Clinical trial NCT03356717: Effect of an Observer Tool on Learning Outcomes During High Fidelity Simulation
Official title: Impact of the Use of an Observer Tool Based on Technical Skills on Learning Outcomes in Anesthesia Residents Undergoing High Fidelity Simulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Simulation
Keywords: simulation, high-fidelity, observer tool; learning outcomes
Lead sponsor: Université Paris-Sud
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 89
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized study
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

residents in anesthesia

Exclusion Criteria:

none

Primary outcomes:
measure: Learning outcomes assessing knowledge of technical skills
timeFrame: measured before and immediately after the session
Secondary outcomes:
measure: self assessment of the effect of the simulation session on non-technical skills
timeFrame: measured immediately after the session
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Université Paris Sud
Study officials:
affiliation: Université Paris-Sud
name: BENHAMOU Dan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.