One-day Training Simulation With 4 Immersive ScenariosNCT02804425
Comparison of Learning Outcomes Between the Roles of Learner During an Immersive Simulation
A study testing actor-spectator in people with One-day Training Simulation With 4 Immersive Scenarios, run by Université Paris-Sud at 1 site in France.
Trial summary
The use of simulation in medical education has been associated with positive results in the acquisition of knowledge, skills, behaviors and in patient outcome. According to Kolb et al, high-fidelity simulation provides concrete experience that is the basis for self-reflection, further experimentation and immersive… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- One-day Training Simulation With 4 Immersive Scenarios
- What is being tested?
- actor-spectator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2016to Oct 2016
- 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
- 3nd to 4rd year anesthesia (PGY3-PGY4) residents of Ile de France registered to the simulation session
- And having agreed to participate
Who cannot join
- Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (< 18 years)
- Refusal to participate in the study
- Refusal to sign the confidentiality clause
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Learning Outcomes Between the Roles of Learner (Actor-spectator and Spectator-only) During an Immersive Simulation
The use of simulation in medical education has been associated with positive results in the acquisition of knowledge, skills, behaviors and in patient outcome. According to Kolb et al, high-fidelity simulation provides concrete experience that is the basis for self-reflection, further experimentation and immersive learning named experiential learning. However the important number of learners and the extensive human resources required to deliver mannequin patient-based simulation limit its use for initial and repeated training. In general, 2-4 trainees participate in each scenario while others may look at the progress of the scene through video transmission in a neighboring room while all trainees met thereafter for the debriefing. In typical learning sessions, all trainees act as a participant at least once. However, due to the increasing number of trainees, the investigators anticipate that some trainees might remain spectators during the whole simulation session.
In our simulation unit (LabForSIMS- Faculté de Médecine Paris Sud), a simulation session for all third to forth year anesthesia residents (PGY3-4) of Ile de France has been established a few years ago. Each session includes a one-day training with 4 different immersive scenarios using a high fidelity mannequin. Each scenario is attended by 3 residents. In years before 2014, the number of anesthesia residents to be trained was 35 and each of them could play the role of an actor at least once in the session (actor-spectator). In a previous preliminary study, the investigators found that the learning outcomes were similar for all residents at the end of the day, whatever the scenario in which they had played and those scenarios for which they had remained spectators. This led to the hypothesis that being an actor in a scenario might be less important than attending the whole session and participating in all debriefings. However, to our knowledge, few study has explored the outcomes of the learning process for spectators-only.
The number of residents sharply increased to 110 from 2014 to 2016. Due to time constraints and limitation in the number of trained teachers, the investigators see that inevitably, several trainees will remain spectators during the whole session. The purpose of this study is thus to determine whether the status of the learner (actor-spectator vs spectator-only) during an immersive simulation has an impact of learning outcomes.
Read the detailed description
Inclusions After ethical agreement, this observational single-center open study will be conducted in the simulation center of the Paris Sud medical school (LabForSIMS). After written consent, all anesthesia residents of Ile de France (PGY3-PGY4) will attend a one-day simulation session and will be included in the study. Four immersive scenarios will be performed using a high-fidelity adult mannequin (cardiac arrest, local anesthetic systemic toxicity, malignant hyperthermia and abdominal hemorrhage after trauma). Pedagogical objectives to be mastered will include both technical and non-technical skills.
Before the training session, residents will be randomized into 2 groups:
- "actor-spectator" group (role of actor during at least one scenario in the simulation session). Three residents will participate in each scenario (one playing the role of the anesthesia resident, one playing the role of the staff physician and the third being called for help). Residents not involved in the scenario will observe the scene with direct videotransmission (role of ''spectators''). Actors and spectators will participate in all debriefings after each scenario.
- and "spectator-only" (observer during the whole one-day session but participation in the debriefing part of the four scenarios).
Primary Outcome Measures: Evaluation of learning
- Satisfaction (Kirkpatrick Level 1 ) A satisfaction questionnaire will be recorded at the end of the simulation session (Likert scale (0 to 10)).
- Evaluation of medical knowledge (Kirkpatrick level 2) Before (pre test) and following (post test) the simulation one-day session, residents will complete a test of medical knowledge, indicating their role. This test will include 16 questions (4 questions per scenario), completed with additional questions unrelated with program training.
- Evaluation of non-technical skills (Kirkpatrick level 2) An auto evaluation questionnaire evaluating self perceived non-technical skills will be recorded at the end of the simulation one-day session (Likert scale (0 to 10)).
- Evaluation of changes in professional practice (Kirkpatrick Level 3) A questionnaire evaluating if the simulation program will modify professional practice will be recorded at the end of the simulation session (Likert scale (0 to 10)).
Secondary outcome measures: Learning retention The same questionnaire will be recorded three months after the sessions.
- Being tested
- actor-spectator
- Keywords
- Medical Education, Simulation, Anesthesia crisis management, Learning outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
actor-spectatorOther
"actor-spectator" group : actor at least once during the simulation session
| Study group | Role | What they receive |
|---|---|---|
| "actor-spectator" group | Experimental | actor at least once during the immersive simulation session Receives: Other: actor-spectator |
| "spectator-only" group | No intervention | observer during the whole one-day session but participation in the debriefing part of the four scenarios |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of learning: (1) Satisfaction (Kirkpatrick Level 1 )
A satisfaction questionnaire will be recorded at the end of the simulation session (Likert scale (0 to 10)).
Measured: 3 months
Evaluation of learning: (2) Evaluation of medical knowledge (Kirkpatrick level 2)
Before (pre test) and following (post test) the simulation one-day session, residents will complete a test of medical knowledge, indicating their role.
Measured: 3 months
Evaluation of learning: (3) Evaluation of non-technical skills (Kirkpatrick level 2)
An auto evaluation questionnaire evaluating self perceived non-technical skills will be recorded at the end of the simulation one-day session (Likert scale (0 to 10)).
Measured: 3 months
Evaluation of learning: (4) Evaluation of changes in professional practice (Kirkpatrick Level 3)
A questionnaire evaluating if the simulation program will modify professional practice will be recorded at the end of the simulation session (Likert scale (0 to 10)).
Measured: 3 months
Secondary outcomes (1)
Learning retention: Evaluation of medical knowledge and non technical skills (Kirkpatrick level 2), and changes in professional practice (Kirkpatrick Level 3)
The same questionnaire will be recorded three months after the sessions
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start20 Jun 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One-day Training Simulation With 4 Immersive ScenariosStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Paris-Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Blanie, Université Paris-Sud
- Investigators
- Antonia Blanie, Principal investigator, Faculté de médecine Paris Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804425
- Sponsor's protocol ID
- LabForSIMS-001
- Status last verified
- Nov 2018
- First submitted
- 7 Jun 2016
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data for all participants for all primary and secondary outcomes will be available within 6 months of study completion
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Learning Outcomes Between the Roles of Learner (Actor-spectator and Spectator-only) During an Immersive Simulation
- ClinicalTrials.gov ID
- NCT02804425
- Acronym / sponsor ID
- LabForSIMS-001
- Keywords
- Medical Education, Simulation, Anesthesia crisis management, Learning outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Université Paris-SudUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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 in medical education has been associated with positive results in the acquisition of knowledge, skills, behaviors and in patient outcome. According to Kolb et al, high-fidelity simulation provides concrete experience that is the basis for self-reflection, further experimentation and immersive learning named experiential learning. However the important number of learners and the extensive human resources required to deliver mannequin patient-based simulation limit its use for initial and repeated training. In general, 2-4 trainees participate in each scenario while others may look at the progress of the scene through video transmission in a neighboring room while all trainees met thereafter for the debriefing. In typical learning sessions, all trainees act as a participant at least once. However, due to the increasing number of trainees, the investigators anticipate that some trainees might remain spectators during the whole simulation session.
In our simulation unit (LabForSIMS- Faculté de Médecine Paris Sud), a simulation session for all third to forth year anesthesia residents (PGY3-4) of Ile de France has been established a few years ago. Each session includes a one-day training with 4 different immersive scenarios using a high fidelity mannequin. Each scenario is attended by 3 residents. In years before 2014, the number of anesthesia residents to be trained was 35 and each of them could play the role of an actor at least once in the session (actor-spectator). In a previous preliminary study, the investigators found that the learning outcomes were similar for all residents at the end of the day, whatever the scenario in which they had played and those scenarios for which they had remained spectators. This led to the hypothesis that being an actor in a scenario might be less important than attending the whole session and participating in all debriefings. However, to our knowledge, few study has explored the outcomes of the learning process for spectators-only.
The number of residents sharply increased to 110 from 2014 to 2016. Due to time constraints and limitation in the number of trained teachers, the investigators see that inevitably, several trainees will remain spectators during the whole session. The purpose of this study is thus to determine whether the status of the learner (actor-spectator vs spectator-only) during an immersive simulation has an impact of learning outcomes.
Detailed description
Inclusions After ethical agreement, this observational single-center open study will be conducted in the simulation center of the Paris Sud medical school (LabForSIMS). After written consent, all anesthesia residents of Ile de France (PGY3-PGY4) will attend a one-day simulation session and will be included in the study. Four immersive scenarios will be performed using a high-fidelity adult mannequin (cardiac arrest, local anesthetic systemic toxicity, malignant hyperthermia and abdominal hemorrhage after trauma). Pedagogical objectives to be mastered will include both technical and non-technical skills.
Before the training session, residents will be randomized into 2 groups:
- "actor-spectator" group (role of actor during at least one scenario in the simulation session). Three residents will participate in each scenario (one playing the role of the anesthesia resident, one playing the role of the staff physician and the third being called for help). Residents not involved in the scenario will observe the scene with direct videotransmission (role of ''spectators''). Actors and spectators will participate in all debriefings after each scenario.
- and "spectator-only" (observer during the whole one-day session but participation in the debriefing part of the four scenarios).
Primary Outcome Measures: Evaluation of learning
- Satisfaction (Kirkpatrick Level 1 ) A satisfaction questionnaire will be recorded at the end of the simulation session (Likert scale (0 to 10)).
- Evaluation of medical knowledge (Kirkpatrick level 2) Before (pre test) and following (post test) the simulation one-day session, residents will complete a test of medical knowledge, indicating their role. This test will include 16 questions (4 questions per scenario), completed with additional questions unrelated with program training.
- Evaluation of non-technical skills (Kirkpatrick level 2) An auto evaluation questionnaire evaluating self perceived non-technical skills will be recorded at the end of the simulation one-day session (Likert scale (0 to 10)).
- Evaluation of changes in professional practice (Kirkpatrick Level 3) A questionnaire evaluating if the simulation program will modify professional practice will be recorded at the end of the simulation session (Likert scale (0 to 10)).
Secondary outcome measures: Learning retention The same questionnaire will be recorded three months after the sessions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "actor-spectator" group | Experimental | Other: actor-spectatoractor at least once during the immersive simulation session |
| "spectator-only" group | No intervention | –observer during the whole one-day session but participation in the debriefing part of the four scenarios |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 3nd to 4rd year anesthesia (PGY3-PGY4) residents of Ile de France registered to the simulation session
- And having agreed to participate
Key exclusion criteria (3 listed)
- Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (< 18 years)
- Refusal to participate in the study
- Refusal to sign the confidentiality clause
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 |
|---|---|---|
| actor-spectator"actor-spectator" group : actor at least once during the simulation session | Other | "actor-spectator" group |
Primary outcome
Evaluation of learning: (1) Satisfaction (Kirkpatrick Level 1 )
Time frame: 3 months
A satisfaction questionnaire will be recorded at the end of the simulation session (Likert scale (0 to 10)).
Evaluation of learning: (2) Evaluation of medical knowledge (Kirkpatrick level 2)
Time frame: 3 months
Before (pre test) and following (post test) the simulation one-day session, residents will complete a test of medical knowledge, indicating their role.
Evaluation of learning: (3) Evaluation of non-technical skills (Kirkpatrick level 2)
Time frame: 3 months
An auto evaluation questionnaire evaluating self perceived non-technical skills will be recorded at the end of the simulation one-day session (Likert scale (0 to 10)).
Evaluation of learning: (4) Evaluation of changes in professional practice (Kirkpatrick Level 3)
Time frame: 3 months
A questionnaire evaluating if the simulation program will modify professional practice will be recorded at the end of the simulation session (Likert scale (0 to 10)).
1 secondary outcome
Learning retention: Evaluation of medical knowledge and non technical skills (Kirkpatrick level 2), and changes in professional practice (Kirkpatrick Level 3)
Time frame: 4 months
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 23 Nov 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all participants for all primary and secondary outcomes will be available within 6 months of study completion
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 Blanie principal investigator
Faculté de médecine 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 actor-spectator in people with One-day Training Simulation With 4 Immersive Scenarios, 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 2 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: finished, as of the sponsor's last update on 23 Nov 2018. 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?
Evaluation of learning: (1) Satisfaction (Kirkpatrick Level 1 ) (time frame: 3 months). The study lists 4 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 23 Nov 2018.