Effect of the Training Toolbox in the Emergency Medecine on Medical Students' Performance in the Objective Structured Clinical Examination in France : a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Overall end-of-clerkship objective structured clinical examination score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single masking: OSCE outcome assessors were unaware of cluster allocation and had not delivered the ECOX intervention. Students and teachers were not blinded. The investigator enrolling students knew the allocation sequence. Masking applied to examiner-rated OSCE outcomes; self-reported anxiety was collected from unblinded participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: ECOX workplace-based training toolbox (Other)
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.
结局指标
主要结局
Overall end-of-clerkship objective structured clinical examination score
时间窗: 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.
evaluate the value of the ECOX tool in improving the final grade for service OSCE compared with standard learning during the training course.
时间窗: 10 weeks
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.
次要结局
- State anxiety immediately before the end-of-clerkship OSCE(Immediately before the end-of-clerkship OSCE, at approximately 10 weeks)
- Describing the OSCE tool versus control of psychological status prior to OSCE(10 weeks)
- Evaluate the OSCE tool versus control of student know-how(10 weeks)
研究者
Nicolas RIFFET-VIDAL
Responsable DRCI
University Hospital, Angers