Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial

PLoS One. 2017 Feb 2;12(2):e0170905. doi: 10.1371/journal.pone.0170905. eCollection 2017.

Abstract

Background: In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST) on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED) visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients.

Methods and findings: This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110) were randomized to pharmacogenetic profiling (n = 57). The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53) received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR), 0.65; 95% confidence interval (CI), 0.32-1.28; P = 0.21) and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27-0.82; P = 0.007). The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31-1.21; P = 0.16) and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34-0.99; P = 0.045). Differences in composite outcomes at 60 days (exploratory endpoints) were also found. Of the total 124 drug therapy recommendations passed on to clinicians, 96 (77%) were followed. These findings should be verified with additional prospective confirmatory studies involving real-world applications in larger populations to broaden acceptance in routine clinical practice.

Conclusions: Pharmacogenetic testing of polypharmacy patients aged 50 and older, supported by an appropriate CDST, considerably reduced re-hospitalizations and ED visits at 60 days following enrollment resulting in potential health resource utilization savings and improved healthcare.

Trial registration: ClinicalTrials.gov NCT02378220.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Decision Support Systems, Clinical*
  • Drug-Related Side Effects and Adverse Reactions / genetics
  • Drug-Related Side Effects and Adverse Reactions / prevention & control
  • Female
  • Gene Expression Profiling
  • Home Care Agencies
  • Home Care Services*
  • Hospitalization
  • Humans
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care
  • Pharmacogenomic Variants*
  • Polypharmacy*
  • Prospective Studies

Associated data

  • ClinicalTrials.gov/NCT02378220

Grant support

The study was supported by a small non conditional research grant from Genelex Corporation (http://genelex.com/) in the form of compensation for time to author LSE. Genelex Corporation provided in-kind services consisting of buccal swab collection materials, shipping, genotyping all patient DNA and providing the YouScript® report. The Genelex Corporation and Mountain-Whisper-Light Statistics provided support in the form of salaries for authors [NAM, KCA, RKT and MBN] and played a role in the design and conduct of the study; management and analysis of data; and the preparation and review of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.