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.
These results demonstrate the impact of a pharmacist-driven renal medication dosing intervention within a PCMH on medication use and safety for patients with CKD.
BACKGROUND
Preventative health services, including herpes zoster vaccination rates, remain low despite known benefits. A new care model to improve preventative health services is warranted. The objective of this study is to investigate whether the functions of an electronic medical record, in combination with a pharmacist as part of the care team, can improve the herpes zoster vaccination rate.
METHODS
This study was a 6-month, randomized controlled trial at a General Internal Medicine clinic at The Ohio State University. The 2589 patients aged 60 years and older without documented herpes zoster vaccination in the electronic medical record were stratified on the basis of activated personal health record status, an online tool used to share health information between patient and provider. Of the 674 personal health record users, 250 were randomized to receive information regarding the herpes zoster vaccination via an electronic message and 424 were randomized to standard of care. Likewise, of the 1915 nonpersonal health record users, 250 were randomized to receive the same information via the US Postal Service and 1665 were randomized to standard of care. After pharmacist chart review, eligible patients were mailed a herpes zoster vaccine prescription. Herpes zoster vaccination rates were compared by chi-square tests.
RESULTS
Intervention recipients had significantly higher vaccination rates than controls in both personal health record (relative risk, 2.7; P = .0007) and nonpersonal health record (relative risk, 2.9; P = .0001) patient populations.
CONCLUSIONS
Communication outside of face-to-face office visits, by both personal health record electronic message and information by mail, can improve preventative health intervention rates compared with standard care.
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