Effectiveness of an Arabic CPIC-Based Pharmacogenomics Microlearning Program on Community Pharmacists' Clinical Decision-Making in Jordan
2026年7月27日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
150
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Amman Governorate
-
Amman、Amman Governorate、ヨルダン
- Petra University
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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:
|
|
介入なし：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
immediate post-intervention clinical decision-making score
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Immediate post-intervention PGx knowledge scores
時間枠：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
時間枠：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
時間枠：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
時間枠：Day 0 post intervention
|
Intervention acceptability outcomes score 1-5, with higher scores indicating greater acceptability.
|
Day 0 post intervention
|
|
Contamination and external learning
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月15日
一次修了 (実際)
2026年7月15日
研究の完了 (実際)
2026年7月15日
試験登録日
最初に提出
2026年7月23日
QC基準を満たした最初の提出物
2026年7月27日
最初の投稿 (実際)
2026年7月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月30日
QC基準を満たした最後の更新が送信されました
2026年7月27日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- Petra university
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。