High Fidelity Simulation TrainingDEBRIEF-SIM2NCT03307421
Team Debriefing With Instructor vs Team Debriefing Without Instructor After Simulating a Vital Emergency in a Multidisciplinary Team
A study testing debriefing without instructor and debriefing with instructor in people with High Fidelity Simulation Training and Simulation Training, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Comparison between a team debriefing with an instructor and a team debriefing without an instructor, on improving non-technical skills (TEAM score) after simulating a vital emergency in a multidisciplinary team as part of the initial training Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Fidelity Simulation Training, Simulation Training
- What is being tested?
- debriefing without instructor and debriefing with instructor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2017to 12 Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Common Inclusion Criteria
- Men and women of full age (> 18 years)
- Informed consent signed
- Affiliation to or a beneficiary of a French social security scheme.
- Physician Inclusion Criteria
- Internal from 3rd to 10th semester anesthesia resuscitation of the CHU of Besançon, Dijon, Lyon or Strasbourg.
- IADE students from the nursing school of Besançon, Dijon Lyon or Strasbourg.
Who cannot join
- Subject without health insurance
- Pregnant woman
- Subject being in the exclusion period of another study or planned by the "National Volunteer File".
- Subject refusing to sign the confidentiality clause
- Internal first-year anesthesia-resuscitation.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de besançon
Besançon, 25000
Floriane CICERON, PH, fciceron@chu-besancon.fr
About this study
Official title: Comparison Between a Team Debriefing With an Instructor and a Team Debriefing Without an Instructor, on Improving Non-technical Skills (TEAM Score) After Simulating a Vital Emergency in a Multidisciplinary Team as Part of the Initial Training
Comparison between a team debriefing with an instructor and a team debriefing without an instructor, on improving non-technical skills (TEAM score) after simulating a vital emergency in a multidisciplinary team as part of the initial training
Read the detailed description
In spite of the enthusiasm that the simulation raises, its use remains rather complicated in the training of the interns in anesthesiologists-resuscitators (DESAR) and nursing anesthesiologists (EIADE) . Its development has two main limitations: financial and human. Indeed, it mobilizes the medical and paramedical staff already in place, which is a difficulty in a context of demographic constraints.
A simulation session typically takes place in 3 stages: briefing, simulation and debriefing.
The debriefing, the pedagogical pillar of the sessions, demonstrated its influence on the improvement of participants' performances. Different works have tried to define the ideal debriefing method , but its modalities are yet to be defined. To reduce this time Boet and al proposed the assisted video debriefing without instructor. Its principle is that the team of learners will debrief themselves, watching the video recording of their performance. Learners have as a teaching aid a grid that recalls the principles of team work and the technical recommendations of the pathology addressed. This debriefing would therefore reduce the training time and facilitate access to the simulation. However, its pedagogical effectiveness has not been compared to the "gold standard" instructor-team debriefing on initial training and long-term acquisition. The objective of this study is therefore to demonstrate the non-inferiority of a method of debriefing without an instructor (SI) compared to a method of debriefing of team with instructor (AI) on the improvement of a score of non-technical competence (TEAM score) after simulation of a vital emergency in a multidisciplinary team as part of the initial training.
All the DESAR (except the 1st years) and EIADE of the participating centers are eligible. After information on the study and collection of their written consent, the binomials (DESAR + EIADE) will be constituted by drawing lots and randomized by stratification by center, either in debriefing AI or SI.
At D1, they will have a first simulation followed by a debriefing (AI or SI) according to their randomization and immediately after this debriefing, a second simulation. There will be no systematic debriefing behind this second session, but a team of trainers will be able to debrief the binomials that wish to do so. Six months later, the last simulation will take place, followed for all the pairs of an AI debriefing.
The pairs will be evaluated a posteriori, blinded by trained evaluators, for the 3 sessions on a non-technical competence score the TEAM Score and a technical skill score specialized in the pathology encountered. Finally learners will give their self-efficacy before and after each debriefing, and before the 3rd session.
Throughout the course of the study psychological care will be provided: a clearly identified person who is specialized in this pedagogical technique will be present and each participant will have his / her telephone contact details and the usual structures during a psychological distress.
- Being tested
- debriefing without instructor, debriefing with instructor
- Keywords
- simulation, debriefing, team score, multidisciplinarity, DEBRIEF sim II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
debriefing without instructorOther
Also called video assisted
The randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital.
The sequence of scenarios for each binomial will also be determined by randomization.
debriefing with instructorOther
The randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital.
| Study group | Role | What they receive |
|---|---|---|
| debriefing without instructor | Other | Team debriefing without an instructor will be organized as follows. The pairs of participants will be placed in a room with direct access to the video recording of their passage on the simulator. Two documents will be made available to help participants structure their debriefing: one targeting non-technical skills, based on the TEAM Score, and one recalling recommendations on ACR care. Despite its absence at the time of the debriefing, the instructor will be present during the briefing and during the simulation. Receives: Other: debriefing without instructor |
| debriefing with instructor | Other | The team debriefing with an instructor will begin immediately after the simulator run and will be governed by the principle of "no judgment" described by Rudolph .
A portion of the video of the participants' pass may be reviewed and used to support the debriefing (depending on the utility judged by the debrief). Each center will use its own team of trainers, but it will have a predefined plan and predefined objectives, which are provided in advance in order to obtain a standardized debriefing. Moreover, these trainers will not be beginners but will have some expertise in the pedagogy of simulation. They will have to have a DU in a simulation or pedagogy trainer (recommendations from SofraSim) and will have to carry out 15 debriefings per year Receives: Other: debriefing with instructor |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAM SCORE
TEAM Score is a non-technical skills assessment score. This score consists of four items (leadership, teamwork, task management, overall score). Each of these items is rated from 0 to 4, which is a score of 44, to which is added an overall score of 10 points. This score is validated and reflects teamwork skills [30] [31] [32] [33].
The scoring of the TEAM score will be carried out by a pair composed of a doctor in anesthesia-resuscitation and a nurse anesthetist trained and trained beforehand. This notation will be done afterwards simulations thanks to the registration of passage of the binomials on simulators.
Measured: 6 months
Secondary outcomes (2)
technical score
The T score is a technical skills assessment score adapted to the scenarios of this study and based on the Formalized Recommendations of Experts published by the SFAR and the guidelines of the European Resuscitation Council
Measured: 6 months
sense of self-efficacy (SEP)
To evaluate this SEP, we will use a visual analog scale: it will be represented by a horizontal line on which the participants will have to put a vertical line.
This scale will be written out of 100, the score will be determined by the distance (in mm) that separates the left side of the horizontal line from the vertical line affixed by the participant. The leftmost part will correspond to 'I feel totally capable', the right part to 'I feel totally incapable'.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start12 Oct 2017
- Primary completion12 Dec 2018 (estimated)
- Study completion12 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Fidelity Simulation TrainingStudies 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
- 2 parallel groups, stratified by center, randomized by center
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- ALOUANE Mael
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307421
- Sponsor's protocol ID
- DEBRIEF-SIM II
- Acronym
- DEBRIEF-SIM2
- Status last verified
- Dec 2017
- First submitted
- 28 Sep 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between a Team Debriefing With an Instructor and a Team Debriefing Without an Instructor, on Improving Non-technical Skills (TEAM Score) After Simulating a Vital Emergency in a Multidisciplinary Team as Part of the Initial Training
- ClinicalTrials.gov ID
- NCT03307421
- Acronym / sponsor ID
- DEBRIEF-SIM2 / DEBRIEF-SIM II
- Keywords
- simulation, debriefing, team score, multidisciplinarity, DEBRIEF sim II
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- ALOUANE Mael
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 12 Dec 2018 (estimated)
- Study completion
- 12 Dec 2018 (estimated)
- First posted
- 11 Oct 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.
Comparison between a team debriefing with an instructor and a team debriefing without an instructor, on improving non-technical skills (TEAM score) after simulating a vital emergency in a multidisciplinary team as part of the initial training
Detailed description
In spite of the enthusiasm that the simulation raises, its use remains rather complicated in the training of the interns in anesthesiologists-resuscitators (DESAR) and nursing anesthesiologists (EIADE) . Its development has two main limitations: financial and human. Indeed, it mobilizes the medical and paramedical staff already in place, which is a difficulty in a context of demographic constraints.
A simulation session typically takes place in 3 stages: briefing, simulation and debriefing.
The debriefing, the pedagogical pillar of the sessions, demonstrated its influence on the improvement of participants' performances. Different works have tried to define the ideal debriefing method , but its modalities are yet to be defined. To reduce this time Boet and al proposed the assisted video debriefing without instructor. Its principle is that the team of learners will debrief themselves, watching the video recording of their performance. Learners have as a teaching aid a grid that recalls the principles of team work and the technical recommendations of the pathology addressed. This debriefing would therefore reduce the training time and facilitate access to the simulation. However, its pedagogical effectiveness has not been compared to the "gold standard" instructor-team debriefing on initial training and long-term acquisition. The objective of this study is therefore to demonstrate the non-inferiority of a method of debriefing without an instructor (SI) compared to a method of debriefing of team with instructor (AI) on the improvement of a score of non-technical competence (TEAM score) after simulation of a vital emergency in a multidisciplinary team as part of the initial training.
All the DESAR (except the 1st years) and EIADE of the participating centers are eligible. After information on the study and collection of their written consent, the binomials (DESAR + EIADE) will be constituted by drawing lots and randomized by stratification by center, either in debriefing AI or SI.
At D1, they will have a first simulation followed by a debriefing (AI or SI) according to their randomization and immediately after this debriefing, a second simulation. There will be no systematic debriefing behind this second session, but a team of trainers will be able to debrief the binomials that wish to do so. Six months later, the last simulation will take place, followed for all the pairs of an AI debriefing.
The pairs will be evaluated a posteriori, blinded by trained evaluators, for the 3 sessions on a non-technical competence score the TEAM Score and a technical skill score specialized in the pathology encountered. Finally learners will give their self-efficacy before and after each debriefing, and before the 3rd session.
Throughout the course of the study psychological care will be provided: a clearly identified person who is specialized in this pedagogical technique will be present and each participant will have his / her telephone contact details and the usual structures during a psychological distress.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 parallel groups, stratified by center, randomized by center
| Arm | Type | Receives |
|---|---|---|
| debriefing without instructor | Other | Other: debriefing without instructorTeam debriefing without an instructor will be organized as follows. The pairs of participants will be placed in a room with direct access to the video recording of their passage on the simulator. Two documents will be made available to help participants structure their debriefing: one targeting non-technical skills, based on the TEAM Score, and one recalling recommendations on ACR care. Despite its absence at the time of the debriefing, the instructor will be present during the briefing and during the simulation. |
| debriefing with instructor | Other | Other: debriefing with instructorThe team debriefing with an instructor will begin immediately after the simulator run and will be governed by the principle of "no judgment" described by Rudolph . A portion of the video of the participants' pass may be reviewed and used to support the debriefing (depending on the utility judged by the debrief). Each center will use its own team of trainers, but it will have a predefined plan and predefined objectives, which are provided in advance in order to obtain a standardized debriefing. Moreover, these trainers will not be beginners but will have some expertise in the pedagogy of simulation. They will have to have a DU in a simulation or pedagogy trainer (recommendations from SofraSim) and will have to carry out 15 debriefings per year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Common Inclusion Criteria
- Men and women of full age (> 18 years)
- Informed consent signed
- Affiliation to or a beneficiary of a French social security scheme.
- Physician Inclusion Criteria
Key exclusion criteria (5 listed)
- Subject without health insurance
- Pregnant woman
- Subject being in the exclusion period of another study or planned by the "National Volunteer File".
- Subject refusing to sign the confidentiality clause
- Internal first-year anesthesia-resuscitation.
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 |
|---|---|---|
| debriefing without instructorAlso: video assistedThe randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital. The sequence of scenarios for each binomial will also be determined by randomization. | Other | debriefing without instructor |
| debriefing with instructorThe randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital. | Other | debriefing with instructor |
Primary outcome
TEAM SCORE
Time frame: 6 months
TEAM Score is a non-technical skills assessment score. This score consists of four items (leadership, teamwork, task management, overall score). Each of these items is rated from 0 to 4, which is a score of 44, to which is added an overall score of 10 points. This score is validated and reflects teamwork skills [30] [31] [32] [33]. The scoring of the TEAM score will be carried out by a pair composed of a doctor in anesthesia-resuscitation and a nurse anesthetist trained and trained beforehand. This notation will be done afterwards simulations thanks to the registration of passage of the binomials on simulators.
2 secondary outcomes
technical score
Time frame: 6 months
sense of self-efficacy (SEP)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing debriefing without instructor and debriefing with instructor in people with High Fidelity Simulation Training and Simulation Training, run by Centre Hospitalier Universitaire de Besancon 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 7 inclusion and 5 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 26 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Depierre (0381218745, sdepierre@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEAM SCORE (time frame: 6 months). 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 26 Dec 2017.