NCT07735572

Brief Summary

Pharmacogenomics (PGx) presents a vital opportunity to optimize medication safety, yet community pharmacists often lack the applied clinical training required to interpret and act upon genetic data. This study aimed to evaluate the effectiveness of an Arabic Clinical Pharmacogenetics Implementation Consortium (CPIC)-based microlearning program on the clinical decision-making, knowledge, confidence, and readiness of community pharmacists in Jordan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 23, 2026

Last Update Submit

July 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • immediate post-intervention clinical decision-making score

    The total score ranged from 0 to 12, with higher scores indicating better applied PGx clinical decision-making. This outcome was selected as the primary outcome because the intervention was designed to improve pharmacists' applied ability to interpret PGx information and translate it into appropriate medication-related recommendations. The clinical vignette approach allowed assessment of practical decision-making rather than factual knowledge alone.

    Day 0 post intervention

Secondary Outcomes (9)

  • Immediate post-intervention PGx knowledge scores

    Day 0 post intervention

  • Change in PGx knowledge

    Day 0 post intervention

  • Confidence and readiness score

    Day 0 post intervention

  • Intervention acceptability outcomes score

    Day 0 post intervention

  • Contamination and external learning

    Day 0 post intervention

  • +4 more secondary outcomes

Study Arms (2)

Intervention arm procedures

ACTIVE COMPARATOR

Participants allocated to the intervention group received an Arabic CPIC-based pharmacogenomics microlearning program delivered over a 10-day period. The intervention was brief, clinically focused, and suitable for community pharmacy practice. The intervention included four modules: 1. Introduction to pharmacogenomics and its relevance to medication safety. 2. CYP2C19-clopidogrel case-based module. The clopidogrel module was based on the CPIC guideline for CYP2C19 genotype and clopidogrel therapy, which provides recommendations for using CYP2C19 phenotype information when clopidogrel therapy is considered (Lee et al., 2022). 3. CYP2C9/VKORC1-warfarin case-based module. The warfarin module was based on the CPIC guideline for pharmacogenetics-guided warfarin dosing, which discusses the clinical use of CYP2C9, VKORC1, CYP4F2, and rs12777823 genotype information when available (Johnson et al., 2017). 4. Pharmacist communication, referral, and documentation module. Each module included a s

Other: immediate post-intervention clinical decision-making score

Control arm procedures

NO INTERVENTION

Participants allocated to the control group did not receive any pharmacogenomics educational intervention during the study period. They continued their usual professional practice and completed the same baseline, immediate post-intervention, and four-week follow-up assessments as the intervention group. This no-intervention/wait-list control approach was selected to allow the study to estimate the added effect of the Arabic CPIC-based microlearning program compared with usual practice.

Interventions

Participants allocated to the intervention group received an Arabic CPIC-based pharmacogenomics microlearning program delivered over a 10-day period. The intervention was brief, clinically focused, and suitable for community pharmacy practice. The intervention included four modules: 1. Introduction to pharmacogenomics and its relevance to medication safety. 2. CYP2C19-clopidogrel case-based module. The clopidogrel module was based on the CPIC guideline for CYP2C19 genotype and clopidogrel therapy, which provides recommendations for using CYP2C19 phenotype information when clopidogrel therapy is considered (Lee et al., 2022). 3. CYP2C9/VKORC1-warfarin case-based module. The warfarin module was based on the CPIC guideline for pharmacogenetics-guided warfarin dosing, which discusses the clinical use of CYP2C9, VKORC1, CYP4F2, and rs12777823 genotype information when available (Johnson et al., 2017). 4. Pharmacist communication, referral, and documentation module. Each module included a sh

Intervention arm procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants had to be licensed pharmacists working in a community pharmacy in Jordan
  • Participants had to be capable of comprehending the Arabic language
  • Participants have access to internet-enabled devices (smartphones, tablets, computers)
  • Participants give informed consent electronically and agree to take all assessments longitudinally (baseline, immediate post-intervention, and follow-up four weeks later).

You may not qualify if:

  • Participants having an advanced postgraduate specialty or previous training in PGx (This criteria helps eliminate the problem of ceiling effect in order to evaluate the intervention as intended for a specific target audience: community pharmacists without advanced precision medicine training.)
  • Participants being involved in PGx research, curriculum development, and/or delivering PGx services
  • Participants providing incomplete baseline surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Petra University

Amman, Amman Governorate, Jordan

Location

Related Publications (1)

  • Al-Kubaisi, K. A., Abdel-Qader, D. H., Al Mazrouei, N., Ibrahim, R., & Alhusban, A. (2026). Pharmacogenomics knowledge and implementation readiness among community pharmacists in Jordan: A national cross-sectional study. PLOS ONE, 21(5), e0349439. https://doi.org/10.1371/journal.pone.0349439 Althubaiti, A. (2016). Information bias in health research: Definition, pitfalls, and adjustment methods. Journal of Multidisciplinary Healthcare, 9, 211-217. https://doi.org/10.2147/JMDH.S104807 Bank, P. C. D., Caudle, K. E., Swen, J. J., Gammal, R. S., Whirl-Carrillo, M., Klein, T. E., Relling, M. V., & Guchelaar, H.-J. (2018). Comparison of the guidelines of the Clinical Pharmacogenetics Implementation Consortium and the Dutch Pharmacogenetics Working Group. Clinical Pharmacology & Therapeutics, 103(4), 599-618. https://doi.org/10.1002/cpt.762 Campbell, M. K., Piaggio, G., Elbourne, D. R., & Altman, D. G. (2012). CONSORT 2010 statement: Extension to cluster randomised trials. BMJ, 345, e5661. https://doi.org/10.1136/bmj.e5661 Caudle, K. E., Klein, T. E., Hoffman, J. M., Müller, D. J., Whirl-Carrillo, M., Gong, L., McDonagh, E. M., Sangkuhl, K., Thorn, C. F., Schwab, M., Agúndez, J. A. G., Freimuth, R. R., Huser, V., Lee, M. T. M., Iwuchukwu, O. F., Crews, K. R., Scott, S. A., Wadelius, M., Swen, J. J., Tyndale, R. F., Stein, C. M., Roden, D. M., Relling, M. V., Williams, M. S., & Johnson, S. G. (2014). Incorporation of pharmacogenomics into routine clinical practice: The Clinical Pharmacogenetics Implementation Consortium guideline development process. Current Drug Metabolism, 15(2), 209-217. https://doi.org/10.2174/1389200215666140130124910 Chan, A.-W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., Gøtzsche, P. C., Krleža-Jerić, K., Hróbjartsson, A., Mann, H., Dickersin, K., Berlin, J. A., Doré, C. J., Parulekar, W. R., Summerskill, W. S. M., Groves, T., Schulz, K. F., Sox, H. C., Rockhold, F. W., Rennie, D., & Moher, D. (2013). SPIRIT 2013 statement: Defining standard proto

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Due to the educational nature of the intervention, participants could not be blinded to their group allocation. However, clinical decision-making cases were scored using a predefined answer key and standardized scoring rubric. Data analysis was conducted using coded group labels where feasible to reduce analytical bias. These procedures are important because cluster trials involving provider behavior are particularly vulnerable to performance and detection biases if blinding is not addressed carefully .
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 30, 2026

Study Start

March 15, 2026

Primary Completion

July 15, 2026

Study Completion

July 15, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations