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Clinical Trial Summary

The academic training of French postgraduate students in general practice (E3CMG) is facing a challenge due to the increasing gap between the number of students and the available teaching hours. To accommodate the growing number of students, asynchronous acquisition of knowledge prior to a reduced face-to-face teaching would maintain the capacity to provide socio-constructivist teaching useful for developing problem-solving skills (i.e. thesis design and feasibility assessment). The main objective of this randomized controlled trial is to evaluate the effect of hybrid versus face-to-face socio-constructivist teaching on French E3CMG course assessment and evaluation.


Clinical Trial Description

The E3CMG will be invited to attend one of the two teaching days in accordance with the usual university procedure. They will be gathered in an amphitheater at the start of the teaching session (9:00 a.m.), where they will receive oral and written information about the study. Blocked randomization with randomly selected block sizes will be performed among students who have signed a written consent to participate in the study. Non-participants in the study will be assigned to one of the two teaching formats without randomization and respecting the need to achieve close class sizes. Their teaching assessments will not be extracted and analyzed as part of the study. This late randomization procedure makes it possible to - allow students to change teaching day without regard to the study - avoid contamination bias caused by some students accessing the asynchronous interactive course before class - ensure compliance with the study protocol (systematic access to the asynchronous interactive course by students in the intervention group) - Control the time spent on the asynchronous interactive course to ensure that the time spent by students actually corresponds to that stated in the protocol. - To limit missing data management procedures: data collection on the day of teaching, and randomization only of students present on the day of teaching (limits attrition bias). The 4 teachers on the first teaching day will be randomly assigned to the groups (May 14). If they take part in the second teaching day (05/21), they will teach in the other group in order to minimize a bias in the evaluation of the main judgment criterion linked to teacher quality. The study begins on May 14, 2024 or May 21, 2024, depending on the participant's assigned teaching day, and ends on 11/14/2024. The maximum duration of participation in the study is therefore 6 months. The student's actual participation is 1 day, as data collection on 14/11 is automated and does not require any intervention by the participant. No health data will be collected. Data will be collected via a self-administered questionnaire with a randomized order of questions at the end of the teaching day, and at 6 months via the university's database of thesis forms. The number of participants to be included in the study is 72 per arm. This is necessary to demonstrate a difference in the primary endpoint of 10%, with a standard deviation of 4 points, an alpha risk of 5%, and a statistical power of 85%, for a two-tailed t-test of comparison of observed means. The theoretical maximum number of students included in the study was 83 per group, allowing for a 13% refusal rate (n=22 students). A two-sided superiority test will be conducted, with a multivariate analysis and sensitivity analysis. To account for multiple comparisons regarding secondary objectives, a fixed sequence procedure will be performed. Once one hypothesis is tested and found to be not significantly different from the null hypothesis, all subsequent tests and results will be considered as explanatory. The secondary objectives described below are classified according to this procedure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06409273
Study type Interventional
Source Research on Healthcare Performance Lab U1290
Contact Pierre-Yves Meunier, MD
Phone +33658930614
Email pierre-yves.meunier@univ-lyon1.fr
Status Not yet recruiting
Phase N/A
Start date May 14, 2024
Completion date November 14, 2024

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