Impact of Unexpected Death in Simulation: Skill Retention, Stress and Emotions
Phase: NA
Conditions: Crisis Resource Management (CRM) Skills, Stress, Advanced Cardiovascular Life Support (ACLS) Skills
Sponsor: Ottawa Hospital Research Institute

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IMPACTOFUNEXPECTEDDEATHINSIMULATION:Skill
Retention,StressandEmotions
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“IMPACTOFMEDICALCRISISSIMULATION:SkillRetention,Stressand
Emotions”(alternativetitleforblinding)
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Version1.14/10.10.2014
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ConfidentialityStatement
The information contained in this document, especially unpublished data, is the property of the
investigatorslistedbelow.Itisthereforeprovidedtoyouinconfidenceasaninvestigator,potential
investigator,orconsultant,forreviewbyyou,yourstaff,andanIndependentEthicsCommitteeor
Institutional Review Board. It is understood that this information will not be disclosed to others
without written authorization from the Principal Investigators, except to the extent necessary to
obtain informed consent from those persons to whom the interventional devices may be
administered.

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1.
INVESTIGATORS

Dr.KarlSchebesta,MD(CoͲPrincipalInvestigator)
FellowinSimulationandMedicalEducation,UniversityofOttawaSkillsandSimulationCentre&The
AcademyforInnovationinMedicalEducation,FacultyofMedicine,UniversityofOttawa,Ottawa,
Ontario,Canada
AssistantProfessor,DepartmentofAnesthesiology,GeneralIntensiveCareandPainManagement,
MedicalUniversityofVienna,Vienna,Austria
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Dr.SylvainBoet,MD,MEd,PhD(PrincipalInvestigator)
StaffAnesthesiologist,TheOttawaHospital,GeneralCampus
AssistantProfessor,DepartmentofAnesthesiology,UniversityofOttawa
SeniorResearchAssociate,TheAcademyforInnovationinMedicalEducation,FacultyofMedicine,
UniversityofOttawa,Ottawa,Ontario,Canada
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Dr.KristinaKhanduja,MBChB,MEd(CoͲInvestigator)
AssistantProfessorandStaffAnesthesiologist,
DepartmentofAnesthesiology,MountSinaiHospital,
UniversityofToronto

DrMeghanAndrews,MD,FRCPC(CoͲInvestigator)
AnesthesiologyFellowinSimulationandMedicalEducation
UniversityofOttawaSkillsandSimulationCentre&TheAcademyforInnovationinMedical
Education,FacultyofMedicine,UniversityofOttawa,Ottawa,Ontario,Canada

Dr.VickiLeBlanc,PhD(CoͲInvestigator)
AssociateDirector,TheWilsonCenter,UniversityofToronto
AssistantProfessor,FacultyofDentistryandtheFactorͲInwentashFacultyofSocialWork,University
ofToronto,Toronto,Ontario,Canada
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Dr.MDylanBouldMBChB,FRCA,MEd(SeniorResponsibleInvestigator)
StaffAnesthesiologist,TheChildren’sHospitalofEasternOntario,
AssistantProfessor,DepartmentofAnesthesiology,UniversityofOttawa,
SeniorResearchAssociate,TheAcademyforInnovationinMedicalEducation,FacultyofMedicine,
UniversityofOttawa,Ottawa,Ontario,Canada
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1.1
Investigatorsresponsibilities
Theresearchteamcombinesastrongacademic,educationandclinicalbackground.Dr.SylvainBoet
isafacultyAnesthesiologistatTheOttawaHospitalandaSeniorResearchAssociateattheAcademy
forInnovationinMedicalEducation(AIME).HeholdsaMastersinEducationandiscurrentlyaPhD
candidate.Hehaspublishedextensivelyinsimulationandmedicaleducation.Dr.KarlSchebestaisa
FellowinSimulationandMedicalEducationattheUniversityofOttawaSkillsandSimulationCentre
&TheAcademyforInnovationinMedicalEducation,isaSeniorResearchAssociateattheDept.of
Anaesthesie atthe Medical Universtiy of Vienna and has published in the field of simulation and
medical education. Kristina Khanduja, MBChB, MEd is a Staff Anesthesiologist at Mount Sinai
HospitalandAssistantProfessorintheDepartmentofAnesthesiaattheUniversityofToronto.She
holdsafellowshipinmedicalsimulationandaMastersinEducationforhealthcareprofessionals.Dr
MeghanAndrewsisanAnesthesiologyFellowinSimulationandMedicalEducationattheUniversity
ofOttawaSkillsandSimulationCentre&TheAcademyforInnovationinMedicalEducationDr.Vicki
LeBlanc holds a PhD in psychology, serves as the Associate Director for the Wilson Centre for
ResearchinEducation,andisaninternationallyrecognizedexpertinstressandsimulation.Dr.M.
Dylan Bould is faculty Anesthesiologist at the Children’s Hospital of Eastern Ontarioand a Senior
Research Associate at AIME. He holds a Masters in Education and has published extensively in
medicaleducationandsimulation.
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Allinvestigatorsareinvolvedinthedevelopmentoftheoriginalidea,studyprotocolandscenario
scripts.KS,SBandDBwillberesponsibleforREBapproval,preparationofacasereportform.VLwill
furthermoreprovideanexpertreviewofstressandemotionassessmentmethods.MA,KS,KK,SB
andDBwillberesponsibleforrecruitmentofparticipants,conductingthetrial,datacollectionand
data analysis as well as training of expert reviewers and confederate actors. KS, SB and DB will
thereafterpreparetheinitialmanuscript.Allinvestigatorswillreviewandoptimizethemanuscript
beforeitispassedontoajournal.KSandSBwillpresenttheresultsofthistrialatinternational
conferences.

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2.
ABSTRACT
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Background
HighͲfidelity 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.
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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.
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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simulationͲbasededucation.
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3.
BACKGROUND
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TrainersaremorefrequentlyemployinghighͲfidelitymedicalsimulationtoallowlearnerstoacquire
complexskillsatminimalrisktorealpatients.1Thepresenceofcrticialobserversduringsuchtraining
invokes a stress response and emotional reactions in participants. Invoking emotional responses,
both positive and negative, appears to enhance the participant’s memory of the event and can
amelioratelearning.2Someeducationalresearcherstakeadvantageofsuchresponsestoovercome
the challenges presented by workload, rising expectations, and resource limitations to create a
memorablesimulationlearningevent.
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Theutilityofstressforenhancinglearningiscontroversialanditsusemaybeanetnegative.2,3Stress
is closely associated with anxiety and is generally considered a negative occurrence. Cogntiive
appraisaltheoryconsiderstheperceptionofwhethertheresourcesavailabletoapersonfacinga
stressful incident are adequate; if they are, then the situation is viewed as a challenge whereas
inadequateresourcescausethesituationtobeseenas athreat.Situationsperceived asathreat
invokeanxietyinthesubjectandactivatebiologicalpathways,specificallyinthesympatheticnervous
systemandthehypthalamicͲpituitaryͲadrenalaxis.4,5Endocrineactivitycausethesubjecttobemore
attentive and perceptive and to develop stronger memories of the threatening events.6Ͳ9 There
appearstobeadirectcorrelationbetweenthecortisollevelsinanindividualduringaneventandthe
degreeofretentionofthememoryofthatevent,thoughheightenedcortisolmaynegativelyaffect
the recall of older memories during the event.6 Despite the promising evidence in favour of
heighteningcortisolduringlearning,educatorsalmostmustconsidertheconsequencesofinflicting
negativeemotionsandstressontoparticipants.Thepositiveeffectsofcortisolonmemorydecayas
cortisolconcentrationsincrease,ultimatelycausingimpairmentoflearningandperformanceatvery
highlevels.8Ontheotherhand,situationsappraisedasachallengearenotaccompaniedbycortisol
releaseandmayresultinlessretention.10
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Evidence consistently suggests that learning and retention are affected by emotional states, both
positiveandnegative.11PositiveemotionsencourageindividualstoabsorbgreaterdegreesofhighͲ
levelinformation,whilenegativeemotionsreinforcethelearningofspecificdetails.Thetranslation
ofknowledgetoanewsituationisfacilitatedbypositiveemotionsoccurringwhentheknowledge
was gained, while negative emotions that occur during learning improve the individual’s recall of
detail information pertaining to the specific situation in which they were learning. In carefully
balancing the effects of emotions and stress on learning, some educators have used intentional
stressorsasaneffectiveelementineducationalefforts.3,12Manypotentialstressorsarepresentin
medicalsimulation,includingtimepressures,unfamiliarityoftheenvironment,ineffectivemedical
treatmentsandbadpatientoutcomes.Theuseofadeliberatelybadpatientoutcomehasbecomea
particularlyheateddiscussionwithinthemedicaleducationfieldandthereisascarcityofevidence
tosupportthisdiscussion.
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Criticalcaresituationscaninvokeapowerfulstressresponseandnegativeemotionsintheirdemand
forexpedientactionsandquickdecisionsinrapidlychangingsituations.Thedeathofapatientcan
have a potent effect on a provider’s emotions even if he or she is highly experienced in clinical
care.13,14 Educators commonly make efforts to prepare medical learners for expected death by
causingthedeathofthemannequininasimulationforwhichdeathistheexpectedoutcome.15An

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unexpecteddeathofthemannequinmayoccurinasimulationsessioninwhichthelearnerdoesnot
correctly manage the situation.16,17 The use of unexpected death in simulation is unsupported by
evidence.15,16,18Educatorsinfavourofitsuseproposethatunexpecteddeathmayhelptocementthe
eventasmemorable2andtherebyenhancelearning.3,12Theothersideofthediscussionfearsthat
unexpected death in simulation will exacerbate negative emotions and subject learners to undue
stress, including the physical manifestations of stress.  Such an experience could also cause
psychologicaldamagetoparticipantsorleadthemtowithdrawfromsimulationresearch.16,18,19To
date, the literature discussing the impact of simulated death on learning has been limited to
retrospectivesurveysandopinionpieces.15,16,20Thetrueeffectthatunexpecteddeathhasonstress
levels,performanceandretentionremainstobeseen.
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Thisstudyaimstoelucidatetheeffectofunexpecteddeathinasimulationscenarioontheretention
of crisis management skills. We hypothesize that unexpected death will be detrimental to the
retentionoftheseskillsandwillresultinincreasedstressandnegativeemotionsamongparticipants.
4.
OBJECTIVESOFTHECLINICALINVESTIGATION(HYPOTHESIS)
4.1
PrimaryObjective
Ourprimaryobjectiveistoevaluatetheimpactofanunexpectedsimulateddeathexperienceon
nonͲtechnicalskillretentionat3months.Wehypothesizethattheunexpecteddeathofasimulated
patientduringasimulatedcardiacarrestscenariowillimpairtheretentionofthisskill.
4.2
SecondaryObjectives
Oursecondaryobjectivesare:
(i)
To assess if unexpected death of a simulated patient is associated with an impaired
retentionoftechnicalresuscitationskills.
(ii)
Toexamineifunexpecteddeathofasimulatedpatientisassociatedwithfuturehigher
stresslevelsandstrongeremotionsduringsimulatedcrisis.
(iii)
To investigate the relationship between stress levels as well as emotions and future
performanceincrisis.
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Wefurthermorehypothesize,thatsimulateddeathwillleadtohigherstresslevelsaswellasmore
negativeemotionsandwilltherebyimpacttheabilitytoretaincriticalskills.
5.
DESIGNOFTHECLINICALINVESTIGATION
Thisstudywillbedesignedasmulticenter,investigatorblinded,randomized,controlled,prospective
trialwithqualitativeandquantitativemethodology.
5.1
Population
5.1.1
Subjectpopulation
Residents and fellows of the departments of anesthesiology, critical care, emergency medicine,
medicine,obstetricsandgynecology,surgeryandfamilymedicineattheUniversityofOttawaand
the University of Toronto, including all subspecialities, will be invited to participate in this trial.
Participants will be recruited by means of personalized contact via email, phone invitations and
posterͲadvertisementattherespectivedepartments.
5.1.2
Inclusioncriteria
Participants will be enrolled after approval of the respective site coordinator. Participants are
required to refrain from physical strains, smoking, drinking caffeinated or low pH beverages and

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eatingforatleastonehourbeforeenrollment.Furthermoreparticipantswillbeincludedbetween11
AMand8PM,whencortisollevelsaremoststable.
5.1.3
Exclusioncriteria
Residentswithphysicalburdenlimitingtheirabilitytomanagesimulatedcrisisandpregnantwomen
willbeexcluded.Participantswithaknownendocrinediseaseortakingcorticosteroidswillnotbe
enrolled.
5.1.4
Withdrawalofparticipants
Criteriaforwithdrawal
Participantsmayprematurelydiscontinuefromtheinvestigationatanytime.
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Participantsmustbewithdrawnunderthefollowingcircumstances:
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attheirownrequest
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iftheinvestigatorfeelsitwouldnotbeinthebestinterestofthesubjecttocontinue
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if the subject violates conditions laid out in the consent form / information sheet or
disregardsinstructionsbytheclinicalinvestigationpersonal
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Inallcases,thereasonwhyparticipantsarewithdrawnmustberecordedindetailinthecasereport
form (CRF). Should the investigation be discontinued prematurely, all investigation materials
(complete,partiallycompletedandemptyCRFs)willberetained.
6.
METHODOLOGY
InstitutionalethicsapprovalwillbesoughtfromtheOttawaHospitalResearchEthicsBoardandthe
University of Toronto Research Ethics Board for Health Sciences. Informed consent and a
confidentiality agreement will be obtained from participants.Participants will be enrolled after
approval from their resident site coordinator. They are asked to refrain form physical strains,
smoking, drinking caffeinated or low pH beverages and eating for at least one hour before
participating.Thetrialwillbeconductedbetween11AMand8PMtowarrantystablecortisollevels.
All participants will be asked to switch of their mobile phones and pagers in order to prevent
distractionduringthestudy.
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InitialTest
After a standardized accommodation phase of 15 minutes, all participants will be exposed to a
prerecorded,15minutelongvideoͲreviewoftheactualadvancedcardiaclifesupportalgorithms.We
willcollectbaselinedataincludingdemographicdata,stressmarkersanddataonanxietytherafteras
describedbelow.
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Immediately before a short scenario briefing the participants will be randomized to either the
intervention(unexpecteddeath)orcontrol(survive)group.Participantsfrombothgroupswillhave
toindividuallymanageasimulatedinͲhospitalcardiacarrestscenarioasteamleader(AppendixC).At
the initial test, in the intervention group (unexpected death), the scenario will be designed to
ultimately lead to the death of the simulation mannequin, regardless of the participant’s
performance.Inthecontrolgroup(survive),themannequinwillsurvive.Wewillattempttoensure
thatparticipantsdonotanticipatetheseriesofeventsintheretentionresuscitationscenariobased
ontheirexperienceduringtheintialrescuscitationscenario(recallbias).Therefore,thescenarioswill
be different in terms of order of the presenting arrhythmia. For example the participant who
managesapatientwithventricularfibrillation(VF),thenpulselesselectricalactivity(PEA),followed
byasystole in the initial scenario will go on to manage a patient with pulseless electrical activity
(PEA), then ventricular fibrilliation (VF), then return of spontaneous circulation (ROSC) in the
retentiontest.Theclinicalstemsofthescenariosintheintitialtestversustheretentiontestwillalso

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differslightlyinordertoeliminatethepotentialforthisrecallbiasdecribedabove.Insummary,the
scenarios are of equal complexity, but differ primarily with respect to the clinical context, initial
cardiacarrestrhythmandpreͲdeterminedoutcome(AppendixC).
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TwowellͲtrainedconfederateswillactasregisterednurseandasrespiratorytherapistwithinthe
team.Theseroleswereprescriptedtoensurestandardizationforeachparticipant.Theconferderates
willbeinstructedtohelpandtoperformtaskswhendirectedbutnottooffercrisismanagement
advice or differential diagnoses. An individualized, videoͲassisted, instructorͲled, structured
debriefing lasting 30 minutes will follow the initial scenario. As suggested by Gaba, highly
experienced and well prepared instructors will lead the debriefing phase in order to deal with
potentialupcomingemotionsandissues.19Allscenariosanddebriefingswillbevideorecordedfor
performanceanalysis.
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RetentionTest
Previousdatahaveshownthat,evenwithhighͲfidelitysimulation,resuscitationknowledgeandskills
deterioratebetweenasearlyas2weeksand1yearafterthelearningintervention,withafaster
decayinskill.21,22Thereforearetentiontestisplanned3monthsaftertheinitialtest.Afterashort
accommodation phase of 15 minutes and assessment of baseline data a standardized scenario
briefing will be done. Participants from both groups will be asked to be teamͲleader in a cardiac
arrestscenariototestforskillretention.Again,twoconfederates,oneactingasregisterednurseand
oneactingasrespiratorytherapistwillbeteammemebers.Whilethescenarioswillbethesameasin
theinitialtest,thecasepresentationofthescenarioandthemannequin“outcome”willbeswitched
fortheretentiontest.Themannequinwillsurviveforthe“unexpecteddeath”groupanditwilldiein
the “survive” group. That way, each participant will be exposed to simulation death in the study
once.Tomaximizelearningopportunitiesforparticipantsinthisstudy,anindividualizeddebriefing
withaspeciallytrainedfacilitatorwillfollowtheretentiontestaswell.
Allscenariosanddebriefingswillbevideorecordedforfutherperformanceanalysis.
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Followingtheretentionscenarioandcompletionofriskassessment,participantswillbeinterviewed
to determine their subjective views of their decisionͲmaking and performance within  an  orally
administeredsurveyapproximately30minutesinlength.
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BothPhases
The setting and equipment will be the same in the initial and the retention phase, reflecting an
appropriatelyequippednormalwardroomatourhospital.SimMan(Laerdal,Stavanger,Norway)
willbeusedasthestandardizedsimulationmannequininallscenarios.Themannequinwillbeplaced
inapatientbed.Themannequinwillbeoperatedbyanexperiencedsimulationspecialistfroma
separatedcontrolroom.Allscenarioswillbepeerreviewedandvalidatedbyexpertsinthefieldof
medicalsimulationandresuscitation.Thescenarioswillbeprescriptedforadurationofmaximum15
minutes. The confederates acting as team members during the scenarios will receive extensive
precoursetrainingwithprescriptedresponsesandinteractions.Predefined,peerreviewedcueswill
begivenbythesupportingstaffincasetheparticipantsfailtorecognizethecardiacarrestsituation.
Thesecueswillincludetherepetitionofthecasepresentationandvitalparameters.

Each phase is accompanied by assessment of baseline data, stress parameters and emotions. All
scenarios and debriefings will be video recorded to allow performance assessment by two
independentexpertsratersblindedtogroupallocation.

In order to collect meaningful qualitative data from a maximum of subjects, all subjects will be
exposed to unexpected death either during their initial or retention scenario. Subjects of group
“unexpecteddeath”willhavetheirsimulatedpatientsurviveduringtheretentiontestwhilesubjects
fromthegroup“survive”willhavetheirpatientdieduringtheretentionscenario.Thecourseofboth



subsets of scenarios is the same up until the final two minutes, and the final outcome of the
scenarioswillnotbeseenbytheexpertraters.Therefore,wedonotconsiderthistrialasacrossover
design.

6.1
Datacollection
6.1.1
Demographicsandknowledge
Demographic data including age, gender, postͲgraduateͲyear level, specialty, previous advanced
cardiacarrestexperienceandtrainingaswellassimulationexperiencewillbecollectedintheinitial
andretentionphaseafterashortstandardizedaccommodationphase.

6.1.2
PerformanceAssessment

NonͲTechnicalSkill
NonͲtechnical skills for crisis resource management including leadership, communication skills,
problemsolving,resourceutilization,situationawarenessandoverallperformancewillbeevaluated
by using the established and validated Ottawa Global Rating Scale.23,24 Two blinded, independent
expertraterswillreviewallvideorecordedscenarios.Bothraterswillbeintensivelytrainedinusing
thechecklistpriortothestartofthestudyinordertoimproveinterͲraterreliability.Thesametwo
raterswillassessallscenarios.

TechnicalSkill
Technicalskillperformancewillbemeasuredbyusingataskspecificchecklist.Forthispurposewe
willuseaninternalyvalidatedandadaptedversionoftheAmericanHeartAssociation’sMegacode
Checklist. The main items will be the team leader performance, management of the initial
tachycardia, management of the pulseless electrical activity and the actions taken during the
following ventricular fibrillation. Post resuscitation care will not be assessed to guarantee the
blindingoftheinvestigators.Thereforeatotalscoreof18pointsinsteadof21willbereachable.
Furthermore the overall performance will be rated using “pass“ and “fail“. The same two
investigatorswhoassessedfornonͲtechnicalskillswillassessallscenariosfortechnicalskillsaswell.
6.1.3
StressAssessment
Acutestresswillbeassessedbymeansofsalivarycortisol,theStateͲTraitAnxietyInventory(STAI)
andquestionnairealignedwiththecognitiveappraisaltheory.4,5,10,25

SalivaryCortisol
TheactivationofthehypothalamicͲpituitaryͲadrenalaxisassurrogateforpsychologicalstresswillbe
measured using salivary cortisol levels that show a close to linear relationship to plasma cortisol
levels.4,5,26Cortisollevelswillbemeasuredinbothsimulationtests(initialtestandretentiontest).
Salivarycortisolpeaksat20to40minutesaftertheonsetofastressor.4Inordertoapporachcortisol
kinetic,5cortisolsampleswillbeobtainedperparticipantperscenario:whenparticipantsarriveat
thesimulationcenter(sample0),justbeforeeachscenario(sample1),immediatelyattheendofthe
eachscenario(sample2),30minutesafterthestartofthescenario(sample3),andattheendofthe
debriefingphase(sample4).Thecortisolsamplingschedulefortheinitialandtheretentiontestwill
be identically, resulting in a total of 10 cortisol samples per participants (see Appendix D). A roll
shapedsyntheticsalivacollector(SalivetteforCortisoltesting,Starstedt,Montreal,Quebec,Canada)
willbeusedandwillbefrozenatͲ20°CuntilanalysisusinganELISAtechniqueattheTechnische
UniversitatDresden,Germany.

StateͲTraitAnxietyInventory(STAI)



ToevaluateacuteandsubjectivestressthestandardizedtestbatteryoftheSTAIwillbeused.With
STAI state anxietyatthe verygiven momentcan bemeasured using 20 statementstowhichthe
participantsagreeordisagreeonafourpointLikertͲlikescale(1–notatall,4verymuchso).Thesub
scoresaresummedupandprovideasensitivebasisforacutechangesinanxietyrelatedtostressful
simulation.10,25STAIwillbeassessedaftertherestingphasebeforeeachscenarioandimmediately
afterthedebriefingoftheinitialandtheretentionscenario.

CognitiveAppraisal
Cognitiveappraisalwillbemeasuredattheendofeachscenariobriefingandimmediatelyafterthe
scenariousingthemethoddescribedbyTamokaetal.andevaluatedfortheuseinsimulationby
Harvey et al.10,27,28 Primary appraisal (demand) will be measured by asking the question “How
demandingdoyouexpecttheupcomingtasktobe?”beforethescenarioand“Howdemandingwas
thetaskyoujustcompleted?”afterthescenario.Secondaryappraisal(resources)willbeassessedat
bothtimesbyasking“Howableare/wereyoutocopewiththistask?”10pointLikertͲlikescalewill
be used for this assessment. A cognitive appraisal index will be calculated thereafter by dividing
resultsofprimaryappraisalbyresultsofsecondaryappraisal.Anindex<1willindicatethatresources
donotmeetdemandsandthetaskisappraisedas“threat”whileanindex>1,whereresourcesare
greaterthandemandswillindicatea“challenge”.
6.1.4
EmotionAssessment
Emotionsareinevitablylinkedtotheoccurrenceofexpectedandunexpecteddeathwhiletreatinga
patientorpatientsimulator.16Asthesefeelingsmayfosterorimpairthelearningeffect,emotions
that occurred throughout the simulation scenarios will be asessed. Participants will be asked to
classifytheiremotionstheyexperiencedthroughoutthestudybyusingtheestablishedPositiveand
Negative Affect Schedule (PANAS) at the end of each scenario. This assessment will be done
immediatelyafterdebriefingoftherespectivescenarios.
6.1.5
Survey
Following each scenario and completion of risk assessment, participants will be interviewed to
determinetheirsubjectiveviewsoftheirdecisionͲmakingandperformance.Inordertocontextualize
theeffectsofsimulateddeath,anopenendedorallyadministeredsurveywillfollowtheretention
testphase(seeAppendixE)forallsubjects.Theorallyadministeredsurveyswillbeapproximately30
minutesinlengthandwillberecordedfortranscription.Transcriptswillbeanonymized.ThisopenͲ
endedsurveyisintendedtoprovidebasiccontextualinformation,thusdatawillbeanalyzedusing
inductive thematic analysis 29Ͳ31 to create general themes. Analysis will be guided by a Research
Associatewithspecializedqualitativeresearchtraining.Findingsfromthequalitativecomponentwill
helptoinformdirectionsforfutureresearch.
6.1.6
DebriefingAsssement
In order to assess the debriefing quality and avoid potential bias by inconsistent quality, all
debriefingswillbevideorecordedandratedbytwoindependentexpertratersusingthevalidated8Ͳ
item5ͲpointOSADscale.32Again,theraterswillbeintensivelytrainedinusingthescalepriortothe
startofthestudy.
6.2
Randomization
Inordertocreategroupsofparticipantsthataresimilarinregardsoftheirbaselinecharacteristics
andinordertoincreasethepowerofourstudywewillusetheapproachofstratifiedrandomization
toallocatetheparticipantstotheinterventionandcontrolgroup.Inordertokeepthenumberof
strata and the resulting covariates small we will stratify the participants regarding their level of
training(PGY1–PGY3residents,vs.PGY4–PGY5residentsandfellows),theirlikelihoodofproviding
acute care (acute care specialities will include anesthesia, emergency medicine and critical care
trainedpersonnel).Thereaftercomputerblockrandomizationwillbeperformedusingthealgorithm
provided at www.randomization.com for all subgroups. Participants will be assigned to the



intervention (initial test ending with asystole) and control (initial test ending with sinus rhythm)
groupsina1:1ratio.Toensureevenallocationtotheinterventionandcontrollgroupblocksof4
participants will be predefined. Sealed, numbered, opaque envelopes, containing the random
allocation,willbeopenedaftertherestingperiodimmediatelybeforescenariobriefingbegins.
6.3
Blinding
Investigatorsperformingdataanalysisandvideoraterswillbeblindedtogroupallocationbyediting
audio/videomaterialinsuchawaythatthefinalendofthescenario,withtheoccurrenceofdeathor
return of spontaneous circulation is not visible. Participants will be blinded to the nature of the
study,theirgroupassignmentandscenarioatthetimeofenrollementandscenariobriefingduring
theinitialandretentiontest.
6.4
Benefitandriskassessment
6.4.1
Benefits
Byparticipatinginthistrialallparticipantswillbenefitfromashortreviewoftheactualresuscitation
guidelines and will have the opportunity to improve their technical and nonͲtechnical skills in
resuscitationandteamworkwithintwohighͲfidelitysimulationsessionswithvideodebriefingfreeof
charge. Furthermore, as the save environment of simulation and stress exposure training do
effectivelyreducestateanxietyaswellasperformanceanxietyduringarealemergencysituationand
enhanceperformanceduringstress,participantswillbenefitfromthesepositiveeffectsduringreal
clinicalemergencies.
6.4.2
Risks
BycreatingaclosetorealsettingandurgingtheparticipantstoimmerseintothescenariohighͲ
fidelitysimulationisknowntoincreasephysiologicalandpsychologicalstressthroughoutthe
simulationsignificantlyabovebaselinelevels.Especiallywiththeoccurrenceofdeath,whichisa
potentstressorintherealclinicalsettings,emotionsandstressmightbeaggravated.However,
normalstresslevelsarereachedattheendoftheadjunctedstructurizeddebriefingsatcommonhigh
stakessimulationsessions.

Inordertodetectanyseriousnegativereactionstothescenarios,allscenarioswillbedebriefedby
an experienced simulation instructor. The debriefers will specifically ask the subjects about their
feelings and thoughts about the death of the “patient”, and will provide debriefing and coping
strategiesfordealingwithdeathinthereallifesetting.Participantswithoverwhelmingemotional
responses, and who are emotionally troubled by the simulation experience, will be offered a
voluntaryprofessionalreferraltothecounselingserviceoftheUniversityofOttawaortheUniversity
ofToronto.InpreviousstudiesbyoneofthecoͲinvestigators(VLeBlanc)lookingathighlystressful
situations with over 400 front line workers and trainees, the subjects’ stress levels consistently
returnedto baseline levels attheendofthe scenarios.Anyresidualnegativeemotions following
suchscenarioswereconsistentlyduetoreflectionsontheirownlevelofperformanceratherthanon
theemotionalcomponentsofthescenariosthemselves.

Fruthermorethereisaminimalriskofphysicalstrainwithinthisstudy.Inordertominimizethisrisk,
allparticipantswillbefamiliarizedwiththemannequinpriortostratingthefirstscenario.



7.
ANALYSIS
7.1
Quantitativeanalysis
7.1.1
Primaryoutcomeparameter
ThedifferenceinretentionofnonͲtechnicalskillsforcrisismanagementbetweentheintervention
and the control group (measured by the Ottawa Global Rating), specified as the difference in
performancebetweentheinitialandtheretentiontest,willbeourprimaryoutcome.
7.1.2
Secondaryoutcomeparameters
Secondaryoutcomeswillbe(i)technicalresuscitationskills(performanceandretention)measured
by the American Heart Association’s Megacode Checklist (ii) stress including salivary cortisol,
cognitiveappraisalandSTAIand(iii)valenceofemotions.
7.2
Samplesizeconsiderations
ApriorisamplesizecalculationwasperformedonthebasisofanestimatedCohen’sdeffectsizeof
0.8,whichisconsideredlargeandacceptableforateachingintervention.33WeaimatatwoͲtailed
levelofsignificanceofp<0.05andapowerof0.8.Usingtherecommendedsamplesizeestimation
approachforANCOVA34withanestimatedr2of0.12,derivedbyaprevious,notnowpublishedtrial
(Boet.Setal,Learningcrisisresourcemanagement:Practiceversusobserving,CAS2013Abstract
1653689,accessibleathttp://www.cas.ca/English/AMͲAbstractsͲ2013),anumberof46participants
wouldbeneeded.Inordertoaccountforanestimatedattritionrateof20%weneedtorecruit56
participants. G*Power for MAC (version 3.12, Düsseldorf, Germany) was used for sample size
calculations.
7.3
Statisticalanalysis
Asithasbeensuggestedasbestpracticeforstratifiedrandomizedcontrolledtrials,ANCOVAwillbe
usedtoanalyzetheoutcomeparametersusingtheleveloftraining(PGY1Ͳ3vsPGY4Ͳ5andfellows)
and specialities (acute care specialities vs. nonͲacute care specialities) as covariates.35 Group
assignment(unexpecteddeath,alive)willbeusedastheindependentvariable.Demographicdata
willbeanalyzedusinganunpairedStudent’stͲtestorchiͲsquaretest,whereappropriate.

Curved/linear regression analysis will be performed to assess the correlations between each
outcomeandstressaswellasemotions.Asitiscommonpractice,resultsofLikertͲlikescaleswillbe
treatedasintervalͲmeasuresandtherebyanalyzedbyusingparametrictests.36,37
7.4
Qualitativeanalysis
Qualitativedatawillbeanalyzedaccordingtogroundedtheorybysorting,codingandredefininginto
emergenttopics.Thereafterinterviewtranscriptswillbecomparedagainsteachother.38,39Byusing
aniterativeapproach,ongoingpreliminaryanalysisoftheresultsgatheredbythesemiͲstructured
interviewswillleadtoadaptationoftheinterviews.Therebythematiccategorieswillbeestablished
andcontinuouslyrefined.Thisprocesswillbeperformeduntilcodingresultsinanexplanationofthe
observations,andsaturationisreached.
8.
IMPLICATIONSANDLIMITATIONS
8.1
Implications
Overthepastdecades,highͲfidelitysimulationhasgonefrombeingarelativelylimitedteachingtool
tooneofthemost,cuttingedgewaystoteachmedicaltrainees.Severalstudieshavedemonstrated
the effectiveness of simulation in teaching both technical and nonͲtechnical skills, such as Crisis
Resource Management.40Ͳ42 However, by creating an environment that requires the learners to
immerse into a “makeͲbelieve world”, participants are exposed to a high level of stress and



emotions.18Asofyet,noworkhasbeendonetoestablishpreciselytheimpactofanunexpected
simulationdeathonskillsretentionofresidents.

Even though medical professionals are exposed to patient death on a regular basis, theseevents
have been shown to be linked to a considerable emotional and stress load, even in the most
experiencedpersonnel.However,transferringsuchaneventintothesecureenvironmentofmedical
simulationisamatterofcurrentdiscussion.16,18,19Especially,theimpactoftheunexpecteddeathofa
mannequinremainsunclear.Whilesomeeducatorsfearexaggeratednegativefeelings,distraction
fromthelearningobjectiveandrefusaloffurthersimulationsessions,theoccurrenceofdeathasa
“toͲbeͲremembered event”2 might improve the learning outcome.43 Presently, simulated death is
mostlyavoidedpartlybecauseoflackofreliabledataonitsimpactonlearners.Thisstudyaimsto
compareskillsretentionat3monthsafterexperiencingornotsimulatedunexpecteddeath.Indoing
so, we hope to provide the foundation for an evidenceͲbased approach to effective scenario
development in simulation education. The results of this trial will have immediate and practical
impact on the simulation scenario design, and may serve as evidenceͲbased guidance for the
developmentofuniversalsimulationguidelines.

Littleisknownontheemotionaleffectsofmedicaleducationincludingsimulation.Thisstudyisa
collaborativeeffortbetweensimulationexperts,specialistsincrisismanagement,stressandmedical
educationandthefindingswillbeapplicableandgeneralizableacrossseveraldisciplines.Itisthe
intention of the study to evaluate a skill that is as generalizable as possible. The investigation of
stresslevels,cognitiveloadandemotionswilldeepenourunderstandingoftheeffectsofsimulationͲ
basededucationonlearnersandwillpotentiallyhelptoimproveteachingeffectiveness.Theeffectof
negative emotion on learning and retention has implications for education outside this particular
stressor(simulateddeath)toothercausesoflearnerdistressandmaybegeneralizableoutsideof
simulation. Our insights into the effects of emotions and stress on learning and skills may be
applicabletootherteachingtechniques,potentiallyhavingalargeimpactonmedicaleducation.
8.2
Limitations
Thestudydesignislimitedbythesamplesize.Asmalldifferencebetweenthetwogroupsmight
thereforenotresultinasignificantwayandthestudymightbeunderpoweredtodrawdefinitive
conclusions. However, all aspects of the study will be hypothesis generating, no matter of the
resultingpowerandtherebywillhelptodirectfurtherinvestigations.
9.
PUBLICATION

Thefindingsofthisstudywillbepublishedbytheinvestigatorsinascientificjournalandpresented
atscientificmeetings.Also,weplantodisseminatetheknowledgegainedfromourstudyviaopen
accessmethods,inordertoincreasereadershipandimpact.Opensourcepublicationallowsreaders
toreadpublicationsforfreeandisproventoincreasecitationsofpublications.

KarlSchebestawillbeassignedasfirstandcorrespondingauthor,whileSylvainBoetwillbethelast
andseniorauthor.Therankingoftheotherauthorswillbedoneinaccordancetotheircontribution
tothestudy.






10.
REFERENCES

1.
MaranNJ,GlavinRJ:LowͲtohighͲfidelitysimulationͲacontinuumofmedicaleducation?
MedEduc2003;37Suppl1:22Ͳ8
2.
LeBlancVR:TheEffectsofAcuteStressonPerformance:ImplicationsforHealthProfessions
Education.AcademicMedicine2009;84:S25ͲS33
3.
DeMaria Jr S, Levine AI: The Use of Stress to Enrich the Simulated Environment, The
ComprehensiveTextbookofHealthcareSimulation,Springer,2013,pp65Ͳ72
4.
Kirschbaum C, Hellhammer DH: Salivary Cortisol, Encyclopedia of Stress (Second Edition).
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AndrewS,NoelR,IanC,GioraFeuersteinA2ͲEditorͲinͲChief:¬†¬†GeorgeFinkAssociateEditors:Bruce
McEwenERdKRRGCASNRICGF.NewYork,AcademicPress,2007,pp405Ͳ409
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Hellhammer DH, Wust S,Kudielka BM: Salivary cortisol as a biomarker in stress research.
Psychoneuroendocrinology2009;34:163Ͳ171
6.
CahillL, Gorski L, Le K: Enhanced human memory consolidation with postͲlearning stress:
interactionwiththedegreeofarousalatencoding.LearnMem2003;10:270Ͳ4
7.
NaterUM,MoorC,OkereU,StallkampR,MartinM,EhlertU,KliegelM:Performanceona
declarative memory task is better in high than low cortisol responders to psychosocial stress.
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