NCT03470818

Brief Summary

The primary objective of this study is to assess if letting learners know in advance what medical illnesses will be practiced in an upcoming simulation session and providing them with instruction regarding that medical content ahead of time (flipped classroom model) will allow them to focus on the application of Crisis Resource Management (CRM) principles during a simulation session and result in an increase retention of theses skills. Secondary objectives of this study are to assess the relationship between the study intervention and learners' emotional responses and its impact on the retention of non-technical skills, in occurrence CRM

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

4 years

First QC Date

March 7, 2018

Last Update Submit

November 24, 2022

Conditions

Keywords

Medical EducationFlipped ClassroomAnxietySimulationAchievement Emotions

Outcome Measures

Primary Outcomes (1)

  • Overall Crisis Resource Management skills

    The between group difference in Crisis Resource Management skills three months post instruction measured by the overall Ottawa Crisis Resource Management Global Rating Scale mean score Scale ranges: 1 - 7 Higher scores are associated with better performance

    Three months

Secondary Outcomes (7)

  • Specific Crisis Resource Management skills

    3 months

  • Stress response with salivary cortisol

    Baseline and 3 months

  • Stress response with State Trait Inventory Index

    Baseline and 3 months

  • Stress response difference with State Trait Anxiety Inventory

    3 months

  • Stress response difference with salivary cortisol

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Preparatory instructional videos (flipped classroom model) 32 participants Application of a flipped classroom model Prior to the simulation session, the intervention group will have received the study intervention. This consists in the provision of preparatory instruction about the medical knowledge required to complete the task work of the upcoming simulated acute care clinical situation. The format used to convey this off-loaded educational content will be short (approximately 15 minutes) narrated video PowerPoint presentations; every relevant medical situation incorporated in the simulation case will have a dedicated video presentation. These videos will be available to the intervention group participants on a web-based platform one week prior to the simulation session

Other: Preparatory instructional videos (flipped classroom model)

Control group

SHAM COMPARATOR

Sham videos Participants in the control group will also be called to watch an online video prior to the simulation activity. However, this video presentation will not have any form of information regarding the upcoming simulation case; it will be an introductory video discussing the capacities of the simulation facility. This will limit any unwanted "snowball" effect where discussion between research participants could lead the control group participants to inquire about a video presentation that they would not exposed to.

Other: Sham video

Interventions

The intervention consists in the provision of preparatory instruction about the medical knowledge required to complete the task work of the upcoming simulated acute care clinical situation. The format used to convey this off-loaded educational content will be short (approximately 15 minutes) narrated video PowerPoint presentations; every relevant medical situation incorporated in the simulation case will have a dedicated video presentation. These videos will be available to the intervention group participants on a web-based platform one week prior to the simulation session

Intervention group

Participants in the control group will be called to watch an online video prior to the simulation activity. However, this video presentation will not have any form of information regarding the upcoming simulation case; it will be an introductory video discussing the capacities of the simulation facility. This will limit any unwanted "snowball" effect where discussion between research participants could lead the control group participants to inquire about a video presentation that they would not exposed to.

Control group

Eligibility Criteria

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

You may qualify if:

  • First year residents in any surgical or medical specialty (including family medicine) that are required to achieve competencies in CRM skills per residency program requirements

You may not qualify if:

  • endocrine disorders affecting cortisol metabolism (i.e., hypo/hyperthyroidism, Cushing's syndrome/disease, adrenal insufficiency, etc.)
  • Corticosteroid therapy (except for topical)
  • Use of drugs interfering with physiologic stress response (i.e., antidepressant medication, benzodiazepines, beta-blockers, calcium channel blockers, etc.)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 20, 2018

Study Start

January 19, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations