NCT06124430

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

November 7, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

November 3, 2023

Last Update Submit

November 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Describing the ECOX tool versus control of psychological status prior to ECOS

    10 weeks

  • Evaluate the ECOX tool versus control of student know-how

    10 weeks

Study Arms (2)

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.

Other: ECOX box

Interventions

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.

ECOX Interventional Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Students present during their internship in the emergency department will be offered the opportunity to take part in a study of educational research in the emergency department.

You may qualify if:

  • 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.

You may not qualify if:

  • Refusal to participate in the study.
  • Student returning to the emergency department and having already participated in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Weeks
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Responsable DRCI

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 9, 2023

Study Start

November 7, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11