- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mhamed Sami Mebazaa, professor
- Número de telefone: 00216 22252589
- E-mail: msmebazaa@gmail.com
Estude backup de contato
- Nome: Ben Haj youssef, assistant
- Número de telefone: 00216 96874336
- E-mail: amani.benhajyoussef@fmt.utm.tn
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
students' overall performance
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Scores for each domain
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- Simulated mini-CEX
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .