Clinical trial NCT02937545: Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting
Official title: Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacogenetics
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2016-10-18
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Number of Patient Participants' Acceptance of PGx Services Offered in Community Pharmacy Setting
timeFrame: Post-study Survey (after test results received)
measure: Number of Patient Participants Who Recalled All Test Results
timeFrame: Post-study (after test results received)
measure: Number of Patient Participants Who Considered Time With Pharmacist to be Worthwhile
timeFrame: Post-study (after test results received)
measure: Number of Patient Participants' With High Medication Adherence
timeFrame: Baseline (prior to testing)
measure: Number of Patient Participants With High Medication Adherence (Post-study)
timeFrame: Post-Study (after test results received)
measure: Number of Patient Participants Who Reported Understanding of Implications of Test Results
timeFrame: Post-study (after test results received)
Secondary outcomes:
measure: Number of Pharmacist Participants Who Reported Strong Likelihood to Continue to Deliver PGx Testing
timeFrame: Post-study (3 months)
measure: Average Score of PGx Knowledge Assessment by Pharmacist Participants
timeFrame: Baseline (prior to start of study)
measure: Number of Pharmacist Participants Who Reported 'Reimbursement' as Most Common Barrier to Delivery of PGx Testing
timeFrame: Post-study (3 months)
measure: Number of Participating Pharmacists Who Feel Qualified to Deliver PGx Testing
timeFrame: Post-study (3 months)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References: