- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05795387
Add-on Video-based Training on Mental Status Examination Skills (VV-RCT)
Add-on Video-based Training: Effect on Mental Status Examination Skills in 5th Year Medical Students - an Educational RCT
The goal of this clinical triall is to investigate the training effect of access to authentic patient video on mental status examination performance among 5th year Danish medical students.
Aim:
To investigate if
- Students with add-on access to an authentic patient video e-library have improved Mental Status Examination precision compared to students that only have an add-on e-library with simulated patient videos.
- Number of videos watched correlate to mental status examination test scores.
Study Overview
Status
Conditions
Detailed Description
The main study is a a two-armed, pragmatic cluster-randomised, superiority, partial-blinded, randomized controlled trial where the interventions are e-learning courses that serves as add-on learning material during the psychiatric clerkship.
Two student groups are compared. The experimental intervention(V) is a larger e-learning module, where the students have access to 23 authentic patient video vignettes and an e-module on mental status exam including demonstration videos with simulated patients (actor videos). The comparator students (N-V) only have access to the e-module on mental status exam including demonstration videos with simulated patients. All students participate in the regular Psychiatry curriculum i.e. 16 lectures in one week and psychiatric clerkship in three weeks.
As students have their clerkship in 10 different facilities across the Island of Zealand, we carry out cluster-randomization based on clerkship location.
Communication, recruitment and data management is carried out within the university teaching platform (CANVAS), by manual extraction, and by questionnaires distributed by SurveyXact.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Mental Health Service Capital Region
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Slagelse, Denmark, 4200
- Mental Health Service Region Zealand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consent
- 5th year medical student at the University of Copenhagen on the psychiatric clinical rotation
Exclusion Criteria:
- Previous acess to the video library.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Add-on Intervention - Video-based self-regulated training
The intervention consist of access to the video e-library on their e-learning platform. The video e-library consists of 23 videos of brief patient interviews, mostly with inpatients, with adjoining MSE written by three faculty psychiatrists. Selected videos are used for demonstration of phenomena, and five videos will have audio explanation of the resulting MSE. As well as the authentic patient videos on the e-library there are some pages with written theoretical instructions on the MSE, a brief animated movie and some simulated videos by an actor all regarding the MSE. |
Authentic patient videos for self-regulated training as well as written e-course material, both on the mental status exam
|
|
Active Comparator: Non-video group
For the present trial, also the NV students will receive the same non-authentic patient material I.E written theoretical instructions on the MSE, a brief animated movie and some simulated videos by an actor all regarding the MSE.
Ensuring it is the authentic patient video e-library and not the theoretical information responsible for the expected difference in scores.
|
Written material on the mental status exam
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental status exam skills test
Time Frame: A week after the intervention
|
The test consists of three subtests each consisting of a video vignette, not accessible in the library (i.e.
none of the students had seen it previously) with a forced choice test (FCT).
This results in a scoring range of -15 to + 15 points per FCT.
The MSE-skills test score consists of the student's average score of the three FCTs.
|
A week after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MSE skill test score stratification
Time Frame: Baseline
|
We will explore if there is a difference between gender, each individual video and attitude towards psychiatry on the MSE skill test score
|
Baseline
|
|
General evaluation of the clinical rotation
Time Frame: Immediately after the intervention
|
The evaluation is carried out by a validated questionnaire of 10 items, to be answered on a 5-point Likert scale.
Purpose-made supplementary questions concerning the student's number of patient encounters alone and with a doctor/staff and area of interest in psychiatry
|
Immediately after the intervention
|
|
Questions concerning use of the video e-library
Time Frame: Immediately after the intervention
|
time spend on each task/video ; evaluation of/satisfaction with the different element of the e-library
|
Immediately after the intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Sidse M Arnfred, Professor, Research Unit Psychotherapy and Psychopathology Psychiatry West
- Principal Investigator: Esben B Schäfer, MD, Research Unit Psychotherapy and Psychopathology Psychiatry West
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VV_RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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