Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting

Study Overview
=================
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.

Official Title
-----------------
Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting

Conditions
-----------------
Pharmacogenetics

Intervention / Treatment
-----------------
* Other: Medication Therapy Management
* Other: Pharmacogenetic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PGx Only<br>Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results. | Other: Pharmacogenetic testing<br>* Community pharmacist will provide pharmacogenetic testing.<br>* Other names: PGx;|
| Experimental: PGx + MTM<br>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: Medication Therapy Management<br>* Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing<br>* Other names: MTM + PGx;Other: Pharmacogenetic testing<br>* Community pharmacist will provide pharmacogenetic testing.<br>* Other names: 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | Pharmacist Post-Study survey question: I feel qualified to provide PGx testing at my pharmacy (Answer response: strongly agree/agree). | Post-study (3 months) |