Crisis Resource Management (CRM) SkillsNCT03441425
Impact of Unexpected Death in Simulation: Skill Retention, Stress and Emotions
A study testing Unexpected death in people with Crisis Resource Management (CRM) Skills and Stress, run by Ottawa Hospital Research Institute at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crisis Resource Management (CRM) Skills, Stress, Advanced Cardiovascular Life Support (ACLS) Skills
- What is being tested?
- Unexpected death
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Nov 2014to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not a resident or fellow in one of the departments indicated above
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital
Ottawa, Ontario, K1Y4E9
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
About this study
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.
- Conditions
- Crisis Resource Management (CRM) Skills, Stress, Advanced Cardiovascular Life Support (ACLS) Skills
- Being tested
- Unexpected death
- Keywords
- CRM Skills, ACLS, Simulation, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unexpected deathOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Unexpected death | Experimental | 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. Receives: Other: Unexpected death |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-technical Crisis Resource Management (CRM) skills
Assessed using the Ottawa Global Rating Scale
Measured: 3 months
Secondary outcomes (5)
Technical CRM skills
Assessed using a checklist derived from the American Heart Association's Megacode Checklist
Measured: 3 months
Salivary cortisol
Biomarker of stress
Measured: 5 time points during each of the 2 simulation days
State-trait anxiety inventory
Self-perceived anxiety questionnaire
Measured: 3 time points during each of the 2 simulation days
Cognitive appraisal
Ratio of perceived preparedness versus demands of a task
Measured: 2 time points during each of the 2 simulation days
Positive and Negative Affect Schedule (PANAS)
Classification of emotions experienced
Measured: 1 time point during each of the 2 simulation days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start10 Nov 2014
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crisis Resource Management (CRM) SkillsStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain Boet, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441425
- Sponsor's protocol ID
- 20130171-01H
- Status last verified
- Mar 2020
- First submitted
- 15 Feb 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Unexpected Death in Simulation: Skill Retention, Stress and Emotions
- ClinicalTrials.gov ID
- NCT03441425
- Acronym / sponsor ID
- 20130171-01H
- Conditions
- Crisis Resource Management (CRM) Skills, Stress, Advanced Cardiovascular Life Support (ACLS) Skills
- Keywords
- CRM Skills, ACLS, Simulation, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 10 Nov 2014 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Unexpected death | Experimental | Other: Unexpected deathThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not a resident or fellow in one of the departments indicated above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unexpected death | Other | Unexpected death |
Primary outcome
Non-technical Crisis Resource Management (CRM) skills
Time frame: 3 months
Assessed using the Ottawa Global Rating Scale
5 secondary outcomes
Technical CRM skills
Time frame: 3 months
Salivary cortisol
Time frame: 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
Cognitive appraisal
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain Boet, MD principal investigator
The Ottawa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unexpected death in people with Crisis Resource Management (CRM) Skills and Stress, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-technical Crisis Resource Management (CRM) skills (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.