Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting

Not Applicable

Completed

Conditions: Pharmacogenetics

Interventions: Other: Medication Therapy Management
Other: Pharmacogenetic testing

Registration Number: NCT02937545

Lead Sponsor: Duke University

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 190

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGx + MTM	Medication Therapy Management	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.
PGx Only	Pharmacogenetic testing	Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results.
PGx + MTM	Pharmacogenetic testing	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.

Primary Outcome Measures

Name	Time	Method
Number of Patient Participants' With High Medication Adherence	Baseline (prior to testing)	Pre-study (baseline) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree")
Number of Patient Participants With High Medication Adherence (Post-study)	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")
Number of Patient Participants Who Considered Time With Pharmacist to be Worthwhile	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".
Number of Patient Participants Who Recalled All Test Results	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)
Number of Patient Participants' Acceptance of PGx Services Offered in Community Pharmacy Setting	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)
Number of Patient Participants Who Reported Understanding of Implications of Test Results	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 Outcome Measures

Name	Time	Method
Number of Pharmacist Participants Who Reported Strong Likelihood to Continue to Deliver PGx Testing	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")
Average Score of PGx Knowledge Assessment by Pharmacist Participants	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)
Number of Participating Pharmacists Who Feel Qualified to Deliver PGx Testing	Post-study (3 months)	Pharmacist Post-Study survey question: I feel qualified to provide PGx testing at my pharmacy (Answer response: "strongly agree/agree").
Number of Pharmacist Participants Who Reported 'Reimbursement' as Most Common Barrier to Delivery of PGx Testing	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")