NCT03184142

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

June 8, 2017

Last Update Submit

May 8, 2018

Conditions

Keywords

IntimidationSimulationMedical educationSurgical education

Outcome Measures

Primary Outcomes (2)

  • Comfort in reporting intimidation

    Based on post-intervention questionnaire question.

    6 weeks after enrollment

  • Perception of intimidation after intervention

    Based on post-intervention Negative Acts Questionnaire (NAQ-R)

    6 weeks after enrollment

Secondary Outcomes (4)

  • Baseline prevalence of intimidation

    at enrollment

  • Before and after comparison

    at enrollment vs 6 weeks post-intervention

  • Reasons for not reporting intimidation

    at enrollment

  • Frequency of intimidation reporting

    6 weeks post-intervention

Study Arms (3)

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.

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.

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).

Behavioral: Control group

Interventions

SimulationBEHAVIORAL

Students witness the intimidation of one of their peers (who is an actor) by a professor (also an actor). (see arm description)

Simulation
VideoBEHAVIORAL

Student watch a 15-minute intimidation video (see arm description).

Video
Control groupBEHAVIORAL

No intervention. The students suture for 70 minutes

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical students at the University of Montreal at the beginning of their surgical clerkship rotation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculté de Médecine de l'Université de Montréal

Montreal, Quebec, H3T 1J4, Canada

Location

Related Publications (4)

  • 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.

    PMID: 26073477BACKGROUND
  • Isaranuwatchai 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.

    PMID: 23728476BACKGROUND
  • Curtis 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.

    PMID: 23280528BACKGROUND
  • Einarsen 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.

    BACKGROUND

MeSH Terms

Interventions

Videotape RecordingControl Groups

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Erica Patocskai, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Students cannot be masked as an arm undergoes a simulation intervention. The researcher evaluating the outcomes through the questionnaires will be blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Single-blind randomised controlled trial with two experimental arms and a control arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Oncologist, Director of surgical Clerkship

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 12, 2017

Study Start

June 15, 2017

Primary Completion

December 21, 2017

Study Completion

December 21, 2017

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations