Effectiveness of Simulation-based Training on Transoesophageal Echocardiography Learning (SIMULATOR)

Groupe des jeunes de la filiale d'imagerie cardiovasculaire

Status: Completed

Conditions: Valvular Heart Disease; Cardiovascular Diseases; Knowledge, Attitudes, Practice

Treatments: Diagnostic Test: TEE simulation-based training

Study type: Interventional

Funder types: Other

Identifiers

NCT05564507

JFIC001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 2 patient groups

TEE simulation-based training group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: TEE simulation-based training

TEE traditional group

No Intervention group

Description:

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).