Knowledge, Attitudes, PracticeSIMULATORNCT05564507
Effectiveness of Simulation-based Training on Transoesophageal Echocardiography Learning
A study testing TEE simulation-based training in people with Knowledge, Attitudes, Practice and Cardiovascular Diseases, run by Groupe des jeunes de la filiale d'imagerie cardiovasculaire at 1 site in France.
Trial summary
Background: Simulation-based training in transesophageal echocardiography (TEE) seems promising. However, data are limited to non-randomized or single-center studies. Objectives: This large multicenter randomized, parallel-group, unblinded, study will assess the impact of simulation-based versus traditional teaching… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knowledge, Attitudes, Practice, Cardiovascular Diseases, Valvular Heart Disease
- What is being tested?
- TEE simulation-based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 1 Feb 2022
- 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
- All consecutive fellows in cardiology of all training levels (year 1-4) who have never performed a TEE alone.
Who cannot join
- Fellows who had already performed a TEE alone, with or without supervision, were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Study to Assess the Impact of SIMULation-bAsed Training on Transoesophageal echocardiOgraphy leaRning for Cardiology Fellows
Background:
Simulation-based training in transesophageal echocardiography (TEE) seems promising. However, data are limited to non-randomized or single-center studies.
Read more
Objectives:
This large multicenter randomized, parallel-group, unblinded, study will assess the impact of simulation-based versus traditional teaching on TEE knowledge and performance for medical fellows in cardiology.
Eligibility:
- All consecutive fellows in cardiology of all training levels (year 1-4)
- who have never performed a TEE alone
Design:
- Multicenter, parallel-group, unblinded, randomized study with a prospective enrollment of all consecutive fellows in cardiology of all training level (year 1 to 4) who were recruited in 42 centers throughout France.
- Randomization with stratification by center will be performed at the individual (fellow) level in 1:1 ratio to assign all the fellows to the traditional group or to the TEE simulation-based training group.
- Each participant will complete two different tests during the study: 1) a pre-training test before starting the educational program; and 2) a final test performed 3 months after the end of the educational program. Each of these tests will include a theoretical test and a practical test on a TEE simulator.
- The coprimary outcomes of the study to compare the two groups will be the scores in the final theoretical and practical tests after the training will be completed.
Read the detailed description
Background:
Recent studies suggested that simulation-based transesophageal echocardiography (TEE) teaching is displaying significant benefit over conventional methods based on academic lectures in terms of improving TEE skills and accelerating learning. However, evidence on the impact of simulation-based training in TEE is scarce. Indeed, all the studies assessing the effectiveness of TEE simulation-based teaching were non-randomized or randomized with limited single-center sample size
Objectives:
This large multicenter randomized, parallel-group, unblinded, study will assess the impact of simulation-based versus traditional teaching on TEE knowledge and performance for medical fellows in cardiology.
Methods:
The SIMULATOR study will be a multicenter, parallel-group, unblinded, randomized study including all consecutive fellows in cardiology of all training level (year 1 to 4) who will be randomized (1:1) to either a TEE simulation group or to a traditional group through 42 French centers. Fellows who had already performed a TEE alone, with or without supervision, will be excluded. All the fellows will give their consent to participate to the study and agree to provide their honest answers and thoughts about their skills and confidence about their practices.
Each participant will complete two different tests during the study: 1) a pre-training test before starting the educational program; and 2) a final test performed 3 months after the end of the educational program. Each of these tests will include a theoretical test and a practical test on a TEE simulator.
Endpoints:
The coprimary endpoints of the study will be the difference in the final theoretical and practical tests score after the training between the two groups. The secondary endpoints will be the difference in change in theoretical and practical tests scores from pre- to final training. In addition, we will assess the global score defined as the sum of the theoretical test and the practical test scores, the TEE exam duration, and the self-assessment of proficiency of the fellows.
Sample size calculation:
Details regarding the determination of the sample size have been reported previously. Based on recent available literature and considering normalized 0-100 points score ranges for the two co-primary outcomes, a minimally important difference of 5 points (standard deviation 7 points) will be considered for the difference in change from pre- to post-training scores in theoretical and practical tests between the two randomized groups. Under these assumptions, a sample size of 50 subjects per group (for an overall population of 100 participants) will provide 90% power to detect a statistically significant difference between the two groups at a significance level of alpha = 2.5%, applying a Bonferroni correction to account for multiple testing of the two co-primary outcomes.
- Being tested
- TEE simulation-based training
- Keywords
- Simulation-based training, Education, Transesophageal echocardiography, Simulation
- Medical subject headings
- Behavior, Cardiovascular Diseases, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEE simulation-based trainingDiagnostic test
All participants of the TEE simulation-based training group received:
- a traditional didactic training using e-learning with a national free-access online course;
- two teaching sessions using a TEE simulator for 2 hours per session. The simulation session will involve standardized initial teaching of normal cardiac, including anatomy of mitral valve with some mitral regurgitation cases, aortic valve, tricuspid valve, interatrial septum, and left atrial appendage, and demonstration of image acquisition by the teacher (time duration: 30 min). The duration of each session was 2 h with a 6:1 student to instructor ratio. Each subject had a dedicated 20 min of hands-on to manipulate the probe and undertake a sequential TEE examination under the supervision of the teacher. Other participants could watch their colleagues working on the TEE simulator.
| Study group | Role | What they receive |
|---|---|---|
| TEE simulation-based training group | Experimental | All participants of the TEE simulation group received:
1) a traditional didactic training using e-learning with a national free-access online course; and 2) two teaching sessions using a TEE simulator for 2 hours per session. Receives: Diagnostic Test: TEE simulation-based training |
| TEE traditional group | No intervention | All participants of the TEE traditional group received only a traditional didactic training using e-learning with a national free-access online course (same e-learning program allocated for the TEE simulation group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the final theoretical test score after the training between the two groups.
Each resident completed two sets of tests during the study:
- a pre-training test before starting the training program to assess the baseline TEE level of each resident; and 2) a final test performed 3 months after the end of the training program.
The theoretical test included 20 video-based questions online that evaluate recognition of standard TEE views, normal anatomy and some pathological cases as already described. The fellows were given 90 seconds for each question to choose the best answer out of a multiple-choice of 5 propositions. Each question was scored on 5 points (5 points if all the propositions were correct and 0 point if at least one error was observed), for a total of 100 points per test.
Measured: 3 months after completion of the training program
Difference in the final practical test score after the training between the two groups.
Each resident completed two sets of tests during the study:
- a pre-training test before starting the training program to assess the baseline TEE level of each resident; and 2) a final test performed 3 months after the end of the training program. Each of these tests included a practical test on a TEE simulator .
Immediately after each theoretical test (pre-training and final tests), all fellows underwent the practical test. The fellows were asked to show ten basic views on a TEE simulator, as previously described, and were given a maximum of one minute for each view. The practical test was stopped after a maximum of 10 minutes. Each view was scored on 10 points using the modified Ferrero grading scale, for a total of 100 points per practical test.
Measured: 3 months after completion of the training program
Secondary outcomes (5)
Difference in change in theoretical test scores from pre- to final training
Difference in change in theoretical test scores from pre- to final training.
The theoretical test included 20 video-based questions online that evaluate recognition of standard TEE views, normal anatomy and some pathological cases as already described. The fellows were given 90 seconds for each question to choose the best answer out of a multiple-choice of 5 propositions. Each question was scored on 5 points (5 points if all the propositions were correct and 0 point if at least one error was observed), for a total of 100 points per test.
Measured: 3 months after completion of the training program
Difference in change in practical test scores from pre- to final training
Difference in change in practical test scores from pre- to final training.
To standardize the training and the practical test on TEE simulator, all trainers followed a dedicated webinar of 30 minutes presenting the entire content of each session and the final test. Immediately after each theoretical test (pre-training and final tests), all fellows underwent the practical test. The fellows were asked to show ten basic views on a TEE simulator, as previously described, and were given a maximum of one minute for each view. The teacher timed the duration between the TEE probe introduction and obtention by the trainee of all ten views required. The practical test was stopped after a maximum of 10 minutes. Each view was scored on 10 points using the modified Ferrero grading scale, for a total of 100 points per practical test.
Measured: 3 months after completion of the training program
Difference in the final global score after the training between the two groups.
The global score was defined as the sum of the theoretical test and the practical test scores, the TEE exam duration, and the self-assessment of proficiency of the fellows.
Measured: 3 months after completion of the training program
Difference in TEE exam duration after the training between the two groups.
The trainer measured the TEE exam duration during the practical test using simulator.
Measured: 3 months after completion of the training program
Self-assessment of proficiency of the fellows
The self-assessment of proficiency of all the fellows was assessed with four standardised questions asked before and immediately after the training program:
- "Do you feel ready to perform a TEE alone?",
- "Do you feel confident to perform a TEE alone?",
- "Do you feel comfortable with TEE probe introduction?" and 4) "Do you feel comfortable with TEE probe manipulation?". Each question was graded from 1 (lower grade) to 5 (higher grade).
In the simulation group, satisfaction after the simulation training was assessed by an anonymous questionnaire including six statements on different aspects of the training, as already published.
Measured: 3 months after completion of the training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Nov 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe des jeunes de la filiale d'imagerie cardiovasculaire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564507
- Sponsor's protocol ID
- JFIC001
- Acronym
- SIMULATOR
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pezel T, Dreyfus J, Mouhat B, Thebaut C, Audureau E, Bernard A, Badie YL, Bohbot Y, Fard D, Nguyen LS, Monteil C, Biere L, Le Ven F, Canu M, Ribeyrolles S, Mion B, Bazire B, Fauvel C, Cautela J, Cambet T, Le Tourneau T, Donal E, Lafitte S, Magne J, Mansencal N, Coisne A; SIMULATOR investigators. Effectiveness of Simulation-Based Training on Transesophageal Echocardiography Learning: The SIMULATOR Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):248-256. doi: 10.1001/jamacardio.2022.5016.
PubMed 37070491
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Study to Assess the Impact of SIMULation-bAsed Training on Transoesophageal echocardiOgraphy leaRning for Cardiology Fellows
- ClinicalTrials.gov ID
- NCT05564507
- Acronym / sponsor ID
- SIMULATOR / JFIC001
- Keywords
- Simulation-based training, Education, Transesophageal echocardiography, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Groupe des jeunes de la filiale d'imagerie cardiovasculaireUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 3 Oct 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.
Background:
Simulation-based training in transesophageal echocardiography (TEE) seems promising. However, data are limited to non-randomized or single-center studies.
Objectives:
This large multicenter randomized, parallel-group, unblinded, study will assess the impact of simulation-based versus traditional teaching on TEE knowledge and performance for medical fellows in cardiology.
Eligibility:
- All consecutive fellows in cardiology of all training levels (year 1-4)
- who have never performed a TEE alone
Design:
- Multicenter, parallel-group, unblinded, randomized study with a prospective enrollment of all consecutive fellows in cardiology of all training level (year 1 to 4) who were recruited in 42 centers throughout France.
- Randomization with stratification by center will be performed at the individual (fellow) level in 1:1 ratio to assign all the fellows to the traditional group or to the TEE simulation-based training group.
- Each participant will complete two different tests during the study: 1) a pre-training test before starting the educational program; and 2) a final test performed 3 months after the end of the educational program. Each of these tests will include a theoretical test and a practical test on a TEE simulator.
- The coprimary outcomes of the study to compare the two groups will be the scores in the final theoretical and practical tests after the training will be completed.
Detailed description
Background:
Recent studies suggested that simulation-based transesophageal echocardiography (TEE) teaching is displaying significant benefit over conventional methods based on academic lectures in terms of improving TEE skills and accelerating learning. However, evidence on the impact of simulation-based training in TEE is scarce. Indeed, all the studies assessing the effectiveness of TEE simulation-based teaching were non-randomized or randomized with limited single-center sample size
Objectives:
This large multicenter randomized, parallel-group, unblinded, study will assess the impact of simulation-based versus traditional teaching on TEE knowledge and performance for medical fellows in cardiology.
Methods:
The SIMULATOR study will be a multicenter, parallel-group, unblinded, randomized study including all consecutive fellows in cardiology of all training level (year 1 to 4) who will be randomized (1:1) to either a TEE simulation group or to a traditional group through 42 French centers. Fellows who had already performed a TEE alone, with or without supervision, will be excluded. All the fellows will give their consent to participate to the study and agree to provide their honest answers and thoughts about their skills and confidence about their practices.
Each participant will complete two different tests during the study: 1) a pre-training test before starting the educational program; and 2) a final test performed 3 months after the end of the educational program. Each of these tests will include a theoretical test and a practical test on a TEE simulator.
Endpoints:
The coprimary endpoints of the study will be the difference in the final theoretical and practical tests score after the training between the two groups. The secondary endpoints will be the difference in change in theoretical and practical tests scores from pre- to final training. In addition, we will assess the global score defined as the sum of the theoretical test and the practical test scores, the TEE exam duration, and the self-assessment of proficiency of the fellows.
Sample size calculation:
Details regarding the determination of the sample size have been reported previously. Based on recent available literature and considering normalized 0-100 points score ranges for the two co-primary outcomes, a minimally important difference of 5 points (standard deviation 7 points) will be considered for the difference in change from pre- to post-training scores in theoretical and practical tests between the two randomized groups. Under these assumptions, a sample size of 50 subjects per group (for an overall population of 100 participants) will provide 90% power to detect a statistically significant difference between the two groups at a significance level of alpha = 2.5%, applying a Bonferroni correction to account for multiple testing of the two co-primary outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEE simulation-based training group | Experimental | Diagnostic Test: TEE simulation-based trainingAll participants of the TEE simulation group received: 1) a traditional didactic training using e-learning with a national free-access online course; and 2) two teaching sessions using a TEE simulator for 2 hours per session. |
| TEE traditional group | No intervention | –All participants of the TEE traditional group received only a traditional didactic training using e-learning with a national free-access online course (same e-learning program allocated for the TEE simulation group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive fellows in cardiology of all training levels (year 1-4) who have never performed a TEE alone.
Key exclusion criteria (1 listed)
- Fellows who had already performed a TEE alone, with or without supervision, were excluded.
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 |
|---|---|---|
| TEE simulation-based trainingAll participants of the TEE simulation-based training group received: 1. a traditional didactic training using e-learning with a national free-access online course; 2. two teaching sessions using a TEE simulator for 2 hours per session. The simulation session will involve standardized initial teaching of normal cardiac, including anatomy of mitral valve with some mitral regurgitation cases, aortic valve, tricuspid valve, interatrial septum, and left atrial appendage, and demonstration of image acquisition by the teacher (time duration: 30 min). The duration of each session was 2 h with a 6:1 student to instructor ratio. Each subject had a dedicated 20 min of hands-on to manipulate the probe and undertake a sequential TEE examination under the supervision of the teacher. Other participants could watch their colleagues working on the TEE simulator. | Diagnostic test | TEE simulation-based training group |
Primary outcome
Difference in the final theoretical test score after the training between the two groups.
Time frame: 3 months after completion of the training program
Each resident completed two sets of tests during the study: 1) a pre-training test before starting the training program to assess the baseline TEE level of each resident; and 2) a final test performed 3 months after the end of the training program. The theoretical test included 20 video-based questions online that evaluate recognition of standard TEE views, normal anatomy and some pathological cases as already described. The fellows were given 90 seconds for each question to choose the best answer out of a multiple-choice of 5 propositions. Each question was scored on 5 points (5 points if all the propositions were correct and 0 point if at least one error was observed), for a total of 100 points per test.
Difference in the final practical test score after the training between the two groups.
Time frame: 3 months after completion of the training program
Each resident completed two sets of tests during the study: 1) a pre-training test before starting the training program to assess the baseline TEE level of each resident; and 2) a final test performed 3 months after the end of the training program. Each of these tests included a practical test on a TEE simulator . Immediately after each theoretical test (pre-training and final tests), all fellows underwent the practical test. The fellows were asked to show ten basic views on a TEE simulator, as previously described, and were given a maximum of one minute for each view. The practical test was stopped after a maximum of 10 minutes. Each view was scored on 10 points using the modified Ferrero grading scale, for a total of 100 points per practical test.
5 secondary outcomes
Difference in change in theoretical test scores from pre- to final training
Time frame: 3 months after completion of the training program
Difference in change in practical test scores from pre- to final training
Time frame: 3 months after completion of the training program
Difference in the final global score after the training between the two groups.
Time frame: 3 months after completion of the training program
Difference in TEE exam duration after the training between the two groups.
Time frame: 3 months after completion of the training program
Self-assessment of proficiency of the fellows
Time frame: 3 months after completion of the training program
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 3 Oct 2022.
- Derived from this study: PubMed 37070491Pezel T, Dreyfus J, Mouhat B, Thebaut C, Audureau E, Bernard A, Badie YL, Bohbot Y, Fard D, Nguyen LS, Monteil C, Biere L, Le Ven F, Canu M, Ribeyrolles S, Mion B, Bazire B, Fauvel C, Cautela J, Cambet T, Le Tourneau T, Donal E, Lafitte S, Magne J, Mansencal N, Coisne A; SIMULATOR investigators. Effectiveness of Simulation-Based Training on Transesophageal Echocardiography Learning: The SIMULATOR Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):248-256. doi: 10.1001/jamacardio.2022.5016.
- 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.
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 TEE simulation-based training in people with Knowledge, Attitudes, Practice and Cardiovascular Diseases, run by Groupe des jeunes de la filiale d'imagerie cardiovasculaire 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 3 Oct 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?
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?
Difference in the final theoretical test score after the training between the two groups. (time frame: 3 months after completion of the training program). The study lists 2 primary outcomes in all. 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 NCT05564507, which also lists 1 linked publication.
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 3 Oct 2022.