development of a community- based clinical registry for ... · how is data managed? • paent...

DevelopmentofaCommunity-BasedClinicalRegistryforPa:ents

withCochlearImplants

JedGrisel,MDTerryGriffin,PhDOctober15,2015

Disclosures•  501(c)3•  Supporters

–  Cochlear–  AdvancedBionics–  WichitaFallsAreaCommunityFounda:on–  UnitedRegionalHealthCareSystem–  MidwesternStateUniversity–  Echometer–  J.SBridwellFounda:on–  BryantEdwardsFounda:on–  Jim&VickyMcCoy–  BoardMembers

Background•  WhyisbeXerdataneededintheCochlearImplantCommunity?– Reachnewmarkets– Affectpublicpolicy– Nego:atewithpayers–  Improvecareforpa:ents

HowisDataManaged?•  ElectronicHealthRecords– Advantages

•  Clinicaldocumenta:on,billing

– Disadvantages•  Siloed•  Non-standardized•  Myopicviewofpa:ent’sjourney

HowisDataManaged?•  Pa:entRegistry– Apa:entregistryisanorganizedsystemthatusesobserva:onalstudymethodstocollectuniformdata(clinicalandother)toevaluatespecifiedoutcomesforapopula:ondefinedbyapar:culardisease,condi:on,orexposure,andthatservesapredeterminedscien:fic,clinical,orpolicypurpose(s).

(AHRQ.gov)

Datamanagementtechnologyinavalue-drivenworld

•  HIPAA-secure•  Cloud-based•  Builtaroundcollabora:on•  Pa:entcentered–datafollowspa:ents•  Uniquelyiden:fiespa:ent/provider/organiza:on•  Encouragesevidence-basedcare

Methods•  Cochlearimplantdatamanagementplaeorm

DataElements•  Supportedbyliterature

– Elementsevaluatedbasedon•  Feasibility•  Keepingdatasetconcise•  Valuetobodyofknowledge

Methods•  Logis:cs– Dataentrymustnotcreatedoublework–  Integratedintoworkflowtominimizedisrup:onsandideallysavestheclinician:me

•  DataAccess– Accesstodatagrantedtoprovidersinvolvedinpa:ent’scare(CareTeam)

Methods•  TechnicalRequirements:Implementa:on

–  RESTfulAPI–  Tokenizedaccess(sessionmanagement)–  Widgetbasedsystem–  UI/UXdesignbasedonworkflowandforthroughput–  DesignedforDataaggrega:on–  InputValida:on–  NISTLevelIISecurity–  Audi:ngandLogging

Methods•  TechnicalRequirements:Security–  EncryptedDiskStorageandDatabase–  TwoFactorAuthen:ca:on–  VPN(SecureSocketAccess)–  Firewalled–  IntrusionDetec:on–  Penetra:onTes:ng–  Raid(RedundantStorage)

Results•  CareTeams–  MaintainHIPAAsecuritybygran:ngaccessonlytothoseinvolvedinpa:ent’scare

– Use“Invita:on”and“Accept/Reject”procedure

CareTeams

Results•  DataInput–  CarePhases(MilestoneVisits)

•  KeyInforma:onorganizedaccordingtopa:ent’sprogressalongtheirimplantjourney

-  Toviewalldataelements,pleasevisit-  aii-hermes.org/dataElements.php

Input:CarePhases

Results•  DataInput–  Toolbar(Non-MilestoneVisits)

•  Demographics•  Syndromes/E:ologies•  Surgeries•  Medica:ons•  HearingAidInforma:on•  AudiometricTes:ng(Non-Milestone)•  SpeechandLanguageDevelopmentInforma:on

Input:Toolbar

Results•  DataOutput– Pa:entReports

Output:Pa:entReports

Results•  DataOutput– DataQueryTool

Output:DataQueryTool

ResultsSta%s%cs

Par:cipa:ngFacili:es 11(7ac:ve,4pending)(5academic,6private)

Pa:entsrecorded 79

TotalannualCIcaseload

~520

StatesRepresented 4(Texas,California,Arizona,Ohio)

ServicesRepresented Surgery,Audiology,Speech,Educa:on

Conclusion•  Aswere-imaginehowdataismanaged,wecan–  Improvecollabora:onamongproviders– Armourcausewithrobustdatasetsthataffectpolicy

–  Improvecareforourpa:ents

Acknowledgements•  AnneLam– AiiExecu:veDirector&DatabaseManager

•  UniversityofSouthernCaliforniaCarusoFamilyCenterforChildhoodCommunica:on