Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting

NCT ID: NCT02937545

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2019-09-10

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.

Conditions

Pharmacogenetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PGx Only

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

Group Type: EXPERIMENTAL

Pharmacogenetic testing

Intervention Type: OTHER

Community pharmacist will provide pharmacogenetic testing.

PGx + MTM

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.

Group Type: EXPERIMENTAL

Medication Therapy Management

Intervention Type: OTHER

Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing

Pharmacogenetic testing

Intervention Type: OTHER

Community pharmacist will provide pharmacogenetic testing.

Interventions

Medication Therapy Management

Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing

Intervention Type: OTHER

Pharmacogenetic testing

Community pharmacist will provide pharmacogenetic testing.

Intervention Type: OTHER

Other Intervention Names

MTM + PGx; PGx

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2R01GM081416-08A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00068552

Identifier Type: -

Identifier Source: org_study_id