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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06124430
Other study ID # 202300116
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 7, 2023
Est. completion date November 1, 2024

Study information

Verified date November 2023
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 260
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
ECOX box
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Outcome

Type Measure Description Time frame Safety issue
Primary evaluate the value of the ECOX tool in improving the final grade for service ECOS compared with standard learning during the training course. 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 Describing the ECOX tool versus control of psychological status prior to ECOS Average STAI-Y (State-Trait Anxiety) scores between the two groups. 10 weeks
Secondary Evaluate the ECOX tool versus control of student know-how The average scores on the behavioral assessment during the service ECOS between the two groups. 10 weeks
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