- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03441425
Impact of Unexpected Death in Simulation: Skill Retention, Stress and Emotions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background High-fidelity simulation is an increasingly used teaching tool that is proven to be effective for learning. According to the literature, by gradually increasing stress and emotions, more effective learning can be achieved. However, allowing the simulated patient to "die", as a deliberate stressor, is controversial. There is no previous research on the educational effect of letting a simulated patient die. We aim to evaluate the effects of simulated unexpected death on skill retention, stress levels, and emotions. We hypothesize that the occurrence of unexpected death will impact skill retention, and will be associated with higher stress levels and stronger emotions.
Methods After Institutional Research Ethics Board approval, 56 residents and fellows of different medical specialties will be randomized to either the intervention (unexpected death) or control (survive) group. Participants from both groups will have to individually manage a simulated cardiac arrest crisis. In the intervention group, the scenario will end by the death of the simulated patient, whilst in the control group the simulated patient will survive. Each participant will be immediately debriefed by a trained instructor. Three months later, skill retention will be assessed in a similar scenario. Crisis management performance of all scenarios will be rated by 2 blinded raters. Biological stress, cognitive appraisal, and emotions will be measured during both scenarios.
Implications The impact of simulated unexpected death on skill retention of residents and fellows will provide instructors with evidence to optimize scenario design and approach the role of stress and emotions in simulation-based education.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y4E9
- The Ottawa Hospital
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be a resident or a fellow in the department of anesthesiology, critical care, emergency medicine, medicine, obstetrics and gynecology, surgery or family medicine at the University of Ottawa or the University of Toronto
- Participants are requested to refrain from physical strains, smoking, drinking caffeinated or low pH beverages and eating for at least one hour before enrollment
- Participants will be included between 11 AM and 8 PM, when cortisol levels are most stable
Exclusion Criteria:
- Not a resident or fellow in one of the departments indicated above
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
The control group participants will complete a cardiac arrest simulation scenario on the first day in which the mannequin returns to spontaneous circulation at the end of the scenario.
They will then complete a retention simulation session three months later.
|
|
EXPERIMENTAL: Unexpected death
The experimental group participants will complete a cardiac arrest simulation scenario on the first day in which the mannequin unexpectedly dies at the end of the scenario.
They will then complete a retention simulation session three months later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-technical Crisis Resource Management (CRM) skills
Time Frame: 3 months
|
Assessed using the Ottawa Global Rating Scale
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical CRM skills
Time Frame: 3 months
|
Assessed using a checklist derived from the American Heart Association's Megacode Checklist
|
3 months
|
Salivary cortisol
Time Frame: 5 time points during each of the 2 simulation days
|
Biomarker of stress
|
5 time points during each of the 2 simulation days
|
State-trait anxiety inventory
Time Frame: 3 time points during each of the 2 simulation days
|
Self-perceived anxiety questionnaire
|
3 time points during each of the 2 simulation days
|
Cognitive appraisal
Time Frame: 2 time points during each of the 2 simulation days
|
Ratio of perceived preparedness versus demands of a task
|
2 time points during each of the 2 simulation days
|
Positive and Negative Affect Schedule (PANAS)
Time Frame: 1 time point during each of the 2 simulation days
|
Classification of emotions experienced
|
1 time point during each of the 2 simulation days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20130171-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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