SimulationNCT03356717
Effect of an Observer Tool on Learning Outcomes During High Fidelity Simulation
A study testing educational intervention with observer tool and educational intervention in people with Simulation, run by Université Paris-Sud at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Simulation
- What is being tested?
- educational intervention with observer tool and educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2017to 30 Jun 2017
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- residents in anesthesia
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Use of an Observer Tool Based on Technical Skills on Learning Outcomes in Anesthesia Residents Undergoing High Fidelity Simulation
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.
Read more
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.
Read the 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.
- Conditions
- Simulation
- Being tested
- educational intervention with observer tool, educational intervention
- Keywords
- simulation, high-fidelity, observer tool; learning outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational intervention with observer toolBehavioural
To assess if the use of an observer tool by observers during high fidelity simulation improves learning outcomes
educational interventionBehavioural
without observer tool
| Study group | Role | What they receive |
|---|---|---|
| educational intervention - observer tool | Experimental | Participants in this arm will be given the observer tool (OT) before the scenario and will be explained how to use it, i.e. observe all details of the scenario on the screen and tick on the OT all actions which are done by active participants.The observer tool will also be used to engage observers during the debriefing session.
The scenario will then be observed in a screen (i.e. the scenario is played by active participants in an adjacent room using direct video-recording and transmission. Receives: Behavioral: educational intervention with observer tool |
| without observer tool | Active comparator | Participants in this arm will not be given the observer tool (OT) before the scenario but will be asked to observe all details of the scenario on the screen.The observers will also be asked to participate during the debriefing session. Receives: Behavioral: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning outcomes assessing knowledge of technical skills
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: change will be assessed
Measured: measured before and immediately after the session
Secondary outcomes (1)
self assessment of the effect of the simulation session on non-technical skills
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
Measured: measured immediately after the session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start23 Jun 2017
- Primary completion29 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- randomized study
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Paris-Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Benhamou, Université Paris-Sud
- Investigators
- BENHAMOU Dan, MD, Principal investigator, Université Paris-Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356717
- Sponsor's protocol ID
- UParis-Sud
- Status last verified
- Nov 2017
- First submitted
- 22 Jun 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26987738Suet 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.
PubMed 34120134
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of an Observer Tool Based on Technical Skills on Learning Outcomes in Anesthesia Residents Undergoing High Fidelity Simulation
- ClinicalTrials.gov ID
- NCT03356717
- Acronym / sponsor ID
- UParis-Sud
- Conditions
- Simulation
- Keywords
- simulation, high-fidelity, observer tool; learning outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Université Paris-SudUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 29 Nov 2017 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized study
| Arm | Type | Receives |
|---|---|---|
| educational intervention - observer tool | Experimental | Behavioral: educational intervention with observer toolParticipants in this arm will be given the observer tool (OT) before the scenario and will be explained how to use it, i.e. observe all details of the scenario on the screen and tick on the OT all actions which are done by active participants.The observer tool will also be used to engage observers during the debriefing session. The scenario will then be observed in a screen (i.e. the scenario is played by active participants in an adjacent room using direct video-recording and transmission. |
| without observer tool | Active comparator | Behavioral: educational interventionParticipants in this arm will not be given the observer tool (OT) before the scenario but will be asked to observe all details of the scenario on the screen.The observers will also be asked to participate during the debriefing session. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- residents in anesthesia
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| educational intervention with observer toolTo assess if the use of an observer tool by observers during high fidelity simulation improves learning outcomes | Behavioural | educational intervention - observer tool |
| educational interventionwithout observer tool | Behavioural | without observer tool |
Primary outcome
Learning outcomes assessing knowledge of technical skills
Time frame: measured before and immediately after the session
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: change will be assessed
1 secondary outcome
self assessment of the effect of the simulation session on non-technical skills
Time frame: measured immediately after the session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Background: PubMed 26987738Lai 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.
- Derived from this study: PubMed 34120134Suet 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.
- Observer roles that optimise learning in healthcare simulation education: a systematic review. O'Regan et al. Advances in Simulation (2016) 1:4Link provided by the sponsor.
- 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.
BENHAMOU Dan, MD principal investigator
Université Paris-Sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention with observer tool and educational intervention in people with Simulation, 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 1 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: finished, as of the sponsor's last update on 29 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning outcomes assessing knowledge of technical skills (time frame: measured before and immediately after the session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356717, which also lists 2 linked publications.
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 29 Nov 2017.