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Clinical Trials/NCT01970774
NCT01970774
Completed
Not Applicable

Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing

Duke University1 site in 1 country30 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pharmacogenetics
Sponsor
Duke University
Enrollment
30
Locations
1
Primary Endpoint
Number of recommended drug selection/dosing adjustments
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
October 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Physician time to perform MTM and PGx(end of study, approx. 9 months)

Study Sites (1)

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