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Sürgősségi strukturált klinikai vizsgálati tréningdoboz (ECOX)

2026. szeptember 21. frissítette: Nicolas RIFFET-VIDAL, University Hospital, Angers

Az ECOX oktatóeszköz használatának hatása a sürgősségi osztályon az EBESZ orvostanhallgatók számára: 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.

A tanulmány áttekintése

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

310

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Egyéb
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.

Nincs beavatkozás: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Overall end-of-clerkship objective structured clinical examination score
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
State anxiety immediately before the end-of-clerkship OSCE
Időkeret: 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

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Overall professional behavior score at the end-of-clerkship OSCE
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2023. november 7.

Elsődleges befejezés (Tényleges)

2025. október 31.

A tanulmány befejezése (Tényleges)

2025. november 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2023. november 3.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2023. november 3.

Első közzététel (Tényleges)

2023. november 9.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 24.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 21.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

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