Emergency Structured Clinical Examination Training bOX (ECOX)

Effect of the Training Toolbox in the Emergency Medecine on Medical Students' Performance in the Objective Structured Clinical Examination in France : a Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Medical Education; Clinical Competence; Examination-Related Anxiety
• Intervention / Treatment: Other: ECOX workplace-based training toolbox

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • CHU Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: ECOX workplace-based training toolbox; 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.
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall end-of-clerkship objective structured clinical examination score	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State anxiety immediately before the end-of-clerkship OSCE	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall professional behavior score at the end-of-clerkship OSCE	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	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	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	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	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	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	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	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.

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): September 24, 2026
• Last Update Submitted That Met QC Criteria: September 21, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Emergency medicine; Medical students; State anxiety; Cluster-randomized controlled trial; Clinical competence; Undergraduate medical education; Objective structured clinical examination; Workplace-based learning
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 202300116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No