Effect of an Observer Tool on Learning Outcomes During High Fidelity Simulation

Impact of the Use of an Observer Tool Based on Technical Skills on Learning Outcomes in Anesthesia Residents Undergoing High Fidelity Simulation

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.

Study Overview

• Status: Completed
• Conditions: Simulation
• Intervention / Treatment: Behavioral: educational intervention with observer tool; Behavioral: educational intervention

Detailed Description

The increasing use of high-fidelity simulation in France during the anesthesia curriculum 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. This leads to a new situation in which not all residents can be an active participant in scenarios with some remaining observers all along the simulation sessions. Based on Kolb experiential theory, this situation should lead to a decreased knowledge acquisition. Previous studies have however 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, after informed consent will be obtained, 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. In addition, self-efficacy of the simulation sessions will be explored through the responses to additional questionnaires evaluating the change in non-technical skills after the sessions.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94275
    • Université Paris Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

residents in anesthesia

Exclusion Criteria:

none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: educational intervention - observer tool; 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; To assess if the use of an observer tool by observers during high fidelity simulation improves learning outcomes
Active Comparator: without observer tool; 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; without observer tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
self assessment of the effect of the simulation session on non-technical skills	Self-efficacy of the simulation sessions will be explored through the responses to additional questionnaires evaluating the change in non-technical skills after the sessions	measured immediately after the session

Collaborators and Investigators

• Sponsor: Université Paris-Sud
• Investigators: Principal Investigator: BENHAMOU Dan, MD, Université Paris-Sud

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Observer roles that optimise learning in healthcare simulation education: a systematic review. O'Regan et al. Advances in Simulation (2016) 1:4

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2017
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: simulation, high-fidelity, observer tool; learning outcomes
• Other Study ID Numbers: UParis-Sud

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No