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NCT03356717 Clinical Trial

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

Simulation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03356717
Other study ID # UParis-Sud
Secondary ID
Status Completed
Phase N/A
First received June 22, 2017
Last updated November 28, 2017
Start date June 23, 2017
Est. completion date June 30, 2017

Study information
Verified date November 2017
Source Université Paris-Sud
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 89
Est. completion date June 30, 2017
Est. primary completion date June 29, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

residents in anesthesia

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• educational intervention with observer tool
To assess if the use of an observer tool by observers during high fidelity simulation improves learning outcomes
• educational intervention
without observer tool

Locations
Country Name City State
France Université Paris Sud Le Kremlin-Bicêtre

Sponsors (1)
Lead Sponsor Collaborator
Université Paris-Sud

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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