Clinical trial NCT03441425: Impact of Unexpected Death in Simulation: Skill Retention, Stress and Emotions
Official title: Impact of Unexpected Death in Simulation: Skill Retention, Stress and Emotions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crisis Resource Management (CRM) Skills
Stress
Advanced Cardiovascular Life Support (ACLS) Skills
Keywords: CRM Skills
ACLS
Simulation
Stress
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-technical Crisis Resource Management (CRM) skills
timeFrame: 3 months
Secondary outcomes:
measure: Technical CRM skills
timeFrame: 3 months
measure: Salivary cortisol
timeFrame: 5 time points during each of the 2 simulation days
measure: State-trait anxiety inventory
timeFrame: 3 time points during each of the 2 simulation days
measure: Cognitive appraisal
timeFrame: 2 time points during each of the 2 simulation days
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: 1 time point during each of the 2 simulation days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Sylvain Boet, MD
role: PRINCIPAL_INVESTIGATOR
References: