Pharmacogenomics
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERimmediate post-intervention clinical decision-making score
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: 1. Introduction to pharmacogenomics and its relevance to medication safety. 2. CYP2C19-clopidogrel case-based module. The clopidogrel module was based on the CPIC guideline for CYP2C19 genotype and clopidogrel therapy, which provides recommendations for using CYP2C19 phenotype information when clopidogrel therapy is considered (Lee et al., 2022). 3. CYP2C9/VKORC1-warfarin case-based module. The warfarin module was based on the CPIC guideline for pharmacogenetics-guided warfarin dosing, which discusses the clinical use of CYP2C9, VKORC1, CYP4F2, and rs12777823 genotype information when available (Johnson et al., 2017). 4. Pharmacist communication, referral, and documentation module. Each module included a sh
Sponsors
University of Petra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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 .
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| immediate post-intervention clinical decision-making score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate post-intervention PGx knowledge scores | Day 0 post intervention | Immediate post-intervention PGx knowledge scores ranged from 0 to 10, with higher scores indicating greater knowledge. |
| Change in PGx knowledge | 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. |
| Confidence and readiness score | 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. |
| Intervention acceptability outcomes score | Day 0 post intervention | Intervention acceptability outcomes score 1-5, with higher scores indicating greater acceptability. |
| Contamination and external learning | 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. |
| Intervention process outcomes | 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. |
| Major PGx interpretation errors | 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 |
| Four-week retention outcomes | 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. |
| Post-study PGx | 4 week post intervention | Post-study PGx use assessed at four-week follow-up included self-reported PGx-related professional behaviors after study participation. |
Countries
Jordan
Outcome results
None listed