- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jeehye Lee, MD
- Telefonnummer: +82-31-5189-8966
- E-mail: jlee0531@yuhs.ac
Studiesteder
-
-
Gyeonggi-do
-
Yongin-si, Gyeonggi-do, Sydkorea, 16995
- Yonsei University Yongin Severance Hospital
-
Kontakt:
- Jeehye Lee, MD
- Telefonnummer: +82-31-5189-8966
- E-mail: jlee0531@yuhs.ac
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in teamwork selfefficacy score
Tidsramme: Baseline and Week 7
|
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.
|
Baseline and Week 7
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in readiness for interprofessional learning score
Tidsramme: Baseline and Week 7
|
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.
|
Baseline and Week 7
|
|
Program completion rate
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jeehye Lee, MD, Yonsei University Yongin Severance Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Surgical-IPE-001
- 6-2025-0077 (Andet bevillings-/finansieringsnummer: Yonsei University College of Medicine)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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