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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07735572
Effectiveness of an Arabic CPIC-Based Pharmacogenomics Microlearning Program on Community Pharmacists' Clinical Decision-Making in Jordan
Effectiveness of an Arabic CPIC-Based Pharmacogenomics Microlearning Program on Community Pharmacists' Clinical Decision-Making in Jordan: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Amman Governorate
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Amman, Amman Governorate, Jordán
- Petra University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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:
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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:
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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immediate post-intervention clinical decision-making score
Periodo de tiempo: Day 0 post intervention
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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.
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Day 0 post intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Immediate post-intervention PGx knowledge scores
Periodo de tiempo: Day 0 post intervention
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Immediate post-intervention PGx knowledge scores ranged from 0 to 10, with higher scores indicating greater knowledge.
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Day 0 post intervention
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Change in PGx knowledge
Periodo de tiempo: Day 0 post intervention
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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.
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Day 0 post intervention
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Confidence and readiness score
Periodo de tiempo: Day 0 post intervention
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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.
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Day 0 post intervention
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Intervention acceptability outcomes score
Periodo de tiempo: Day 0 post intervention
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Intervention acceptability outcomes score 1-5, with higher scores indicating greater acceptability.
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Day 0 post intervention
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Contamination and external learning
Periodo de tiempo: Day 0 post intervention
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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.
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Day 0 post intervention
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Intervention process outcomes
Periodo de tiempo: Day 0 post intervention
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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.
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Day 0 post intervention
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Major PGx interpretation errors
Periodo de tiempo: Day 0 post intervention
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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
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Day 0 post intervention
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Four-week retention outcomes
Periodo de tiempo: 4 week post intervention
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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
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Post-study PGx
Periodo de tiempo: 4 week post intervention
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Post-study PGx use assessed at four-week follow-up included self-reported PGx-related professional behaviors after study participation.
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4 week post intervention
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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
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Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Petra university
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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