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SimulationNCT05397756

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

A study testing observer tool in people with Simulation and Education, run by Université Paris-Sud at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Simulation, Education
What is being tested?
observer tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteFrance
Study dates
13 Jun 2022to 1 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • all anesthesiology residents of Paris participating in a full-day of crisis management training at the LabforSIMS-Faculty of Medicine Paris-Saclay

Who cannot join

  • declines active participation in the session
  • previously included in a CRM training session at LabforSIMS
  • no video-recorded

Trial locations and contacts

1 site in 1 country.

Antonia Blanié, MD PhD contact

33 1 45 21 34 47

antonia.blanie@aphp.fr

Dan Benhamou, MD Pr contact

33 1 45 21 34 47

dan.benhamou@aphp.fr

France1 site
  • LabForSIMS - Faculté de Médecine Paris Saclay

    Le Kremlin-Bicêtre, Île-de-France Region, 94275

    Antonia Blanié, MD PhD, 33 1 45 21 34 47, antonia.blanie@aphp.fr

    Dan Benhamou, MD Pr, 33 1 45 21 34 47, dan.benhamou@aphp.fr

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
observer tool
Keywords
simulation, education, observer tool, non-technical skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observer toolOther

    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

Study groups in NCT05397756
Study groupRoleWhat they receive
group (OT+)ExperimentalIn 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
Receives: Other: observer tool
group (OT-)No interventionIn this group (OT-), the resident will not be given the observer tool and will observe other residents without any physical support.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 min by video after the end of the session by an external evaluator

Secondary outcomes (4)
  1. 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))

    Measured: 10 min by video after the end of the session by an external evaluator

  2. 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

    Measured: 10 min by video after the end of the session by an external evaluator

  3. level of Satisfaction

    Satisfaction will be assessed by a Likert scale (0 to 10) (Kirkpatrick level 1)

    Measured: 1 min and the end of the session by all residents

  4. future professional impact

    The expected future professional impact of the training will be assessed by a Likert scale (0 to 10) (Kirkpatrick level 3)

    Measured: 1 min and the end of the session by all residents

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start13 Jun 2022 (estimated)
  3. Primary completion20 Jul 2022 (estimated)
  4. Study completion1 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment, not blinded, randomized study
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05397756
Sponsor's protocol ID
LabForSims-006
Status last verified
May 2022
First submitted
25 May 2022
Last updated
31 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing observer tool in people with Simulation and Education, run by Université Paris-Sud at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Antonia Blanié, MD PhD (33 1 45 21 34 47, antonia.blanie@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

individual performance of non-technical skills (time frame: 30 min by video after the end of the session by an external evaluator). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.

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