Hybrid Course Assessment and Evaluation

NCT ID: NCT06409273

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-14
• Study Completion Date: 2024-11-14

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.

Conditions

Education, Medical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Hybrid course : asynchronous online interactive course (2h30, 45%) followed by face-to-face socio constructivist teaching (3h00, 55%)

Group Type: EXPERIMENTAL

Hybrid course on medical thesis for post graduates general practice students

Intervention Type: OTHER

Students randomised to the intervention group will log on to interactive online teaching for a maximum time of 2.5 hours, and then follow face-to-face socio-constructivist teaching in small groups (n=22 max), building on the knowledge they have acquired. The aim of this peer-to-peer face-to-face teaching is to develop problem-solving skills.

Control

Face-to-face socio constructivist teaching (100%) (5h30)

Group Type: ACTIVE_COMPARATOR

Face-to-face teaching on medical thesis for post graduates general practice students

Intervention Type: OTHER

Students randomised to the control group will be taught entirely face-to-face in small groups (n=22 max). The course duration and teaching objectives are identical to those of the intervention group. Student consent and randomization will be carried out on the morning of the course to avoid contamination and attrition bias.

Interventions

Hybrid course on medical thesis for post graduates general practice students

Students randomised to the intervention group will log on to interactive online teaching for a maximum time of 2.5 hours, and then follow face-to-face socio-constructivist teaching in small groups (n=22 max), building on the knowledge they have acquired. The aim of this peer-to-peer face-to-face teaching is to develop problem-solving skills.

Intervention Type: OTHER

Face-to-face teaching on medical thesis for post graduates general practice students

Students randomised to the control group will be taught entirely face-to-face in small groups (n=22 max). The course duration and teaching objectives are identical to those of the intervention group. Student consent and randomization will be carried out on the morning of the course to avoid contamination and attrition bias.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Postgraduate general practice students registered for assessed course.

Exclusion Criteria

• Unsigned written consent to participate after oral and written information

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

Sponsors

Research on Healthcare Performance Lab U1290

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rémy Boussageon, MD, PhD

Role: STUDY_CHAIR

Lyon 1 University & LBBE UMR 5558, CNRS

Marion Lamort-Bouché, MD, PhD

Role: STUDY_DIRECTOR

Research on Healthcare Performance Lab U1290, Inserm

Pierre-Yves Meunier, MD

Role: PRINCIPAL_INVESTIGATOR

University Lyon 1

Sophie Schlatter, PhD

Role: STUDY_CHAIR

Research on Healthcare Performance Lab U1290, Inserm

Central Contacts

Pierre-Yves Meunier, MD

Role: CONTACT

pierre-yves.meunier@univ-lyon1.fr

+33658930614

Marion Lamort-Bouché, MD, PhD

Role: CONTACT

marion.lamort-bouche@univ-lyon1.fr

Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id