in Situ SimulationNCT04922203
Transfer of Non-technical Skills From Simulation to Clinical Practice
A study testing in Situ Simulation in people with in Situ Simulation, run by Jean François Brichant at 1 site in Belgium.
Trial summary
Since 1988, simulation has been proposed as a teaching tool in Anesthesia. The simulation environment allows to teach learners non-technical skills which are a combination of cognitive, social, and personal resources complementary to procedural skills that contribute to an efficient and safe performance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- in Situ Simulation
- What is being tested?
- in Situ Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 28 May 2021to 30 Sep 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Internship in the ambulatory surgery unit
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are the Non Technical Skills Taught to Residents in Anesthesiology During in Situ Simulation Sessions Transferred to Clinical Practice
Since 1988, simulation has been proposed as a teaching tool in Anesthesia. The simulation environment allows to teach learners non-technical skills which are a combination of cognitive, social, and personal resources complementary to procedural skills that contribute to an efficient and safe performance.
Non-technical skills traditionally used in Anesthesia are task management, situational awareness, teamwork and decision making. They can be indirectly measured with validated scales (e.g. Anesthesia Non-Technical Skills (ANTS) system). In addition to these basic skills, specific skills such as Anesthesia Crisis Resource Management (ACRM) are required when the patient presents a critical clinical situation.
Read more
Simulation, as proposed by Gaba, was initially practiced in centers specifically designed for this purpose. More recently, we have proposed the model of in situ simulation, i.e. in the usual workplace with the usual work team, as another option for the practice of simulation.
There are many theories about the transfer of learning. Transfer can be defined as what remains of the completed training that the learner actually uses, i.e. the final real effect.
Nevertheless, almost 30 years after the introduction of simulation in the training of anesthesiologists, data demonstrating the interest of this teaching in terms of transfer of learning of non-technical skills to clinical practice or benefits for patients are rare.
The main objective of this study is to evaluate the transfer of non-technical skills taught in a training program including in situ simulation to clinical practice by anesthesiology residents.
- Conditions
- in Situ Simulation
- Being tested
- in Situ Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in Situ SimulationOther
2 sessions of in situ simulation with 4 crisis scenarios and debriefing focused on non technical skills
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Anesthesiology residents do not receive any in situ simulation sessions during the observation period |
| Simulation group | Experimental | Anesthesiology residents receive in situ simulations sessions during the observation period Receives: Other: in Situ Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANTS (Anesthesia non technical skills) score
15 items - From 1(poor) to 4 (good) for each item - Minimum 15 - Maximum 60
Measured: Once a day for 5 consecutive days between the first and the 15th day after enrollment in the study
ANTS (Anesthesia non technical skills) score
15 items - From 1(poor) to 4 (good) for each item - Minimum 15 - Maximum 60
Measured: Once a day for 5 consecutive days between the 30th and 45th day after enrollment
ANTS (Anesthesia non technical skills) score
15 items - From 1(poor) to 4 (good) for each item - Minimum 15 - Maximum 60
Measured: Once a day for 5 consecutive days between the 3rd and the 4th month after enrollment
Secondary outcomes (3)
DOPS (Direct Observation of Procedural Skills) scale
Measured: Once within the first 15 days of enrollment
DOPS (Direct Observation of Procedural Skills) scale
Measured: Once between the 30th and the 45th day after enrollment
DOPS (Direct Observation of Procedural Skills) scale
Measured: Once between the 3rd and the 4th month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start28 May 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Situ 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jean François Brichant
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922203
- Sponsor's protocol ID
- 2018-71
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are the Non Technical Skills Taught to Residents in Anesthesiology During in Situ Simulation Sessions Transferred to Clinical Practice
- ClinicalTrials.gov ID
- NCT04922203
- Acronym / sponsor ID
- 2018-71
- Conditions
- in Situ Simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jean François BrichantUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 10 Jun 2021 (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.
Since 1988, simulation has been proposed as a teaching tool in Anesthesia. The simulation environment allows to teach learners non-technical skills which are a combination of cognitive, social, and personal resources complementary to procedural skills that contribute to an efficient and safe performance.
Non-technical skills traditionally used in Anesthesia are task management, situational awareness, teamwork and decision making. They can be indirectly measured with validated scales (e.g. Anesthesia Non-Technical Skills (ANTS) system). In addition to these basic skills, specific skills such as Anesthesia Crisis Resource Management (ACRM) are required when the patient presents a critical clinical situation.
Simulation, as proposed by Gaba, was initially practiced in centers specifically designed for this purpose. More recently, we have proposed the model of in situ simulation, i.e. in the usual workplace with the usual work team, as another option for the practice of simulation.
There are many theories about the transfer of learning. Transfer can be defined as what remains of the completed training that the learner actually uses, i.e. the final real effect.
Nevertheless, almost 30 years after the introduction of simulation in the training of anesthesiologists, data demonstrating the interest of this teaching in terms of transfer of learning of non-technical skills to clinical practice or benefits for patients are rare.
The main objective of this study is to evaluate the transfer of non-technical skills taught in a training program including in situ simulation to clinical practice by anesthesiology residents.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Anesthesiology residents do not receive any in situ simulation sessions during the observation period |
| Simulation group | Experimental | Other: in Situ SimulationAnesthesiology residents receive in situ simulations sessions during the observation period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Internship in the ambulatory surgery unit
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| in Situ Simulation2 sessions of in situ simulation with 4 crisis scenarios and debriefing focused on non technical skills | Other | Simulation group |
Primary outcome
ANTS (Anesthesia non technical skills) score
Time frame: Once a day for 5 consecutive days between the first and the 15th day after enrollment in the study
15 items - From 1(poor) to 4 (good) for each item - Minimum 15 - Maximum 60
ANTS (Anesthesia non technical skills) score
Time frame: Once a day for 5 consecutive days between the 30th and 45th day after enrollment
15 items - From 1(poor) to 4 (good) for each item - Minimum 15 - Maximum 60
ANTS (Anesthesia non technical skills) score
Time frame: Once a day for 5 consecutive days between the 3rd and the 4th month after enrollment
15 items - From 1(poor) to 4 (good) for each item - Minimum 15 - Maximum 60
3 secondary outcomes
DOPS (Direct Observation of Procedural Skills) scale
Time frame: Once within the first 15 days of enrollment
DOPS (Direct Observation of Procedural Skills) scale
Time frame: Once between the 30th and the 45th day after enrollment
DOPS (Direct Observation of Procedural Skills) scale
Time frame: Once between the 3rd and the 4th month after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in Situ Simulation in people with in Situ Simulation, run by Jean François Brichant at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 10 Jun 2021. 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 Belgium. 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?
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?
ANTS (Anesthesia non technical skills) score (time frame: Once a day for 5 consecutive days between the first and the 15th day after enrollment in the study). The study lists 3 primary outcomes in all. 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 10 Jun 2021.