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.
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.
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
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.
- Conditions
- Simulation, Education
- 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 group | Role | What they receive |
|---|---|---|
| group (OT+) | Experimental | 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 Receives: Other: observer tool |
| group (OT-) | No intervention | In 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.
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)
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
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
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
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.
- First posted31 May 2022
- Study start13 Jun 2022 (estimated)
- Primary completion20 Jul 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Université Paris-Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Blanié, MD PhD, Principal investigator, LabForSIMS - Faculté de Médecine Paris Saclay
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
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05397756
- Acronym / sponsor ID
- LabForSims-006
- Conditions
- Simulation, Education
- Keywords
- simulation, education, observer tool, non-technical skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Université Paris-SudUniversity, hospital or other
- Study start
- 13 Jun 2022 (estimated)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment, not blinded, randomized study
| Arm | Type | Receives |
|---|---|---|
| group (OT+) | Experimental | Other: observer toolIn 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 |
| group (OT-) | No intervention | –In this group (OT-), the resident will not be given the observer tool and will observe other residents without any physical support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all anesthesiology residents of Paris participating in a full-day of crisis management training at the LabforSIMS-Faculty of Medicine Paris-Saclay
Key exclusion criteria (3 listed)
- declines active participation in the session
- previously included in a CRM training session at LabforSIMS
- no video-recorded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observer toolThe 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 | Other | group (OT+) |
Primary outcome
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.
4 secondary outcomes
each category of the ANTS score
Time frame: 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
level of Satisfaction
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia Blanié, MD PhD principal investigator
LabForSIMS - Faculté de Médecine Paris Saclay
1 site in 1 country: see every site and its status.
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.