Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02937545

Enrollment

190

Registered

2016-10-18

Start date

2017-02-22

Completion date

2019-09-10

Last updated

2021-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacogenetics

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.

Interventions

OTHERMedication Therapy Management

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

OTHERPharmacogenetic testing

Community pharmacist will provide pharmacogenetic testing.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Patient Participants Who Reported Understanding of Implications of Test Results	Post-study (after test results received)	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)
Number of Patient Participants Who Recalled All Test Results	Post-study (after test results received)	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)
Number of Patient Participants Who Considered Time With Pharmacist to be Worthwhile	Post-study (after test results received)	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.
Number of Patient Participants' With High Medication Adherence	Baseline (prior to testing)	Pre-study (baseline) survey question: In the last 7 days, I took all doses as prescribed (Response: strongly agree)
Number of Patient Participants With High Medication Adherence (Post-study)	Post-Study (after test results received)	Post-study (follow-up) survey question: In the last 7 days, I took all doses as prescribed (Response: strongly agree)
Number of Patient Participants' Acceptance of PGx Services Offered in Community Pharmacy Setting	Post-study Survey (after test results received)	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)

Secondary

Measure	Time frame	Description
Number of Pharmacist Participants Who Reported 'Reimbursement' as Most Common Barrier to Delivery of PGx Testing	Post-study (3 months)	Pharmacist Post-Survey Question: Of the following potential barriers to providing PGx testing services, please indicate the greatest perceived barrier (most common response: reimbursement)
Number of Pharmacist Participants Who Reported Strong Likelihood to Continue to Deliver PGx Testing	Post-study (3 months)	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)
Number of Participating Pharmacists Who Feel Qualified to Deliver PGx Testing	Post-study (3 months)	Pharmacist Post-Study survey question: I feel qualified to provide PGx testing at my pharmacy (Answer response: strongly agree/agree).
Average Score of PGx Knowledge Assessment by Pharmacist Participants	Baseline (prior to start of study)	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)

Countries

United States

Participant flow

Recruitment details

Enrolled 154 patient participants and 36 pharmacist participants for a total of 190. Patients and pharmacists were assigned to the PGx only or PGx + MTM study arm.

Participants by arm

Arm	Count
PGx Only (Patients) Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results. Pharmacogenetic testing: Community pharmacist will provide pharmacogenetic testing.	67
PGx + MTM (Patients) 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. Medication Therapy Management: Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing Pharmacogenetic testing: Community pharmacist will provide pharmacogenetic testing.	83
Total	150

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	1	0	0	0
Overall Study	Withdrawal by Subject	1	2	6	7

Baseline characteristics

Characteristic	PGx + MTM (Patients)	Total	PGx Only (Patients)
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	45 Participants	67 Participants	22 Participants
Age, Categorical Between 18 and 65 years	38 Participants	83 Participants	45 Participants
Age, Continuous	64.2 years	61.1 years	57.3 years
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Black or African American	7 Participants	9 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	3 Participants	2 Participants
Race (NIH/OMB) White	74 Participants	135 Participants	61 Participants
Region of Enrollment United States	83 Participants	150 Participants	67 Participants
Sex: Female, Male Female	55 Participants	89 Participants	34 Participants
Sex: Female, Male Male	28 Participants	61 Participants	33 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 67	0 / 83	0 / 15	0 / 21
other Total, other adverse events	0 / 67	0 / 83	0 / 15	0 / 21
serious Total, serious adverse events	0 / 67	0 / 83	0 / 15	0 / 21

Outcome results

Primary

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)

Time frame: Post-study Survey (after test results received)