- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mhamed Sami Mebazaa, professor
- Numéro de téléphone: 00216 22252589
- E-mail: msmebazaa@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Ben Haj youssef, assistant
- Numéro de téléphone: 00216 96874336
- E-mail: amani.benhajyoussef@fmt.utm.tn
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
students' overall performance
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Scores for each domain
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Simulated mini-CEX
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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