- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01653704
Learning Crisis Resource Management: Practicing Versus Observational Role in Simulation Training
January 7, 2019 updated by: Ottawa Hospital Research Institute
The purpose of this study is to compare the effectiveness in learning crisis resource management (CRM) principles when being an active participant in simulation-based education versus being an observer participant.
The investigators hypothesize that active participants will improve their CRM skills more than observer participants.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This will be a prospective randomized controlled study.
Participants will be randomized to one of two groups with stratification according to their level of training: the active group and the observer group.
Each participant of the active group will be paired with one of the participants from the observer group.
The active participant will manage individually a simulated crisis scenario (pretest) while the paired observer participant will observe the scenario from outside the simulation room using a video transmission system.
Immediately after, both participants will be debriefed by a trained instructor focused on CRM principles.
The same active and observer participants will then individually manage another simulated crisis scenario (post-test).
Two independent raters, blinded to the study design and to the randomization groups, will review the videos of all scenarios in a random order and rate each participant on their CRM performance using a global rating scale (GRS).
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y3E9
- University of Ottawa Skills and Simulation Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- emergency medicine residents from the University of Ottawa
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: active management of crises scenario
participants assigned to actively manage a crisis scenario
|
active role in managing crisis scenario
|
|
Active Comparator: Observer role in crisis scenario
Observational role in management of crises scenario
|
observational role in crisis scenario
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Ottawa GRS Score
Time Frame: 1 day
|
The Ottawa GRS scale is a reliable and valid scale used to measure CRM performance in high fidelity simulation.
The scale assesses five main CRM categories: leadership, problem solving, situational awareness, resource allocation and communication skills.
In addition to these five categories, there is a category on overall performance of the participant.
Each category is measured on a 7 point Likert scale with descriptive anchors to provide guidelines on alternating points along the scale.
The categorical scores will be summed to give a total score of 6 to 42.
Higher values represent a better outcome.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anita Lai, MD, University of Ottawa
- Principal Investigator: Sylvain Boet, MD, University of Ottawa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
July 16, 2012
First Submitted That Met QC Criteria
July 27, 2012
First Posted (Estimate)
July 31, 2012
Study Record Updates
Last Update Posted (Actual)
January 14, 2019
Last Update Submitted That Met QC Criteria
January 7, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 20120008-01H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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