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

NCT04889014 | Completed

• 1 other identifier: 1602413309
• Study Type: interventional
• Target: 233
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in Pharmacogenomics Knowledge Assessment

  Improvement in performance on a knowledge assessment including eleven questions

  8-12 weeks

Secondary Outcomes (1)

• Change in Self Assessment Questionnaire

  8-12 weeks

Study Arms (2)

Personal genomic educational testing (PGET)

ACTIVE COMPARATOR

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)

No personal genomic educational testing (NPGET)

PLACEBO COMPARATOR

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

Genetic: No personal genomic educational testing (NPGET)

Interventions

Personal genomic educational testing (PGET) GENETIC

PGET consisted of a panel of pharmacogenomic variants

Personal genomic educational testing (PGET)

No personal genomic educational testing (NPGET) GENETIC

Lack of pharmacogenomic testing

No personal genomic educational testing (NPGET)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unwilling or unable to provide consent for participation

Sponsors & Collaborators

• University of Arizona: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Instructors and all study personnel were blinded to participant PGET assignment, PGx results, and survey results.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 17, 2021
• Study Start: March 3, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share