Efficacy of Personal Pharmacogenomic Testing as an Educational Tool in the Pharmacy Curriculum

Sponsor

University of Arizona (Other)

Overall Status

Completed

CT.gov ID

NCT04889014

Collaborator

(none)

233

Enrollment

Arms

59.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the use of personal genomic educational testing (PGET) on student knowledge and clinical skills surrounding pharmacogenomic testing to ensure it is of educational benefit to our student population. Students will be provided the opportunity to opt-in to test their own pharmacogenomic panel while participating in the standard curriculum. Students will have the option of using their own reports or dummy reports during classroom activities. Our hypothesis is that those students who have their own pharmacogenomics tested will show better overall performance.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Genetic: Personal genomic educational testing (PGET) Genetic: No personal genomic educational testing (NPGET)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

233 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

We investigated the effect of PGET on student knowledge, comfort, and attitudes related to pharmacogenomics (PGx) in a non-blinded, randomized controlled trial. Consenting participants were randomized to receive PGET or no PGET (NPGET) during four subsequent years of a PGx course.We investigated the effect of PGET on student knowledge, comfort, and attitudes related to pharmacogenomics (PGx) in a non-blinded, randomized controlled trial. Consenting participants were randomized to receive PGET or no PGET (NPGET) during four subsequent years of a PGx course.

Masking:

Single (Investigator)

Masking Description:

Instructors and all study personnel were blinded to participant PGET assignment, PGx results, and survey results.

Primary Purpose:

Other

Official Title:

Efficacy of Personal Pharmacogenomic Testing as an Educational Tool in the Pharmacy Curriculum

Actual Study Start Date :

Mar 3, 2016

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Personal genomic educational testing (PGET) PGET group participants received their own pharmacogenomic testing results prior to the course modules covering material tested in the knowledge assessment	Genetic: Personal genomic educational testing (PGET) PGET consisted of a panel of pharmacogenomic variants
Placebo Comparator: No personal genomic educational testing (NPGET) No PGET (NPGET) group participants did not receive their own pharmacogenomic testing results until after study completion.	Genetic: No personal genomic educational testing (NPGET) Lack of pharmacogenomic testing

Arm

Intervention/Treatment

Active Comparator: Personal genomic educational testing (PGET)

PGET group participants received their own pharmacogenomic testing results prior to the course modules covering material tested in the knowledge assessment

Genetic: Personal genomic educational testing (PGET)

PGET consisted of a panel of pharmacogenomic variants

Placebo Comparator: No personal genomic educational testing (NPGET)

No PGET (NPGET) group participants did not receive their own pharmacogenomic testing results until after study completion.

Genetic: No personal genomic educational testing (NPGET)

Lack of pharmacogenomic testing

Outcome Measures

Primary Outcome Measures

Change in Pharmacogenomics Knowledge Assessment [8-12 weeks]
Improvement in performance on a knowledge assessment including eleven questions

Secondary Outcome Measures

Change in Self Assessment Questionnaire [8-12 weeks]
Improvement in Likert Scale Responses for 27 questions (scale of 1[worst] to 6[best])

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Willingness to provide informed consent for participation in the study
Enrolled in 3rd year Doctor of Pharmacy course

Exclusion Criteria:

Unwilling or unable to provide consent for participation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Arizona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arizona

ClinicalTrials.gov Identifier:

NCT04889014

Other Study ID Numbers:

1602413309

First Posted:

May 17, 2021

Last Update Posted:

May 17, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 17, 2021