Medical EducationECOXNCT06124430
Emergency Structured Clinical Examination Training bOX
A study testing ECOX workplace-based training toolbox in people with Medical Education and Clinical Competence, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Education, Clinical Competence, Examination-Related Anxiety
- What is being tested?
- ECOX workplace-based training toolbox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- ECOX workplace-based training toolbox
- Keywords
- Medical students, Undergraduate medical education, Emergency medicine, Clinical competence, Cluster-randomized controlled trial, State anxiety, Objective structured clinical examination, Workplace-based learning
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECOX workplace-based training toolboxOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the 10-week clerkship
Secondary outcomes (1)
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.
Measured: Immediately before the end-of-clerkship OSCE, at approximately 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start7 Nov 2023
- Primary completion31 Oct 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nicolas RIFFET-VIDAL, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124430
- Sponsor's protocol ID
- 202300116
- Acronym
- ECOX
- Status last verified
- Sep 2026
- First submitted
- 3 Nov 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06124430
- Acronym / sponsor ID
- ECOX / 202300116
- Keywords
- Medical students, Undergraduate medical education, Emergency medicine, Clinical competence, Cluster-randomized controlled trial, State anxiety, Objective structured clinical examination, Workplace-based learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ECOX plus usual training | Experimental | Other: ECOX workplace-based training toolboxStudents 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECOX workplace-based training toolboxEducational 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. | Other | ECOX plus usual training |
Primary outcome
Overall end-of-clerkship objective structured clinical examination score
Time frame: 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.
1 secondary outcome
State anxiety immediately before the end-of-clerkship OSCE
Time frame: Immediately before the end-of-clerkship OSCE, at approximately 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECOX workplace-based training toolbox in people with Medical Education and Clinical Competence, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall end-of-clerkship objective structured clinical examination score (time frame: At the end of the 10-week clerkship). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.