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CompletedNCT03441425Updated Mar 24, 2020

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

An interventional study of Unexpected death in Crisis Resource Management (CRM) Skills, Stress and Advanced Cardiovascular Life Support (ACLS) Skills, sponsored by Ottawa Hospital Research Institute. Completed at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • CRM Skills
  • ACLS
  • Simulation
  • Stress
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Not a resident or fellow in one of the departments indicated above
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • 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.

    Other: Unexpected death

Interventions

  • OtherUnexpected death
05

What researchers measure

Primary outcomes

  1. Non-technical Crisis Resource Management (CRM) skills

    Assessed using the Ottawa Global Rating Scale

    Time frame: 3 months

Secondary outcomes

  1. Technical CRM skills

    Assessed using a checklist derived from the American Heart Association's Megacode Checklist

    Time frame: 3 months

  2. Salivary cortisol

    Biomarker of stress

    Time frame: 5 time points during each of the 2 simulation days

  3. State-trait anxiety inventory

    Self-perceived anxiety questionnaire

    Time frame: 3 time points during each of the 2 simulation days

  4. Cognitive appraisal

    Ratio of perceived preparedness versus demands of a task

    Time frame: 2 time points during each of the 2 simulation days

  5. Positive and Negative Affect Schedule (PANAS)

    Classification of emotions experienced

    Time frame: 1 time point during each of the 2 simulation days

06

Study locations

2 sites
  • The Ottawa Hospital
    Ottawa, Ontario K1Y4E9, Canada
  • Mount Sinai Hospital
    Toronto, Ontario M5G 1X5, Canada
07

References and documents

Study documents

  • Study protocol · Oct 10, 2014
  • Statistical analysis plan · Feb 6, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03441425
Lead sponsor
Ottawa Hospital Research Institute
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Nov 10, 2014
Primary completion
Jun 1, 2018
Completion
Jun 1, 2018
Last update
Mar 24, 2020

Study contacts

Sylvain Boet, MD
principal investigator · The Ottawa Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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