- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07679672
Simulation-Based Learning on Clinical Reasoning, Knowledge Retention, and Transfer in Undergraduate Medical Education (SIMCORE)
Does Video-Based Patient Simulation Improve Clinical Reasoning Skills in Medical Students?
This randomized controlled trial evaluates whether a digital, video-based clinical-reasoning simulation improves clinical-reasoning performance compared with conventional lecture-based teaching across multiple clinical disciplines, including orthopedics and ophthalmology.
Within each discipline, participants are randomly allocated 1:1 to an intervention group or a control group. The intervention group learns the assigned topic through an interactive, web-based simulation built on real patient video cases with structured clinical-reasoning steps. The control group receives the same learning objectives and content through a standard didactic lecture, over a comparable duration.
After the learning session, all participants complete the same set of standardized clinical scenarios, scored with a predefined rubric. The primary outcome is the post-intervention clinical-reasoning score. Secondary outcomes include diagnostic accuracy, confidence, and satisfaction.
The trial uses a shared protocol across discipline-specific cohorts to allow consistent, pre-specified comparison of simulation-based versus lecture-based instruction.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Background. Clinical reasoning is a core competency across medical disciplines, yet traditional lectures offer limited interactive practice. A digital simulation using authentic patient cases may strengthen reasoning, but comparative evidence is limited.
Objective. To compare a digital, video-based clinical-reasoning simulation with conventional lecture-based teaching on clinical-reasoning performance, using a single shared design applied across discipline-specific cohorts (e.g., orthopedics, ophthalmology, paediatrics).
Design. Single-center, parallel-group, two-arm randomized controlled trial with 1:1 allocation, replicated as pre-specified cohorts by clinical discipline under one common protocol.
Participants. Eligible learners (medical students / residents) within each discipline-specific cohort at primarily Altinbas University.
Randomization. Computer-generated 1:1 randomization performed separately within each cohort; outcome assessors blinded to allocation.
Interventions. Intervention - interactive, web-based clinical-reasoning simulation using real patient video cases with structured reasoning steps. Control - didactic lecture delivering identical learning objectives and content over a comparable duration.
Outcomes. Primary - post-intervention clinical-reasoning score on standardized scenarios rated with a predefined rubric. Secondary - diagnostic accuracy, participant confidence, satisfaction.
Cohorts & analysis. Each discipline-specific cohort is analyzed separately with an independent-samples t-test; inter-rater reliability assessed where applicable. Total target enrollment (n=250) across all cohorts.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Istanbul, Turquia (Türkiye)
- Altinbas University MP Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Enrolled as a [final-year medical student / resident] in the relevant discipline (orthopedics or ophthalmology) at the participating institution
- Completed the baseline orientation and agreed to participate
- Available for the full learning session and the post-session assessment
Exclusion Criteria:
- Prior completion of the same simulation module or equivalent structured training on the topic
- Did not complete the assigned learning session
- Incomplete post-session assessment data
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Simulation
Interactive, web-based clinical-reasoning simulation built on real patient video cases.
Learners actively work through structured decision points (history, examination, differential diagnosis, investigation, management) and receive immediate feedback.
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Interactive, web-based clinical-reasoning simulation built on real patient video cases.
Learners actively work through structured decision points (history, examination, differential diagnosis, investigation, management) and receive immediate feedback.
Outros nomes:
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Comparador Ativo: Lecture
Instructor-led didactic lecture delivering identical learning objectives through expert explanation and slides.
Learners receive content passively, without interactive decision steps or video-based case progression.
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Instructor-led didactic lecture delivering identical learning objectives through expert explanation and slides.
Learners receive content passively, without interactive decision steps or video-based case progression.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Clinical-reasoning performance score
Prazo: Immediately after the learning session (same day)
|
Performance on a set of standardized clinical scenarios completed after the learning session, rated with a predefined scoring rubric.
Higher scores indicate better clinical-reasoning performance.
Assessed separately within each discipline-specific cohort.
Scored using the five-domain Clinical Reasoning Score System; total range 0-100, with higher scores indicating better clinical-reasoning performance.
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Immediately after the learning session (same day)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Diagnostic accuracy
Prazo: Immediately after the learning session (same day)
|
Proportion of standardized scenarios in which the participant reached the correct diagnosis, scored against a predefined answer key.
Reported as the percentage of scenarios with a correct diagnosis (0-100%); higher values indicate better performance.
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Immediately after the learning session (same day)
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Participant confidence
Prazo: Immediately after the learning session (same day)
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Self-reported confidence in clinical decision-making, measured on a structured rating scale after the session.
Measured on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree); higher scores indicate greater confidence.
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Immediately after the learning session (same day)
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Participant satisfaction
Prazo: Immediately after the learning session (same day)
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Self-reported satisfaction with the learning method, measured on a structured rating scale after the session.
Measured on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree); higher scores indicate greater satisfaction.
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Immediately after the learning session (same day)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Omer Tontus, MD
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- Altinbas
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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