Trial Outcomes & Findings for Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting (NCT NCT02937545)
NCT ID: NCT02937545
Last Updated: 2021-06-03
Results Overview
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)
COMPLETED
NA
190 participants
Post-study Survey (after test results received)
2021-06-03
Participant Flow
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.
Participant milestones
| Measure |
PGx Only (Patients)
Patients received pharmacogenetic testing only. Participating pharmacist made recommendations for drug/dose changes based on PGx results. Data collected from both patients and pharmacists.
|
PGx + MTM (Patients)
Patients received pharmacogenetic testing along with medication therapy management (MTM). 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 made recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results. Data collected from both patients and pharmacists.
Medication Therapy Management: Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing
|
PGx Only (Pharmacists)
Patients received pharmacogenetic testing only. Participating pharmacist made recommendations for drug/dose changes based on PGx results. Data collected from both patients and pharmacists.
|
PGx + MTM (Pharmacists)
Patients received pharmacogenetic testing plus medication therapy management (MTM). Participating pharmacist made recommendations for drug/dose changes based on PGx results and conducted MTM. Data collected from both patients and pharmacists.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
69
|
85
|
15
|
21
|
|
Overall Study
COMPLETED
|
67
|
83
|
9
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
6
|
7
|
Reasons for withdrawal
| Measure |
PGx Only (Patients)
Patients received pharmacogenetic testing only. Participating pharmacist made recommendations for drug/dose changes based on PGx results. Data collected from both patients and pharmacists.
|
PGx + MTM (Patients)
Patients received pharmacogenetic testing along with medication therapy management (MTM). 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 made recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results. Data collected from both patients and pharmacists.
Medication Therapy Management: Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing
|
PGx Only (Pharmacists)
Patients received pharmacogenetic testing only. Participating pharmacist made recommendations for drug/dose changes based on PGx results. Data collected from both patients and pharmacists.
|
PGx + MTM (Pharmacists)
Patients received pharmacogenetic testing plus medication therapy management (MTM). Participating pharmacist made recommendations for drug/dose changes based on PGx results and conducted MTM. Data collected from both patients and pharmacists.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
6
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting
Baseline characteristics by cohort
| Measure |
PGx Only (Patients)
n=67 Participants
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.
|
PGx + MTM (Patients)
n=83 Participants
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.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Continuous
|
57.3 years
n=5 Participants
|
64.2 years
n=7 Participants
|
61.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-study Survey (after test results received)Population: Participants who completed the pre/post-study surveys.
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)
Outcome measures
| Measure |
PGx Only (Patients)
n=21 Participants
Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
|
PGx + MTM (Patients)
n=17 Participants
Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
|
|---|---|---|
|
Number of Patient Participants' Acceptance of PGx Services Offered in Community Pharmacy Setting
|
14 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Post-study (after test results received)Population: Participants who completed the pre/post-study surveys.
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)
Outcome measures
| Measure |
PGx Only (Patients)
n=21 Participants
Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
|
PGx + MTM (Patients)
n=17 Participants
Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
|
|---|---|---|
|
Number of Patient Participants Who Recalled All Test Results
|
13 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Post-study (after test results received)Population: Participants who completed the pre/post-study surveys.
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".
Outcome measures
| Measure |
PGx Only (Patients)
n=21 Participants
Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
|
PGx + MTM (Patients)
n=17 Participants
Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
|
|---|---|---|
|
Number of Patient Participants Who Considered Time With Pharmacist to be Worthwhile
|
16 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to testing)Population: Participants who completed the pre/post-study surveys.
Pre-study (baseline) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree")
Outcome measures
| Measure |
PGx Only (Patients)
n=21 Participants
Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
|
PGx + MTM (Patients)
n=17 Participants
Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
|
|---|---|---|
|
Number of Patient Participants' With High Medication Adherence
|
15 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Post-Study (after test results received)Population: Participants who completed the pre/post-study surveys.
Post-study (follow-up) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree")
Outcome measures
| Measure |
PGx Only (Patients)
n=21 Participants
Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
|
PGx + MTM (Patients)
n=17 Participants
Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
|
|---|---|---|
|
Number of Patient Participants With High Medication Adherence (Post-study)
|
11 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Post-study (after test results received)Population: Participants who completed the pre/post-study surveys.
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")
Outcome measures
| Measure |
PGx Only (Patients)
n=21 Participants
Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
|
PGx + MTM (Patients)
n=17 Participants
Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
|
|---|---|---|
|
Number of Patient Participants Who Reported Understanding of Implications of Test Results
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Post-study (3 months)Population: Pharmacists who completed the survey.
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")
Outcome measures
| Measure |
PGx Only (Patients)
n=7 Participants
Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
|
PGx + MTM (Patients)
n=9 Participants
Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
|
|---|---|---|
|
Number of Pharmacist Participants Who Reported Strong Likelihood to Continue to Deliver PGx Testing
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (prior to start of study)Population: All participating pharmacists.
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)
Outcome measures
| Measure |
PGx Only (Patients)
n=15 Participants
Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
|
PGx + MTM (Patients)
n=21 Participants
Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
|
|---|---|---|
|
Average Score of PGx Knowledge Assessment by Pharmacist Participants
|
5.4 score on a scale
Interval 4.0 to 7.0
|
5.3 score on a scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Post-study (3 months)Population: Pharmacists who completed the study.
Pharmacist Post-Survey Question: Of the following potential barriers to providing PGx testing services, please indicate the greatest perceived barrier (most common response: "reimbursement")
Outcome measures
| Measure |
PGx Only (Patients)
n=7 Participants
Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
|
PGx + MTM (Patients)
n=9 Participants
Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
|
|---|---|---|
|
Number of Pharmacist Participants Who Reported 'Reimbursement' as Most Common Barrier to Delivery of PGx Testing
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Post-study (3 months)Population: Pharmacists who completed the survey.
Pharmacist Post-Study survey question: I feel qualified to provide PGx testing at my pharmacy (Answer response: "strongly agree/agree").
Outcome measures
| Measure |
PGx Only (Patients)
n=7 Participants
Received pharmagenetic (PGx) testing from the pharmacist and no additional services (related to the study).
|
PGx + MTM (Patients)
n=9 Participants
Received pharmacogenetic (PGx) testing plus medication therapy management (MTM)
|
|---|---|---|
|
Number of Participating Pharmacists Who Feel Qualified to Deliver PGx Testing
|
7 Participants
|
7 Participants
|
Adverse Events
PGx Only (Patients)
PGx + MTM (Patients)
PGx Only (Pharmacists)
PGx + MTM (Pharmacists)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place