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

27. července 2026 aktualizováno: Derar H. Abdel-Qader, University of Petra

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

150

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Jordán
    • Amman Governorate
      • Amman, Amman Governorate, Jordán
        • Petra University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Intervention arm procedures

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
Jiný: immediate post-intervention clinical decision-making score

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
Žádný zásah: Control arm procedures
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
immediate post-intervention clinical decision-making score
Časové okno: Day 0 post intervention
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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Immediate post-intervention PGx knowledge scores
Časové okno: Day 0 post intervention
Immediate post-intervention PGx knowledge scores ranged from 0 to 10, with higher scores indicating greater knowledge.
Day 0 post intervention
Change in PGx knowledge
Časové okno: Day 0 post intervention
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.
Day 0 post intervention
Confidence and readiness score
Časové okno: Day 0 post intervention
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.
Day 0 post intervention
Intervention acceptability outcomes score
Časové okno: Day 0 post intervention
Intervention acceptability outcomes score 1-5, with higher scores indicating greater acceptability.
Day 0 post intervention
Contamination and external learning
Časové okno: Day 0 post intervention
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.
Day 0 post intervention
Intervention process outcomes
Časové okno: Day 0 post intervention
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.
Day 0 post intervention
Major PGx interpretation errors
Časové okno: Day 0 post intervention
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
Day 0 post intervention
Four-week retention outcomes
Časové okno: 4 week post intervention

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.
4 week post intervention
Post-study PGx
Časové okno: 4 week post intervention
Post-study PGx use assessed at four-week follow-up included self-reported PGx-related professional behaviors after study participation.
4 week post intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Petra

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

  • 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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. března 2026

Primární dokončení (Aktuální)

15. července 2026

Dokončení studie (Aktuální)

15. července 2026

Termíny zápisu do studia

První předloženo

23. července 2026

První předloženo, které splnilo kritéria kontroly kvality

27. července 2026

První zveřejněno (Aktuální)

30. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • Petra university

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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