Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting
2 other identifiers
interventional
190
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedStudy Start
First participant enrolled
February 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2019
CompletedResults Posted
Study results publicly available
June 3, 2021
CompletedJune 3, 2021
May 1, 2021
2.5 years
October 17, 2016
April 12, 2021
May 10, 2021
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (4)
Number of Pharmacist Participants Who Reported Strong Likelihood to Continue to Deliver PGx Testing
Post-study (3 months)
Average Score of PGx Knowledge Assessment by Pharmacist Participants
Baseline (prior to start of study)
Number of Pharmacist Participants Who Reported 'Reimbursement' as Most Common Barrier to Delivery of PGx Testing
Post-study (3 months)
Number of Participating Pharmacists Who Feel Qualified to Deliver PGx Testing
Post-study (3 months)
Study Arms (2)
PGx Only
EXPERIMENTALPatients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results.
PGx + MTM
EXPERIMENTALPatients 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.
Interventions
Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing
Community pharmacist will provide pharmacogenetic testing.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who have previously undergone pharmacogenetic testing will not be eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke University
Durham, North Carolina, 27708, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susanne B Haga
- Organization
- Duke University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2016
First Posted
October 18, 2016
Study Start
February 22, 2017
Primary Completion
September 10, 2019
Study Completion
September 10, 2019
Last Updated
June 3, 2021
Results First Posted
June 3, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share