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Completed

NCT Number: NCT02937545

Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting

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.

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Key information

Conditions

Pharmacogenetics

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medication therapy management

Other

Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing

Other names: MTM + PGx

Pharmacogenetic testing

Other

Community pharmacist will provide pharmacogenetic testing.

Other names: PGx

Primary outcomes

  1. 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)

  2. 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)

  3. 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".

  4. 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")

  5. 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")

  6. 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")

Secondary outcomes

  1. 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")

  2. 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)

  3. 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")

  4. 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").

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2016
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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