Impact of Unexpected Death in Simulation: Skill Retention, Stress and Emotions

Stress Clinical Trial

Official title:

Impact of Unexpected Death in Simulation: Skill Retention, Stress and Emotions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441425
• Other study ID #: 20130171-01H
• Status: Completed
• Phase: N/A
• Start date: November 10, 2014
• Est. completion date: June 1, 2018

Study information

• Verified date: March 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Some educational researchers deliberately induce stress upon learners to in order to enhance retention; this practice is controversial and its utility must be weighed against the negative emotional effects it may have on participants. In this study we investigate the effect of the unexpected death of a simulation mannequin on the retention of non-technical and technical crisis resource management skills and consider the emotional impact of this acute stressor.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cardiovascular Life Support (ACLS) Skills
• Crisis Resource Management (CRM) Skills
• Stress

Intervention

Other:
• Unexpected death

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-technical Crisis Resource Management (CRM) skills	Assessed using the Ottawa Global Rating Scale	3 months
Secondary	Technical CRM skills	Assessed using a checklist derived from the American Heart Association's Megacode Checklist	3 months
Secondary	Salivary cortisol	Biomarker of stress	5 time points during each of the 2 simulation days
Secondary	State-trait anxiety inventory	Self-perceived anxiety questionnaire	3 time points during each of the 2 simulation days
Secondary	Cognitive appraisal	Ratio of perceived preparedness versus demands of a task	2 time points during each of the 2 simulation days
Secondary	Positive and Negative Affect Schedule (PANAS)	Classification of emotions experienced	1 time point during each of the 2 simulation days