NCT02804425

Brief Summary

The use of simulation in medical education has been associated with positive results in the acquisition of knowledge, skills, behaviors and in patient outcome. According to Kolb et al, high-fidelity simulation provides concrete experience that is the basis for self-reflection, further experimentation and immersive learning named experiential learning. However the important number of learners and the extensive human resources required to deliver mannequin patient-based simulation limit its use for initial and repeated training. In general, 2-4 trainees participate in each scenario while others may look at the progress of the scene through video transmission in a neighboring room while all trainees met thereafter for the debriefing. In typical learning sessions, all trainees act as a participant at least once. However, due to the increasing number of trainees, the investigators anticipate that some trainees might remain spectators during the whole simulation session. In our simulation unit (LabForSIMS- Faculté de Médecine Paris Sud), a simulation session for all third to forth year anesthesia residents (PGY3-4) of Ile de France has been established a few years ago. Each session includes a one-day training with 4 different immersive scenarios using a high fidelity mannequin. Each scenario is attended by 3 residents. In years before 2014, the number of anesthesia residents to be trained was 35 and each of them could play the role of an actor at least once in the session (actor-spectator). In a previous preliminary study, the investigators found that the learning outcomes were similar for all residents at the end of the day, whatever the scenario in which they had played and those scenarios for which they had remained spectators. This led to the hypothesis that being an actor in a scenario might be less important than attending the whole session and participating in all debriefings. However, to our knowledge, few study has explored the outcomes of the learning process for spectators-only. The number of residents sharply increased to 110 from 2014 to 2016. Due to time constraints and limitation in the number of trained teachers, the investigators see that inevitably, several trainees will remain spectators during the whole session. The purpose of this study is thus to determine whether the status of the learner (actor-spectator vs spectator-only) during an immersive simulation has an impact of learning outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

June 20, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

June 7, 2016

Last Update Submit

November 20, 2018

Conditions

Keywords

Medical EducationSimulationAnesthesia crisis managementLearning outcomes

Outcome Measures

Primary Outcomes (4)

  • Evaluation of learning: (1) Satisfaction (Kirkpatrick Level 1 )

    A satisfaction questionnaire will be recorded at the end of the simulation session (Likert scale (0 to 10)).

    3 months

  • Evaluation of learning: (2) Evaluation of medical knowledge (Kirkpatrick level 2)

    Before (pre test) and following (post test) the simulation one-day session, residents will complete a test of medical knowledge, indicating their role.

    3 months

  • Evaluation of learning: (3) Evaluation of non-technical skills (Kirkpatrick level 2)

    An auto evaluation questionnaire evaluating self perceived non-technical skills will be recorded at the end of the simulation one-day session (Likert scale (0 to 10)).

    3 months

  • Evaluation of learning: (4) Evaluation of changes in professional practice (Kirkpatrick Level 3)

    A questionnaire evaluating if the simulation program will modify professional practice will be recorded at the end of the simulation session (Likert scale (0 to 10)).

    3 months

Secondary Outcomes (1)

  • Learning retention: Evaluation of medical knowledge and non technical skills (Kirkpatrick level 2), and changes in professional practice (Kirkpatrick Level 3)

    4 months

Study Arms (2)

"actor-spectator" group

EXPERIMENTAL

actor at least once during the immersive simulation session

Other: actor-spectator

"spectator-only" group

NO INTERVENTION

observer during the whole one-day session but participation in the debriefing part of the four scenarios

Interventions

"actor-spectator" group : actor at least once during the simulation session

"actor-spectator" group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nd to 4rd year anesthesia (PGY3-PGY4) residents of Ile de France registered to the simulation session
  • And having agreed to participate

You may not qualify if:

  • Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (\< 18 years)
  • Refusal to participate in the study
  • Refusal to sign the confidentiality clause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculté de médecine Paris Sud

Le Kremlin-Bicêtre, 94275, France

Location

Study Officials

  • Antonia Blanie

    Faculté de médecine Paris Sud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 17, 2016

Study Start

June 20, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 23, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all participants for all primary and secondary outcomes will be available within 6 months of study completion

Locations