- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Amman Governorate
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Amman, Amman Governorate, 요르단
- Petra University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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immediate post-intervention clinical decision-making score
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Immediate post-intervention PGx knowledge scores
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Petra university
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