Medication Therapy Management With Pharmacogenetic Testing

Overview

This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are minimal with the primary risks being associated with loss of confidentiality, typical discomfort associated with acquiring blood samples, and genetic discrimination.

Full Title of Study: “Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Interventions

  • Other: MTM with PGx
    • Patients will attend MTM sessions and receive PGx testing

Arms, Groups and Cohorts

  • Experimental: MTM and PGx
    • Participants attend two MTM sessions and have PGx testing

Clinical Trial Outcome Measures

Primary Measures

  • Patient satisfaction with MTM and PGx
    • Time Frame: 3 months after completion of MTM2
    • This will be assessed by a quantitative survey
  • Change in clinical biomarkers associated with drug therapy
    • Time Frame: baseline and 2 months
    • Changes in biomarkers before and after MTM/PGx will be measured. Biomarkers of study group will be compared to chart-review control
  • Number of recommended drug selection/dosing adjustments
    • Time Frame: approximately 9 months
    • Drug selection/doing changes will be compared between study population and chart-review controls

Secondary Measures

  • Physician time to perform MTM and PGx
    • Time Frame: end of study, approx. 9 months

Participating in This Clinical Trial

Inclusion Criteria

  • currently prescribed 3 medications, one of which must be simvastatin or clopidogrel – 18 years of age or older – English speaking – patients of Mahesh Patel or William Kraus at Duke Southpoint Clinic Exclusion Criteria:

  • if patient has ever had MTM or PGx

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Susanne Haga, PhD, Principal Investigator, Duke University

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