NCT05795387

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

January 31, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

March 3, 2023

Last Update Submit

March 20, 2023

Conditions

Keywords

e-learningpsychopathologymental status examination

Outcome Measures

Primary Outcomes (1)

  • Mental status exam skills test

    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 Outcomes (3)

  • MSE skill test score stratification

    Baseline

  • General evaluation of the clinical rotation

    Immediately after the intervention

  • Questions concerning use of the video e-library

    Immediately after the intervention

Study Arms (2)

Experimental Add-on Intervention - Video-based self-regulated training

EXPERIMENTAL

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.

Other: Video-based self-regulated training on the mental status exam

Non-video group

ACTIVE COMPARATOR

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.

Other: E-course with written material on the mental status exam

Interventions

Authentic patient videos for self-regulated training as well as written e-course material, both on the mental status exam

Experimental Add-on Intervention - Video-based self-regulated training

Written material on the mental status exam

Non-video group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Consent
  • th year medical student at the University of Copenhagen on the psychiatric clinical rotation

You may not qualify if:

  • Previous acess to the video library.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mental Health Service Capital Region

Copenhagen, 2100, Denmark

Location

Mental Health Service Region Zealand

Slagelse, 4200, Denmark

Location

Study Officials

  • Sidse M Arnfred, Professor

    Research Unit Psychotherapy and Psychopathology Psychiatry West

    STUDY DIRECTOR
  • Esben B Schäfer, MD

    Research Unit Psychotherapy and Psychopathology Psychiatry West

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
As mentioned, it will not be possible to mask students or local lecturers to allocation group. PI receives the clerkship student enrolment list from the faculty, randomize at clerkship location level and merge it with the consent lists collected digitally in SurveyXact. The students that have consented to participation receives individual invitation to the designated e-module. The instructor carrying out the digital mental status examination test, has no information of arm allocation. Statistical analysis will be performed by researcher blind to arm allocation, and masking will only be broken when the primary outcomes have been analyzed and a conclusion has been formulated based on the masked allocations.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A parallel group, superiority, partial-blinded, cluster-randomized controlled trial where both interventions are an addition to the regular psychiatric clerkship.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

April 3, 2023

Study Start

January 31, 2021

Primary Completion

March 7, 2023

Study Completion

March 7, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations