- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT06124430
БЛОК для обучения проведению экстренного структурированного клинического обследования (ECOX)
Влияние использования учебного пособия ECOX в отделении неотложной помощи на ОСС для студентов-медиков: рандомизированное контролируемое исследование
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Angers, Франция, 49000
- CHU Angers
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
|
Без вмешательства: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall end-of-clerkship objective structured clinical examination score
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
State anxiety immediately before the end-of-clerkship OSCE
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall professional behavior score at the end-of-clerkship OSCE
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 202300116
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