- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06124430
Emergency Structured Clinical Examination Training bOX (ECOX)
Effect of Using the ECOX Teaching Tool in the Emergency Department on OSCEs for Medical Students: Randomized Controlled Trial
This is a pragmatic, randomized, controlled study carried out in the emergency department of Angers University Hospital.
All students on placement over a 10-week period will be able to take part in the study. After a clear explanation to the students during the welcome meeting, followed by the collection of free and informed non-opposition, the students will be assigned according to the "ECOX" or "traditional" approach, depending on the randomization status of the internship period. The inclusion arm will be the same for all students over the placement period.
For the traditional approach (control group), students will participate in the OSCEs of the services scheduled at the end of the internship. Students will use the various revision methods usually offered to them by the faculty or in the emergency department, apart from the "ECOX tool". Revision methods are left to their own discretion. Students will complete the internship without any knowledge of the ECOX tool.
For the ECOX approach, students included in the intervention arm will be invited to use the ECOX tool. They will have the various ECOX grids and a stopwatch at their disposal in the 2 units of the emergency department. They will have around thirty evaluation grids at their disposal. The students will choose the ECOX grid corresponding to their initial situation, based on the nurse's triage of the patient. They must ask the patient's permission to practice with them. They must not look at the ECOX grid. As with the on-duty ECOS, they will have 7 minutes to complete the interview and clinical examination. Once this time has elapsed, they will have to compare their answers with the expectations of the grid. They may also be observed by a co-external study participant, a department intern or a senior staff member who is not involved in the OSCE evaluation. They will act as observers and complete the grid. The students will then be able to propose modifications to the grids. Each completed grid will be returned to a drawer in the cubicle, to assess adherence to the tool and suggestions for grid modifications, as well as any comments.
Students will be able to use them as many times as they like during the course and before the service ECOS.
Study Overview
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- Medical student in a non-ERASMUS emergency department
- Participating in the service ECOS planned at the end of the internship
- No free and informed consent from the student.
Exclusion Criteria:
- Refusal to participate in the study.
- Student returning to the emergency department and having already participated in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control Group
Students will take part in the ECOS of the departments scheduled at the end of their internship.
Students will use the various revision methods usually offered to them by the faculty or in the emergency department, apart from the ECOX tool.
Revision methods are left to their own discretion.
|
|
ECOX Interventional Group
Students will take part in the ECOS of the departments scheduled at the end of their internship.
Students will use the ECOX tool available in the emergency department to practice before taking the on-duty OSCEs.
|
For the ECOX approach, they will have the various ECOX grids and a stopwatch at their disposal in the 2 units of the emergency department.
There will be around thirty evaluation grids at their disposal.
Students will choose the ECOX grid corresponding to a starting situation.
Once the time limit has elapsed, they must compare their answers with the grid's expectations.
Each completed grid will be returned to a drawer in the box, to assess adherence to the tool and suggestions for grid modifications, as well as any comments.
Students will be able to use them as many times as they wish during the course and before the service ECOS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluate the value of the ECOX tool in improving the final grade for service ECOS compared with standard learning during the training course.
Time Frame: 10 weeks
|
the students' average score on the end-of-course OSCEs.
This criterion will correspond to the average of all students per arm, who passed the same OSCE stations from one course to the next.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Describing the ECOX tool versus control of psychological status prior to ECOS
Time Frame: 10 weeks
|
Average STAI-Y (State-Trait Anxiety) scores between the two groups.
|
10 weeks
|
Evaluate the ECOX tool versus control of student know-how
Time Frame: 10 weeks
|
The average scores on the behavioral assessment during the service ECOS between the two groups.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202300116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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