NCT06409273

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

May 14, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

7 days

First QC Date

May 7, 2024

Last Update Submit

May 12, 2024

Conditions

Keywords

Medical educationStudentsdissertations, academicEvaluation studiesEducational measurement

Outcome Measures

Primary Outcomes (1)

  • Self-assessment score for learning outcomes

    Sum of self-assessment score for knowledge (10 points) and self-assessment score for skills (10 points). Maximum value = 20, Minimum Value = 0. Higher score means a better outcome.

    At the end of the teaching day

Secondary Outcomes (6)

  • Overall satisfaction score

    At the end of the teaching day

  • Self-assessment score for knowledge (10 points)

    At the end of the teaching day

  • Self-assessment score for skills (competencies) (10 points)

    At the end of the teaching day

  • Satisfaction score 1

    At the end of the teaching day

  • Satisfaction score 2

    At the end of the teaching day

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Hybrid course on medical thesis for post graduates general practice students

Control

ACTIVE COMPARATOR

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

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

Interventions

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

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postgraduate general practice students registered for assessed course.

You may not qualify if:

  • Unsigned written consent to participate after oral and written information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Rémy Boussageon, MD, PhD

    Lyon 1 University & LBBE UMR 5558, CNRS

    STUDY CHAIR
  • Marion Lamort-Bouché, MD, PhD

    Research on Healthcare Performance Lab U1290, Inserm

    STUDY DIRECTOR
  • Pierre-Yves Meunier, MD

    University Lyon 1

    PRINCIPAL INVESTIGATOR
  • Sophie Schlatter, PhD

    Research on Healthcare Performance Lab U1290, Inserm

    STUDY CHAIR

Central Study Contacts

Pierre-Yves Meunier, MD

CONTACT

Marion Lamort-Bouché, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

May 14, 2024

Primary Completion

May 21, 2024

Study Completion

November 14, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Data obtained through this study may be provided to qualified researchers with academic interest on medical education. Data or samples shared will be coded.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data requests can be submitted immediatly after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access Criteria
Approval of the request by Pierre-Yves Meunier (principal investigator) and Marion-Lamort Bouché (study director) and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. For more information or to submit a request, please contact pierre-yves.meunier@univ-lyon1.fr