Effectiveness of Simulation-based Training on Transoesophageal Echocardiography Learning

NCT ID: NCT05564507

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 385 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-02-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

TEE simulation-based training group

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.

Group Type: EXPERIMENTAL

TEE simulation-based training

Intervention Type: DIAGNOSTIC_TEST

All 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.

TEE traditional group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TEE simulation-based training

All 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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe des jeunes de la filiale d'imagerie cardiovasculaire

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Augustin Coisne

Lille, Hauts-de-France, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37070491 (View on PubMed)

Other Identifiers

JFIC001

Identifier Type: -

Identifier Source: org_study_id