- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Amman Governorate
-
Amman, Amman Governorate, Jordânia
- Petra University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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:
|
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:
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
immediate post-intervention clinical decision-making score
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Immediate post-intervention PGx knowledge scores
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Day 0 post intervention
|
Intervention acceptability outcomes score 1-5, with higher scores indicating greater acceptability.
|
Day 0 post intervention
|
|
Contamination and external learning
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- Petra university
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .