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- Ensaio Clínico NCT07570134
Simulation-Based Interprofessional Education for Operating Room Teams (Surgical IPE)
Simulation-Based Interprofessional Education for Surgical Residents: A Prospective Study Design for Team-Based Competency Development
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Effective teamwork and communication among operating room team members are important for patient safety and perioperative care. However, early-career surgical residents and nursing staff may have limited opportunities to learn team-based competencies together in a structured, interprofessional format. This study is a single-center, prospective, single-arm pilot study designed to evaluate the feasibility and preliminary educational effects of a simulation-based interprofessional education program for operating room teams. Eligible participants will be assigned to interprofessional teams consisting of surgical residents, anesthesia nurse practitioners, and operating room nurses. The educational intervention will include two simulation-based sessions conducted during the study period. Each session will last approximately 60 minutes and will include a scenario-based team exercise followed by structured debriefing. Representative scenario themes may include operating room safety events, communication challenges, equipment or instrument-related events, and intraoperative crisis management. The primary outcome is the change in teamwork self-efficacy from baseline to Week 7, assessed using a 15-item interprofessional teamwork self-efficacy questionnaire. Secondary outcomes include the change in readiness for interprofessional learning, assessed using the Readiness for Interprofessional Learning Scale, and program completion rate. Optional semi-structured interviews may be conducted after completion of the educational sessions to explore participants' perceptions of the program, perceived relevance to clinical practice, and suggestions for improvement.
Interview participation and audio recording, if performed, will be optional and based on separate consent. No investigational drug, biologic product, or medical device will be used in this study.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jeehye Lee, MD
- Número de telefone: +82-31-5189-8966
- E-mail: jlee0531@yuhs.ac
Locais de estudo
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Gyeonggi-do
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Yongin-si, Gyeonggi-do, Coréia do Sul, 16995
- Yonsei University Yongin Severance Hospital
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Contato:
- Jeehye Lee, MD
- Número de telefone: +82-31-5189-8966
- E-mail: jlee0531@yuhs.ac
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults aged 19 years or older.
- Affiliated with Yongin Severance Hospital and meeting one of the following criteria:
- Postgraduate year 1-2 surgical resident;
- Newly appointed anesthesia nurse practitioner with less than 6 months of experience in the relevant role;
- Newly appointed operating room nurse with less than 6 months of operating room experience.
- Able to participate in the planned study procedures during the study period.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Individuals who do not provide written informed consent.
- Individuals who are unable to complete the baseline or post-intervention questionnaires.
- Individuals whose rotation, leave of absence, resignation, transfer, or work schedule change makes participation in the study procedures infeasible.
- Individuals judged by the investigator to be inappropriate for study participation.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Simulation-Based Interprofessional Education
Participants assigned to this single study arm will receive two simulation-based interprofessional education sessions during the study period.
Each session will include a scenario-based operating room team exercise and structured debriefing focused on teamwork, role clarity, communication, situational awareness, and collaboration.
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The intervention consists of two 60-minute simulationbased interprofessional education sessions for operating room team members.
Each session includes a representative operating room scenario and structured debriefing.
Debriefing topics include role clarity, shared mental model, situational awareness, open communication, cross-monitoring, mutual respect, and application to clinical practice.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in teamwork selfefficacy score
Prazo: Baseline and Week 7
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Teamwork self-efficacy will be assessed using a 15-item interprofessional teamwork selfefficacy questionnaire.
Each item is scored on a 6-point Likert-type scale, with higher scores indicating greater confidence in team-based competencies.
The outcome will be calculated as the change in total score from baseline to Week 7.
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Baseline and Week 7
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in readiness for interprofessional learning score
Prazo: Baseline and Week 7
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Readiness for interprofessional learning will be assessed using the 19-item Readiness for Interprofessional Learning Scale.
Items are scored on a 5- point Likert scale, and reverseworded items will be recoded according to the scoring plan.
Higher adjusted scores indicate greater readiness for interprofessional learning.
The outcome will be calculated as the change in overall score from baseline to Week 7.
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Baseline and Week 7
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Program completion rate
Prazo: Through Week 7
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Program completion rate will be calculated as the proportion of enrolled participants who complete the baseline assessment, two simulationbased education sessions, and Week 7 post-intervention assessment.
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Through Week 7
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeehye Lee, MD, Yonsei University Yongin Severance Hospital
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
- Surgical-IPE-001
- 6-2025-0077 (Número de outro subsídio/financiamento: Yonsei University College of Medicine)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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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 .