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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03184142
Other study ID # 16.422
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2017
Est. completion date December 21, 2017

Study information

Verified date May 2018
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date December 21, 2017
Est. primary completion date December 21, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Simulation
Students witness the intimidation of one of their peers (who is an actor) by a professor (also an actor). (see arm description)
Video
Student watch a 15-minute intimidation video (see arm description).
Control group
No intervention. The students suture for 70 minutes

Locations

Country Name City State
Canada Faculté de Médecine de l'Université de Montréal Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Comfort in reporting intimidation Based on post-intervention questionnaire question. 6 weeks after enrollment
Primary Perception of intimidation after intervention Based on post-intervention Negative Acts Questionnaire (NAQ-R) 6 weeks after enrollment
Secondary Baseline prevalence of intimidation Based on pre-intervention Negative Acts Questionnaire (NAQ-R) at enrollment
Secondary Before and after comparison Difference between pre and post-intervention Negative Acts Questionnaire (NAQ-R) at enrollment vs 6 weeks post-intervention
Secondary Reasons for not reporting intimidation Open-ended question asking why students don't report intimidation at enrollment
Secondary Frequency of intimidation reporting Did the students report intimidation during the 6 weeks of their surgical clerkship? 6 weeks post-intervention