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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05397756
Other study ID # LabForSims-006
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 13, 2022
Est. completion date July 1, 2023

Study information

Verified date May 2022
Source Université Paris-Sud
Contact Antonia Blanié, MD PhD
Phone 33 1 45 21 34 47
Email antonia.blanie@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The use of simulation is recommended in anesthesiology education. Given a large number of residents, all of them will not be active participants during high-fidelity simulation sessions but will only be observers. To increase the positive effects of the simulation when the learner is in the role of observer, some authors have proposed to strengthen the educational effect through the use of an observer tool that observers must complete by analyzing the progress of the task performed by their colleagues. This is a list describing the set of key points to be achieved. However, data concerning the educational value of these observer tools are limited. Studies on the use of these tools during crisis management training in the operating room assessed by high-fidelity simulation have shown improved learning outcomes for technical skills but no study has evaluated yet their effect on non-technical skills. The effect on these skills can hardly be assessed by measuring the resident's perception or knowledge and an objective assessment of performance is necessary. The objective of this study will be to evaluate if using an observer tool (OT) dedicated to non-technical skills improves the learning of these skills in anesthesia residents during high-fidelity simulation.


Description:

The use of simulation is recommended in anesthesiology education. Given a large number of residents, all of them will not be active participants during high-fidelity simulation sessions but will only be observers. To increase the positive effects of the simulation when the learner is in the role of observer, some authors have proposed to strengthen the educational effect through the use of an observer tool that observers must complete by analyzing the progress of the task performed by their colleagues. This is a list describing the set of key points to be achieved. However, data concerning the educational value of these observer tools are limited. Studies on the use of these tools during crisis management training in the operating room assessed by high-fidelity simulation have shown improved learning outcomes for technical skills but no study has evaluated yet their effect on non-technical skills. The effect on these skills can hardly be assessed by measuring the resident's perception or knowledge and an objective assessment of performance is necessary. The objective of this study will be to evaluate if using an observer tool (OT) dedicated to non-technical skills improves the learning of these skills in anesthesia residents during high-fidelity simulation. This prospective and randomized study will be performed in the simulation center of Paris-Saclay University (LabForSIMS) during crisis management training of anesthesia residents. The high-fidelity based-simulation session is a full-day training with 5 different crisis scenarios. For each scenario, two residents will play the role of the senior anesthesiologist and the anesthesia resident respectively. A third resident will play the role of another senior anesthesiologist and will be called as a backup person. Participants will neither be aware in advance of the role they would be assigned nor of the scenario in which they would be involved. Observers will be seated in an adjacent room in which the scenario is broadcasted by live video transmission. After each scenario, all residents will participate to a debriefing with 2 instructors (experts in anesthesia and simulation). The debriefing will be carried out using the RAS method (reaction, analysis, and synthesis). The actors will be initially invited to give their feelings and emotions. Then the analysis phase will allow for a reflective analysis of the situation by encouraging active participants and observers to highlight the positive and negative points concerning technical and non-technical skills (defined by the educational objectives of each scenario. Decontextualization will then be promoted. The first 3 scenarios will focus on technical skills and the 2 others on technical and non-technical skills. Finally, the conclusion part will highlight the key educational objectives of each scenario. Anesthesia residents of the Paris area will be enrolled after having given their written consent and video copyright. Training days will be randomized according to the strategy used when residents will observe the simulation scenarios: - OT+ group: during the whole training day, the observers will use an observer tool (based on non-technical skills) when they will be not role role-playing - OT- group: no observer tool will be used The observer tool used will be the Anaesthetist Non-Technical Skills (ANTS) tool previously published by Fletcher et al. and translated in French. The ANTS scoring system uses four categories assessing task management, teamworking, situation awareness, and decision-making. It will only be used to reinforce learning and will not be used by the residents for summative evaluation. All the scenarios will be recorded and anonymously retained. The primary outcome will be the individual performance of non-technical skills assessed by the ANTS score measured by an external evaluator analyzing each video (scenario 1 = pre-test and scenarios 2,3,4 = post-test). The ANTS scoring system uses four categories assessing task management, teamworking, situation awareness, and decision-making (1 to 4 points by category). The minimum score is 4 and the maximum 16. During the first scenario, and whatever the randomization list, 3 residents will be active participants, and an analysis of their basic performance will be used as a pre-test. Then, depending on the randomization (use of OT or not), the observers will be given the ANTS (or not) tool for scenarios 1,2, and 3. Those residents who will be active participants in scenarios 2,3 or 4 will be assessed regarding their non-technical performance depending on whether they had used (or not) an OT when being in the role of observer in the previous scenarios. This design leads to the fact that some residents may have completed 1, 2, or 3 OTs prior to their active participation in a scenario (e.g. observers of scenarios 1 and 2 will be evaluated for their performance in Scenario 3). At the end of the day, a questionnaire will be filled out (via a QR code) by all residents in order to collect their personal characteristics and to analyze several secondary outcomes such as satisfaction and the expected future professional impact of the training.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date July 1, 2023
Est. primary completion date July 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - all anesthesiology residents of Paris participating in a full-day of crisis management training at the LabforSIMS-Faculty of Medicine Paris-Saclay Exclusion Criteria: - declines active participation in the session - previously included in a CRM training session at LabforSIMS - no video-recorded

Study Design


Related Conditions & MeSH terms


Intervention

Other:
observer tool
The observer tool used will be the Anaesthetist Non-Technical Skills (ANTS) tool previously published by Fletcher et al. and translated in French. The ANTS scoring system uses four categories assessing task management, teamworking, situation awareness and decision-making. The observers will use an observer tool it when they will be not role role-playing

Locations

Country Name City State
France LabForSIMS - Faculté de Médecine Paris Saclay Le Kremlin-Bicêtre Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Université Paris-Sud

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary individual performance of non-technical skills The primary outcome will be the individual performance of non-technical skills assessed by the ANTS score measured by an external evaluator analyzing each video (Kirkpatrick level 2) .
The Anaesthetist Non-Technical Skills (ANTS) tool previously published by Fletcher et al. translated in French. The ANTS scoring system uses four categories assessing task management, teamworking, situation awareness and decision-making (1 to 4 points by categories). The minimum score is 4 and the maximum 16.
30 min by video after the end of the session by an external evaluator
Secondary each category of the ANTS score Separate analysis of each categories of the ANTS score (task management, teamworking, situation awareness and decision-making (1 to 4 points by categories)) 10 min by video after the end of the session by an external evaluator
Secondary Team performance Team performance will be assessed by a Team performance observation tool published and translated in French by Maignan et al. (Kirkpatrick level 2) (0 to 4 points by items).
Number of OT used and degree of completeness
10 min by video after the end of the session by an external evaluator
Secondary level of Satisfaction Satisfaction will be assessed by a Likert scale (0 to 10) (Kirkpatrick level 1) 1 min and the end of the session by all residents
Secondary future professional impact The expected future professional impact of the training will be assessed by a Likert scale (0 to 10) (Kirkpatrick level 3) 1 min and the end of the session by all residents
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