; Genetics; Race

PMID:
26747051
PMCID:
PMC4818169
[Available on 2017-03-01]
DOI:
10.1016/j.cct.2015.12.020
[Indexed for MEDLINE]
Free PMC Article

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