- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07663760
Impact of a Simulated Mini-CEX on Clinical Performance During a Real-World Mini-CEX
Impact of a Simulated Mini-CEX on Clinical Performance During a Real-World Mini-CEX: A Multicenter Study in Anesthesiology and Intensive Care Medicine
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mhamed Sami Mebazaa, professor
- Phone Number: 00216 22252589
- Email: msmebazaa@gmail.com
Study Contact Backup
- Name: Ben Haj youssef, assistant
- Phone Number: 00216 96874336
- Email: amani.benhajyoussef@fmt.utm.tn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Fifth-year medical students (DCEM3) enrolled at the Faculty of Medicine of Tunis within the acute medicine program.
- Students completing their clinical clerkship during the second semester of the 2025-2026 academic year in one of the three participating anesthesiology and intensive care departments.
- Students who voluntarily agree to participate and have provided written informed consent.
Exclusion Criteria:
- Students who do not complete the entire educational curriculum (absence from either of the two assessments).
- Students who have already received similar training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DCEM3 students
Fifth-year medical students in the second cycle during their internship in anesthesiology and intensive care.
|
Mini-CEX educational assessment during pre-anesthetic consultation: Volunteer fifth-year medical students were assessed by trained anesthesiology faculty using the mini-CEX tool.
The intervention consisted of a structured two-step assessment of pre-anesthetic consultation: a standardized simulation followed by a real clinical encounter.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
students' overall performance
Time Frame: Through study completion, up to 4 weeks
|
measured by the mean score on the Mini-CEX checklist, compared between simulated consultation and real consultation. The overall performance is assessed using the unabbreviated Mini-Clinical Evaluation Exercise (Mini-CEX) checklist. The global score is measured on a 9-point Likert scale, ranging from 1 (insufficient/unsatisfactory performance) to 9 (exceptional/exemplary performance). Higher scores indicate a better clinical performance and greater student autonomy. |
Through study completion, up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scores for each domain
Time Frame: at the and of each Mini-CEX , Through study completion, up to 4 weeks
|
Scores for each domain (history taking, physical examination, clinical judgment, communication skills, professionalism, organization and efficiency, and overall clinical performance).
Measured by the Mini-Clinical Evaluation Exercise (Mini-CEX) checklist, compared between the simulated consultation (baseline) and the real clinical consultation.
The checklist uses a 9-point Likert scale where 1 represents the lowest performance (insufficient) and 9 represents the highest performance (exceptional).
Higher scores indicate a better clinical outcome.
|
at the and of each Mini-CEX , Through study completion, up to 4 weeks
|
|
Inter-rater reproducibility of Mini-CEX
Time Frame: at the end of the simulated Mini-CEx, Through study completion, up to 4 weeks
|
Inter-rater reproducibility was evaluated using the Intraclass Correlation Coefficient (ICC
|
at the end of the simulated Mini-CEx, Through study completion, up to 4 weeks
|
|
Individual performance gain
Time Frame: at the end of the internship, Through study completion, up to 4 weeks
|
Individual performance gain (delta between simulated and real Mini-CEX scores) Calculated as the change score between the real clinical consultation and the simulated consultation (Real score minus Simulated score) using the unabbreviated Mini-Clinical Evaluation Exercise (Mini-CEX).
The original Mini-CEX scale ranges from a minimum value of 1 (insufficient performance) to a maximum value of 9 (exceptional performance).
The resulting performance gain score ranges from -8 to +8.
A higher or positive score indicates a better outcome (improvement/performance gain), a score of 0 indicates no change, and a negative score indicates a decrease in performance.
|
at the end of the internship, Through study completion, up to 4 weeks
|
|
Learner and faculty satisfaction
Time Frame: at the end of internship, Through study completion, up to 4 weeks
|
Learner and faculty satisfaction, as well as their recommendation for the use of the Mini-CEX throughout the curriculum, assessed using a Likert scale.
Assessed via a post-internship questionnaire completed by both students (learners) and professors (faculty) regarding their satisfaction with the Mini-Clinical Evaluation Exercise (Mini-CEX) and their recommendation for its integration throughout the curriculum.
Responses are evaluated on a 5-point Likert scale, ranging from a minimum score of 1 (Strongly disagree / Very dissatisfied) to a maximum score of 5 (Strongly agree / Very satisfied).
Higher scores indicate a better outcome, representing higher levels of satisfaction and a stronger recommendation for curriculum implementation.
|
at the end of internship, Through study completion, up to 4 weeks
|
|
The time required to complete the consultation
Time Frame: at the end of each Mini-Cex, Through study completion, up to 4 weeks
|
The time required to complete the consultation (measured in minutes)
|
at the end of each Mini-Cex, Through study completion, up to 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Simulated mini-CEX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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