Effectiveness of an Arabic CPIC-Based Pharmacogenomics Microlearning Program on Community Pharmacists' Clinical Decision-Making in Jordan: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- immediate post-intervention clinical decision-making score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Due to the educational nature of the intervention, participants could not be blinded to their group allocation. However, clinical decision-making cases were scored using a predefined answer key and standardized scoring rubric. Data analysis was conducted using coded group labels where feasible to reduce analytical bias. These procedures are important because cluster trials involving provider behavior are particularly vulnerable to performance and detection biases if blinding is not addressed carefully .
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
immediate post-intervention clinical decision-making score
时间窗: 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.
次要结局
- Immediate post-intervention PGx knowledge scores(Day 0 post intervention)
- Change in PGx knowledge(Day 0 post intervention)
- Confidence and readiness score(Day 0 post intervention)
- Intervention acceptability outcomes score(Day 0 post intervention)
- Contamination and external learning(Day 0 post intervention)
- Intervention process outcomes(Day 0 post intervention)
- Major PGx interpretation errors(Day 0 post intervention)
- Four-week retention outcomes(4 week post intervention)
- Post-study PGx(4 week post intervention)
研究者
Derar H. Abdel-Qader
Clinical Professor
University of Petra