NCT03499002

Brief Summary

The purpose of this project is to compare in situ simulation with standard lab simulation. To do this, 30 pre-clinical medical students will be randomized into the lab or ER and taught how to suture a simple laceration. To do this, a synthesized 'skin' will be placed over a volunteer's arm and will have an incision of a predetermined length.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Status
withdrawn

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

March 26, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 13, 2019

Status Verified

April 1, 2018

Enrollment Period

1 month

First QC Date

March 26, 2018

Last Update Submit

March 11, 2019

Conditions

Sutured LacerationLaceration

Keywords

SimulationMedical StudentsIn Situ Simulation

Outcome Measures

Primary Outcomes (1)

  • How each simulated learning environment effects a student's ability to learn how to suture

    Each student will complete a post survey questionnaire after their attempt to suture in the ER department. This will help determine the impact and therefore, which environment was more conducive to learning how to suture.

    1 week

Study Arms (2)

Simulation Lab

EXPERIMENTAL
Other: Simulated Learning Environment

ER in situ Simulation

EXPERIMENTAL
Other: Simulated Learning Environment

Interventions

Simulated Learning EnvironmentOTHER

Intervention is the environment in which the medical student will learn to practice how to suture. The end goal is to determine the impact each environment has on their ability to learn the skill.

Also known as: Simulation lab, ER in situ simulation
ER in situ SimulationSimulation Lab

Eligibility Criteria

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

You may qualify if:

  • Pre clinical medical students (year one or two)

You may not qualify if:

  • Medical students not in first or second year training
  • Extensive knowledge or background with suturing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Roussin CJ, Weinstock P. SimZones: An Organizational Innovation for Simulation Programs and Centers. Acad Med. 2017 Aug;92(8):1114-1120. doi: 10.1097/ACM.0000000000001746.

    PMID: 28562455RESULT

  • Jagneaux T, Caffery TS, Musso MW, Long AC, Zatarain L, Stopa E, Freeman N, Quin CC, Jones GN. Simulation-Based Education Enhances Patient Safety Behaviors During Central Venous Catheter Placement. J Patient Saf. 2021 Sep 1;17(6):425-429. doi: 10.1097/PTS.0000000000000425.

    PMID: 28984729RESULT

  • Sorensen JL, Ostergaard D, LeBlanc V, Ottesen B, Konge L, Dieckmann P, Van der Vleuten C. Design of simulation-based medical education and advantages and disadvantages of in situ simulation versus off-site simulation. BMC Med Educ. 2017 Jan 21;17(1):20. doi: 10.1186/s12909-016-0838-3.

    PMID: 28109296RESULT

  • Ullman E, Kennedy M, Di Delupis FD, Pisanelli P, Burbui AG, Cussen M, Galli L, Pini R, Gensini GF. The Tuscan Mobile Simulation Program: a description of a program for the delivery of in situ simulation training. Intern Emerg Med. 2016 Sep;11(6):837-41. doi: 10.1007/s11739-016-1401-2. Epub 2016 Feb 9.

    PMID: 26861702RESULT

  • Haji FA, Rojas D, Childs R, de Ribaupierre S, Dubrowski A. Measuring cognitive load: performance, mental effort and simulation task complexity. Med Educ. 2015 Aug;49(8):815-27. doi: 10.1111/medu.12773.

    PMID: 26152493RESULT

  • Rosen MA, Hunt EA, Pronovost PJ, Federowicz MA, Weaver SJ. In situ simulation in continuing education for the health care professions: a systematic review. J Contin Educ Health Prof. 2012 Fall;32(4):243-54. doi: 10.1002/chp.21152.

    PMID: 23280527RESULT

  • Petrosoniak A, Auerbach M, Wong AH, Hicks CM. In situ simulation in emergency medicine: Moving beyond the simulation lab. Emerg Med Australas. 2017 Feb;29(1):83-88. doi: 10.1111/1742-6723.12705. Epub 2016 Oct 17.

    PMID: 27748042RESULT

  • Naismith LM, Cheung JJ, Ringsted C, Cavalcanti RB. Limitations of subjective cognitive load measures in simulation-based procedural training. Med Educ. 2015 Aug;49(8):805-14. doi: 10.1111/medu.12732.

    PMID: 26152492RESULT

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Chrystal Horwood, MD

    Memorial University of Newfoundland and Labrador

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Research assistant will be present when student randomly chooses which environment they will learn how to suture in. The principal investigator will be unaware of this randomization.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 17, 2018

Study Start

April 1, 2018

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

March 13, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share