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

NCT ID: NCT03441425

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-10

Study Completion Date

2018-06-01

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Unexpected death

Intervention Type OTHER

Interventions

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Unexpected death

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvain Boet, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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20130171-01H

Identifier Type: -

Identifier Source: org_study_id

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