Education, MedicalHOMENCT06409273
Hybrid Course Assessment and Evaluation
A study testing Hybrid course on medical thesis for post graduates general practice students and Face-to-face teaching on medical thesis for post graduates general practice students in people with Education, Medical, run by Research on Healthcare Performance Lab U1290.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Education, Medical
- What is being tested?
- Hybrid course on medical thesis for post graduates general practice students and Face-to-face teaching on medical thesis for post graduates general practice students
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 14 May 2024to 14 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postgraduate general practice students registered for assessed course.
Who cannot join
- Unsigned written consent to participate after oral and written information
Trial locations and contacts
No sites are listed yet.
Marion Lamort-Bouché, MD, PhD contact
About this study
Official title: Effect of Hybrid Versus Face-to-face Teaching on Course Assessment and Evaluation in Postgraduate General Practice Students: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Hybrid course on medical thesis for post graduates general practice students, Face-to-face teaching on medical thesis for post graduates general practice students
- Keywords
- Medical education, Students, dissertations, academic, Evaluation studies, Educational measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid course on medical thesis for post graduates general practice studentsOther
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.
Face-to-face teaching on medical thesis for post graduates general practice studentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Hybrid course : asynchronous online interactive course (2h30, 45%) followed by face-to-face socio constructivist teaching (3h00, 55%) Receives: Other: Hybrid course on medical thesis for post graduates general practice students |
| Control | Active comparator | Face-to-face socio constructivist teaching (100%) (5h30) Receives: Other: Face-to-face teaching on medical thesis for post graduates general practice students |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the teaching day
Secondary outcomes (6)
Overall satisfaction score
Sum of the satisfaction score for knowledge-related learning objectives (satisfaction score 1, 10 points) and the satisfaction score for skill-related learning objectives (satisfaction score 2, 10 points). Maximum value = 20, Minimum Value = 0. Higher score means a better outcome.
Measured: At the end of the teaching day
Self-assessment score for knowledge (10 points)
10-point score based on a questionnaire completed by students to assess knowledge acquisition. Maximum value = 10, Minimum Value = 0. Higher score means a better outcome.
Measured: At the end of the teaching day
Self-assessment score for skills (competencies) (10 points)
10-point score based on a questionnaire completed by students to assess problem-solving skills acquisition. Maximum value = 10, Minimum Value = 0. Higher score means a better outcome.
Measured: At the end of the teaching day
Satisfaction score 1
10-point score for student satisfaction regarding knowledge-related learning objectives. Maximum value = 10, Minimum Value = 0. Higher score means a better outcome.
Measured: At the end of the teaching day
Satisfaction score 2
10-point score for student satisfaction regarding skills-related learning objectives. Maximum value = 10, Minimum Value = 0. Higher score means a better outcome.
Measured: At the end of the teaching day
Submitting a thesis form
A thesis form is a document submitted by students to the university department of general medicine for proofreading before validation concerning the problematization and feasibility of the project. The course evaluated is likely to improve the time taken to submit the thesis form.
Measured: 6 months after the course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start14 May 2024 (estimated)
- Primary completion21 May 2024 (estimated)
- Study completion14 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, MedicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research on Healthcare Performance Lab U1290
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rémy Boussageon, MD, PhD, Study chair, Lyon 1 University & LBBE UMR 5558, CNRSMarion Lamort-Bouché, MD, PhD, Study director, Research on Healthcare Performance Lab U1290, InsermPierre-Yves Meunier, MD, Principal investigator, University Lyon 1Sophie Schlatter, PhD, Study chair, Research on Healthcare Performance Lab U1290, Inserm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409273
- Sponsor's protocol ID
- HOME
- Acronym
- HOME
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest on medical education. Data or samples shared will be coded.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hybrid Versus Face-to-face Teaching on Course Assessment and Evaluation in Postgraduate General Practice Students: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06409273
- Acronym / sponsor ID
- HOME / HOME
- Conditions
- Education, Medical
- Keywords
- Medical education, Students, dissertations, academic, Evaluation studies, Educational measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Research on Healthcare Performance Lab U1290University, hospital or other
- Study start
- 14 May 2024 (estimated)
- Primary completion
- 21 May 2024 (estimated)
- Study completion
- 14 Nov 2024 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Hybrid course on medical thesis for post graduates general practice studentsHybrid course : asynchronous online interactive course (2h30, 45%) followed by face-to-face socio constructivist teaching (3h00, 55%) |
| Control | Active comparator | Other: Face-to-face teaching on medical thesis for post graduates general practice studentsFace-to-face socio constructivist teaching (100%) (5h30) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postgraduate general practice students registered for assessed course.
Key exclusion criteria (1 listed)
- Unsigned written consent to participate after oral and written information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid course on medical thesis for post graduates general practice studentsStudents 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. | Other | Intervention |
| Face-to-face teaching on medical thesis for post graduates general practice studentsStudents 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. | Other | Control |
Primary outcome
Self-assessment score for learning outcomes
Time frame: At the end of the teaching day
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.
6 secondary outcomes
Overall satisfaction score
Time frame: At the end of the teaching day
Self-assessment score for knowledge (10 points)
Time frame: At the end of the teaching day
Self-assessment score for skills (competencies) (10 points)
Time frame: At the end of the teaching day
Satisfaction score 1
Time frame: At the end of the teaching day
Satisfaction score 2
Time frame: At the end of the teaching day
Submitting a thesis form
Time frame: 6 months after the course
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest on medical education. Data or samples shared will be coded.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Lamort-Bouché, MD, PhD contact
Rémy Boussageon, MD, PhD study chair
Lyon 1 University & LBBE UMR 5558, CNRS
Marion Lamort-Bouché, MD, PhD study director
Research on Healthcare Performance Lab U1290, Inserm
Pierre-Yves Meunier, MD principal investigator
University Lyon 1
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid course on medical thesis for post graduates general practice students and Face-to-face teaching on medical thesis for post graduates general practice students in people with Education, Medical, run by Research on Healthcare Performance Lab U1290.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Yves Meunier, MD (+33658930614, pierre-yves.meunier@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-assessment score for learning outcomes (time frame: At the end of the teaching day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.