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

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

Interventional

Enrollment (Actual)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 2100
        • Mental Health Service Capital Region
      • Slagelse, Denmark, 4200
        • Mental Health Service Region Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2021

Primary Completion (Actual)

March 7, 2023

Study Completion (Actual)

March 7, 2023

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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