NCT03356717

Brief Summary

The increasing use of high-fidelity simulation is limited by the imbalance between the growing number of students and the human resources available in such a way that all residents cannot play a role during scenarios. The learning outcomes of observers need to be studied in more depth. Previous studies have provided controversial results but overall no significant differences in learning outcomes can be demonstrated between observers and participants engaged as players in scenarios. Moreover, preliminary data suggest that learning outcomes of observers might be improved by using an observer tool during the scenario. However, no high-quality study has yet shown if this assumption is verified. In the present study, 3rd-4th year residents in anesthesia will be randomized before high fidelity scenarios to act as observers only or active participants in some scenarios and observers in others. The main outcome parameter will be the learning outcomes by comparing data obtained before and after the sessions by using questionnaires specifically dedicated to the knowledge of technical skills in the management of crisis scenarios.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 23, 2017

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

6 days

First QC Date

June 22, 2017

Last Update Submit

November 28, 2017

Conditions

Keywords

simulation, high-fidelity, observer tool; learning outcomes

Outcome Measures

Primary Outcomes (1)

  • Learning outcomes assessing knowledge of technical skills

    The main outcome parameter will be the learning outcomes by comparing data obtained before and after the sessions by using questionnaires specifically dedicated to the knowledge of technical skills in the management of crisis scenarios: change will be assessed

    measured before and immediately after the session

Secondary Outcomes (1)

  • self assessment of the effect of the simulation session on non-technical skills

    measured immediately after the session

Study Arms (2)

educational intervention - observer tool

EXPERIMENTAL

Participants in this arm will be given the observer tool (OT) before the scenario and will be explained how to use it, i.e. observe all details of the scenario on the screen and tick on the OT all actions which are done by active participants.The observer tool will also be used to engage observers during the debriefing session. The scenario will then be observed in a screen (i.e. the scenario is played by active participants in an adjacent room using direct video-recording and transmission.

Behavioral: educational intervention with observer tool

without observer tool

ACTIVE COMPARATOR

Participants in this arm will not be given the observer tool (OT) before the scenario but will be asked to observe all details of the scenario on the screen.The observers will also be asked to participate during the debriefing session.

Behavioral: educational intervention

Interventions

To assess if the use of an observer tool by observers during high fidelity simulation improves learning outcomes

educational intervention - observer tool

without observer tool

without observer tool

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • residents in anesthesia

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Paris Sud

Le Kremlin-Bicêtre, 94275, France

Location

Related Publications (2)

  • Lai A, Haligua A, Dylan Bould M, Everett T, Gale M, Pigford AA, Boet S. Learning crisis resource management: Practicing versus an observational role in simulation training - a randomized controlled trial. Anaesth Crit Care Pain Med. 2016 Aug;35(4):275-81. doi: 10.1016/j.accpm.2015.10.010. Epub 2016 Mar 14.

    PMID: 26987738BACKGROUND
  • Suet G, Blanie A, De Montblanc J, Benhamou D. Use of an Observer Tool to Enhance Observers' Learning of Anesthesia Residents During High-Fidelity Simulation: A Randomized Controlled Trial. Simul Healthc. 2022 Feb 1;17(1):e75-e82. doi: 10.1097/SIH.0000000000000584.

Related Links

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • BENHAMOU Dan, MD

    Université Paris-Sud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and Intensive Care Medicine, Chair of the simulation center

Study Record Dates

First Submitted

June 22, 2017

First Posted

November 29, 2017

Study Start

June 23, 2017

Primary Completion

June 29, 2017

Study Completion

June 30, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations