- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07663760
Impact of a Simulated Mini-CEX on Clinical Performance During a Real-World Mini-CEX
Impact of a Simulated Mini-CEX on Clinical Performance During a Real-World Mini-CEX: A Multicenter Study in Anesthesiology and Intensive Care Medicine
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mhamed Sami Mebazaa, professor
- Número de teléfono: 00216 22252589
- Correo electrónico: msmebazaa@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ben Haj youssef, assistant
- Número de teléfono: 00216 96874336
- Correo electrónico: amani.benhajyoussef@fmt.utm.tn
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Fifth-year medical students (DCEM3) enrolled at the Faculty of Medicine of Tunis within the acute medicine program.
- Students completing their clinical clerkship during the second semester of the 2025-2026 academic year in one of the three participating anesthesiology and intensive care departments.
- Students who voluntarily agree to participate and have provided written informed consent.
Exclusion Criteria:
- Students who do not complete the entire educational curriculum (absence from either of the two assessments).
- Students who have already received similar training.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: DCEM3 students
Fifth-year medical students in the second cycle during their internship in anesthesiology and intensive care.
|
Mini-CEX educational assessment during pre-anesthetic consultation: Volunteer fifth-year medical students were assessed by trained anesthesiology faculty using the mini-CEX tool.
The intervention consisted of a structured two-step assessment of pre-anesthetic consultation: a standardized simulation followed by a real clinical encounter.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
students' overall performance
Periodo de tiempo: Through study completion, up to 4 weeks
|
measured by the mean score on the Mini-CEX checklist, compared between simulated consultation and real consultation. The overall performance is assessed using the unabbreviated Mini-Clinical Evaluation Exercise (Mini-CEX) checklist. The global score is measured on a 9-point Likert scale, ranging from 1 (insufficient/unsatisfactory performance) to 9 (exceptional/exemplary performance). Higher scores indicate a better clinical performance and greater student autonomy. |
Through study completion, up to 4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Scores for each domain
Periodo de tiempo: at the and of each Mini-CEX , Through study completion, up to 4 weeks
|
Scores for each domain (history taking, physical examination, clinical judgment, communication skills, professionalism, organization and efficiency, and overall clinical performance).
Measured by the Mini-Clinical Evaluation Exercise (Mini-CEX) checklist, compared between the simulated consultation (baseline) and the real clinical consultation.
The checklist uses a 9-point Likert scale where 1 represents the lowest performance (insufficient) and 9 represents the highest performance (exceptional).
Higher scores indicate a better clinical outcome.
|
at the and of each Mini-CEX , Through study completion, up to 4 weeks
|
|
Inter-rater reproducibility of Mini-CEX
Periodo de tiempo: at the end of the simulated Mini-CEx, Through study completion, up to 4 weeks
|
Inter-rater reproducibility was evaluated using the Intraclass Correlation Coefficient (ICC
|
at the end of the simulated Mini-CEx, Through study completion, up to 4 weeks
|
|
Individual performance gain
Periodo de tiempo: at the end of the internship, Through study completion, up to 4 weeks
|
Individual performance gain (delta between simulated and real Mini-CEX scores) Calculated as the change score between the real clinical consultation and the simulated consultation (Real score minus Simulated score) using the unabbreviated Mini-Clinical Evaluation Exercise (Mini-CEX).
The original Mini-CEX scale ranges from a minimum value of 1 (insufficient performance) to a maximum value of 9 (exceptional performance).
The resulting performance gain score ranges from -8 to +8.
A higher or positive score indicates a better outcome (improvement/performance gain), a score of 0 indicates no change, and a negative score indicates a decrease in performance.
|
at the end of the internship, Through study completion, up to 4 weeks
|
|
Learner and faculty satisfaction
Periodo de tiempo: at the end of internship, Through study completion, up to 4 weeks
|
Learner and faculty satisfaction, as well as their recommendation for the use of the Mini-CEX throughout the curriculum, assessed using a Likert scale.
Assessed via a post-internship questionnaire completed by both students (learners) and professors (faculty) regarding their satisfaction with the Mini-Clinical Evaluation Exercise (Mini-CEX) and their recommendation for its integration throughout the curriculum.
Responses are evaluated on a 5-point Likert scale, ranging from a minimum score of 1 (Strongly disagree / Very dissatisfied) to a maximum score of 5 (Strongly agree / Very satisfied).
Higher scores indicate a better outcome, representing higher levels of satisfaction and a stronger recommendation for curriculum implementation.
|
at the end of internship, Through study completion, up to 4 weeks
|
|
The time required to complete the consultation
Periodo de tiempo: at the end of each Mini-Cex, Through study completion, up to 4 weeks
|
The time required to complete the consultation (measured in minutes)
|
at the end of each Mini-Cex, Through study completion, up to 4 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Simulated mini-CEX
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .