NEW ATA Telestroke Guidelines - Télémédecine 360...consistent with an acute stroke syndrome, using telemedicine communication technologies. Although telestroke practices may include

©AmericanTelemedicineAssociation

ACKNOWLEDGEMENTS

TheAmericanTelemedicineAssociation(ATA)wishestoexpresssincereappreciationtotheATATelestrokePracticeGuidelinesWorkGroupandtheATAPracticeGuidelinesCommitteeforthedevelopmentoftheseguidelines.Theirhardwork,diligenceandperseverancearehighlyappreciated.

•PracticeGuidelinesWorkGroup•Co-Chair:BartM.Demaerschalk,MD,MSc,FAHA,FRCP(C),ProfessorofNeurology,ChairofCerebrovascularDiseasesDivision,MayoClinicCollegeofMedicine,DirectorofSynchronous(Telemedicine)Care,MayoClinicCenterforConnectedCare,MayoClinicCollegeofMedicineCo-Chair:JillBerg,PhD,RN,FAHA,FAAN,VicePresidentofEducation,AscensionHealthWisconsin,President,ColumbiaCollegeofNursing

•WorkGroupMembers•

OpeoluAdeoye,MD,MS,FACEP,FAHA,AssociateProfessor,Co-Director,UCStrokeTeamDepartmentofEmergencyMedicine,UniversityofCincinnatiBrianChong,MD.FRCP(C),Consultant,NeuroradiologyandNeurologicalSurgery,MayoClinicCollegeofMedicineHartmutGross,MDFACEP,ProfessorofEmergencyMedicineandNeurology,AssistantProfessorofPediatrics,DepartmentofEmergencyMedicine,MedicalCollegeofGeorgiaatAugustaUniversityinAugustaKarinNystrom,MSN,APRN,FAHA,StrokeCoordinator/NursePractitioner,YaleSchoolofMedicineLeeH.Schwamm,MD,FAHA,ExecutiveViceChairman,DepartmentofNeurology,C.MillerFisherChair&ChiefofMGHStrokeServices,ProfessorofNeurology,HarvardMedicalSchoolLawrenceR.Wechsler,MD,HenryB.HigmanProfessorandChair,DepartmentofNeurologyUniversityofPittsburghMedicalSchool,VicePresidentforTelemedicine,UniversityofPittsburghMedicalCenterSallieWhitchurch,BSN,RN,PostAcuteCareClinicalDirector,InTouchHealth

•ATAPracticeGuidelinesCommittee•Chair:ElizabethA.Krupinski,PhD,Professor&ViceChairforResearch,DepartmentofRadiology&ImagingSciences,EmoryUniversity


•CommitteeMembers•

NinaAntoniotti,RN,MBA,PhD,ExecutiveDirectorofTelehealthandClinicalOutreach,SIUSchoolofMedicineJillBerg,PhD,RN,FAHA,FAAN,VicePresidentofEducation,AscensionHealthWisconsin,President,ColumbiaCollegeofNursingDavidBrennan,MSBE,Director,TelehealthInitiatives,MedStarHealthAnneBurdick,MD,MPH,AssociateDeanforTelemedicineandClinicalOutreach,ProfessorofDermatology,Director,LeprosyProgram,UniversityofMiamiMillerSchoolofMedicineJerryCavallerano,PhD,OD,StaffOptometrist,AssistanttotheDirector,JoslinDiabetesCenter,BeethamEyeInstituteHelenK.Li,MD,AdjunctAssociateProfessor,UniversityofTexasHealthScienceCenter

•ATAStaff•JordanaBernard,MBA,ChiefProgramOfficerJonathanD.Linkous,CEO


TELESTROKEGUIDELINES

TABLEOFCONTENTS

PREAMBLE 1

SCOPE 2

INTRODUCTION 2

ADMINISTRATIVEGUIDELINES 3

CLINICALGUIDELINES 10

TECHNICALGUIDELINES 14

CONCLUSION 16

APPENDIX 17Definitions 17

References 19 RecommendedReadings 20

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PREAMBLEBackground.TheAmericanTelemedicineAssociation(ATA),withmembersfromthroughouttheUnitedStatesandtheworld,istheprincipalorganizationbringingtogethertelemedicineproviders,healthcareinstitutions,vendorsandothersinvolvedinprovidingremotehealthcareusingtelecommunications.ATAisanonprofitorganizationthatseekstobringtogetherdiversegroupsfromtraditionalmedicineandhealthcare,academia,technologyandtelecommunicationscompanies,e-health,alliedprofessionalandnursingassociations,medicalsocieties,governmentandotherstoovercomebarrierstotheadvancementoftelemedicinethroughtheprofessional,ethicalandequitableimprovementinhealthcaredelivery.ATAhasembarkedonanefforttoestablishpracticeguidelinesandtechnicalrequirementsfortelemedicinetohelpadvancethescienceandtoassuretheuniformqualityofservicetopatients.Theseguidelines,basedonclinicalandempiricalexperience,aredevelopedbyworkgroupsthatincludeexpertsfromthefieldandotherstrategicstakeholdersanddesignedtoserveasbothanoperationalreferenceandaneducationaltooltoaidinprovidingappropriatecareforpatients.ThepracticeguidelinesandrequirementsgeneratedbyATAundergoathoroughconsensusandrigorousreview,withfinalapprovalbytheATABoardofDirectors.Existingproductsarereviewedandupdatedperiodicallyastimeandresourcespermit.Board-approvedpracticeguidelineswillbeconsideredforaffirmation,update,orsunsetatleastevery4years.Practiceguidelinesthathavebeensunsetmaycontinuetohaveeducationalvaluebutmaynotrepresentthemostcurrentknowledgeandinformationaboutthesubjectmatter.

Disclaimer.Thepracticeofhealthcareisanintegrationofboththescienceandartofpreventing,diagnosing,andtreatingdiseases.Accordingly,itshouldberecognizedthatcompliancewiththeseguidelineswillnotguaranteeaccuratediagnosesorsuccessfuloutcomeswithrespecttothetreatmentofindividualpatients,andATAdisclaimsanyresponsibilityforsuchoutcomes.Theseguidelinesareprovidedforinformationalandeducationalpurposesonlyanddonotsetalegalstandardofmedicalorotherhealthcare.Theyareintendedtoassistprovidersindeliveringeffectiveandsafemedicalcarethatisfoundedoncurrentinformation,availableresources,andpatientneeds.Thepracticeguidelinesandtechnicalrequirementsrecognizethatsafeandeffectivepracticesrequirespecifictraining,skills,andtechniques,asdescribedineachdocument,andarenotasubstitutefortheindependentprofessionaljudgment,training,andskilloftreatingorconsultingproviders.Ifcircumstanceswarrant,aprovidermayresponsiblypursueacourseofactiondifferentfromtheguidelineswhen,inthereasonablejudgmentoftheprovider,suchactionisindicatedbytheconditionofthepatient,restrictionsorlimitsonavailableresources,oradvancesininformationortechnologysubsequenttopublicationoftheguidelines.Likewise,thepracticeguidelinesandtechnicalrequirementsinthisdocumentdonotpurporttoestablishbindinglegalstandardsforcarryingouttelemedicineinteractions.Rather,theyaretheresultoftheaccumulatedknowledgeandexpertiseoftheATAworkgroupsandtheirreviewofthecurrentliteratureinthefieldandareintendedtoimprovethetechnicalqualityandreliabilityoftelemedicineencounters.Theadministrativeproceduresandtechnicalaspectsofspecifictelemedicinearrangementsmayvarydependingontheindividualcircumstances,includinglocationoftheparties,resources,natureoftheinteraction,andinthecaseofchildrenandadolescents,theadultsresponsiblefortheirwelfareuntiltheageofmajority.


SCOPEThefollowingtelestrokeguidelinesweredevelopedtoassistpractitionersinprovidingassessment,diagnosis,management,and/orremoteconsultativesupporttopatientsexhibitingsymptomsandsignsconsistentwithanacutestrokesyndrome,usingtelemedicinecommunicationtechnologies.Althoughtelestrokepracticesmayincludeabroaderutilizationoftelemedicineacrosstheentirecontinuumofstrokecare,withsomeevenconsultingonallneurologicemergencies,thisdocumentfocusesontheacutephaseofstroke,includingbothpre-andin-hospitalencountersforcerebrovascularneurologicalemergencies.Theseguidelinesdescribeanetworkofaudio-visualcommunicationandcomputersystemsfordeliveryoftelestrokeclinicalservices,andincludeoperations,management,administration,andeconomicrecommendations.Theseinteractiveencounterslinkpatientswithacuteischemicandhemorrhagicstrokesyndromeswithacutecarefacilitieswithremoteandon-sitehealthcarepractitionersprovidingaccesstoexpertise,enhancingclinicalpractice,andimprovingqualityoutcomesandmetrics.Theseguidelinesapplyspecificallytotelestrokeservices,andtheydonotprescribeorrecommendoverallclinicalprotocolsforstrokepatientcare.Rather,thefocusisontheuniqueaspectsofdeliveringcollaborativebedsideandremotecarethroughthetelestrokemodel.

Thetelestrokeguidelinescontainrequirements,recommendations,oractionsthatareidentifiedbytextcontainingthekeywords“shall,”“should,”and“may.”“Shall”indicatesarequiredactionwheneverfeasibleandpracticalunderlocalconditions.“Should"indicatesanoptimalrecommendedactionthatisparticularlysuitable,withoutmentioningorexcludingothers.“May”indicatesadditionalpointsthatmaybeconsideredtofurtheroptimizethetelestrokehealthcareprocess.

PleaserefertotheglossaryintheAppendixfordefinitionsutilizedinthisdocument.

INTRODUCTION

Despiteadvancesinacutestroketreatment,strokeremainsthefifthmostcommoncauseofdeathandtheleadingcauseforlong-termadultdisabilityworldwide.2Thereisevidenceforeffectivemeanstoreducerecurrenceandimprovingoutcomesbymeansofearlyplateletinhibition,3intravenousalteplase,4StrokeUnitutilization,5endovascularthrombectomy,6andhemicraniectomyinmalignantmiddlecerebralarteryinfarction.7However,highpatientnumbers,limitedspecializedexpertise,andgeographicdeterminants,remainmajorbarriersthatnegativelyimpactimplementationofevidence-basedmanagement.8Theseissuesareespeciallytrueforremoteandruralareas.Inthelate1990s,theideaoftelestroketookshape,inanefforttobringmuchneededspecialexpertisetoalargerproportionofstrokepatients.Telestrokeistheuseofinteractivevideoconferencingtechnologies,specificallyforthetreatmentofpatientswithacutestroke.9Theterms“telestroke,”“TeleStroke,”“teleStroke,”and“Tele-stroke”allrefertothesamecareconcept;acentralizedorremotelybasedstrokecareteamwithastrokephysicianatadistantsitenetworkedwiththeremotestrokepatientatanoriginatingsite.Telestrokeprogramsprovideservicesforacutestrokepatientsinavarietyofsettingsincluding,butnotlimitedto,MobileStrokeUnits,EmergencyDepartments(EDs),IntensiveCareUnits(ICUs),MedicalSurgicalUnits,etc.,thatdonothaveaccesstoonsitestrokephysicianservices.


Approximately87%ofacutestrokesareischemic.10SelectivepatientsaregenerallygoodcandidatesforIValteplase,athrombolyticagentthathelpsreverseorpreventdisabilityfromthistypeofstroke,ifadministeredwithintheguidelinerecommendedtimelinewindowforthrombolytictherapy.Themorequicklythepatientreceivesalteplase,thegreaterthechancesforrecoverywithminimaltonodeficits.Patientswhoreceivealteplasewithinthefirst90minutesofsymptomonsetarenearlythreetimesmorelikelythanpatientswhodidnotreceivealteplase,tohavefavorableoutcomesthreemonthsafterthestrokeexperience.11AlteplaseremainstheonlyFDAapprovedreperfusiondruginacuteischemicstroke.Thefollowingguidelinesaredesignedtoaidinthedevelopmentofeffective,safe,andsustainabletelestrokepractices.Thedevelopmentoftheseguidelineshasbeenacollaborative,systematicapproach,basedonthebestavailableevidenceandclinicalexpertise.Theseguidelinesareintendedtopromotestandardizationoftelestrokecaredelivery,providingguidelinesforminimumrequirementsfordeliveringsafeandeffectivecare,andthuspositivelyimpactingclinicaloutcomes.Itisadvisedthatguidelines,positionstatements,andstandardsfromotherprofessionalorganizationsandsocietiesbereviewedandincorporatedintopracticeaswell.

ADMINISTRATIVEGUIDELINES

ORGANIZATIONSProfessionalentitiesprovidingandreceivingtelestrokeservicesshallfollowtheagreeduponstandardoperatingandadministrativepoliciesandproceduresoftherelevantgoverningorganizations.

LEADERSHIP

Executiveleadershipattheoriginatingsiteshallcultivateasharedvisionoftheincorporationofthetelestrokemodelofcareintotheinnovativecaredeliverymodel.Thisvisionshouldbeclearlyarticulatedthroughouttheentireorganization.ExecutiveleadershipattheoriginatingsiteshallincorporateprinciplesofchangemanagementandtheAmericanAssociationofCritical-CareNurses(AACN)StandardsforEstablishingandSustainingHealthyWorkEnvironments,12toguidestrategicplanningandexecutivedecision-making.Executiveleadershipatboththeoriginatinganddistantsitesshouldrecruitanddevelopleaders(sometimesreferredtoasStrokeChampions)toimplementandsustaincaremodelsthatsupportinterprofessionalpartnershipswiththegoaloftransformingclinicalworkbybuildingcollaborativerelationshipstoenhancepatientcare.Executiveleadershipattheoriginatinganddistantsitesshallensurethattelestrokeclinicalleadersareappropriatelypositionedwithintheorganizationtoparticipateinkeydecision-makingforumswiththeauthoritytomakenecessarydecisions.PoliciesandproceduresshallreflectthattelestrokerolesareintegratedintotheAcuteStrokeResponse,aswellasqualityassuranceprocessesandsentineleventreviews.Escalationprocessesshouldbecreatedandsustainedtofocusonpatientsafetyandallowhealthcare


professionalsadvocacyonbehalfofpatientsandtheirfamilies,regardlessofpracticesetting.Allhealthcareprofessionalsshouldhaveamechanismtoreport,investigate,andresolveissuessurroundingpatientsafetyandquality.Themechanismshouldbenon-punitiveandsensitivetoensuringthattheclosecollaborativerelationshipbetweentelestrokeconsultantsandreceivingfacilitystaffisnotcompromised.Thesamestandardsshouldbeappliedtoprovidersparticipatinginadistributednetworkthroughaproviderorganizationorothercooperativearrangements.Ideally,providersmaybepartofalargerorganization.

ROLESANDRESPONSIBILITIESForsuccessfuloperationofatelestrokesystem,thereshouldbeagreeduponkeyrolesandresponsibilities.Thereshouldbesupportandbuy-inofkeystakeholders,suchashospitaladministrators,informationtechnology(IT),clinicalpersonnel,humanresources,legal,andfinance,amongothers.TheTelestrokeHub/DistantSitePhysicianDirector:ThephysicianchampionfortelestrokeatboththeHub/DistantandSpoke/Originatingsitesshallsupervisetheadministrativeissuesthatcommonlyarise.AttheHub/Distantsite,thetelestrokephysicianchampionmaybenamedmedicaldirector.Thisroleshouldcultivateenthusiasmfortelemedicineamongotherstrokecenterclinicians,developandmaintainrelationshipswithSpoke/Originatingtelestrokesites,anddesignevidence-basedcarepathways.Thisrolemaybebestservedbyavascularneurologistorvascularneurosurgeon,orotherstrokeexpert.Qualificationsforthisroleshallincludevascularneurologyfellowshiptrainingorequivalent,attendanceatcoursesincerebrovasculardiseasesandtelemedicine,andcontinuingmedicaleducation(CME)creditsinstrokeandtelemedicine.AtelestrokechampionattheSpoke/Originatingsiteshouldbefamiliarwithtelestrokeprotocols,telemedicinetechnologyplatforms,criteriafortransfertoasiteprovidinghigherlevelsofcare,referralarrangements,cerebrovasculardisease,andtelemedicineingeneral.TelestrokeProgramManager:Thisrole,basedattheHub/Distantsite,shouldinterfacewithmedicalstaffservices,IT,legalofficesatboththestrokecenterandatallsupportedSpoke/Originatingsites/hospitals.Thisroleshouldensurecontractsareinplace,licensureandcredentialingarecurrent,trainingandeducationarebeingdelivered,billingandcodingareaccuratelyperformed,qualitymeasuresareinplace,qualityassuranceprocessesarebeingfollowed,andoveralladministrativeoversightisprovidedforthetelestrokeprogram,underthemedicaldirector’ssupervision.EmergencyDepartmentStrokeChampion:EDphysicianrolesattelestrokeSpoke/Originatingsitefacilitiesshouldincludefamiliaritywithtelestrokealertcriteria,processesandproceduresforinitiatingatelestrokecallandconsultation,telemedicinetechnologyplatforms,andstrokeclinicalprotocols.EDnurserolesshouldincludeinteractionwithEmergencyMedicalSystem(EMS)personnel,intakeofanacutestrokepatient,triage,recognition,rapidevaluation,andstroketreatmentprotocols.OtherTelestrokeRoles:Qualificationsforrolesofothercontributingtelestrokeprovidersshouldbefocusedonoptimalacutestrokecare,telemedicinetechnologyproficiency,troubleshooting,andfamiliaritywithworkingeffectivelywithinregionalstrokesystemsofcare.Otherhospitalproviderrolesmaydependonthescopeofthepractice,butcouldincludehospitalists,neurointerventionalists,intensivists,andradiologists.


TelestrokerolesatSpoke/OriginatingsitesmayalsoincludeEMSpersonnel,PhysicianAssistants(PAs),AdvancedPracticeNurses(APNs-NursePractitioners),laboratoryandradiologypersonnel,ITadministrators,orotherpersonnelwhoarecommittedtotrainingclinicalprovidersandprovidingqualityoversighttotheprogram.TheoriginatingandreceivingfacilitiesshalldesignateanITliaisonwithspecializedtraininginthehardware,software,andclinicalalgorithmsassociatedwithtelestrokeservices,asthisroleiscriticaltotheseamlessfunctioningofthetechnology.ManysmallorruralhospitalsmaynothavetheITresourcestoensuresomeonehasspecializedtraining.ItcouldbetheresponsibilityoftheDistantSiteand/orthetelemedicinetechnologyvendortoprovidesupporttotheOriginatingSite,dependingonthearrangementandavailablepersonnelattheOriginatingSite.Theoversightshouldincludeareviewofconsecutivetelestrokecasesfortimelinessofemergencyevaluations,correctnessofclinicaldecision-making,appropriatenessoftreatmentdelivery,andcomprehensivenessofpost-EDcareforthepatientsnottransferredtothestrokecenter.Forthoseorganizationsthatutilizetelestrokeservicesforinpatientswithsuspectedacutestrokesyndromes,thesameoversightshouldbeapplied.Additionalpersonnelincludinghospitalists,neuro-hospitalists,rapidresponseteams,andotheremergencyresponderswouldbeincludedinthesereviews.

HUMANRESOURCEMANAGEMENTTheorganizationshallcreateguidelinesforEMS,ED,generalinpatient,andICUsettingswhichspecificallydescribetelestrokeprocesses,rolesandresponsibilities,appropriatestaffingmodels,hoursofoperation(24/7/365unlesstelestrokeservicesarebackfillingspecificvacanttimeslots),methodsofcommunication(e.g.,telephone,video,VoiceOverInternetProtocol[VOIP]audiointegratedwithvideo),proceduresaroundroutineandemergencystrokecaredelivery,andplanforescalationprocesses(e.g.,power,equipment,orInternetfailure,orpatientrequiringtransfertoanotherfacilityforhigherlevelofcareorendovasculartreatment).Theseguidelinesshouldmatchtheneedsofthepatientpopulationandbedsidehealthcareprofessionals.Eachorganizationshouldsupportorientation,staffdevelopment,andcompetencyoftelestrokeprograms.AnOn-Calllistshallbeavailablesothatstaffknowexactlywhotocallwhenanacutestrokepatientpresents.Ideally,asinglecallshouldactivatetheacutestroketeam,whichincludesthetelestrokeconsultant.HEALTHPROFESSIONALS:REGULATORYCONSIDERATION(ACCREDITATION/CERTIFICATION)

Telestrokeprofessionals(typicallyNeurologists,Neurosurgeons,andEmergencyMedicinephysicians)shallbefullylicensed,registered,andcredentialedwiththeirrespectiveregulatory,licensing,andaccreditingagencies,withconsiderationtoadministrative,legislative,andregulatoryrequirementsofthesitewherethepatientandSpoke/Originatingsitehealthcareprofessionalarelocated.Thisconsiderationshallincludeallfederalandstateregulationsregardingprescriptiveauthority,anditshallbeupdatedaschangesoccur.Credentialingviareciprocityprocessesshallbeadoptedtominimizerecurrentpaperworkburdenonbothends.Statelicensureandregulationrulesareundergoingincreasingnationalandregionaldebate.TheATA(www.americantelemed.org),theFederationofStateMedicalBoards(FSMB)(www.fsmb.org),andtheRobertJ.WatersCenterforTelehealth&e-HealthLaw(CTel)(http://ctel.org)providehelpfulresourcesforlocatingthemostcurrentstaterequirementsforpracticingtelemedicine.


Healthcareprofessionalsshallbeawareoftheirlocusofaccountabilityandallrequirements(includingthoseforliabilityinsurance)thatapplywhenprovidingtelestrokeservices.Thetelestrokeleadershipandtheorganization’slegalcounselshouldinsurethatmalpracticecarriersarenotifiedwhenanewclinicianisplanningtoprovideclinicalservicesviatelemedicine.Likewise,whenaphysicianisnolongerprovidingclinicalcare,thecarriershouldalsobenotified.Theuseoftelestrokemodalitiesshallestablishahealthcareprofessional-patientrelationship,whichincludesallresponsibilitiesinherentinthatrelationship.Telestrokehealthcareprofessionalsmayneedtonegotiatewithlocalfacilitiestoallowanexemptionfromcertainobligationscontainedinthefacilities’regulationsandbylaws(e.g.,TBtestingrequirement,non-strokerelatedcommitteemeetings)whileprovidingtelestrokeservices.Thesenegotiationsshouldnotexempttelestrokehealthcareprofessionalsfromparticipationinlocalhospitalcommitteesrelevanttotheirtelestrokeprograms.Healthcareprofessionalsprovidingtelestrokeservicesshallhavethenecessaryclinicalpreparation,orientation,ongoingeducation,andprofessionaldevelopmenttoensuretheypossessthenecessarycompetenciestopromotequalitycareandpatientsafety.

PRIVACYANDCONFIDENTIALITYTelestrokehealthcareprofessionalsandhealthcareorganizationsintheUnitedStatesshallincorporatetherequirementsforprivacyandconfidentialityinaccordancewiththeHealthInsurancePortabilityandAccountabilityAct(HIPAA)andtheHealthInformationforEconomicsandCriticalHealthAct(HITECH).IntheUnitedStates,additionalstateregulationsshallbefollowedforprivacy,confidentiality,andpatientrights;thesemayapplyaboveandbeyondrequirementsinplaceforgeneralhealthcareinteractions.Telestrokeservicesprovidedtopatientsphysicallylocatedinothercountriesshalloperateinconformancewiththeprivacylawsineffectforthatcountry.Otherinternationallawsshallbeconsultedandimplementedasappropriate.Policiesandproceduresshalladdresstheprivacyandsecurityneedsofthepatientfrombothatechnologicalandhumanrightsperspective.Examplesincludecapabilities,communicationrestrictions,andprocessesthatprotectpatientprivacyduringremoteaudio/visualassessment.Providersshouldconsulttheirlegalcounselregardingrecordingconsults.Organizationsprovidingtelestrokeservicesshallhavepoliciestomaintainpatientprivacy/confidentialitywhenvisitorsfromoutsideoftheorganizationtourthetelestrokecenter/facilities/equipment.Allidentifiedpossibleacutestrokepatientsandtheirfamiliesshallreceiveinformation,includingtheroleofthetelestrokeprograminpatientmanagement,theuseofthetechnology,andassuranceofconfidentiality,astimepermitsintheemergentsetting.Informationnotconveyedbeforethetherapeuticinteractionensuedcanbecommunicatedaftertreatmenthasbeendeliveredandstabilizationestablished.Somestateregulationsmayrequireconsentfortelemedicineconsultations;therefore,thesetelemedicineconsentsshallbeincludedaspartoftheorganization’sgeneralconsentprocess.Frequently,thetelemedicineconsentisincludedaspartofthegeneralconsentfortreatment.


FISCALMANAGEMENTOrganizationsshallestablishbudgetsthatencompassthecostofimplementation,whichmayincludesuchitemsashardware,software,datalines,licensingfees,credentialingfees,callreimbursement,marketingandcommunicationcosts,personnel,supplies,andrealestate.Thebudgetshouldalsoincludeon-goingexpensesrelatedtomaintenanceoftheprogram,whichmayincludesuchitemsashardwareandsoftwareupgrades,equipmentreplacements,andstaffeducation.Thebudgetshouldalsoidentifycurrentandprojectedrevenueforoperatingthetelestrokeservices.Revenueitemsmayincludepayerreimbursements,privatecontributions,grants,andgeneralsupportfromthehealthcarefacilityand/orhealthcaresystem.Organizationsmayconsiderafinancialmodelthataddressespossibleexpansionand/orenhancementofthetelestrokeservices.ThesemodificationsmayincludeexpansiontoadditionalSpoke/Originatingsites,additionalequipment,and/orusingexistingequipmentforotherservicessuchasteleneurology.Fiscalmetricsshouldbecustomizedtoreflectthegoalsoftheindividualtelestrokeprogram,andtheyrequireregularreevaluationattheexecutivelevel.

MANAGEMENTOFPATIENTRECORDSThetelestrokeprogramshoulduseprocessesandpoliciesfordocumentation,storage,andretrievalofhealthrecords,consistentwiththeorganization,industry,andgovernmentstandards.Interoperabilityshouldbeprioritizedtoensuretheseamlessflowofinformationbetweenpatientinformationsystemstoenhanceclinicalsupportandpromoteprovisionofemergencystrokecare.Directinterfacesbetweenthetelestrokeprogramandhospitalelectronichealthrecords(EHRs),laboratory,pharmacyandbedsidemonitoringsystemrepresentthehigheststandardsofinteroperability.Duetotheemergentnatureofacutestrokemanagement,andtherealitythatconsultantsoftenprovideservicesatmanydifferentfacilities,thisideal,two-waysharedinterfaceofinformationsystemsmaynotbefeasibleorrealistic.However,thislevelofinterfaceshouldbethegoal.

DOCUMENTATIONANDELECTRONICHEALTHRECORDPoliciesandproceduresregardingclinicaldocumentationthatoriginatesfromthetelestrokeserviceshallbeestablishedincompliancewithorganizationallegalandriskmanagementoversight.Thegoalofsuchdocumentationshouldbeclarityofthetelestrokeclinicalintervention(evaluation,assessment,consents,andrecommendations)andacompleteclinicalpicture,basedontheavailabledatainthetelestrokeconsultant’snotethatisintegratedintothepatient’spermanentEHR.Ifthepatientistransferred,thetelestrokeconsultationnoteshallbepartoftherecordssentwiththepatienttothereceivingfacility.Coordination,andwhenpossible,integrationoftheEHRfortelestrokeconsultdocumentationshouldbedoneasitisimportantforthepreventionoferrorsandtimelyaccesstoaccuratepatientdata.Dedicatedtelemedicinesoftwarepackagesmaybeusedtofacilitatestandardtelestrokeconsultdocumentationacrossanetwork,wheredirectaccesstotheEHRisnotfeasibleorpractical.


WORKFLOWANDCOMMUNICATION

Documentationpoliciesandproceduresshallbedevelopedforthesuccessfulpatientcarehand-offortransferofresponsibility.Directpeer-to-peercommunicationsshallbeencouragedtominimizepossiblemiscommunications.

DATARETRIEVAL

ThereshallbetheabilityforthetelestrokephysiciantoaccessandreviewcurrentdataspecifictotheconsultfromPictureArchivingCommunicationSystems(PACS–aradiologyimagetransmissionsystem)tofacilitatecommunicationandthedecision-makingprocess.Thereshallbeaccesstobedsidedatatofurtherfacilitatecommunicationanddecisionmaking.

TELESTROKETRAINING

AdequateorientationandtrainingofEMS,hospital,EDstaff,radiologytechnologists,andphysiciansparticipatingintelestrokeshallbeoffered,asitisvitaltothesuccessandcollaborationbetweentheremoteHub/Remotestrokeconsultant/neurologistandtheonsiteSpoke/Originatingtelestroketeam.Ongoingtrainingmaybenecessaryduringsoftwareupgrades,duringqualityinitiatives,andfornewhospitalemployeesandphysicians.Forthoseoriginatingfacilitiesthataccesstelestrokeservicesonapart-timebasis(e.g.,offhoursornights/weekends–whentheremaybeagapinneurologycoverage),therewouldbetwoalgorithmsfordirectingtheacutestrokeevaluation.Assuch,intermittentormocktrainingsessionsmaybewarrantedtoensurethatstaffonallshiftsmaintaincompetencywiththeuseoftelestrokewhenincludedintheacutestrokealgorithm.Trainingshouldencouragestaffacceptanceoftheuseoftelestrokeservices.Thistrainingshouldincludeeffortstobuildtrustanddevelopintegratedteamworkflows,incorporatingbothonsitestaffandremotephysicians.Specialtrainingmayberequired.

PATIENTRIGHTSANDRESPONSIBILITIES

Patientsandfamiliesshallbeinformedandeducatedabouttheroleoftelestrokeintheintegratedcaredeliverymodel.Useofremotehealthcareprofessionalsandaudio/visualtechnologyshallbeincludedaspartoftelestrokespecificpatienteducation.Healthcareprofessionalsshouldbeparticularlymindfulwiththeuseofaudio/visualtechnologyfortheprovisionofpatient/familyprivacywithsensitivitytoculturalconsiderations.Appropriatelanguagetranslationservicesshouldbeemployedforpatientsandfamilies,whenappropriate.Apprehensionsregardingtheroleoftelestrokeand/orcomponentsoftheaudio/visualtechnologyshouldbeaddressedcollaborativelywiththepatient/family,thetelestrokeconsultant,andthebedsideteam.Theyalsomaybeaddressedthroughorganizationalpolicies.

QUALITYANDOUTCOMES

Telestrokeservicesshallhavesystematicqualityimprovementandperformancemanagementprocessesinplacethatcomplywithallorganizational,regulatory,andaccreditingrequirements.Thequality


indicatorsshallincludeadministrative,technical,andclinicalcomponentsfortheprovisionoftelestrokeservices.Further,theyshallbeusedtomaketechnical,programmatic,andclinicalchangesbaseduponbestnewevolvingtechnology,practiceprinciples,evidence-basedguidelines,clinicalresearch,andanychangingservicerequirements.Telestrokestaff,administrators,andlocalstrokecoordinators/championsshouldbealignedtomeetspecificprogramoutcomesandprocessmeasures.Inadditiontosharedgoals,thehospitalandtelestrokeservicemayhaveuniquemetricsbasedontheiruniquecontributionstotheprogram.Aprocessforthereportinganddisseminationofqualitymetricsandoutcomesshouldbedevelopedtofacilitatebothadministrativeandoperationalanalyses.Telestrokevalueisoptimizedbyincreasingqualityandaccesswhilecontrollingcost.Ongoingmonitoringandevaluationofcosts,access,andqualityshouldbeperformedbyboththehospitalreceivingtelestrokeservicesandthetelestrokeprovidingorganizations,toidentifyopportunitiesateachsiteforenhancedvalue.Telestrokeservicesshallhaveaprocessinplacetomonitorqualityandoutcomemetrics.Domainsofqualitymeasuresshouldincludetechnologyparameters,andprocessmeasures.Theadequacyofvideoandaudioconnectionsduringtelestrokeconsultationsandtechnologyfailurespreventingadequatepatientevaluationsshouldbedocumentedandreported.CTqualityandreadabilityarealsoimportanttotelestrokeassessments.Telestrokenetworksshouldrecord,ataminimum,timesfromdoortoCTscan,cameraconnection,completionofconsult,andadministrationofintravenousalteplase,whenapplicable.Forpatientstransferredforendovasculartherapy,timetodecision,andtimefromdoor-intodoor-outarealsoimportantmeasures.Thetrainingofpersonnelinvolvedintelestrokenetworks,includingphysicians,nurses,andadministrators,shouldbedefinedanddocumented.Relevantoutcomesshouldincludepercentofpatientstreatedwithintravenousalteplase,strokemimics,transfers,complications,andpatientandprovidersatisfaction.Qualityandoutcomemeasuresshouldbereviewedbytelestrokeleadershiponaregularbasis.Resultsshouldbeusedtoimproveprocessesbyacontinualloopoffeedbackandreassessment.InHub/DistantandSpoke/Originatingnetworks,bothHub/DistantandSpoke/Originatingsitesshouldcontributetoacommonqualityandoutcomesmonitoringprocess,andtheyshouldshareresultstoensureuniformityofpatientcare,implementationofimprovementssystem-wide,andidentificationofopportunitiesforenhancedvalue.

RESEARCHPROTOCOLS/INCORPORATINGCLINICALTRIALSINTOTELESTROKENETWORKS

Researchinvolvingtelestroke’scontributionstopatientcareandclinicaloutcomesandpatientrecruitmentintolargerstudies,especiallytrialsrecruitingruralpopulationsshouldbeencouragedandsupportedbytheorganization;suchresearchopportunitiesshallbeincompliancewiththeorganizations’institutionalreviewboard(IRB)approvalprocess.Telestrokenetworksshouldbeencouragedtocontributetoknowledgebyofferingpatientstheopportunitytoparticipateinclinicaltrials.Usingtelemedicine,investigatorscanidentifypatientsappropriateforclinicaltrials.Physiciansperformingtelestrokeconsultsshouldbeawareofactiveclinicaltrialsandtheinclusion/exclusioncriteria.Clinicalfeatures,detailsofhistory,andCTfindings,canbereviewedremotelytoselectpatientsappropriateforspecifictrials.Withaccurateremoteassessments,unnecessarytransferstoassesspossibletrialcandidatescanbeavoided.Insomecases,thetrialmightbeinitiatedattheremotesite,andinothersituations,atransfermaybenecessaryforthepatienttobeenrolledataparticipatingsite.Identificationandrecruitmentofpatientsfromruralhospitalsincreases


thediversityofstudypopulationsandreachesareasnottypicallyincludedinclinicaltrials.Recruitmentthroughlargetelestrokenetworksalsoexpandsthepoolofstrokepatientscontributingtohigherenrollment,morerapidcompletionofstudies,andgreateropportunitiesforgeneralization.Telemedicineitselfcouldbethesubjectoftrialscomparingtelestrokeandin-personevaluations.Researchactivitiesshouldalwaysconformtostudyprotocolsandcomplywithgoodresearchpractices,asoutlinedbythelocalorcentralIRBs.

PHYSICALCONSIDERATIONS

Thephysicallayout(includingspace,equipmentplacement,andsecureexaminationspace)andergonomicsoftheED,generaladmissionsfloor,andICUshouldbeaddressedearlyinthetelestrokeplanningprocess.Thisprocessshouldincludeinputfromclinicians,technologyengineers,andphysicalplantengineers.Architecturaldesignshouldconsidercommunicationessentialsbetweenandamongtelestroketeammembersandstafffromthevariouspotentialcareareas.Thesemayincludeaudio/visualequipmentstorage,wirelessequipmentplacement,aswellasdedicatedbandwidthtoprovidestable,reliablecommunication,andassuranceofquietenvironmentstoallowclear,optimalinteractionsthroughouttheacutecarefacility.Tofacilitateitsadministration,storageofalteplaseintheEmergencyDepartmentisstronglyrecommended.

NETWORKS

Hospitalsreceivingtelestrokeconsultationswillhavevaryingservicestheycanprovide,butminimallyincludeheadCTscanimagingandadministrationofIValteplase.IfthereisneedforunavailableICUcare,additionalstrokediagnosticworkuporcare,orendovascularintervention,transfershouldproceedtotheclosestavailableandqualifiedfacilitybygroundorairtransport,assafety,time,orcomplexityconcernsdictate.Prearrangednetworktransferprotocolsshouldhelpexpediteandfacilitatepatienttransferstothesedestinationfacilities.

CLINICALGUIDELINES

SETTINGPROGRAMGOALS

Executiveleadershipshalldirectboththetelestrokeandbedsidestrokeleadershipinthereviewofprogramgoalsandthedeterminationofpriorities.Telestrokeserviceisnotdesignedtoreplacelocalservices,buttocomplementoraugmentlocalstrokecarethroughtheleveragingofresourcesandthestandardizationofprocesses.Operationalexecutionshallbedesignedtoattainprogramgoalswithindefinedstandardsofcare.Telestrokeprogramsfrequentlyhavesimilargoalsincludingimprovedpatientoutcomes,costsavings,andtheleveragingofresources,butthestructureofeachprogrammayvarydependingupontheorganizationalgoals,typesofavailabletechnicalandhumanresourcesandtypesandsizesofacutecarefacilitiesreceivingclinicalservice.


OPERATIONAL/SERVICEHOURS

Telestrokeoperational/servicehoursshouldbe24hoursperday,7daysperweek,andeverydayoftheyear.Thereshallnotbedowntimeexceptwhenthetechnologyunexpectedlymalfunctions.Forallfacilities,thereshouldbea“back-up”planinwhichtheacutestroketeamcanrelyonothercommunicationmodalitiestoconfernecessaryclinicalinformationtomakeaninformedrecommendationforacutemanagement.

TYPESOFPATIENTSSERVED

Theexecutive,stroke,andtelestrokeleadershipshalldeterminethescopeoftelestrokepatientservice.Whenthescopeofthetelestrokeresponsibilityisdetermined,flexibilityshouldbebasedonpatientneeds,availableservices,andmaintenanceofthestandardofcare,accordingtothegoalsofthetelestrokeprogram.Bydefinition,thetelestrokeserviceisdesignedtoprovideassessment,diagnosis,management,anddispositiondecisionmakingservicestopatientswithacutestroke.However,howanorganizationdefinestheutilizationofthetelestrokeresourcevaries.Thedecisiontoprovidetelestrokeservicestoallpatients,regardlessofclassification(ischemicandhemorrhagic),severity,timesincestrokeonset,andtreatmentopportunitiesshouldbedeterminedbythetelestrokeandstrokeleadershipteam.Additionally,sometelestrokeprogramsprovideservicetoacutestrokepatientslocatedoutsidethetraditionalED,suchasinprehospitalmobilestrokeunits,inICUs,inmedicalorsurgicalunits,andininterventionalneuroradiologicalsuites,withtheuseofeithermobiledevicesorhardwiredtechnologies.Mobilestrokeunitsarearelativelynewapplicationinwhichanambulancewithabuilt-inCTscannerandtelemedicinesystemareusedwithqualifiedmedicalpersonnel,toguideandsupportadministrationofIValteplaseinthefield.Sometelestrokeprogramsincorporateendovascularintervention.PatientsrequiringendovascularinterventionmaywellreceiveIVthrombolyticbridgingtherapy.However,theclotburdenmaybetoogreattolysewithIVthrombolytictherapyalone.Ifavailable,thesepatientsshouldbetransferredrapidlytoacomprehensivestrokecenterthathasvascularinterventionalistswhomayattemptinvasiveprocedurestoreopenanoccludedvessel.Forthesepatients,thetimedemergentperiodisnotoveruntiltheinvasiveprocedureopensthevessel,ortheprocedureisdeterminedtobecontraindicated.

STAFFINGMODELS

TelestrokenetworkmodelsgenerallyconsistofSpoke/Originatingsites,wheretheacutestrokepatientsarelocated,andHub/Distantsiteswherethetelestrokeproviderislocated.TelestrokemodelsexisteitherasdistributedstaffingmodelsorHubandSpokestaffingmodels.Inthedistributedmodel,telestrokeservicesaredeliveredtohospitalsfromprovidersatdistantsitesonacontractualbasis.Thedistantprovidersgenerallyhavenoaffiliationwiththehospitalotherthanthatconcerningthediscreteepisodeofcare.Ifapatientrequiresahigherlevelofcare,protocolsexisttotransferthepatienttoaprimaryorcomprehensivestrokecenterinthecommunity.Staffingcoveragefortelestrokeconsultsmaybesuppliedbyanindependentfor-profitcompanyorbyanorganizedgroupofproviders.IntheHubandSpokestaffingnetworkmodel,aregionalstrokecentergenerallyprovidestelestrokeservicesatthedistantsitetohospitalswithintheregion(originatingsites).Thestrokestaffmembersaregenerally


credentialedattheoriginatingsites.Whentransfersareindicated,theregionalHubstrokecenterreceivesthepatientfromtheSpokehospital.Continuityofstrokecareisprovided,beginningbyvirtualcare,andthen(post-transfer)bydirectin-personcare.

TELESTROKEWORKFLOWS

Implementationofatime-sensitiveandefficientworkflowfortelestrokeservicesisthebasisforasuccessfulclinicaloperationforevaluatingandmanagingsuspectedacutestrokepatientsusingremoteexpertise.TheworkflowattheSpoke/Originatingsiteshouldincludeastep-wisesetofprocessesthatoutlinesthepracticeforestablishingatimewindowforidentifyingasuspectedacutestrokepatient,activatinganacutestroketeamfortherapidevaluation,andincorporatingtheactionsforinitiatingatelestrokeconsultationintothatprocess.Dependingontheservicemodel(hubandspokevsdistributed),thecontractedservicesmayhavespecificrequirementsforactivatingaconsult,suchasatime-to-call,turnaround-timeresponse,andinitialavailablepatient-relatedinformation.Theactualvideo-conferencingconsultationcomponentshouldmimicthebedsideconsultationinthatthework-upshouldfollowrecommendedguidelinesfortheevaluationandmanagementofacutestroke.Considerationalsoneedstobegiventothefinaldispositionofthepatient,dependingontherecommendationsfortreatmentandmanagement.Theworkflowshouldincludeseveraloptionsforpost-telestrokecare,suchas“remainsattheSpoke/Originatingsite”or“transferstoahigherlevelofcare.”Requiredresources(i.e.,personnelandequipment)neededfortelestrokeservicesshouldbeclearlyoutlinedinboththebusinessplanandtheworkflowalgorithm.ThisdocumentationappliesnotonlytoEmergencyDepartments,butalsotofacilitiesthathaveinpatientservicesthatmayrequireanacutestrokeresponseteam.Forsomefacilities,telestrokeservicesmayhavealreadybeenbuiltinasanoriginalcomponentoftheiracutestrokeservices.Forfacilitiesthathadestablishedstrokecodeprocessesandaresubsequentlyimplementingtelestrokeservicesasanewoptionintheirstrokecodealgorithm,theworkflowshouldbemodifiedtoaccommodatetheadditionalresources.Regardlessofthemodel,successfultelestrokeworkflowsshouldhavebuilt-inprocessesthatcanaccommodatevariationsthatinevitablyariseduringthehyperacutestrokephasebyrelatingtheinteractionwithotherworkflowprocesses,aswellasconsideringfactorssuchasvolumes,workload,staffschedules,andtechnologyinterference.Theorientationandtrainingofpersonnelwhointerfacewithtelestrokeservicesencompassthemultipleservicesinvolvedwiththeacutestrokeprocess,includingtheEMSteams,EDpersonnel,ancillarysupportservices(radiologyanddiagnosticservices),communicationsoffices,andITsupport.Trainingshallbeorganizedanddirectedbythestrokeprogramleadership,anditshouldbeintegratedintothegeneralorientationtothestrokeprogram.TheorientationofTelestrokeServicesshallconsiderthefollowing:Whoneedstoknow?

● Pre-hospitalEMSpersonnel● Providersthatwillutilizetheservices● Bedsidepractitioners(includingEDandcriticalcarestaff)● Radiology● ITsupport● Rapidresponseteams● Thecommunity● Allnewhiresthatmaybeinvolved


Whatshouldbeincluded?● Theactualprocess● WhattodoincasethereisanITfailure● Benchmarktimes

Content/Training/Competency

● Knowledgeofspecificrolesintheprocess● Mockcodes● Quizzes● Providingandreviewingdocumentation● Stroketeamleadership● Benchmarktimes● Determiningaccuracyoftheevaluation● Ensuringahigh-qualityneurologicalexamincollaborationwiththetelestrokeMDs● Processesandproceduresafterthedecisionismade–notreatment,treatment,ortransfer

PatientandFamilyEducation

● Bedsideprovidersandtelestrokepractitionersshallberesponsible● Pre-andpost-encounterteaching● Explanationoftheserviceaspartoftheprocess● Briefdescription–picturesencouraged● Identificationofcommunityresources

INTEGRATIONSTRATEGIES

Strokesystemsofcareintegrateregionalstrokefacilities,includingacutestroke-readyhospitalsthatoftenhavetelemedicineandteleradiologycapability,primaryandcomprehensivestrokecenters,EMS,andpublicandgovernmentalagenciesandresources.Thegoalsofcreatingstrokesystemsofcareincludestrokeprevention,communitystrokeeducation,optimaluseofEMS,effectiveacuteandsubacutestrokecare,rehabilitation,andperformancereviewofstrokecaredelivery.Essentialtoeffectivestrokesystemsofcarearehospitalswiththecapacityandcommitmenttodeliveracutestrokecare,bothintheEDandonthestrokeunit.13

Thetelestroketeamshouldconsistofabroadrangeofclinical,administrative,andresearchmembersatboththeHub/DistantandSpoke/Originatingsitestofulfillallaspectsofthetelestrokedynamic.Neurologists,EDphysicians,nurses,andradiologistsshouldcollaborateontheprovisionofremotecareforpatientswithacutestroke.14

TogaintheendorsementofSpokehospitals,asuccessfulcollaborationbetweenneurology,neurosurgery/neurointerventionalists,andemergencymedicinepractitionersisessential.Collaborationbetweenemergencymedicineandneurologypractitionersislikelythemostimportantelementofasuccessfultelestrokeprogram.14

Potentiallyefficientmodelsoftelestrokesystemsmayusevascularneurologyspecialty-trainednursepractitioners,physicianassistants,orneurologyresidentsandfellowstoperformpreliminarytriage,screening,andneurologicassessments.Thispreliminaryworkshouldthenbefollowedbyareassessmentorreviewbyasupervisingvascularneurologist,dependingonapplicablestatelaws.HavingemergencymedicinephysicianstrokeleadersparticipateatHub/Distant-and-


Spoke/Originatingcentersisamodelthatappearstobeassociatedwithprogramsuccess.14

TECHNICALGUIDELINES

EQUIPMENT

OrganizationsshouldrefertotheATA’sCoreGuidelinesforTelemedicineOperationsdocumentationforminimumtechnicalrequirements.Additionaltechnicalrequirementsorspecificationsuniquetotelestrokeapplicationsaredescribedbelow.Forthepurposesofthissection,wewilldistinguishbetweenacutestrokeevaluationintheEDorhospitalsetting(acutecare)versusfollow-upcarerenderedinthehospital,post-acutecare,andthecommunity(subacute)care.Organizationsshallprovidetechnologythatoptimizesaudioandvisualclarityforenhancementofclinicalassessment(i.e.,realtime,two-wayaudiovisualsolutionswithminimallatency).Acutecareinteractionsideallyrequirehighqualityvideoconferencingcameras,enabledwithpan-tilt-zoomcapability,whereassubacutecaremaybeabletoberenderedwithsimplertechnologyandfixedlenscameras,suchasinlaptopstabletsormobiledevices.Itisparticularlyimportanttoensurethatanyequipmentusedduringtheencountershallmeettheminimumtechnologyandperformancestandardsnecessary,andtheyshallcomplywithallappropriateprivacyrequirements.Ifspecificapplicationscallfortheuseofperipheraldevicesordigitallycapablemedicalequipment,suchasstethoscopes,otoscopes,ultrasounddevices,etc.,thesedevicesalsoshalladheretorecognizedmedicalstandardsandbeinter-operablewiththetelehealthencounterplatform.Connectivitycanbeachievedthroughwirelessorhardwiredinterfaces,butthereshouldberedundantcapabilitytoensurereliableperformance.Organizationsshouldprovideadequatetelecommunicationsbandwidthtoconnectnearandfarendequipmenttosupporttheprogramgoalsandensurequalitypatientcareservices.Theminimumbandwidthusedshouldbedeterminedinconsultationwiththeclinical,informationtechnology,andbiomedicalstaffofallfacilitiesforsufficientclinicaldiagnosisanddatatransfer.Becausedifferenttechnologiesprovidedifferentvideoqualityresultsatthesamebandwidth,eachendpointshouldusebandwidthsufficienttoachievedependableandreliablequalityserviceduringnormaloperation.Theadequacyofbandwidthshouldbetestedduringtheexpectedhoursofoperation,toensurethatadequatebandwidthexistswhenconsultationsarelikelytooccur.Ensuringadequatebandwidthforalltimesandequipmentisespeciallyimportantifprovidersorpatientswillbeusingpersonaldevicestoconducttheseencounters.Adequatetechnicalsupportshouldbeprovidedtoensurecomplianceofthesedevices,properfunctioning,andsoftwarecompatibility.Periodictestingisnecessarytomeettheseprogramgoals.Ifusingapersonalcomputerormobiledevice,thehealthcareprofessionalshouldconformwiththeITpoliciesoftheenterprise.Devicesshallhaveup-to-datesecuritysoftwarethatisHIPAAcompliant.Healthcareprofessionalsshouldensuretheirpersonalcomputerormobiledevicehasthelatestsecuritypatchesandupdatesappliedtotheoperatingsystemandthirdpartyapplicationsthatmaybeutilizedforthispurpose.15Healthcareprofessionalsandorganizationsshouldutilizemobiledevicemanagementsoftwaretoprovideconsistentoversightofapplications,devices,dataconfiguration,andsecurityofthemobiledevicesusedwithintheorganization.15Whenthehealthcareprofessionalusesamobiledevice,specialattentionshallbeplacedontherelativeprivacyofinformationbeingcommunicatedoversuchtechnology,andaccesstoanypatientcontactinformationstoredonthemobiledevicemustbe


adequatelyrestricted.15Thisprotectionincludesproviderawarenessofthephysicalenvironmentinwhichtheywillperformtheconsultation,andthesecurityofanymobilenetworksthatmightbeaccessed.Privacyscreensandearphonesshouldbeconsideredforlaptopsortabletsthatwillbeusedoraccessedinpublicspaces.Alldevicesorapplicationsshallrequireapassphrase,biometricidentification,orequivalentsecurityfeaturebeforethedevicecanbeaccessed.Ifmulti-factorauthenticationisavailable,itshouldbeused.15Alldevicesshouldbeconfiguredtoutilizeaninactivitytimeoutfunctionthatrequiresapassphraseorre-authentificationtoaccessthedeviceafterthetimeoutthresholdhasbeenexceeded.Thistimeoutshouldnotexceed15minutes.15Ifvideoclipsareused,appropriateprocessesfordispositionofthoseclipsshallbeinplace.Mobiledevicesshouldbekeptinthepossessionofthehealthcareprofessionalwhentravelingorinanuncontrolledenvironment.Unauthorizedpersonsshallnotbeallowedaccesstosensitiveinformationstoredonthedevice,orusethedevicetoaccesssensitiveapplicationsornetworkresources.15HealthcareandinstitutionalITprofessionalsshouldhavethecapabilitytoremotelydisableorremovedatafromanymobiledevicecontainingpersonalhealthinformation(PHI)orsensitiveinstitutionaldata,shouldthedevicebelostorstolen.15Giventheneedforaccesstomultipleservicesandsystemsbymodernhealthcareproviders,policiesshouldrequireuniqueusernamesandpasswordsforallproviderstopreventsharingofaccesskeys,andprovidersshouldnotusethesameusernameandpasswordsacrossmultipleplatformsunlesstheorganizationsupportssinglesignonorfederatedauthentication.Providerswhomustusemultipledifferentusernameandpasswordcombinationsshouldbeencouragedtousepasswordmanagementsoftwaretogenerateandmaintainstrongpasswords.Telestrokeapplicationsshouldsupportatminimumpoint-to-point,andideally,multipartyconnectivity.Providersshouldbeabletoaccessthesystemfromwithinoroutsideofthehealthcarefacility,usingthesameinterfaceanduserexperience.Organizationsshouldconsidertechnologyinteroperabilitywhenselectingsystemsforintegrationofothertelemedicineservicesordocumentationsystems.Interoperabilitywillbeincreasinglyimportantastelestrokeapplicationsentermobilestrokeunits,post-acutecarefacilities,andotheravenuesofcaredelivery.Increasingly,organizationsleveragetelemedicineequipmenttoservetheneedsofmultipleclinicalprograms.Wheneverpossible,equipmentusedfortelestrokeshouldbeadaptabletoservetheneedsofotherclinicalprograms.SystemsshallcomplywithallcurrentandapplicableStateandFederallawsandregulations,governingtheuseofmedicaldevicesandmedicalinformation,i.e.,FoodandDrugAdministration(FDA),HIPAA,HITECH,WasteElectricalandElectronicEquipment(WEEE).Alleffortsshallbetakentomakeaudioandvideotransmissionsecurebyusingpoint-to-pointencryptionthatmeetsrecognizedandacceptedstandards.SystemsshallcomplywiththeFederalInformationProcessingStandard,theU.S.Governmentsecuritystandardusedtoaccreditencryptionstandardsofsoftware,andlistsencryptionsuchasAdvancedEncryptionStandard(AES).Healthcareprofessionalsshouldfamiliarizethemselveswiththetechnologiesavailableregardingcomputerandmobiledevicesecurity,andtheyshouldhelpeducatepatients.15Iforganizationsintendtoprovideservicestopatientslocatedinothercountries,theyshouldbeawareofrelevanttechnicalrestrictionsplacedoninformationsystemstechnologyexportstocertaincountries.Organizationsshallensurepropertestingandmaintenanceforallfunctionalitiesforeachnewlyinstalledinfrastructureorendpoint.Organizationsshallimplementplannedandunplanneddowntimeproceduresthatensurecontinuedserviceandmayincludetheuseofappropriatebackuptechnologiesandclinicalprotocols.Examplesmayinclude:N+1redundancy,devicecomponentredundancy,geographicdispersedinfrastructure,fastfailover,failurenotifications/alerts,and/ordocumentedon-call


proceduresduringplannedorunplannedsystemdowntime.Policiesandproceduresshouldproactivelyaddressongoingequipmentmaintenance,anticipatedequipmentandsoftwareupgrades,performanceofperiodicremotetestsforoperationandfunctionalverification,evaluationofresourceallocation,and24/7technicalsupport.

INFECTIONCONTROL

Organizationsshallhaveinfectioncontrolpoliciesandproceduresinplacefortheuseoftelestrokeequipmentandpatientperipheralsthatcomplywithorganizational,legal,andregulatoryrequirements.

DATAPOLICYANDPROCEDURE

Organizationsshallimplementpoliciesthataddressadequatedatastorageandretrieval,devicesecurity,timezonemanagement,andfollowlongtermstoragestandards,suchasStorageManagementInitiativeSpecification(SMI-S).Recordingsofaudioorvideofootageshouldbeperformedwithappropriateoversightandpatient/providerconsent,whenappropriate.Maintenanceandsecurestorageofallsensitiveinformationshouldbegovernedappropriatelywithwrittenpoliciesandprocedures.Accesstothismaterialshouldberestrictedtothosewithlegitimateneeds.Organizationsthatdocumentmedicalinformationinthirdpartyorelectronichealthrecordsystems,otherthanthestandardhealthrecordsystemoftherequestingsiteorconsultingsite,shouldensuretheserecordsarestoredinamannercompliantwithrelevantprivacyandsecurityregulations.Thereshouldbeawrittenpolicyforhowthisinformationisstoredandcommunicatedtothereferringsiteorconsultingsite,asappropriate.Ifmultipleproviderscontributetothedocumentationoftheclinicalencounter,thenallprovidersinvolvedshouldbeindicatedinthedocumentation,aswouldbeexpectedinatraditionalface-to-faceencounter.Theorganizationshouldhavewrittenpoliciesregardingthesharingofinformationaboutthequalityofconsultationsorbenchmarkperformancecriteriathatallowforcontinuousqualityimprovementwithinthetelestrokenetwork.

CONCLUSION

Thesetelestrokeguidelinesweredevelopedtoassistpractitionersinprovidingassessment,diagnosis,management,and/orremoteconsultativesupporttopatientsexhibitingsymptomsandsignsconsistentwithanacutestrokesyndrome,usingtelemedicinetechnologies.Theseguidelines:

• Definecommonlyusedtelestroketerminology• Introducetheneedfortelestroke• Proposeadministrativeandleadershipstructure,roles,andresponsibilities• Outlineregulatoryconsiderationsforhealthprofessionals• Reviewprivacyandconfidentialityconsiderations• Establishfiscalmanagementstrategies• Setoutmanagementprinciplesfordocumentationandelectronichealthrecords• Proposeworkflowandcommunication• Highlightrequisitetrainingandqualificationsforproviders• Establishpatientrightsandresponsibilities• Featurequalityandoutcomes• Incorporateopportunitiesforresearchprotocols


• Definephysicalandnetworkconsiderations• Presentprogramandoperationalgoalsandexpectations• Displayvariousstaffingmodelsandsystemsofcareintegrationstrategies• Presenttechnicalspecifications

Telestrokeinteractiveencounterslinkpatientswithacuteischemicandhemorrhagicstrokeandacutecarefacilitieswithremoteandon-sitehealthcarepractitionerstoprovideaccesstoexpertise,enhanceclinicalpractice,andimprovequalityoutcomesandmetrics.Whenaclinicaldomainintelemedicineaccruesabodyofevidencesupportingreliabilityandvalidityofthevirtualexamination,accuracyoftheremotediagnosisandtreatmentmanagementdecisionmaking,safetyandefficacyofthetelemedicineassessment,andclinicalandcosteffectivenessoftheparadigm,itissufficientlyprimedforimplementationofguidelinesdesignedforthetelemedicinepractitioner,administrator,andtechnicianalike.Suchisthestateoftelestroketoday.

APPENDIX

DEFINITIONS

Termsanddefinitionsthatarecommonlyusedintelemedicine/telestrokeareavailableontheAmericanTelemedicineAssociation(ATA)website.Forthisdocumentthereareseveraltermsthatneedtobedefinedspecifically:“DistantSite”-Telestrokeproviderlocation;sometimesusedinterchangeablywith“HubSite”whenreferencingaHubandSpokeNetwork.

“DistributedNetwork”-Amodelinwhichtelestrokeservicesareprovidedtomultipleoriginatingsitesthrougharrangementswithanindependentcorporationoranaffiliatednetworkoftelestrokeproviders.Inthissetting,transferagreementsforendovasculartherapyorsubsequentstrokecareshouldbedefinedinadvancetofacilitateallaspectsofacutestrokecare.

“EndovascularIntervention”-Intra-arterialthrombolysisormechanicalthrombectomyforselectedpatientswithlargevesselocclusionsidentifiedduringtheacutetelestrokeinteraction.

“HealthProfessionals”-Individualsengagedintheprovisionofhealthcareandhealth-relatedservices.

“Hub”-Typicallyacomprehensivetertiarycarecenterwherevascularneurologistsandotheracutestrokespecialistscompriseacallpaneldeliveringtelestrokeservicestonetworkaffiliate/partnersites-“spokes.”Ifapatientrequirestransfertoahigherlevelofcare,ahubisusuallythedestination.Somenetworksmayhavemultiplehubs.

“HubandSpoke”-Networksofprimary,secondary,andtertiarycaresettingsthatprovidecaretospecificpatientpopulations.Networksmayvaryinsophistication,withmanyworkingasloose


coalitionsofsegregatedservices.Typically,specialtycareisprovidedtopatientsatremotesettings(oftenruralemergencydepartments)byspecialistsaffiliatedwithlarger,morecomprehensivetertiarycarecenters.Modelsarechangingwithanemphasisonkeepingpatientsintheirlocalcommunitywhenpossible,dependingontheavailablelevelofcare.

“Organization”-Groups,institutions,andbusinessentities.

“OriginatingSite”-Patientlocation;sometimesusedinterchangeablywith“SpokeSite”whenreferencingaHubandSpokenetworkmodel.

“Shall,Should,andMay”-Thisdocumentcontainsrequirements,recommendations,oractionsthatareidentifiedbytextcontainingthekeywords“shall,”“should,”or“may.”“Shall”indicatesarequiredaction,wheneverfeasibleandpracticalunderlocalconditions.Theseindicationsarefoundinboldthroughoutthedocument.“Should”indicatesanoptimalrecommendedactionthatisparticularlysuitable,withoutmentioningorexcludingothers.“May”indicatesadditionalpointsthatcanbeconsideredtofurtheroptimizethehealthcareprocess.“Shallnot”indicatesthatthisactionisstronglyadvisedagainst.

“Spoke”-Theaffiliateorpartnersiteinatelestrokenetwork,underservicedorundersupportedbyneurologists,wherepatientservicesaredelivered.

“Telemedicine”-Telemedicineistheuseofmedicalinformationexchangedfromonesitetoanotherusingelectroniccommunicationsinanefforttoimproveconsumerhealthstatus.Videoconferencing,videoclips,transmissionofstillimages,e-Healthincludingpatientportals,remotemonitoringofvitalsigns,continuingmedicaleducation,andnursingcallcentersareallconsideredpartoftelemedicine.Telemedicineisnotadiscretemedicalspecialty.Productsandservicesrelatedtotelemedicinefrequentlyareincorporatedaspartofalargerinvestmentbyhealthcareinstitutionsineitherinformationtechnologyordeliveryofclinicalcare,orboth.Eveninthereimbursementfeestructure,thereiscommonlynodistinctionmadebetweenservicesprovidedonsiteandthoseprovidedthroughtelemedicine.Separatecodingforbillingofremoteservicesmayberequired.Telemedicineencompassesabroadrangeofpatientprogramsandservices,requiringdifferentprovidersandconsumers.1

“Teleneurology”-Broadapplicationoftelemedicinetothefieldofneurology,bothacuteandambulatorycare.

“Telestroke”-Anetworkofaudio-visualcommunicationandcomputersystemswhichprovidethefoundationforacollaborative,inter-professionalcaremodelfocusingonacutestrokepatients.Telestrokeserviceisdesignedtoaugmentlocalservicesthatarenotimmediatelyavailablebyleveragingremoteexpertiseandresourcesandthestandardizationofprocesses.Itisasubdivisionofteleneurology,involvingtelemedicineconsultationforthetreatmentofneurovascularpatients.Themostcommonapplicationoftelestrokeisforacutestrokepatients(pre-hospitalandhospital),buttelemedicineservicesmayextendwellinadvanceandwellbeyondthattimeframe,andtheymayofferawidevarietyofadditionalservicesfromwellness,remotemonitoring,diseaseprevention,subacute,rehabilitative,andre-integrationintothecommunityphases.Whiletheprimaryroleoftelestrokeisthefacilitationofacutestrokepatients’care,commonstrokemimicswillbeidentifiedandtreatmentrecommendationsmaybeoffered.


“TelestrokeNetwork”-Agroupofprimary,secondary,andtertiarycaresettingsthatprovideacutestrokecaretotheirpatientpopulation.Telestrokenetworksconsistoforiginatingsiteswherethepatientsarelocated,anddistantsiteswherethetelestrokeproviderissituated.Telestrokesystemsexisteitherasadistributedorahubandspokemodel.

REFERENCES1. TelemedicineGlossary.AmericanTelemedicineAssociationwebsite.2016.

http://thesource.americantelemed.org/resources/telemedicine-glossary.AccessedOctober30,2016.

2. MurrayCJ,LopezAD.Measuringtheglobalburdenofdisease.NEnglJMed.2013;369:448–457.

3. InternationalStrokeTrialCollaborativeGroup.TheInternationalStrokeTrial(IST):arandomizedtrialofaspirin,subcutaneousheparin,both,orneitheramong19435patientswithacuteischemicstroke.Lancet.1997;349:1569-1581.

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NEW ATA Telestroke Guidelines - Télémédecine 360...consistent with an acute stroke syndrome, using telemedicine communication technologies. Although telestroke practices may include