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PharmacogenomicsNCT07735572

Effectiveness of an Arabic CPIC-Based Pharmacogenomics Microlearning Program on Community Pharmacists' Clinical Decision-Making in Jordan

A study testing immediate post-intervention clinical decision-making score in people with Pharmacogenomics, run by University of Petra at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pharmacogenomics
What is being tested?
immediate post-intervention clinical decision-making score
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteJordan
Study dates
15 Mar 2026to 15 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
  • Participants withdrawing from the study before randomization. These exclusions were purposefully designed to mitigate baseline expertise bias and ensure the sample accurately reflects the broader, non-specialized community pharmacy workforce.

Trial locations and contacts

1 site in 1 country.

Jordan1 site
  • Petra University

    Amman, Amman Governorate

Other trials in Jordan

About this study

Official title: Effectiveness of an Arabic CPIC-Based Pharmacogenomics Microlearning Program on Community Pharmacists' Clinical Decision-Making in Jordan: A Randomized Controlled Trial

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.

Read the detailed description

A two-arm, parallel-group, wait-list randomized controlled trial was conducted among 150 licensed community pharmacists. Participants were randomly allocated (1:1) to receive either a brief, four-module Arabic CPIC-based microlearning intervention (n=75) or to a control group (n=75). Outcomes were measured at baseline, immediate post-intervention, and four-week follow-up using a validated and reliability-tested instrument featuring 12 standardized clinical vignettes. Data were analyzed using independent t-tests, Fisher's exact tests, and chi-square statistics. A total of 143 pharmacists completed the immediate post-intervention assessment, and 130 completed the four-week follow-up.

Being tested
immediate post-intervention clinical decision-making score

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • immediate post-intervention clinical decision-making scoreOther

    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
Study groups in NCT07735572
Study groupRoleWhat they receive
Intervention arm proceduresActive comparatorParticipants 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
Receives: Other: immediate post-intervention clinical decision-making score
Control arm proceduresNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 0 post intervention

Secondary outcomes (9)
  1. Immediate post-intervention PGx knowledge scores

    Immediate post-intervention PGx knowledge scores ranged from 0 to 10, with higher scores indicating greater knowledge.

    Measured: Day 0 post intervention

  2. Change in PGx knowledge

    Change in Pharmacogenomics (PGx) knowledge was calculated by comparing baseline and immediate post-intervention scores using the PGx Knowledge Assessment scale. The scale consists of 10 multiple-choice questions assessing basic PGx concepts and clinical interpretations. The total score ranges from a minimum of 0 to a maximum of 10. Higher scores indicate greater PGx knowledge.

    Measured: Day 0 post intervention

  3. Confidence and readiness score

    Confidence and readiness scored from 1 to 5. Higher scores indicated greater confidence or readiness. These domains were assessed at baseline, immediately after the intervention period, and at four-week follow-up.

    Measured: Day 0 post intervention

  4. Intervention acceptability outcomes score

    Intervention acceptability outcomes score 1-5, with higher scores indicating greater acceptability.

    Measured: Day 0 post intervention

  5. Contamination and external learning

    Contamination and external learning were assessed in both study arms immediately after the intervention period. These outcomes included self-reported access to PGx educational materials outside the study, source of external PGx information, discussion of study content with another participant, and use of PGx decision-support websites or guidelines during the study period. These items were included to identify potential contamination and to support sensitivity analyses where appropriate.

    Measured: Day 0 post intervention

  6. Intervention process outcomes

    Intervention process outcomes were assessed only among participants allocated to the intervention group. These outcomes included number of completed microlearning modules, completion of case-based questions, and viewing or downloading of the PGx decision checklist.

    Measured: Day 0 post intervention

  7. Major PGx interpretation errors

    Major PGx interpretation errors were assessed using responses to the clinical decision-making vignettes that reflected misunderstanding of an important PGx concept or unsafe professional action. The error categories were prespecified according to clinically relevant PGx recommendations and pharmacist practice responsibilities. For clopidogrel-related cases, major errors included failure to recognize that CYP2C19 poor or intermediate metabolizer status may reduce clopidogrel activation and antiplatelet response, thereby requiring communication with the prescriber to consider an alternative antiplatelet strategy when clinically appropriate (Lee et al., 2022). For warfarin-related cases, major errors included failure to recognize that CYP2C9 and VKORC1 variants may influence warfarin dose requirements and anticoagulation risk, as well as the incorrect assumption that PGx results replace INR monitoring; CPIC guidance supports the use of genotype information to guide warfarin dosing when

    Measured: Day 0 post intervention

  8. Four-week retention outcomes

    Four-week retention outcomes evaluate the sustained effects of the intervention measured at the four-week follow-up. This composite outcome utilizes three separate questionnaire domains:

    PGx Knowledge Assessment scale: Ranges from a minimum of 0 to a maximum of 10, with higher scores indicating greater PGx knowledge.

    Applied PGx Clinical Decision-Making scale (measured via 12 clinical vignettes): Ranges from a minimum of 0 to a maximum of 12, with higher scores indicating better applied PGx decision-making.

    Combined Confidence and Readiness scale: Ranges from a minimum of 1 to a maximum of 10, with higher scores indicating a greater level of confidence and readiness to interpret and use PGx information in practice.

    Measured: 4 week post intervention

  9. Post-study PGx

    Post-study PGx use assessed at four-week follow-up included self-reported PGx-related professional behaviors after study participation.

    Measured: 4 week post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study start15 Mar 2026
  3. Primary completion15 Jul 2026
  4. Study completion15 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07735572
Sponsor's protocol ID
Petra university
Status last verified
Jul 2026
First submitted
23 Jul 2026
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing immediate post-intervention clinical decision-making score in people with Pharmacogenomics, run by University of Petra at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

immediate post-intervention clinical decision-making score (time frame: Day 0 post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07735572, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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