Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting

Duke University

Status: Completed

Conditions: Pharmacogenetics

Treatments: Other: Pharmacogenetic testing; Other: Medication Therapy Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02937545

2R01GM081416-08A1 (U.S. NIH Grant/Contract)

Pro00068552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

PGx Only

Experimental group

Description:

Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results.

Treatment:

Other: Pharmacogenetic testing

PGx + MTM

Experimental group

Description:

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.

Treatment:

Other: Medication Therapy Management

Other: Pharmacogenetic testing