- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jeehye Lee, MD
- Numéro de téléphone: +82-31-5189-8966
- E-mail: jlee0531@yuhs.ac
Lieux d'étude
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Gyeonggi-do
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Yongin-si, Gyeonggi-do, Corée du Sud, 16995
- Yonsei University Yongin Severance Hospital
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Contact:
- Jeehye Lee, MD
- Numéro de téléphone: +82-31-5189-8966
- E-mail: jlee0531@yuhs.ac
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in teamwork selfefficacy score
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in readiness for interprofessional learning score
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jeehye Lee, MD, Yonsei University Yongin Severance Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- Surgical-IPE-001
- 6-2025-0077 (Autre subvention/numéro de financement: Yonsei University College of Medicine)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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