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

27 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

150

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Jordania
    • Amman Governorate
      • Amman, Amman Governorate, Jordania
        • Petra University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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
Inny: 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
Brak interwencji: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
immediate post-intervention clinical decision-making score
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Immediate post-intervention PGx knowledge scores
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Day 0 post intervention
Intervention acceptability outcomes score 1-5, with higher scores indicating greater acceptability.
Day 0 post intervention
Contamination and external learning
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Petra

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

  • 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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 marca 2026

Zakończenie podstawowe (Rzeczywisty)

15 lipca 2026

Ukończenie studiów (Rzeczywisty)

15 lipca 2026

Daty rejestracji na studia

Pierwszy przesłany

23 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 lipca 2026

Pierwszy wysłany (Rzeczywisty)

30 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • Petra university

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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