IntimidationNCT03184142
Increasing Reporting of Intimidation of Medical Students With Simulation
A study testing Simulation and Video in people with Intimidation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Intimidation of medical students by health care professionals is a well-documented phenomenon. Raising awareness of what constitutes intimidation is a preferred method for preventing it through increased reporting. Simulation is a novel method of raising awareness of intimidation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intimidation
- What is being tested?
- Simulation and Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2017to 21 Dec 2017
- 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
- Medical students at the University of Montreal at the beginning of their surgical clerkship rotation.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site
Faculté de Médecine de l'Université de Montréal
Montreal, Quebec, H3T 1J4
About this study
Official title: Increasing Reporting of Intimidation of Medical Students With Simulation: a Randomised Controlled Trial
Intimidation of medical students by health care professionals is a well-documented phenomenon. Raising awareness of what constitutes intimidation is a preferred method for preventing it through increased reporting. Simulation is a novel method of raising awareness of intimidation.
This is a randomised controlled trial comparing the effectiveness of simulation (involving actors), an educational video and no intervention, as adjuncts to group discussion, on students' ability to identify and report intimidation. Medical students from the University of Montreal in Montreal, Canada, will be recruited at the beginning of surgical clerkship. They will complete a standardized and validated pre-intervention questionnaire on their experience with intimidation consisting of multiple choice questions and short answers. They will be randomised to one of the three interventions lasting 70 minutes that will be followed by a 20-minute standardized discussion on intimidation with all students participating together. At the end of their surgical rotation, they will complete a similar post-intervention questionnaire with additional questions pertaining to the reporting of intimidation.
Differences in intimidation reporting after the intervention as well as a before and after comparison of the "Negative Acts Questionnaire" score will be studied.
- Conditions
- Intimidation
- Being tested
- Simulation, Video, Control group
- Keywords
- Intimidation, Simulation, Medical education, Surgical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationBehavioural
Students witness the intimidation of one of their peers (who is an actor) by a professor (also an actor). (see arm description)
VideoBehavioural
Student watch a 15-minute intimidation video (see arm description).
Control groupBehavioural
No intervention. The students suture for 70 minutes
| Study group | Role | What they receive |
|---|---|---|
| Simulation | Experimental | During a suturing class at the simulation center, the students enter a classroom. Although the students are not aware of this, among them is an actor playing the role of a student. One of the two professors is also an actor. As the activity progresses, the professor targets the student played by an actor. The intimidation intensifies until the end. At the end of the activity, there is a debriefing explaining to the students that the bullying professor and the victim were actors. Receives: Behavioral: Simulation |
| Video | Experimental | During a suturing class at the simulation center, after 55 minutes of suturing, the students will be exposed to a 15-minute video on workplace and hospital intimidation and how to manage it. Receives: Behavioral: Video |
| Control | Placebo comparator | During a suturing class at the simulation center, the students suture for the entire 70-minute duration of the activity. They are not exposed to intimidation (control group). Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort in reporting intimidation
Based on post-intervention questionnaire question.
Measured: 6 weeks after enrollment
Perception of intimidation after intervention
Based on post-intervention Negative Acts Questionnaire (NAQ-R)
Measured: 6 weeks after enrollment
Secondary outcomes (4)
Baseline prevalence of intimidation
Based on pre-intervention Negative Acts Questionnaire (NAQ-R)
Measured: at enrollment
Before and after comparison
Difference between pre and post-intervention Negative Acts Questionnaire (NAQ-R)
Measured: at enrollment vs 6 weeks post-intervention
Reasons for not reporting intimidation
Open-ended question asking why students don't report intimidation
Measured: at enrollment
Frequency of intimidation reporting
Did the students report intimidation during the 6 weeks of their surgical clerkship?
Measured: 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start15 Jun 2017
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IntimidationStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind randomised controlled trial with two experimental arms and a control arm
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Érica Patocskai, Université de Montréal
- Investigators
- Erica Patocskai, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184142
- Sponsor's protocol ID
- 16.422
- Status last verified
- May 2018
- First submitted
- 8 Jun 2017
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stone JP, Charette JH, McPhalen DF, Temple-Oberle C. Under the knife: medical student perceptions of intimidation and mistreatment. J Surg Educ. 2015 Jul-Aug;72(4):749-53. doi: 10.1016/j.jsurg.2015.02.003.
PubMed 26073477Isaranuwatchai W, Brydges R, Carnahan H, Backstein D, Dubrowski A. Comparing the cost-effectiveness of simulation modalities: a case study of peripheral intravenous catheterization training. Adv Health Sci Educ Theory Pract. 2014 May;19(2):219-32. doi: 10.1007/s10459-013-9464-6. Epub 2013 Jun 1.
PubMed 23728476Curtis MT, DiazGranados D, Feldman M. Judicious use of simulation technology in continuing medical education. J Contin Educ Health Prof. 2012 Fall;32(4):255-60. doi: 10.1002/chp.21153.
PubMed 23280528Einarsen S, Helge H, Notelaers G. Measuring exposure to bullying and harassment at work: validity, factor structure & psychometric properties of the negative acts questionnaire-revised. Work Stress 23(1):24-44, 2009.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Reporting of Intimidation of Medical Students With Simulation: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03184142
- Acronym / sponsor ID
- 16.422
- Conditions
- Intimidation
- Keywords
- Intimidation, Simulation, Medical education, Surgical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 12 Jun 2017 (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.
Intimidation of medical students by health care professionals is a well-documented phenomenon. Raising awareness of what constitutes intimidation is a preferred method for preventing it through increased reporting. Simulation is a novel method of raising awareness of intimidation.
This is a randomised controlled trial comparing the effectiveness of simulation (involving actors), an educational video and no intervention, as adjuncts to group discussion, on students' ability to identify and report intimidation. Medical students from the University of Montreal in Montreal, Canada, will be recruited at the beginning of surgical clerkship. They will complete a standardized and validated pre-intervention questionnaire on their experience with intimidation consisting of multiple choice questions and short answers. They will be randomised to one of the three interventions lasting 70 minutes that will be followed by a 20-minute standardized discussion on intimidation with all students participating together. At the end of their surgical rotation, they will complete a similar post-intervention questionnaire with additional questions pertaining to the reporting of intimidation.
Differences in intimidation reporting after the intervention as well as a before and after comparison of the "Negative Acts Questionnaire" score will be studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single-blind randomised controlled trial with two experimental arms and a control arm
| Arm | Type | Receives |
|---|---|---|
| Simulation | Experimental | Behavioral: SimulationDuring a suturing class at the simulation center, the students enter a classroom. Although the students are not aware of this, among them is an actor playing the role of a student. One of the two professors is also an actor. As the activity progresses, the professor targets the student played by an actor. The intimidation intensifies until the end. At the end of the activity, there is a debriefing explaining to the students that the bullying professor and the victim were actors. |
| Video | Experimental | Behavioral: VideoDuring a suturing class at the simulation center, after 55 minutes of suturing, the students will be exposed to a 15-minute video on workplace and hospital intimidation and how to manage it. |
| Control | Placebo comparator | Behavioral: Control groupDuring a suturing class at the simulation center, the students suture for the entire 70-minute duration of the activity. They are not exposed to intimidation (control group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical students at the University of Montreal at the beginning of their surgical clerkship rotation.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SimulationStudents witness the intimidation of one of their peers (who is an actor) by a professor (also an actor). (see arm description) | Behavioural | Simulation |
| VideoStudent watch a 15-minute intimidation video (see arm description). | Behavioural | Video |
| Control groupNo intervention. The students suture for 70 minutes | Behavioural | Control |
Primary outcome
Comfort in reporting intimidation
Time frame: 6 weeks after enrollment
Based on post-intervention questionnaire question.
Perception of intimidation after intervention
Time frame: 6 weeks after enrollment
Based on post-intervention Negative Acts Questionnaire (NAQ-R)
4 secondary outcomes
Baseline prevalence of intimidation
Time frame: at enrollment
Before and after comparison
Time frame: at enrollment vs 6 weeks post-intervention
Reasons for not reporting intimidation
Time frame: at enrollment
Frequency of intimidation reporting
Time frame: 6 weeks post-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 9 May 2018.
- Background: PubMed 26073477Stone JP, Charette JH, McPhalen DF, Temple-Oberle C. Under the knife: medical student perceptions of intimidation and mistreatment. J Surg Educ. 2015 Jul-Aug;72(4):749-53. doi: 10.1016/j.jsurg.2015.02.003.
- Background: PubMed 23728476Isaranuwatchai W, Brydges R, Carnahan H, Backstein D, Dubrowski A. Comparing the cost-effectiveness of simulation modalities: a case study of peripheral intravenous catheterization training. Adv Health Sci Educ Theory Pract. 2014 May;19(2):219-32. doi: 10.1007/s10459-013-9464-6. Epub 2013 Jun 1.
- Background: PubMed 23280528Curtis MT, DiazGranados D, Feldman M. Judicious use of simulation technology in continuing medical education. J Contin Educ Health Prof. 2012 Fall;32(4):255-60. doi: 10.1002/chp.21153.
- BackgroundEinarsen S, Helge H, Notelaers G. Measuring exposure to bullying and harassment at work: validity, factor structure & psychometric properties of the negative acts questionnaire-revised. Work Stress 23(1):24-44, 2009.
- Individual participant dataSharing planned: No
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.
Erica Patocskai, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation and Video in people with Intimidation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. 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?
Comfort in reporting intimidation (time frame: 6 weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03184142, which also lists 4 linked publications.
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 9 May 2018.