J. Pers. Med. 2014, 4(1), 1-19; doi:10.3390/jpm4010001
Article

Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease

1,2,* email, 3,4email, 1,2email, 3email, 1,2email, 1email, 3,5email, 3,6email, 3email, 3email, 7email, 8email, 9email, 1,9email, 10email, 3email and 2email
Received: 8 December 2013; in revised form: 19 December 2013 / Accepted: 20 December 2013 / Published: 8 January 2014
(This article belongs to the Special Issue Bringing Personalized Medicine into Clinical Practice)
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract: We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF) or hypertension (HTN), managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC). Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®). OSUWMC patient participants with chronic disease (CD) receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling—active arm, versus web-based only return of results—control arm. Study-specific surveys measure: (1) change in risk perception; (2) knowledge retention; (3) perceived personal control; (4) health behavior change; and, for the active arm (5), overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx) through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices.
Keywords: implementation; genomics; medicine; randomized; patients; counseling; actionable; risk perception; pharmacogenomics
PDF Full-text Download PDF Full-Text [1855 KB, uploaded 8 January 2014 09:01 CET]

Export to BibTeX |
EndNote


MDPI and ACS Style

Sweet, K.; Gordon, E.S.; Sturm, A.C.; Schmidlen, T.J.; Manickam, K.; Toland, A.E.; Keller, M.A.; Stack, C.B.; García-España, J.F.; Bellafante, M.; Tayal, N.; Embi, P.; Binkley, P.; Hershberger, R.E.; Sadee, W.; Christman, M.; Marsh, C. Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease. J. Pers. Med. 2014, 4, 1-19.

AMA Style

Sweet K, Gordon ES, Sturm AC, Schmidlen TJ, Manickam K, Toland AE, Keller MA, Stack CB, García-España JF, Bellafante M, Tayal N, Embi P, Binkley P, Hershberger RE, Sadee W, Christman M, Marsh C. Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease. Journal of Personalized Medicine. 2014; 4(1):1-19.

Chicago/Turabian Style

Sweet, Kevin; Gordon, Erynn S.; Sturm, Amy C.; Schmidlen, Tara J.; Manickam, Kandamurugu; Toland, Amanda E.; Keller, Margaret A.; Stack, Catharine B.; García-España, J. Felipe; Bellafante, Mark; Tayal, Neeraj; Embi, Peter; Binkley, Philip; Hershberger, Ray E.; Sadee, Wolfgang; Christman, Michael; Marsh, Clay. 2014. "Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease." J. Pers. Med. 4, no. 1: 1-19.

J. Pers. Med. EISSN 2075-4426 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert