Clinical trial NCT05564507: Effectiveness of Simulation-based Training on Transoesophageal Echocardiography Learning
Official title: A Multicenter Randomized Study to Assess the Impact of SIMULation-bAsed Training on Transoesophageal echocardiOgraphy leaRning for Cardiology Fellows
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Cardiovascular Diseases
Valvular Heart Disease
Keywords: Simulation-based training
Education
Transesophageal echocardiography
Simulation
Lead sponsor: Groupe des jeunes de la filiale d'imagerie cardiovasculaire
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* All consecutive fellows in cardiology of all training levels (year 1-4) who have never performed a TEE alone.

Exclusion Criteria:

* Fellows who had already performed a TEE alone, with or without supervision, were excluded.

Primary outcomes:
measure: Difference in the final theoretical test score after the training between the two groups.
timeFrame: 3 months after completion of the training program
measure: Difference in the final practical test score after the training between the two groups.
timeFrame: 3 months after completion of the training program
Secondary outcomes:
measure: Difference in change in theoretical test scores from pre- to final training
timeFrame: 3 months after completion of the training program
measure: Difference in change in practical test scores from pre- to final training
timeFrame: 3 months after completion of the training program
measure: Difference in the final global score after the training between the two groups.
timeFrame: 3 months after completion of the training program
measure: Difference in TEE exam duration after the training between the two groups.
timeFrame: 3 months after completion of the training program
measure: Self-assessment of proficiency of the fellows
timeFrame: 3 months after completion of the training program
Other outcomes:
Locations:
city: Lille
country: France
facility: Augustin Coisne
state: Hauts-De-France
Study officials:
References: