Use of an Observer Tool and Learning of Non-technical Skills

May 25, 2022 updated by: Université Paris-Sud

Use of an Observer Tool to Improve the Learning of Non-technical Skills of Anesthesia Residents Observing High-fidelity Simulation Training Sessions: a Randomized Controlled Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ile De France
      • Le Kremlin-Bicêtre, Ile De France, France, 94275
        • LabForSIMS - Faculté de Médecine Paris Saclay
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonia Blanié, MD PhD
        • Sub-Investigator:
          • Dan Benhamou, MD Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group (OT+)
In this group (OT +), 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
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
NO_INTERVENTION: group (OT-)
In this group (OT-), the resident will not be given the observer tool and will observe other residents without any physical support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
individual performance of non-technical skills
Time Frame: 30 min by video after the end of the session by an external evaluator

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
each category of the ANTS score
Time Frame: 10 min by video after the end of the session by an external evaluator
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
Team performance
Time Frame: 10 min by video after the end of the session by an external evaluator

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
level of Satisfaction
Time Frame: 1 min and the end of the session by all residents
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
future professional impact
Time Frame: 1 min and the end of the session by all residents
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Antonia Blanié, MD PhD, LabForSIMS - Faculté de Médecine Paris Saclay

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 13, 2022

Primary Completion (ANTICIPATED)

July 20, 2022

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (ACTUAL)

May 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • LabForSims-006

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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