Trainingsbox voor gestructureerd klinisch onderzoek in noodgevallen (ECOX)
Effect van het gebruik van het ECOX-leermiddel op de afdeling spoedeisende hulp op OVSE's voor medische studenten: gerandomiseerde gecontroleerde studie
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Angers, Frankrijk, 49000
- CHU Angers
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: ECOX plus usual training
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. |
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. |
|
Geen tussenkomst: Usual training alone
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall end-of-clerkship objective structured clinical examination score
Tijdsspanne: 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. |
At the end of the 10-week clerkship
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
State anxiety immediately before the end-of-clerkship OSCE
Tijdsspanne: Immediately before the end-of-clerkship OSCE, at approximately 10 weeks
|
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. |
Immediately before the end-of-clerkship OSCE, at approximately 10 weeks
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall professional behavior score at the end-of-clerkship OSCE
Tijdsspanne: At the end of the 10-week clerkship
|
Examiner-rated professional behavior across the three OSCE stations. Behavior is rated on a 0-2 scale: 0, poor; 1, standard; 2, excellent. The overall professional behavior score is reported on the same 0-2 scale, with higher scores indicating better professional behavior. Scores are compared between groups. |
At the end of the 10-week clerkship
|
|
History-taking station score at the end-of-clerkship OSCE
Tijdsspanne: At the end of the 10-week clerkship
|
Score for the history-taking OSCE station. The raw score ranges from 0 to 20 and is reported on a 0-20 scale. Higher scores indicate better performance. Scores are compared between groups. |
At the end of the 10-week clerkship
|
|
Physical examination station score at the end-of-clerkship OSCE
Tijdsspanne: At the end of the 10-week clerkship
|
Score for the physical examination OSCE station. The raw score ranges from 0 to 12 and is converted to a 0-20 scale by multiplying by 20/12. Higher scores indicate better performance. Scores are compared between groups. |
At the end of the 10-week clerkship
|
|
Procedural skills station score at the end-of-clerkship OSCE
Tijdsspanne: At the end of the 10-week clerkship
|
Score for the procedural skills OSCE station. The raw score ranges from 0 to 16 and is converted to a 0-20 scale by multiplying by 20/16. Higher scores indicate better performance. Scores are compared between groups. |
At the end of the 10-week clerkship
|
|
Professional behavior score during the history-taking station
Tijdsspanne: At the end of the 10-week clerkship
|
Examiner-rated professional behavior during the history-taking OSCE station, on a 0-2 scale: 0, poor; 1, standard; 2, excellent. Higher scores indicate better professional behavior. Scores are compared between groups. |
At the end of the 10-week clerkship
|
|
Professional behavior score during the physical examination station
Tijdsspanne: At the end of the 10-week clerkship
|
Examiner-rated professional behavior during the physical examination OSCE station, on a 0-2 scale: 0, poor; 1, standard; 2, excellent. Higher scores indicate better professional behavior. Scores are compared between groups. |
At the end of the 10-week clerkship
|
|
Professional behavior score during the procedural skills station
Tijdsspanne: At the end of the 10-week clerkship
|
Examiner-rated professional behavior during the procedural skills OSCE station, on a 0-2 scale: 0, poor; 1, standard; 2, excellent. Higher scores indicate better professional behavior. Scores are compared between groups. |
At the end of the 10-week clerkship
|
|
Change in state anxiety from clerkship entry to the end-of-clerkship OSCE
Tijdsspanne: At clerkship entry and immediately before the end-of-clerkship OSCE, approximately 10 weeks later.
|
Change in the French State-Trait Anxiety Inventory state subscale (STAI-Y1) score, calculated as the score immediately before the final OSCE minus the score at clerkship entry. Each score ranges from 20 to 80. The change ranges from -60 to +60, with negative values indicating a reduction in anxiety. Changes are compared between groups. |
At clerkship entry and immediately before the end-of-clerkship OSCE, approximately 10 weeks later.
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 202300116
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .