Medical EducationVV-RCTNCT05795387
Add-on Video-based Training on Mental Status Examination Skills
A study testing Video-based self-regulated training on the mental status exam and E-course with written material on the mental status exam in people with Medical Education, run by Psychiatric Research Unit, Region Zealand, Denmark at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Education
- What is being tested?
- Video-based self-regulated training on the mental status exam and E-course with written material on the mental status exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 2 sitesDenmark
- Study dates
- 31 Jan 2021to 7 Mar 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Consent
- 5th year medical student at the University of Copenhagen on the psychiatric clinical rotation
Who cannot join
- Previous acess to the video library.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Mental Health Service Capital Region
Copenhagen, 2100
Mental Health Service Region Zealand
Slagelse, 4200
About this study
Official title: 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.
Read the 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.
- Conditions
- Medical Education
- Being tested
- Video-based self-regulated training on the mental status exam, E-course with written material on the mental status exam
- Keywords
- e-learning, psychopathology, mental status examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based self-regulated training on the mental status examOther
Authentic patient videos for self-regulated training as well as written e-course material, both on the mental status exam
E-course with written material on the mental status examOther
Written material on the mental status exam
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: E-course with written material on the mental status exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A week after the intervention
Secondary outcomes (3)
MSE skill test score stratification
We will explore if there is a difference between gender, each individual video and attitude towards psychiatry on the MSE skill test score
Measured: Baseline
General evaluation of the clinical rotation
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
Measured: Immediately after the intervention
Questions concerning use of the video e-library
time spend on each task/video ; evaluation of/satisfaction with the different element of the e-library
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start31 Jan 2021
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies 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
- A parallel group, superiority, partial-blinded, cluster-randomized controlled trial where both interventions are an addition to the regular psychiatric clerkship.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Sidse M Arnfred, Professor, Study director, Research Unit Psychotherapy and Psychopathology Psychiatry WestEsben B Schäfer, MD, Principal investigator, Research Unit Psychotherapy and Psychopathology Psychiatry West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795387
- Sponsor's protocol ID
- VV_RCT
- Acronym
- VV-RCT
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-on Video-based Training: Effect on Mental Status Examination Skills in 5th Year Medical Students - an Educational RCT
- ClinicalTrials.gov ID
- NCT05795387
- Acronym / sponsor ID
- VV-RCT / VV_RCT
- Conditions
- Medical Education
- Keywords
- e-learning, psychopathology, mental status examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, DenmarkUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 3 Apr 2023 (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 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel group, superiority, partial-blinded, cluster-randomized controlled trial where both interventions are an addition to the regular psychiatric clerkship.
| Arm | Type | Receives |
|---|---|---|
| Experimental Add-on Intervention - Video-based self-regulated training | Experimental | Other: Video-based self-regulated training on the mental status examThe 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. |
| Non-video group | Active comparator | Other: E-course with written material on the mental status examFor 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Consent
- 5th year medical student at the University of Copenhagen on the psychiatric clinical rotation
Key exclusion criteria (1 listed)
- Previous acess to the video library.
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 |
|---|---|---|
| Video-based self-regulated training on the mental status examAuthentic patient videos for self-regulated training as well as written e-course material, both on the mental status exam | Other | Experimental Add-on Intervention - Video-based self-regulated training |
| E-course with written material on the mental status examWritten material on the mental status exam | Other | Non-video group |
Primary outcome
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.
3 secondary outcomes
MSE skill test score stratification
Time frame: Baseline
General evaluation of the clinical rotation
Time frame: Immediately after the intervention
Questions concerning use of the video e-library
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Sidse M Arnfred, Professor study director
Research Unit Psychotherapy and Psychopathology Psychiatry West
Esben B Schäfer, MD principal investigator
Research Unit Psychotherapy and Psychopathology Psychiatry West
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based self-regulated training on the mental status exam and E-course with written material on the mental status exam in people with Medical Education, run by Psychiatric Research Unit, Region Zealand, Denmark at 2 sites in Denmark.
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 2 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: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental status exam skills test (time frame: A week after the intervention). 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 3 Apr 2023.