Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting

May 10, 2021 updated by: Duke University
This study aims to compare patient use of and satisfaction with community pharmacist-delivered pharmacogenetic (PGx) testing delivered along or as part of a medication therapy management (MTM) service. Pharmacist and patient outcome measures will be collected by surveys, interviews, and review of pharmacy records.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to investigate the delivery of pharmacogenetic (PGx) testing alone or in combination with Medication Therapy Management (MTM) in the community pharmacy setting in order to assess and compare the two delivery models. Using a clust randomized trial, these effects of these two models will be compared. Pharmacist and patient outcome measures will be collected by survey, interviews, and review of pharmacy records. The investigators intend to compare the effect of PGx alone and PGx with MTM from the pharmacy perspective (to assess impact on workflow/operations) and patient perspective (to assess acceptance of testing, understanding of results, medication adherence, and overall satisfaction with delivery model). In the PGx only arm, pharmacists will offer PGx testing to patients who are prescribed one of the 10 eligible drugs (aripiprazole, carisoprodol, celecoxib, citalopram, clopidogrel, metoprolol, nortriptyline, paroxetine, simvastatin, warfarin) and will return results to the patient and physician with any recommendations for drug or dosage changes based on results. In the PGx and MTM arm, pharmacists will offer PGx testing to patients prescribed one of the 10 eligible drugs and provide two MTM sessions: one at the time of testing, and one when results are returned. All patients will be surveyed before PGx testing and 3 months after receiving results. Pharmacists will be surveyed prior to their participation and following the conclusion of the study. Pharmacists will also conduct a chart review of patients and document all interactions with enrolled patients and their providers.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pharmacist participants must be community pharmacists licensed and practicing in North Carolina
  • Patient participants must be prescribed one of the 10 eligible medications (aripiprazole, carisoprodol, celecoxib, citalopram, clopidogrel, metoprolol, nortriptyline, paroxetine, simvastatin, warfarin)
  • Patient participants must be able to consent to participating and testing on their own, and be able to read English

Exclusion Criteria:

  • Patients who have previously undergone pharmacogenetic testing will not be eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PGx Only
Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results.
Other: Pharmacogenetic testing
Community pharmacist will provide pharmacogenetic testing.
Other Names:
  • PGx
Experimental: PGx + MTM
Patients will receive pharmacogenetic testing along with medication therapy management. Two MTM sessions will be conducted: one at the time testing is ordered and the testing sample is collected, and one when results are returned to the patient. Pharmacists will make recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results.
Other: Pharmacogenetic testing
Community pharmacist will provide pharmacogenetic testing.
Other Names:
  • PGx
Other: Medication Therapy Management
Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing
Other Names:
  • MTM + PGx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patient Participants' Acceptance of PGx Services Offered in Community Pharmacy Setting
Time Frame: Post-study Survey (after test results received)
Post-Study Survey question: "Now that you know your test results, would you have taken the test in the first place?" (Response: 'would definitely' have taken the test)
Post-study Survey (after test results received)
Number of Patient Participants Who Recalled All Test Results
Time Frame: Post-study (after test results received)
Post-Study Survey Question: "As best you can, please choose the result of your drug response test for the following genes" (Response: Result selected for all 5 genes)
Post-study (after test results received)
Number of Patient Participants Who Considered Time With Pharmacist to be Worthwhile
Time Frame: Post-study (after test results received)
Patient survey question - "Did you feel your time spent with the pharmacist was worthwhile?". Reported as number of participants who selected answer choice "Yes, definitely".
Post-study (after test results received)
Number of Patient Participants' With High Medication Adherence
Time Frame: Baseline (prior to testing)
Pre-study (baseline) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree")
Baseline (prior to testing)
Number of Patient Participants With High Medication Adherence (Post-study)
Time Frame: Post-Study (after test results received)
Post-study (follow-up) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree")
Post-Study (after test results received)
Number of Patient Participants Who Reported Understanding of Implications of Test Results
Time Frame: Post-study (after test results received)
Post_Study Survey Question: Please indicate your level of agreement with the following statement: "I understood clearly my choices for prevention or early detection of side effects." (Response: "Sometimes/Often")
Post-study (after test results received)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Pharmacist Participants Who Reported Strong Likelihood to Continue to Deliver PGx Testing
Time Frame: Post-study (3 months)
Pharmacist Post-Survey Question: How likely are you to continue providing PGx testing in your pharmacy after the conclusion of the study? (Answer response: "definitely continue")
Post-study (3 months)
Average Score of PGx Knowledge Assessment by Pharmacist Participants
Time Frame: Baseline (prior to start of study)
7-question knowledge assessment of pharmacogenetics. Possible Score Range 0-7; actual range 3-7 (higher scores correspond to higher number of correct answers/higher knowledge)
Baseline (prior to start of study)
Number of Pharmacist Participants Who Reported 'Reimbursement' as Most Common Barrier to Delivery of PGx Testing
Time Frame: Post-study (3 months)
Pharmacist Post-Survey Question: Of the following potential barriers to providing PGx testing services, please indicate the greatest perceived barrier (most common response: "reimbursement")
Post-study (3 months)
Number of Participating Pharmacists Who Feel Qualified to Deliver PGx Testing
Time Frame: Post-study (3 months)
Pharmacist Post-Study survey question: I feel qualified to provide PGx testing at my pharmacy (Answer response: "strongly agree/agree").
Post-study (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of General Medical Sciences (NIGMS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2017

Primary Completion (Actual)

September 10, 2019

Study Completion (Actual)

September 10, 2019

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00068552
  • 2R01GM081416-08A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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