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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
190
Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing
Community pharmacist will provide pharmacogenetic testing.
Duke University
Durham, North Carolina, United States
Number of Patient Participants' Acceptance of PGx Services Offered in Community Pharmacy Setting
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)
Time frame: Post-study Survey (after test results received)
Number of Patient Participants Who Recalled All Test Results
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)
Time frame: Post-study (after test results received)
Number of Patient Participants Who Considered Time With Pharmacist to be Worthwhile
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".
Time frame: Post-study (after test results received)
Number of Patient Participants' With High Medication Adherence
Pre-study (baseline) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree")
Time frame: Baseline (prior to testing)
Number of Patient Participants With High Medication Adherence (Post-study)
Post-study (follow-up) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree")
Time frame: Post-Study (after test results received)
Number of Patient Participants Who Reported Understanding of Implications of Test Results
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")
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Post-study (after test results received)
Number of Pharmacist Participants Who Reported Strong Likelihood to Continue to Deliver PGx Testing
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")
Time frame: Post-study (3 months)
Average Score of PGx Knowledge Assessment by Pharmacist Participants
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)
Time frame: Baseline (prior to start of study)
Number of Pharmacist Participants Who Reported 'Reimbursement' as Most Common Barrier to Delivery of PGx Testing
Pharmacist Post-Survey Question: Of the following potential barriers to providing PGx testing services, please indicate the greatest perceived barrier (most common response: "reimbursement")
Time frame: Post-study (3 months)
Number of Participating Pharmacists Who Feel Qualified to Deliver PGx Testing
Pharmacist Post-Study survey question: I feel qualified to provide PGx testing at my pharmacy (Answer response: "strongly agree/agree").
Time frame: Post-study (3 months)