Clinical trial NCT06409273: Hybrid Course Assessment and Evaluation
Official title: Effect of Hybrid Versus Face-to-face Teaching on Course Assessment and Evaluation in Postgraduate General Practice Students: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Education, Medical
Keywords: Medical education
Students
dissertations, academic
Evaluation studies
Educational measurement
Lead sponsor: Research on Healthcare Performance Lab U1290
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mixed-methods study

1. Single-blind, randomized, controlled trial with two 1:1 parallel arms
2. Qualitative analysis of open-ended questions in a questionnaire
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

• Postgraduate general practice students registered for assessed course.

Exclusion Criteria:

• Unsigned written consent to participate after oral and written information

Primary outcomes:
measure: Self-assessment score for learning outcomes
timeFrame: At the end of the teaching day
Secondary outcomes:
measure: Overall satisfaction score
timeFrame: At the end of the teaching day
measure: Self-assessment score for knowledge (10 points)
timeFrame: At the end of the teaching day
measure: Self-assessment score for skills (competencies) (10 points)
timeFrame: At the end of the teaching day
measure: Satisfaction score 1
timeFrame: At the end of the teaching day
measure: Satisfaction score 2
timeFrame: At the end of the teaching day
measure: Submitting a thesis form
timeFrame: 6 months after the course
Other outcomes:
Locations:
Study officials:
affiliation: Lyon 1 University & LBBE UMR 5558, CNRS
name: Rémy Boussageon, MD, PhD
role: STUDY_CHAIR
affiliation: Research on Healthcare Performance Lab U1290, Inserm
name: Marion Lamort-Bouché, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Lyon 1
name: Pierre-Yves Meunier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research on Healthcare Performance Lab U1290, Inserm
name: Sophie Schlatter, PhD
role: STUDY_CHAIR
References: