Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Boîte de formation à l'examen clinique structuré d'urgence (ECOX)

21 septembre 2026 mis à jour par: Nicolas RIFFET-VIDAL, University Hospital, Angers

Effet de l'utilisation de l'outil pédagogique ECOX au service des urgences sur les OSCE pour les étudiants en médecine : essai contrôlé randomisé

This study assessed whether a training toolbox called ECOX could help medical students prepare for their objective structured clinical examination (OSCE) during an emergency medicine clerkship. The hypothesis was that adding ECOX to usual training would improve examination performance and reduce examination-related anxiety. Eight 10-week clerkship rotations at Angers University Hospital, France, were randomly assigned to usual training alone or usual training plus ECOX, with four rotations in each group. All students in a rotation received the same assignment. ECOX provided a timer and reference assessment grids for practising seven-minute encounters with real patients who agreed to participate. Students could use the toolbox throughout their clerkship. Both groups completed the same three-station examination at the end of the clerkship. Examiners were unaware of group allocation. Anxiety was assessed at the beginning of the clerkship and immediately before the final examination.

Aperçu de l'étude

Description détaillée

This single-center pragmatic educational trial was conducted in the Emergency Department of Angers University Hospital, France. The clerkship rotation was the unit of randomization and the medical student was the unit of analysis. Eight rotations were allocated in a 1:1 ratio in two fixed blocks of four using a sequence generated by a biostatistician in R (blockrand; seed 15). The medical school assigned students to rotations independently of the research team. The investigator enrolling students knew the allocation sequence.

Usual training included supervised clinical care, bedside teaching, simulation, and formal teaching. ECOX was offered in addition to this curriculum during intervention rotations. Students were introduced to the toolbox at rotation entry, and its use was optional. Use was recorded, but the content, duration, and quality of feedback were not assessed. No patient outcomes were collected.

Analyses were adjusted for age, sex, year of study, and previous OSCE experience. CR2 cluster-robust variance estimation with Satterthwaite degrees of freedom was introduced as a post hoc methodological improvement. Supplementary interaction, intracluster correlation, leave-one-rotation-out, and recorded-use analyses were also exploratory and post hoc.

Type d'étude

Interventionnel

Inscription (Réel)

310

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Angers, France, 49000
        • CHU Angers

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Medical student in the fourth, fifth, or sixth year of study undertaking an emergency medicine clerkship at Angers University Hospital.
  • Aged 18 years or older.
  • Free and informed non-opposition obtained after written and oral information, before enrolment.

Exclusion Criteria:

  • Refusal to participate.
  • International exchange student, including ERASMUS students.
  • Student assigned exclusively to on-call duties.
  • Previous enrolment in this study during an earlier emergency medicine rotation.

Analysis population: attendance at the final OSCE was required to measure the primary outcome. Students absent from the final OSCE were excluded from the modified intention-to-treat analysis. For students completing more than one rotation, only the first enrolled rotation was retained.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: ECOX plus usual training

Students assigned by clerkship rotation received the usual emergency medicine curriculum plus access to ECOX throughout the 10-week clerkship. ECOX supported optional, timed practice with consenting real patients, followed by review against reference assessment grids and feedback when an observer was present. Students completed the standard end-of-clerkship OSCE.

Educational intervention added to usual training for one 10-week clerkship. Two boxes, each containing a timer and approximately 30 reference grids based on French national OSCE standards, were available in the emergency department. Students received instructions at rotation entry. After obtaining the patient's verbal agreement, a student performed a seven-minute encounter without prior access to the grid, then reviewed performance against the grid. Sessions could be unobserved, observed by a peer, or supervised by a physician who was not an OSCE examiner. Immediate feedback was expected when an observer was present. Students could repeat exercises as often as they wished, with no mandatory number of sessions. Use was recorded.

Aucune intervention: Usual training alone

Students assigned by clerkship rotation received the usual emergency medicine curriculum, including supervised clinical care, bedside teaching, simulation, and formal teaching. They could use the usual preparation resources available through the faculty and emergency department. No ECOX toolbox was provided during their rotation. Students completed the same end-of-clerkship OSCE as the intervention group.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall end-of-clerkship objective structured clinical examination score
Délai: At the end of the 10-week clerkship

Each student completed three OSCE stations: history taking, physical examination, and procedural skills. Raw maximum scores were 20, 12, and 16, respectively. Each station score was converted to a 0-20 scale. The overall score was the arithmetic mean of these three converted scores, with a possible range of 0-20. Higher scores indicate better performance. Overall scores were compared between randomized groups.

At the end of the 10-week clerkship

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
State anxiety immediately before the end-of-clerkship OSCE
Délai: Immediately before the end-of-clerkship OSCE, at approximately 10 weeks

State anxiety measured with the French State-Trait Anxiety Inventory state subscale (STAI-Y1). The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. Scores immediately before the final OSCE are compared between groups.

Immediately before the end-of-clerkship OSCE, at approximately 10 weeks

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Overall professional behavior score at the end-of-clerkship OSCE
Délai: At the end of the 10-week clerkship

Examiner-rated professional behavior across the three OSCE stations. Behavior is rated on a 0-2 scale: 0, poor; 1, standard; 2, excellent. The overall professional behavior score is reported on the same 0-2 scale, with higher scores indicating better professional behavior. Scores are compared between groups.

At the end of the 10-week clerkship
History-taking station score at the end-of-clerkship OSCE
Délai: At the end of the 10-week clerkship

Score for the history-taking OSCE station. The raw score ranges from 0 to 20 and is reported on a 0-20 scale. Higher scores indicate better performance. Scores are compared between groups.

At the end of the 10-week clerkship
Physical examination station score at the end-of-clerkship OSCE
Délai: At the end of the 10-week clerkship

Score for the physical examination OSCE station. The raw score ranges from 0 to 12 and is converted to a 0-20 scale by multiplying by 20/12. Higher scores indicate better performance. Scores are compared between groups.

At the end of the 10-week clerkship
Procedural skills station score at the end-of-clerkship OSCE
Délai: At the end of the 10-week clerkship

Score for the procedural skills OSCE station. The raw score ranges from 0 to 16 and is converted to a 0-20 scale by multiplying by 20/16. Higher scores indicate better performance. Scores are compared between groups.

At the end of the 10-week clerkship
Professional behavior score during the history-taking station
Délai: At the end of the 10-week clerkship

Examiner-rated professional behavior during the history-taking OSCE station, on a 0-2 scale: 0, poor; 1, standard; 2, excellent. Higher scores indicate better professional behavior. Scores are compared between groups.

At the end of the 10-week clerkship
Professional behavior score during the physical examination station
Délai: At the end of the 10-week clerkship

Examiner-rated professional behavior during the physical examination OSCE station, on a 0-2 scale: 0, poor; 1, standard; 2, excellent. Higher scores indicate better professional behavior. Scores are compared between groups.

At the end of the 10-week clerkship
Professional behavior score during the procedural skills station
Délai: At the end of the 10-week clerkship

Examiner-rated professional behavior during the procedural skills OSCE station, on a 0-2 scale: 0, poor; 1, standard; 2, excellent. Higher scores indicate better professional behavior. Scores are compared between groups.

At the end of the 10-week clerkship
Change in state anxiety from clerkship entry to the end-of-clerkship OSCE
Délai: At clerkship entry and immediately before the end-of-clerkship OSCE, approximately 10 weeks later.

Change in the French State-Trait Anxiety Inventory state subscale (STAI-Y1) score, calculated as the score immediately before the final OSCE minus the score at clerkship entry. Each score ranges from 20 to 80. The change ranges from -60 to +60, with negative values indicating a reduction in anxiety. Changes are compared between groups.

At clerkship entry and immediately before the end-of-clerkship OSCE, approximately 10 weeks later.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 novembre 2023

Achèvement primaire (Réel)

31 octobre 2025

Achèvement de l'étude (Réel)

1 novembre 2025

Dates d'inscription aux études

Première soumission

3 novembre 2023

Première soumission répondant aux critères de contrôle qualité

3 novembre 2023

Première publication (Réel)

9 novembre 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner