Emergency Structured Clinical Examination Training bOX

NCT06124430 | Completed

• 1 other identifier: 202300116
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medical Education; Clinical Competence; Examination-Related Anxiety

Keywords

Medical students; Undergraduate medical education; Emergency medicine; Clinical competence; Cluster-randomized controlled trial; State anxiety; Objective structured clinical examination; Workplace-based learning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• State anxiety immediately before the end-of-clerkship OSCE

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

Other Outcomes (8)

• Overall professional behavior score at the end-of-clerkship OSCE

  At the end of the 10-week clerkship

• History-taking station score at the end-of-clerkship OSCE

  At the end of the 10-week clerkship

• Physical examination station score at the end-of-clerkship OSCE

  At the end of the 10-week clerkship

Study Arms (2)

ECOX plus usual training

EXPERIMENTAL

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

Usual training alone

NO INTERVENTION

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.

Interventions

ECOX workplace-based training toolbox OTHER

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.

ECOX plus usual training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, 49000, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single masking: OSCE outcome assessors were unaware of cluster allocation and had not delivered the ECOX intervention. Students and teachers were not blinded. The investigator enrolling students knew the allocation sequence. Masking applied to examiner-rated OSCE outcomes; self-reported anxiety was collected from unblinded participants.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsable DRCI

Model Details: Single-center, pragmatic, two-arm, parallel-group cluster-randomized controlled trial. Eight 10-week emergency medicine clerkship rotations were randomized 1:1 to usual training alone or usual training plus ECOX, with four rotations per arm, in two fixed blocks of four. The rotation was the unit of randomization and the student was the unit of analysis. All students within a rotation received the same allocation. Each student contributed only the first enrolled rotation.

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: November 7, 2023
• Primary Completion: October 31, 2025
• Study Completion: November 1, 2025
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

FR (1)