AmbulatoryCareOrganizations:ImprovingDiagnosis

by

KathrynMackMcDonald

Adissertationsubmittedinpartialsatisfactionoftherequirementsforthedegreeof

DoctorofPhilosophy

inHealthPolicy

inthe

GraduateDivisionofthe

UniversityofCalifornia,Berkeley

Committeeincharge:

ProfessorStephenM.Shortell,ChairProfessorHectorP.RodriguezProfessorThomasG.RundallProfessorUrmimalaSarkar

Spring2017

©2017KathrynMackMcDonald

AllRightsReserved

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Abstract

AmbulatoryCareOrganizations:ImprovingDiagnosisby

KathrynMackMcDonaldDoctorofPhilosophyinHealthPolicyUniversityofCalifornia,Berkeley

ProfessorStephenM.Shortell,ChairAmbulatorycarecomprisesamajorandincreasinglyimportantpartoftheU.S.andothercountries’healthcaresectors.EveryyearintheU.S.,about80%ofthepopulationseekscareatadoctor’soffice,amountingtoonebillionvisits.Thesevisitsdividealmostequallybetweenprimarycareandspecialtyclinicorganizations.Diagnosticworkispartofmostambulatorycare,andcentraltoover40%ofpatientvisitsthatoriginateduetoanewproblemoraflare-upofanongoingchronicproblem.Yet,therisksassociatedwithdiagnosticfailureshavenotgarneredmuchattentionfromhealthcareleadersandpolicymakersuntilarecentNationalAcademyofMedicine(NAM2015)reportsynthesizedresearchdatawiththestatementthat“mostpeoplewillexperienceatleastonediagnosticerrorintheirlifetime,sometimeswithdevastatingconsequences.”Thisdissertationfirstreviewsorganizationaltheoriesandmeasurementchallengesrelevanttodiagnosticsafetyandqualityinthecontextofambulatorycare,andthenpresentsthreepapersanalyzingspecificorganizationalfactorshypothesizedtoenableorthwartanaccurateandtimelydiagnosis.Thefirstpapertargetsdelayeddiagnosisfrommissedevidence-basedmonitoringinhigh-riskconditions(e.g.,cancer)withinfivespecialtyclinicsinanurbanpubliclyfundedhealthsystem.Thesecondpaperanalyzesstaff-reportedofficeproblemsthatcouldleadtodiagnosticerror(e.g.,nothavingtestresultswhenneeded)inover900primaryandspecialtyclinicsacrossthenation.Thethirdpaperexaminestheassociationsbetweentwotypesoftimepressure(i.e.,encounter-levelandpractice-level),organizationalfactors,andpatienteffectsincludingperceptionsofmisseddiagnosticopportunities.Thethreeprimaryconclusionsfromthisworkare1)organizationalvulnerabilitiesformissedmonitoringcommontothedifferentclinicsincludedchallengeswithdatasystems,communicationshandoffs,population-leveltracking,andpatientactivities,leadingtothedevelopmentof‘designseeds’forcontext-flexiblesolutionstoimprovediagnosticquality;2)twoorganizationalfactors–stageofhealthinformationtechnology(HIT)deploymentandpatientsafetycultureareassociatedwithdiagnostic-relatedofficeproblems,and3)encounterandpractice-leveltimestressorsinprimarycareclinicsareassociatedwithperceptionsofgreateradverseeffectsondiagnosisandtreatment,andworsepatients’experiencesofchroniccarefromtheclinicteam,respectively,aswellasassociatedwithseveralorganizationalfactorsincludingHIT,patient-centeredculture,relationalcoordinationforinterdependentteamwork,andleadershipfacilitationofchangestoaddressfrontlinepracticechallenges.Takentogether,thedissertationpapersalsodemonstratetheapplicabilityoftheNAMImprovingDiagnosisConceptualFrameworkforresearchonambulatorycareorganizations.

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Dedicatedto

Allofuswhenweorlovedonesoccupytheroleofpatientandneedorganizedcare

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ACKNOWLEDGEMENTSMychronologyofgratitudestartswithmyfamily,friendsandcolleagues,somewhoembracedandsomewhoobjectedtotheideaofmygoingbacktograduateschool.Youallknowwhoyouare,andyouknowthatyouhelpedmecrystallizewhyitwasworthstartingandfinishing:enjoylearning,rebelabit(Berkeleyfitsthebillforthat),dosomethingthatmatterstootherpeople’slives,andyes,gainthecredentialthathypotheticallyeasesfutureeffortsinthesamedirection.Withoutsuchclarityofcommitmentandpurpose,Icouldnothaveputintheworkrequired.Thankyouforhelpingmeformthebedrockthatkeptmegoing.Nextupinthechronology:thehealthpolicyprogramfacultyandstaffhaveimpartedknowledgeandknow-howateveryturn.MarquesReddmakesthehealthpolicydoctoralprogramfunctionwellandeasedmyjourney.PattyRamsaydoesthesamefortheorganizationsgroupandgavemethoughtfulsupportthroughout.Berkeley’sfacultyadeptlyhelpedmemeetmygoalofenjoyinglearning.Ididnotfullyanticipatethejoyofsociology,politicalscience,management,law,demography,etc.Igratefullyacknowledgethevisionofthecorefacultyinhealthpolicywhodesignedaprogramwithinterdisciplinarydepth.Forfoundationalcourses,seminarsandone-on-oneconsultations,IamparticularlyindebtedtoAnnKeller,TimothyBrown,RichardScheffler,LonnieSnowden,JoanBloom,WillDow,ToddLaPorte,BarryStaw,MingLeung,BobKagan,SophiaRabe-Hesketh,andRonLee.Semesteraftersemester,Ifeltunboundedgratitudeforallofmypeers,whocontinuouslysharedhowtothriveandsurviveasadoctoralstudent.Ican’tbelieveyouallaredoingorhavedonethislifestepwithbrillianceandhumility!SarahLewisholdsaspecialplaceformodelingremarkableauthenticity,goodnatureandresourcefulness,evenduringourendlesspreparationforthespecialtyfieldexamonorganizationaltheory.ThankgoodnessforGabyGoldstein,especiallyherantidotetodiscouragingmoments:“it’sanhonorandaprivilegetobeagraduatestudent.”Mymemoryisetchedwithnumerousparticularlyhelpfulmomentscourtesyofeachofyou:SanazMobasseri,WeiNg,FrancesWu,CourtneeHamity,BaharNavab,MeganVanneman,NeilSehgal,ChristopherWhaley,JingLi,JanelleDowning,PauletteCha,LaurenHarris,KevinFeeney,JessicaPoon,ThomasHuber,VanessaHurley,andLeeannComfort.Asthechronologymovestothedissertationphase,mygratitudestartswithmydissertationchair,StephenShortell,whohastreatedmetohisprecisionmentorshipformanyyears,startingasmybusinessschooladvisor.Overthepost-MBAyears,Iaskedhim,likeanoracle,threetimesaboutwhetherIshoulddoanotherroundofgraduateschool,andgotamaybe,ano–notnecessary,andthenayes—doit.Althoughtheadvicemightsoundinconsistent,itwasconsistentlyright,exactlytailoredtomysituationateachjunctureofposingthequestion.IwillbeforevergratefulforSteve’sinterestandinvestmentinmycareer,andjustasimportantly,hisexampleoflifelongmindfulcontributionstoboththesocialscienceoforganizationsandappliedhealthcareresearch.Intermsofmyotherphenomenaldissertationcommitteemembers,eachstandsoutinuniquewaysbeyondtheintellectualsupportprovided.Asmy

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qualifyingexamchair,HectorRodriguezplayedacriticalroleingettingmereadyforandthroughmydissertationproposaldefense.Iappreciatehisengagementinmyresearch,manyusefulsuggestions,andcontagiouscollaborativespirit.TomRundallgraciouslyjoinedmycommitteeatamomentofgreatneedforhisinvolvement.Iamgratefulforhiswell-timedideasandthewayshereinforcedmydesiretostaygroundedinorganizationalstudythatimprovescareforpatients.IwanttoexpressmydeepgratitudetoUrmimalaSarkar,whobecameamemberofmycommitteethroughthewondersofserendipityandmoderntechnology.Herambulatorycarepatientsafetylearninglaboratorywastheperfectsettingformeetingmygoalofdoingsomethingthatmatterstopeople’slives.Asaprimarycaredoctorandpracticalresearcher,Urmimalaopenedthedoorformetocontributetoresearchonorganization-levelsolutionstoavertproblemsindiagnosingvulnerablepatients.Perfectfit!MydissertationresearchwouldnothavebeenpossiblewithoutresearchinfrastructureatUCBerkeley,UCSFandStanfordUniversity;andfundingforspecificprojectsfromPCORI,AHRQ,andtheGordonandBettyMooreFoundation.IamparticularlygratefultotheCHOIRteamatBerkeley,theASCENTteamatUCSF,andmyco-authorsnotedonthepapersincludedinthisdissertation.AllmyStanfordHealthPolicycolleagueshaveinspiredmetoworkinthisfield,startingwithMarkHlatkyandAlanGarber.SpecialkudostoDougOwens,SherylDavies,NancyLonhart,SokaKeo,CorinnaHaberland,andTinaHernadez-Boussardforhelpingmeinsomanywaysduringthisbusyperiod.Youhaveallkeptmeafloat!IalsohavedrawnenergyandindividualsupportfrommorecolleaguesthanIdarenamethankstoourconnectionstoorganizationswithworld-improvingaspirations:SocietyforMedicalDecisionMaking,NationalAcademyofMedicine,RelationalCoordinationResearchCollaborationledbyJodyHofferGittell,andSocietytoImproveDiagnosisinMedicine,amongothers.Thechronologyendswithgoodnews.Iwillhavesomediscretionarytime,andlookforwardtospendingitwiththosewhohaveputupwithmyabsence.Ideeplyappreciatetheconstantlove,encouragement,confidenceandpatiencefrommyhusbandDan,mygrown-upkidsPatrick,Evan,Melinda,andHollyMcDonald;mydadP.A.Mack,JoanOlcott,mybrotherJonathanMack,mywiderfamily,includingin-lawsandmanycousins,niecesandnephews.Ginger,LibbyandJoanhavestoodnearmysideforthisjourney,andmyUncleHerbregularlycorrespondswithrelevantobservationsandsources.SeveralofmyclosefriendshavetrodthisPhDpathandhaveknownjustwhatIneed,sotoJennyLanghinrichsen-Rohling,MartyRohling,CharlotteHaug,GudmundHernes,JennyWolf,BruceCampbell,andMeganWagner,youknowhowtrulygratefulIfeelforyourperfectlytailoredformsofsupport.Otherfriendsalsohaveknownwhatmakesadifference,andIfeelsoblessedtohaveyoursupportJeanWeiss,MargaretGruen,CathyConley,FranMaier,PattyHasbrouck,NancyBarrett,MarilynandRobertMarsteller,JohnWong,GillianSanders,DenaBravata,SaraSinger,andallwhoaredeartome.Ihavealsofelttheetherealpresenceofmymother,myfather-in-lawandmymaternalgrandmotherwhoeachtooknoteofmeinwaysthatmadethispossible.Finally,Duke’sdailypresencesnoringonthefloorbesidemewhileIwrotecomfortedme…andremindedmetotrytokeepmyworkinteresting.

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TABLEOFCONTENTS

Introduction:TheNexusofAmbulatoryCareandDiagnosis.........................................................1

OrganizationalTheoryandLinkstoThreePapers’ResearchQuestions........................................9ResearchQuestionsandLinkstoKeyFrameworks................................................................................14CriticalLiteratureGaps..........................................................................................................................16References.............................................................................................................................................18

Paper1—Implementationscienceforambulatorycaresafety:Anovelmethodtodevelopcontext-sensitiveinterventionstoreducequalitygapsinmonitoringhigh-riskpatients............22

Introduction...........................................................................................................................................23Methods.................................................................................................................................................24Results....................................................................................................................................................29Discussion..............................................................................................................................................40Conclusions............................................................................................................................................43References.............................................................................................................................................43

Paper2—Healthinformationtechnologies,patientsafetycultureandmedicalofficeproblemsthatcouldleadtodiagnosticerrors.............................................................................................49

Introduction...........................................................................................................................................50Methods.................................................................................................................................................51Results....................................................................................................................................................54Discussion..............................................................................................................................................60Conclusions............................................................................................................................................62References.............................................................................................................................................62

Paper3—Organizationalinfluencesontimepressurestressorsandpotentialpatientconsequencesinprimarycare......................................................................................................67

Introduction...........................................................................................................................................68Methods.................................................................................................................................................71Results....................................................................................................................................................73Discussion..............................................................................................................................................80Conclusions............................................................................................................................................82References.............................................................................................................................................84

FinalConclusionsandContributions............................................................................................87InsightsforAmbulatoryCareOrganizations..........................................................................................88TheoreticalandMethodologicalContributions.....................................................................................90References.............................................................................................................................................91

Appendices...................................................................................................................................93Appendix1:ScriptforDataCollectiononDesignSeeds........................................................................93Appendix2:FeedbackFormforDataCollectiononDesignSeeds(examples)......................................95Appendix3:AdditionalWorkflows(breast,gastroenterology,urology)withTargets..........................97Appendix4:AllWorkflowsColor-codedasFoundationforProcessTraceSequences..........................99Appendix5.ExcerptsfromACTIVATETeamSurvey:HITandTimePressure/StressorQuestions......102

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LISTOFTABLESTable1.VulnerabilitiesExperiencedbyEachClinic.....................................................................................................33Table2.DesignSeedsRelationshiptoCriticalActivityCategoriesandImplementationContext...............................36Table3.ImportanceRankingofDesignSeedsfromFiveSpecialtyClinics...................................................................39Table4.Officecharacteristics(n=926)........................................................................................................................53Table5.MedicalOfficeProblemsMeasuredinMO-SOPS...........................................................................................55Table6.RegressionResult:PercentDailyorWeeklyProblemFrequency(DependentVariable)................................58Table7.CultureDimensionsandRelatedOfficeProblems*........................................................................................59Table8.DescriptiveStatisticsforKeyVariables..........................................................................................................74Table9.Practice-LevelTimePressure(Chaos)Models................................................................................................78Table10.Encounter-LevelTimePressureModels.......................................................................................................79Table11.PatientExperienceofCare(PACIC)Models.................................................................................................80LISTOFFIGURESFigure1.NAMImprovingDiagnosisFramework.........................................................................................................11Figure2.Co-DevelopmentResearchProcess...............................................................................................................25Figure3.TechnicalInterventionDevelopmentCycle...................................................................................................28Figure4.Socio-TechnicalInterventionDevelopmentCycle:DesignSeedTheory........................................................29Figure5.AbnormalColonoscopyJourneyMap...........................................................................................................31Figure6.EarNoseandThroat(ENT)CancerJourneyMap.........................................................................................31Figure7.ProcessTraceSequences..............................................................................................................................35Figure8.TechnicalInterventionDevelopmentCycle:Example...................................................................................37Figure9.Socio-TechnicalInterventionDevelopmentCycle:DesignSeedExample.....................................................38Figure10.PercentofOfficeStaffthatReportedProblemasHappeningDailyorWeeklybyEHRImplementationLevel............................................................................................................................................................................56Figure11.PercentofOfficeStaffthatReportedProblemasHappeningDailyorWeeklybyE-ReportingImplementationLevel..................................................................................................................................................57Figure12.Stressor-Stress-PerformanceintheAmbulatoryCareContext...................................................................69Figure13.TimeStressorLevelsin16PrimaryCareClinics..........................................................................................76LISTOFABBREVIATIONSAHRQ=AgencyforHealthcareResearchandQualityEHR=electronichealthrecordENT=earnoseandthroatf/u=follow-upGI=gastroenterologyHIT=HealthInformationTechnologyHROs=HighReliabilityOrganizationsMO-SOPS=MedicalOfficeSurveyonPatientSafetyCultureNAM=NationalAcademyofMedicinePCORI=PatientCenteredOutcomesResearchInstitutePCP=primarycareproviderSEIPS=SystemsEngineeringInitiativeforPatientSafety

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CHAPTER1

Introduction:TheNexusofAmbulatoryCareandDiagnosis

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Startingwithcases,aspatientsareanonymouslyreferencedbyphysicians,isalongtraditionforlearningandscholarlyworkinhealthcare.

Case1:DelayedDiagnosis,longenoughdelayfordevastatingconsequences

Case2:DelayedDiagnosis,shortenoughdelaytoimproveprognosis

January2005:A17-year-oldboygoestotheemergencyroombyhimself

Complaint:severepaininhisleftankle

Thedoctorfindsnothingtoexplainthepain,andtellshimheprobablytwistedhisanklewithoutrealizingit.“Gohome,itwillgetbetter.”Hethinksthedoctormustknow,anddecidesnottocomplainabouthispainanymore.

April2005:Theboyisrushedtoemergencyroomwithseverelylaboredbreathing.Imagingshowscancerinhisankleandspreadtohislungs.Ewing’ssarcoma.Heundergoestreatment.

November2006:Soonafterhis18thbirthday,theboydies.

January2005:A17-year-oldgirlgoestotheemergencyroomwithhermother

Complaint:severepaininherleftknee

Thedoctorcanfindnothingtoexplainthepain,andsayssheprobablybumpeditonthesoccerfieldanddoesn’tremember.Sheobjectstothisassessment.Hermotheraskswhattodoaboutthepain.Thedoctorwritesaprescription.

February2005:Whenthepainintensifies,themothercallsthepediatrician,whorefersthegirltoanorthopedicdoctor,whoordersanMRI,whichshowsatumorinhertibia.Herlungsarecheckedandclear.

March2005:SheundergoesayearoftreatmentforEwing’ssarcoma,andmeetstheboyinthehospital.Theybecomefriends.

…….

March2015:Tenyearslater,thegirlremainscancer-free.

Hehada30%survivalchanceatdiagnosisbecausecancerhadspreadtohislungs

Shehada70%survivalchanceatdiagnosis

Thesecontrastingcasesofdiagnosticdelays,onemoredevastatingthantheother,motivateattentiontothebroadlandscapeofambulatorycaresettingsthatpatientstraverseastheyseekanaccurateandtimelyexplanationfortheirhealthcareconcerns.Asmedicalknowledgeexpandsthediagnosticlabelsavailableandthehealthcaredeliverysystemgrowsevermorecomplex,patientsandtheirinformalcaregiverscanplaycriticalrolesinnavigatingeachdiagnosticjourney.Buttheyexpecthelpfromorganizationswheretheyseekcare.

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Withanorganizationallens,thisresearchtargetstwointerwovenareasofimportancetohealthcarepolicymakers,healthcareprofessionals,anddeliverysystemmanagerswhoaimtoassurehighqualitycareforpatients.First,thisresearchfocusesonpatientcareoutsideofthehospital,theambulatorycaresetting.Second,thisresearchdelvesintotherealmofdiagnosticactivitywithinthissetting,andespeciallyanemergingareaofpatientsafetyconcern—diagnosticerror,oritsflipside,diagnosticqualityandsafety.

AmbulatoryCare

AmbulatorycarecomprisesamajorpartoftheU.S.andothercountries’healthcaresectors.AccordingtotheU.S.DepartmentofLabor,theambulatorycaresubsectorhasgrownsteadilyoverthelastdecadefromapproximately500,000to585,000establishments,mostlyprivatefacilities.(1)Forcomparison,theothertwosubsectorshavealsogrownwithcloseto9000hospitaland80,000nursingandresidentialcarefacilitiesintheU.S.attheendof2015.(2)

Over900millionpatientvisitsoccurannuallyinambulatorycareofficesthroughouttheU.S.,withalmosthalftoprimarycarephysicians(general,internalmedicineandpediatrics).(3)Forallcare—tospecialistsandprimarycareoffices—asignificantproportionofvisitsarefornewproblems(34.7%),chroniccareroutineproblems(30.1%),andchroniccareflare-ups(7.7%).(3)Theaveragetimethatdoctorsreportspendingonapatientencounteris22.6minutes,witharangeonthemeantimefrom16.6to33.0minutes,dependingonspecialty.(3)

Fromaneconomicperspective,theoutpatientsettingaccountsfor30.7%ofhealthcareexpendituresintheU.S,onlyslightlybelowtheinpatientlevelof33.8%.(4)TheOrganizationforEconomicDevelopment(OECD)reportedthatannualpercapitagrowthratesforhealthcarespendinginOECDcountriesincreasedmoreforoutpatientcarecomparedtoinpatientcare(i.e.,3.9%versus2.4%for2005to2009,and1.8%growthversus0.7%from2009to2013).(5)TheabsolutepercentageofspendingdedicatedtooutpatientcaretendstobelowerformostotherOECDcountriescomparedtotheU.S.(4)AMcKinseyGlobalInstitutemulti-countrycomparisonfoundthatintheU.S.,theproportionofestimatedexcessspendingforvalue,adjustingforwealth,concentratedintheoutpatientsetting.(6)In2006,theU.S.spentalmost$650billionmorethanexpectedforhealthcare,withtwo-thirdsoftheexcessattributedtooutpatientcare(e.g.,$436ofthe$850billioninU.S.ambulatoryspending).(6)Suchestimatesprovidedtheimpetusforhealthcarereformtargetedinpartoninnovationsinprimarycare,theambulatorysettingmoregenerally,andcoordinationofcareacrossallsettings.Inresponsetopolicy-makingandanaging,morechronicallyillpopulation,from2010to2015,theU.S.healthcaresectoradded1.0millionjobsintheambulatorysettingcomparedto0.4millioninothersettings.(7)Thedynamicsaroundambulatorycareorganizationsmakethemincreasinglyimportantineffortstoimprovecareandreduceunnecessarycosts.

Organization-levelresearchdirectedatambulatorycare,andinparticular,thequalityandsafetyofthecare,hasreceivedrelativelylessattentioncomparedtothatconductedinthemorecircumscribedandhomogeneoushospitalenvironment.(8,9)Someresearchconducted

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withinoracrosshospitalsettingsmaytranslatetotheoutpatientenvironment,buttherearekeydifferencesacrossthesetwomajorsettingsofcarethatcouldinfluencequalityandsafetyoutputs.Forexample,organizationalstructuresaredecidedlydifferentbetweenhospitalsandclinics,suchthathospitalshavequalitydepartments,whileclinicstypicallydonothavethisfunctioncentralizedorevenavailable.Intermsofpatientcare,logisticalcomplexityandinformationexchangeburdenforhighqualityoutpatientteamworkisgreatercomparedtohospitalcare,whilesupportsystemsforsuchchallengesarelesswelldeveloped.(9,10)Sincedecisionstoseekcareandthemanagementofcareextendbeyondanygivenencounterinadoctor’soffice,thepatientroleincareisalsomoresignificant,andcanhaveimportantconsequencesforqualityandsafety.(10,11)Whileasystematicreviewshowedthatpatientsafetyincidentsinprimarycarehavealowerchanceoflong-termharmcomparedtoeventsduringhospitalization,(12)Sarkarnotedthat“thesheervolumeofservicedeliverytranslatesintoasubstantialpublichealthburdenfrompatientsafetyincidentsinprimarycare.”(13)Safetyconcernsinthehospitalenvironmentcenteraroundpreventionoferrorsrelatedtotreatment,asopposedtodiagnosis.(8,12)

DiagnosticSafety

Accordingtoarecenttechnicalbrief,significantgapsexistinambulatorysafetyresearch,notablyalackofstudiesonpatientengagementandtimelyandaccuratediagnosis.(14)Thesetwoareasintertwine,asunderscoredbythepatient-centereddefinitionofdiagnosticerrorputforthinaNationalAcademyofMedicine(NAM,previouslycalledtheInstituteofMedicine)report,ImprovingDiagnosis,releasedin2015:

“Thefailureto:(a)establishanaccurateandtimelyexplanationofthepatient’shealthproblem(s),or(b)communicatethatexplanationtothepatient.”(15)

Thedefinitionincorporatesthenotionthatdiagnosisisbothaneventwherealabelisgiven,eveniftemporaryandbasedoninformationavailableatthetime,andalsoaprocessbywhichmembersofthehealthcaresystemworktodetermineandcommunicatewhathealthproblemscanbeexplained.ItdoesnotspeaktopreventabilityofanerrorbecausetheNAMCommitteeorientedthedefinitionandtheentirereporttoasystemsapproachtoimprovingdiagnosisforpatients.Thesystemsapproachfollowsonyearsofpatientsafetyresearchandpractice.

Whenpatientsseeadoctor,gotothehospital,stayinanursinghomeorotherwisehaveanexposuretothehealthcaresystem,theymayexperienceiatrogenicadverseeventsorotheruntowardeffects.Themereexposuretohealthcare,duringdiagnosisortreatment,carriesrisk.Startingabout25yearsago,someleadersofhealthcarecharacterizedtheseiatrogeniceventsasaproblem,ariskthatthesystemshouldreduce.Someoftheattentionarosefromanesthesiologistsinresponsetoincreasingcostsofmedicalmalpracticeinsurance.Inthelate1990’s,theInstituteforMedicine(nowcalledtheNationalAcademyofMedicine)developeditsfirstreportonpatientsafety,ToErrisHuman,thetitlereflectingthefutilityofpunishingindividualsinordertostoperrors,andsettinguptheneedforabroaderperspectivetotacklea

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systemsproblem.(16)Thereportreceivedsignificantmediaattentionwiththeimageoftheliveslostfromiatrogeniceventsbeingequivalenttoajumbojetfallingoutoftheskyeveryday.Sincethen,muchactivityhasoccurredtolabelmanytypesofpatientsafetyproblemsoriatrogenicadverseeffects,determineunderlyingcauses,andfindremediesincludingattemptstoinfusehealthcarewithacultureofother“highreliabilityorganizations”suchasnuclearpowerplantsoraircraftcarrieroperationswhereterriblerisksaretopofmindforthoserunningtheirsystems.Buttherisksassociatedwithdiagnosticfailuresareonlyrecentlygarneringactionbyhealthcareleadersandpolicymakers(e.g.,aCoalitiontoImproveDiagnosisformedin2015a).

Diagnosticerrorsarepervasive–aboutfivepercentofU.S.adultsseekingoutpatientcareinagivenyearexperienceadiagnosticerror.(17)Errorsindiagnosisarealsothemostcommontypeofpaidmedicalmalpracticeclaimandleadto40,000–80,000deathsperyear.(18)Dependinguponthedatasource,25%to59%ofmalpracticeclaimsareattributabletodiagnosticerrors.(18–21)Astudyofover90,000diagnosis-relatedmalpracticeclaimsfrom1986to2005estimatedpaymentssummingto$34.5billion(inflation-adjustedto2010U.S.dollars).(18)Amongalmost11,000malpracticeclaimsfromthe2005–2009NationalPractitionerDataBank,diagnosisrelatedproblemsaccountedfor45.9%ofpaidclaimsfromoutpatientsettingsand21.1%ofpaidclaimsfrominpatientsettings.(22)TheNAMImprovingDiagnosisCommitteestatedthat“mostpeoplewillexperienceatleastonediagnosticerrorintheirlifetime,sometimeswithdevastatingconsequences.”(15)Strategiestomitigatetheseerrorsarequitelimited,particularlyintheambulatorycaresetting.(14,23)

Widespreadresearchacrossspecialtiesdemonstratesthatinadequatemonitoringinhigh-riskoutpatientsleadstodelayeddiagnosis,onetypeofdiagnosticerror,responsibleforpreventableandsignificantpatientharm.(24–26)Forexample,patientswhohaveapositivefecalbloodtestbutnofollow-upcolonoscopywithinareasonabletimeperiodmayexperienceamissedopportunitytodetectandsuccessfullytreatcoloncancer.Moreresearchisneededtoguideorganizationalstrategiestodetectandrespondrobustlytosuchhigh-risksituationsinambulatorycare.

TogalvanizetheresearchcommunityandinresponsetotheNAMCommittee’srecommendationsforaddressingresearchgaps,theAgencyforHealthcareResearchandQuality(AHRQ)heldaresearchsummitinSeptember2016onimprovingdiagnosis.Thesessionsfocusedonmeasurement,organizationalfactors,andhealthinformationtechnology(HIT),aseachrelatestodiagnosticsafetyandquality.bThesethreeareassignalnationalresearchpriorities,basedonknowngapsintheevidencethatiffilled,wouldbeexpectedtocontributetoimprovementsindiagnosticperformance.(15)

aForcurrentdetails:http://www.improvediagnosis.org/?page=CIDbDetailsathttp://www.ahrq.gov/news/events/ahrq-research-summit-diagnostic-safety.html

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OrganizationalLens

Qualityhasbeenviewedhistoricallyasanorganizationalproblemfromtheperspectiveofevaluatingit,assuringit,andimprovingit.Safety,asapart,sisterordaughterofquality,dependinguponhowtheserelatedareasareconceptualized,isalsoanorganizationalproblem.KimberleyandMinviellearguethatconcernsaboutqualityinhealthcarehavemoved“fromthereflectionofprofessionalbureaucracytoavehicleforfundamentalchange”wherebydeliverysystemsundergoreorganizationtomanage,ratherthansimplyassurequality.(27)Patient-centerednessalsohasearlyrootswiththequalitymanagementperspective.

Theprominenceofqualityandsafety,particularlyfromthepatientandpayerperspectives,continuestoincreasewithmajorshiftsinpaymentpoliciesanddeliverysystemarrangementsintheU.S.andabroad.(7,28–31)However,thereareonlythebeginningsofattentiontotheroleofambulatorycareorganizations–specificallyprimarycareandspecialtycareclinics—inassuringqualityandsafety,especiallythatwhichrelatestothediagnosticaspectsofhealthcare.(14)

Thisstudyaimstotackleacornerofthatvoidbydevelopingthreeresearchpaperstiedtoorganizationaltheoryandlinkedtothefollowingthreedistinctambulatorycaresettings:1)fivedifferentspecialtyclinicsinSanFranciscoservingmostlypoorpeopleandothervulnerablepopulations;2)over900primaryandspecialtyclinicsacrosstheUnitedStatesthatparticipatedinasurveyonorganizationalculture,HITandofficeproblems;and3)16primarycareclinicsfromaccountablecareorganizationsinChicagoandLosAngeles,andtheirpatientswhohavediabetes,cardiovasculardisease,orboth.

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15. CommitteeonDiagnosticErrorinHealthCare,NationalAcademyofMedicine.ImprovingDiagnosisinHealthCare.BaloghEP,MillerBT,BallJR,editors.ImprovingDiagnosisinHealthCare.Washington,D.C.:NationalAcademiesPress;2015.

16. CommitteeonQualityofHealthCareinAmerica,InstituteofMedicine.ToErrIsHuman.KohnL,CorriganJM,DonaldsonMS,editors.ToErrisHuman:BuildingaSaferHealthSystem.Washington,D.C.:NationalAcademiesPress;2000.

17. SinghH,MeyerAND,ThomasEJ.Thefrequencyofdiagnosticerrorsinoutpatientcare:estimationsfromthreelargeobservationalstudiesinvolvingUSadultpopulations.BMJQualSaf.2015/01/16.2014;23(May):1–5.

18. SaberTehraniAS,LeeH,MathewsSC,ShoreA,MakaryMa,PronovostPJ,etal.25-YearsummaryofUSmalpracticeclaimsfordiagnosticerrors1986-2010:ananalysisfromtheNationalPractitionerDataBank.BMJQualSaf.2013/04/24.2013;22(8):672–80.

19. SelbstS,FriedmanM,SinghS.EpidemiologyandetiologyofmalpracticelawsuitsinvolvingchildreninUSemergencydepartmentsandurgentcarecenters.PediatrEmergCare.2005/03/04.2005;21(3):165–9.

20. SchiffGD,KimS,AbramsR,CosbyK,LambertB,ElsteinAS,etal.Diagnosingdiagnosiserrors:lessonsfromamulti-institutionalcollaborativeproject.In:HenriksenK,BattlesJB,MarksES,LewinDI,editors.Advances.Rockville(MD):AgencyforHealthcareResearchandQuality(US);2005.p.24.

21. GandhiTK,KachaliaA,ThomasEJ,PuopoloAL,YoonC,BrennanTA,etal.Missedanddelayeddiagnosesintheambulatorysetting:Astudyofclosedmalpracticeclaims.AnnInternMed.2006/10/04.2006;145(7):488–96.

22. BishopTF,RyanAM,CasalinoLP.Paidmalpracticeclaimsforadverseeventsininpatientandoutpatientsettings.Jama.2011;305(23):2427–31.

23. McDonaldKM,MatesicB,Contopoulos-IoannidisDG,LonhartJ,SchmidtE,PinedaN,etal.Patientsafetystrategiestargetedatdiagnosticerrors:Asystematicreview.Vol.158,AnnalsofInternalMedicine.2013.p.381–9.

24. SinghH,ThomasE,ManiS,SittigD,AroraH,EspadasD.TimelyFollow-UpofAbnormal

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DiagnosticImagingTestResultsinanOutpatientSetting:AreElectronicMedicalRecordsAchievingTheirPotential?ArchInternMed.2009;169(17):1578–86.

25. SinghH,GiardinaTD,MeyerAN,ForjuohSN,ReisMD,ThomasEJ.TypesandOriginsofDiagnosticErrorsinPrimaryCareSettings.JamaInternMed.2013Mar25;173(6):418–25.

26. GandhiTK,KachaliaA,ThomasEJ,PuopoloAL,YoonC.AnnalsofInternalMedicineArticleMissedandDelayedDiagnosesintheAmbulatorySetting :AnnInternMed.2006;145(7):488–96.

27. Kimberley,JR;MinvielleE.QualityasanOrganizationalProblem.In:Mick,StephenS;WyttenbachME,editor.AdvancesinOrganizationalTheory.First.SanFrancisco,CA:Jossey-Bass;2003.p.205–32.

28. TuT,MuhlesteinD,KocotSL,WhiteR.TheImpactofAccountableCareOriginsandFutureofAccountableCareOrganizations[Internet].2015[cited2017Apr18].p.11.Availablefrom:https://www.brookings.edu/wp-content/uploads/2016/06/Impact-of-Accountable-CareOrigins-052015.pdf

29. BerensonRA,UpadhyayDK,KayeDR.PlacingDiagnosisErrorsonthePolicyAgenda.2014;(April):19.

30. HerrelLA,AyanianJZ,HawkenSR,MillerDC.PrimarycarefocusandutilizationintheMedicaresharedsavingsprogramaccountablecareorganizations.BMCHealthServRes.2017;17(1):139.

31. MorrisseyS,BlumenthalD,OsbornR,CurfmanGD,MalinaD.InternationalHealthCareSystems.NEnglJMed.2015Jan1;372(1):75–6.

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CHAPTER2

OrganizationalTheoryandLinkstoThreePapers’ResearchQuestions

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OrganizationalTheories

Thisbackgroundleadstoacentralquestion:Whatextantorganizationaltheoriesarecriticaltounderstandingdiagnosticsafetyandqualityinthecontextofambulatorycare?Fourorganizationaltheoriesareparticularlypertinenttounderstandinghoworganizationsinfluencebetterorworsediagnosticperformance:1)humanfactors,2)highreliabilityorganizations,3)relationalcoordinationforinterdependentteamwork,and4)complexadaptivesystems.

HumanFactorsTheory:NAMConceptualFrameworkforImprovingDiagnosis

TheNAMImprovingDiagnosisFramework(Figure1)drawsheavilyfromhumanfactorsapproachesandtheoryinrelationshiptopatientsafetyandquality,andservesastheguidingconceptualmodelforthethreeresearchpapers.(1,2)Fromanorganizationaltheoryperspective,humanfactorstiestoorganizationaldesignandsystemsapproaches,basedontheearlycontingencytheorists’explicationofthecentralissueoffitbetweenenvironment,organizationalstructureandperformance.(3,4)TheNAMFrameworkhasthreemaincomponents–thediagnosticprocess,theworksystem,andoutcomes.Afeedbacksystemisproposedwherebyoutcomesprovideopportunitiesforlearningatthelevelofindividualpatientsastheymovethroughthediagnosticprocess,andattheleveloftheorganizationasitworkstoimprovecareforitspopulationofpatients.Thediagnosticprocessisconceptualizedasacollaborativeactivity,centeredonthepatientandinvolvingacyclicdecisionmakingprocessofinformationgatheringandclinicalreasoningtodetermineapatient’shealthproblem.Theprocesstranspiresovertime,withinthecontextofalargerworksystemthatinfluencesthediagnosticprocess.Theworksystemiscomposedofdiagnosticteammembers(patients,families,allhealthcareprofessionals),tasks(goal-orientedactions),technologyandtools(includingHIT),theorganizationalcharacteristics(includingculture,rules,procedures,leadership),thephysicalenvironment(suchaslayout,noiseandotherdistractions),andtheexternalenvironment(includingprevailinglegal,payment,reporting,andaccreditationcircumstances).(1)

Allcomponentsoftheworksysteminteract,andeachcomponentcanaffectthediagnosticprocess(e.g.,achangeinleadershipmayaffecttheassignmentoftasksandthetoolsavailable),andconsequentlytheoutcomesforthepatientandsystem.Theworksystemcancorrespondtospecificsettings(orcombinationsthereof)inwhichthediagnosticprocesscanoccur—forexample,primarycareclinics,specialtycareclinics,emergencydepartments,hospitalsandothersitesofcare(includingvirtual,non-traditionalandnewformsoforganizing,suchasaccountablecareorganizations).Eachsettingincludesthesixcomponentsofaworksystemwithnaturaldifferencesthatdependondecisionsandtheenvironmentapplicabletoagivensetting.

Theconceptualframeworkalignswellwithfindingsfromafocusgroupstudythatexploredphysicianperspectivesonimprovingthediagnosticprocessinambulatorycaresettings.(5)In

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11

Figure1.NAMImprovingDiagnosisFramework

Credit:ReprintedwithpermissionfromImprovingDiagnosisinHealthCare,2015bytheNationalAcademyofSciences,CourtesyoftheNationalAcademies

Press,Washington,D.C.

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thestudy,thediscussionswereanalyzedusingtheSystemsEngineeringInitiativeforPatientSafety(SEIPS)model,(2)afoundationfortheNAMImprovingDiagnosisframework.Barriersperceivedtotimelyandaccuratediagnosisincludedfactorsrelatedtoorganizationalculture,informationavailability,andcommunication.Althoughcognitivefactorshavereceivedmuchattentionintheresearchliteratureondiagnosticproblems,thisambulatorycarestudyfoundgreaterconcernabouthealthsystemstructureandinteractionsamonghealthcareprofessionalsandwithpatientsaffectingthediagnosticprocess.(5)

TheNAMreportandothershavehighlightedteamworkamonghealthcareprofessionals,co-productionwiththepatient,andHITashighlyrelevanttotheoftencomplexandtime-sensitivecognitiveworkrelatedtodiagnosis.(1,5–13)Fromthisvantage,twoworkconditionsareparticularlyapplicabletodiagnosticteamworkintheambulatorysettingandinpatienttransitionsacrosssettings–1)leveloftimepressureexperiencedbythehealthcareteamand2)capabilities(andlimits)ofHIT.Furtherstudyofthesefactors(partofthethreepapers)isimportanttounderstandingsomemechanismsbywhichmodernhealthcareorganizationsimpactthegenesisandtrajectoryofeachpatient’sjourneyintheterritorysurroundinganewillnesslabel.

HighReliabilityOrganizationsTheory

Extensivefieldworkonindustriesfacinghazardousconditions(e.g.,nuclearpower)resultedinatheoryofHighReliabilityOrganizations(HROs).(14,15)Theseorganizationsarecharacterizedashavingnearlyerror-freeoperationsincontextsthatareextremelycomplex,dynamic,interdependentandtime-pressured,oftenfeaturesfoundinhealthcarework.WeickandSutcliffeidentifiedfiveprinciplesthatundergirdthewaysHROsorganizemindfullytoanticipate,respondandcontainunexpectedevents:preoccupationwithfailure,reluctancetosimplifyinterpretations,sensitivitytooperations,commitmenttoresilience,anddeferencetoexpertise.(16)CurrentorganizationalmanifestationsoftheseorganizationalapproachesincludeLeanSixSigma,RobustPerformanceImprovement(arecentJointCommissioninitiative)andothervariantstoeliminatewasteandreachzerodefects.

Acrosstheseorganizations,safetycultureisprominent,andthoughttoproducehighreliability.(17)Asafetycultureistheproductofthesharedvalues,attitudes,andpatternsofbehaviorthatdeterminetheobservabledegreeofeffortwithwhichallorganizationalmembersdirecttheirattentionandactionstowardsminimizingpatientharmthatmayresultfromtheprocessofcaredelivery.BuildingfromearliermeasurementresearchoutsidehealthcarebyRobertsetal(18)andwithinhospitalunitsbyShortelletal,(19)Singerandcolleaguesdevelopedthefirsthospital-widemeasureofsafetyculture.(20)Theydemonstratedsafetyculturevariationacrosshospitalsandbytypeofpersonnel(e.g.leadersseemtohaverosecoloredglassescomparedtofrontlineworkers).(20)TheAgencyforHealthcareResearchandQuality(AHRQ)hasdevelopedandfieldedanoffice-basedsafetyculturesurvey.Vogusandcolleagueshavedevelopedasafetycultureframeworkofenabling,enactingandelaboratinginasystemoffeedbackaboutsafetyoutcomes.(21)Forpatientsafety,WalsheandShortellhighlight

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challengeswithlearningresultingfromthe“cultureofsecrecyandprotectionism”inhealthcaresettings,whichtheyreferredtoas“endemic”.(22)Thebarrierstodisclosure,andsubsequentlylearning,maybestrongerfordiagnosticerrors,thougheffortstointroduceapologyanddisclosureinterventions,mostlyinthehospitalsetting,mayhelp.Asystematicreviewoftheliteratureoninterventionstoimprovepatientsafetycultureinprimarycareidentifiedonlytwostudies(electronicmedicalrecordimplementation,physicianworkshopsonriskmanagementandeventaudits)withlowevidenceofeffects.(23)Vogusandcolleaguespointtotheinteractionsbetweenelementsoftheirframeworksuggestingtheneedforanemergentapproach,whichbringsustothenextapplicablesourceofpertinentorganizationaltheory,complexadaptivesystems.Theyalsonotetherelevanceofrelationalcoordination(morebelow)asamechanismtobalanceefficiencyandsafetyconcernsinthehealthcaredomain.(21)

RelationalCoordinationforInterdependentTeamworkTheory

Relationalcoordinationisamutuallyreinforcingprocessofcommunicatingandrelatingforthepurposeoftaskintegration,forexample,taskrelatedtomakingadiagnosisbyallmembersoftheteam,includingthepatient(andfamily).(24)Morespecifically,relationalcoordinationisthecoordinationofworkacrossorganizationalboundariesthroughrelationshipsofsharedgoals,sharedknowledgeandmutualrespect,supportedbyfrequent,timely,accurate,problem-solvingcommunication.(25)Betterrelationalcoordinationistheorizedtoimproveperformanceofaworkprocess,suchasthediagnosticprocess,byimprovingtheworkrelationshipsbetweenpeople(sharedgoals,sharedknowledge,mutualrespect)whoperformdifferentfunctionsinthatworkprocess,leadingtohigherqualitycommunication.Thisenablestaskinterdependenciestobemanagedmoredirectly,inamoreseamlessway,withfewerredundancies,lapses,errorsanddelays.Accordingtorelationalcoordinationtheory,organizationalstructuresservetostrengthenorweakenrelationalcoordinationdependingontheirdesign.(26,27)Relationalcoordinationinturnistheorizedtodriveperformanceoutcomesincludingqualityandsafety,particularlywhenworkishighlyinterdependent,uncertainandtimeconstrained,whichcanbethecasefordiagnosticwork.(24)

Thissimplestructure,processandoutcomesmodelishighlylinearandassuchmaynotcaptureprocessesofchange(e.g.,interventions,plannedoremergent)andtheirimplicationsforoutcomes(e.g.,quality,safety).Gittell,EdmonsonandScheinhaveproposedarelationalmodeloforganizationalchange,arguingthatneworganizationalstructuresarenotsufficientforcreatingnewlevelsofrelationalcoordinationandnewlevelsofperformance.(24,28)Instead,theyhypothesizethatchangeagentsmayneedtobeginwithrelationalinterventionstofosternewworkingrelationshipscharacterizedbysharedgoals,sharedknowledgeandmutualrespect,andworkprocessinterventionsthatcreatenewwaysofworkingtogether.Structuralinterventionsthenemergefromparticipantsthemselves,informedbytheirnewworkingrelationshipsandnewwaysofdoingthework.

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ComplexAdaptiveSystemsTheory

Begun,ZimmermanandDooleyassertthat“improvementofhealthcareorganizationsindividuallyandcollectively,andresearchonthoseorganizations,willbestbefacilitatedbycomprehensiveapplicationofthemetaphorofthesystemasalivingorganism,ratherthanthatofthesystemasamachine.”(29)Othershaveechoedthisview,andincreasinglyplacehealthcareorganizationalresearchwithinacomplexadaptivesystemsperspective,whereemergentproperties,variations,interactions,networks,robustresponsiveness,andrelationshipstakeprecedenceoverpastconstructsfromearlierorganizationaltheory(e.g.standardization,verticalintegration,resourcedependence,etc.).Begunandcolleaguesgeneratedausefullistofimplicationsfororganizationalresearchmethodsinlightofacomplexityperspectivethatincludes:studyemergence,patternsofinteractionsamongagents,coevolutionoftheorganizationandenvironment,qualityofrelationships,andconditionsthatfacilitatechange.(29)

AnewmodeldevelopedbySittigandSinghforstudyingHITincomplexadaptivesystemsisparticularlyrelevanttohealthcarequalityandsafety.InaimingtodevelopacomprehensivemodelintegratingtechnologicalandmeasurementdimensionsofHITwithsocio-technicaldimensions,theycombinedandextendedfourmodels(includingCarayon’sSystemsEngineeringInitiativeforPatientSafety(SEIPS)model(2)thatservedasafoundationfortheNAMconceptualframework).Themodelfeatureseightinterdependentandinter-relateddimensionsreflectingthecompositioncomplexadaptivesystems:hardware/software,clinicalcontent,humancomputerinterface,people,workflowandcommunication,internalorganizationalfeatures(e.g.,procedures,culture),externalrulesandregulations,thatfacilitateorconstraintheprecedingdimensions,andsystemsmeasurementandmonitoringofbothintendedandunintendedconsequencesofHITimplementationanduse.Theyprovideanexampleofapplyingthemodeltothecomplexadaptivesystemsurroundingfollow-upsofalertsrelatedtoabnormaldiagnosticimagingresultsduringvariousstagesofdevelopmentandimplementationofHIT.(30)

ResearchQuestionsandLinkstoKeyFrameworks

Theresearchproceedswiththreepapersdirectedattheproblemofqualityandsafetygapsrelatedtothediagnosticphaseofcareemanatingfromtheambulatorysetting.Subsequentsectionsarededicatedtothespecificdetailsforeachpaper.Atamacrolevel,theresearchquestionsforthethreepapersarerelatedtotheconceptualframeworkfromtheNationalAcademyofMedicine(Figure1)asfollows,withelementsoftheframeworkshowninitalics.

Paper#1“Implementationscienceforambulatorycaresafety:Anovelmethodtodevelopcontext-sensitiveinterventionstoreducequalitygapsinmonitoringhigh-riskpatients”

• WhatWorkSystemfactorsproducerobustmonitoring(SystemsOutcomes)andfewerdiagnosticerrors(PatientOutcomes)?

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Paper#2“Healthinformationtechnologies,patientsafetycultureandmedicalofficeproblemsthatcouldleadtodiagnosticerrors”

• WhataretheassociationsbetweenTools(healthinformationtechnology[HIT]),Organization(patientsafetyculture),andDiagnosticProcess(medicalofficeproblemsthatcouldleadtodiagnosticerrors)?

Paper#3“Organizationalinfluencesontimepressurestressorsandpotentialpatientconsequencesinprimarycare”

• DoDiagnosticTeamMembersperceiveadverseeffectsfromtimepressureontheDiagnosticProcess?WhatWorkSystemandDiagnosticTeamMemberfactorsareassociatedwiththeseeffects?

TheNAMframeworkalsoincludesthecriticalroleoftimeforachievingdiagnosticqualityandsafety(Figure1,Timearrowatthebottomofthediagram).Thethreepapersalsoexploretimeasaworkconditionthatisparticularlysalientinthecurrentambulatorycareenvironment.Studyingtimefromanorganizationalperspectiveistricky,withcontributingliteraturesfromnumerousvantagepointsspanningthephilosophyoftimetothesocialpsychologyoftimetotheexperienceoftimeinorganizations.Anconaandcolleaguesreviewedthisdiverseliteraturefromamanagerialsciencesperspective,andproposedthreecategoriesofinterconnectedvariables—conceptionsoftime,mappingactivitiestotime,andactorsrelatingtotime.(31)AccordingtoAnconaetal,“the(three-category)frameworkpresentedismeanttoprovideastartingpointtobeginadialoguethatspanstheexistingworkandsetsanewresearchagendainthefieldoftimeandorganizations.”(31)

Thisstudy’stime-relatedvariablesaredescribedlater,butinbrief:

• Paper#1:exploringtheimpactofnewworkdesignsontimespentcorrespondstoAncona’sactivitiescategory;

• Paper#2:analyzingworkpace(asasub-dimensionofculture)relatestoallthreeofAncona’scategories;and

• Paper#3:definingchaoticversuscalmworkconditionsasapractice-leveltimepressurelinkstohowactors(practiceteammembers)relatetotime;andassessingperceivedeffectsofencounter-leveltimepressureonpatientsafetycorrespondstoactivitymapping,specificallyhowactivitiesperformed(ormissed)maybesubjecttotimepressureeffects(overlookingachancetodiagnose).

Situatingthisstudy’stime-relatedvariableswithinAncona’stemporalframeworkcouldenablefuturecontributionstoorganizationaltheoryabouttime.Forthediagnosticimprovementfield,suchlinkagescouldenrichcharacterizationsoftheNAMframework’stimedimension.

16

CriticalLiteratureGaps

Whilerelativelystrongfoundationsexistforthesetofresearchpapersfromatheoreticalperspective,theliteraturebaseisextremelylimitedforresearchrelatedtotwokeyelementsofthisstudy:timepressureeffectsanddiagnosticperformanceinambulatorycaresettings.Thelimitedworkissummarizedasbackgroundabouttheneedforresearch,aswellastopositionthisstudy’scontributionstotheseareaswithinarealisticrangeofpossibility.

TimePressureResearchBase

Experimentalstudiesontimepressureeffectsonjudgmentbetweenchoices(sayamongpotentialdiagnosessuspected)pointtodifferentpossibleinformationprocessingadaptationsandresponsestoexperiencingafasterpaceorjustfeelingrushed,especiallyoutsideoflaboratorysettings.(32)Cognitiveprocessingbyexpertsmakingdecisionsunderuncertaintyorambiguity(asisthecasefordiagnosis)seemtouseintuitiveprocessingmoreprominentlythananalyticthinkingwithincreasedtimepressure.(33)Underthesecircumstances,expertiseisanimportantvariable,likelymoderatingthedecrementsinperformancewithincreasingexpertise.However,theevidenceabouttimepressureeffectsinlightoflevelofexpertiseandcomplexityofthetaskismixedforphysiciandecision-making.(34–37)

Therangeofcognitivecontributionstodiagnosticerrorsuggestsaneedforresearchontimepressureeffectsinactualpractice,andinrelationshiptopotentialfailuremodespresentinactualcases–faultyknowledge,faultydatagathering(e.g.ineffectiveorincompleteworkup),faultyinformationprocessing(e.g.,detectionorperceptionofasymptomthatwasnoticeablebeingmissed),andfaultyverification(e.g.,prematureclosureonaninitialdiagnosis,notfollowinguptogathernewdataaboutwhetherthesituationhaschanged).(8,38)Pickingupimportantcontextualcuesrelatedtodiagnosismayalsobeharderwithtimepressure,andsecretpatientsofferamethodforstudyingsuchpotentialeffects.(39)Inaddition,theNAMCommitteeonImprovingDiagnosisrecommendedattentiontodiagnosticteamwork,(1)anareawhereresearchontimepressureeffectsisalsolacking(thoughsomesimulationstudiesincludeteamworkintime-sensitiveclinicalsituations,suchasobstetricemergencieswhichrequiresomediagnosticdecision-making).(40)

Tsigaetalconductedanexperimentalstudyontimepressureeffectsongeneralpractitioners’adherencetoguidelinesfordiagnosticallyrelevantaspectsofcare(e.g.,historytaking,clinicalexamination,labtestingreferrals,likelihoodandcertaintyofthefinaldiagnosis)aswellastreatmentrecommendationsforviralrespiratorytractinfections.(41)Theyfoundathreattopatientsafetyunderthetimepressurecondition:physicianswerelesslikelytoaskquestionsandorexaminethenervoussystemtoconsideradifferentialdiagnosisofmeningitis.Accuracyofthisfairlyroutinediagnosiswasnotdifferentbetweenthetwoconditions,butphysicianswerelessconfidentintheirdiagnosisundertimepressure.Participantsreceivedallofthescenariosandtimeconditions,withacounterbalancingtechniquefororderofpresentation.(41)

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Researchontimepressurewithinambulatorycareislimited,butsomestudieshaveexploredwhethertimespentwithpatientshasapositiveeffectonpatientcare.AlargestudyintheNetherlandsof239generalpracticesshowedstrongpositiveassociationbetweentheamountoftimespentwithpatient’sface-to-face,aswellastimespentinthepracticeoutsideofdirectcare,andpatient’sevaluationsofthephysicianperformance.(42)AnotherstudybyChenetalintheUnitedStatesfoundsomeevidencethatincreasingdurationofprimarycarevisitsconfersamodestassociationwithqualityofcare.(43)Butneitherofthesestudiesassesstimepressureperse.

Linzerandcolleagueshaveconductedseveralstudiesontheeffectsoftimepressure,aswellasarelatedworkcondition—chaoticpracticeenvironment,onphysicianandpatientwellbeing.(44–46)InthePhysicianWorklifeStudy,Linzeretalsurveyedover5,000primaryandspecialtycarephysiciansfrom1996-98,andfoundthattimepressurediminishedjobsatisfaction.(44)Timepressurewasassessedbasedonaratioofreportedtimeneededtoprovidequalitycarecomparedtotimeallotted.Timepressureratiosweresimilaracrossspecialties,withdoctorsreportingneedingonetosixextraminutesperpatienttoprovidequalitycare.(44)Aprimarycarestudy(MEMO-MinimizingError,MaximizingOutcomes)from2001-2005ofover100ambulatoryclinicsintheU.S.assessedphysiciansandtheirpatientswithchronicconditions(diabetes,hypertension,orheartfailure)todetermineassociationsbetweenworkconditions,physicianreactionsandqualityofpatientcare.(45)Roughlyhalfofthephysicians(53%)reportedtimepressureduringofficevisitsandachaoticworkpace(48%).Adverseworkflow(timepressureandchaoticenvironments),aswellaslowworkcontrolandunfavorableorganizationalculturewerestronglyassociatedwithpoorphysicianreactions(e.g.,highstress,burnout).Timepressureratioswereassessedfortwodifferentappointmenttypes.Timepressureforphysicalexaminationappointmentswasmodestlyassociatedwithlowerquality(basedonmedicalrecordreview),buttherewasnoassociationbetweentimepressureforfollow-upvisitsandquality.(45)

MeasurementofDiagnosticSafetyandQuality

Diagnosticerrorsoftengounrecognized,andeventhemostsophisticatedhealthsystemslackmeasurementcapabilitiesmuchlessthefeedbackmechanismsnecessaryforimprovingdiagnosis.(47)Thescienceofqualityandsafetymeasurement,itselfinitsinfancy,mustbedeepened.(48)Asystemfortheassessmentofthevalidityandreliabilityofdiagnosticperformancemeasuresneedstobeestablishedandmadetransparent.(47)Therearemanychallengesthatmustbeovercomeinordertoestablishareliableandsustainablemeasurementinfrastructureforimprovingdiagnosis,orresearchingitheadon.However,someeffortsareunderwayonmeasureconceptsfordiagnosticqualitydrawingfromDonabedian’sframeworkofidentifyingstructuresandprocessesrelatedtooutcomesofdiagnosticsafety.(49–51)Targetedcondition-specificmeasureshavealsobeenusedininterventionalstudiesaimedatmitigatingdiagnosticerror.(52)Studyingdiagnosticsafetyandqualitywillremainachallenge

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withoutwell-validatedmeasures,buttheNationalQualityForumhasworkunderwaytoestablishaframeworkformeasuresinthisarea.c

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CHAPTER3

Paper1—Implementationscienceforambulatorycaresafety:Anovelmethodtodevelopcontext-sensitiveinterventionstoreducequalitygapsinmonitoringhigh-riskpatients

Co-Authors:GeorgeSu,SarahLisker,EmilyPatterson,UrmimalaSarkar

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IntroductionAseminalNationalAcademyofMedicine(NAM)reportassertsthatmostpeoplewillexperienceatleastonediagnosticerror–adelayedorinaccuratediagnosis—inalifetime,“sometimeswithdevastatingconsequences.”(1)Inambulatorycare,oneof20patientsintheUnitedStatesexperiencepotentiallypreventablediagnosticerrorsannually.(2,3)Missedcancerdiagnosesaretheleadingreasonforpaidmedicalmalpracticeclaimsintheambulatorysetting.(4,5)

Widespreadresearchacrossspecialtiesdemonstratesthatinadequatemonitoringinhigh-riskoutpatientsleadstopreventablehigh-riskeventsandsignificantpatientharm.(5,6)Forexample,patientswhohaveapositivefecalbloodtestbutnofollowupcolonoscopywithinareasonabletimeperiodmayexperienceamissedopportunitytodetectandsuccessfullytreatcoloncancer.(7,8)TheNationalComprehensiveCancerNetworkhasmonitoringguidelinesforscreening(activeandinitial)aswellaspost-treatmentcancerrecurrencesurveillance.(7,9–17)Proactiveandefficientstrategiestorespondtohigh-risksituations—suchasoverdueimagingorbloodtests—areurgentlyneededtoreducethesafetygapinevidence-basedmonitoringforcancer.(18–23)Safety-netpopulationsareparticularlypronetofailuresinpatientmonitoring,givenhighprevalenceoflimitedhealthliteracyandlowerEnglishproficiency,aswellasbarrierslikelackoftransportation,inabilitytoleaveworkformedicalappointments,andamyriadofotherobstaclestoengagingwiththehealthcaresystem.(24–27)Atthesametimesafety-nethealthsystemsoftenlackcriticalHITinfrastructureandresources(e.g.,personneltime)todevotetomonitoringthesevulnerablepopulations.(28)Commonsoftwaredevelopmentpracticesfavormassproductionandrapidadoptionoveruser-specifiedcustomizationnecessaryforlong-termsustainabilityinasafety-netsetting.(29,30)Toaccomplishrobustpatientmonitoringandpreventadverseevents,itiscriticaltoidentifysetting-andpopulation-specificvulnerabilitiesandneededattributesofeffectiveinterventions,whethertechnical,social,organizationaloracombination.Theoriesforcomplexdeliverysysteminterventionsstresstheimportanceofstudyinghumanandcontextualaspectsofchange.(31,32)TheNAMImprovingDiagnosisconceptualframeworkincludesthesefactors,amongotherssuchasclinicalreasoningandteamworkthatcontributetodiagnosticsafetyandimprovement.(1)Theframeworkexplicatesthatpatientandsystemsoutcomesareproducedbythediagnosticprocesswhichevolvesovertime,withinthecontextofalargerworksystemcomposedofdiagnosticteammembers,tasks,technologiesandtools,organizationalelements,andthephysicalenvironment.(33–35)Toreducethechanceofmissingacancerdiagnosis,vulnerabilitiesneedtobeaddressedwithinboththeambulatorycare’sdiagnosticprocessandworksystem.Inotherwords,whatworksystemfactorsproducerobustmonitoring(systemsoutcomes)andfewerdiagnosticerrors(patientoutcomes)?Researchinthisareaisnascent,withmanyunknownsaboutspecificvulnerabilities,patient

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safetyinterventionopportunities,andsubsequentimplementations.(1,36)Tayloretalidentifiedfourtheoreticaldomainsofcontextualfeaturesdeterminedbyexpertconsensusasimportantforpatientsafetyinterventionimplementations:safetyculture,teamworkandleadershipinvolvement;structuralorganizationalcharacteristics;externalfactors;andavailabilityofimplementationandmanagementtools.(37)Todeveloptheory-based,context-informedorganizationalinterventionsforclosingthesafetygap,ourstudyintroducesauniqueintegrationofuserexperienceandhumanfactorsmethodologies:journeymappinganddesignseeds.Weapplyjourneymappingtoclinician-centeredworkflowfocusedonpatientsathighriskforamissedmonitoringopportunitytodiagnosecancer.(38)Previousapplicationshavetakentheperspectiveofanindividualpatient’sjourneywithinahealthcaresetting.(39–41)Designseedsaresolutionattributesthatseparatethegoalofamodularintervention(e.g.,alertingpatientsthattheyneedtoreturntotheclinic)fromthemeansforachievingit(e.g.,useofawebportalmessagingsystem).(42)Theyhavetheadvantageofgeneratingmultiplesolutionstothesameproblemsounknownvulnerabilitiesandpreferencescanbeuncovered,interventionscanbetailoredtodifferentcontexts,andmoresolutionvariationscanbeconsideredtoevaluatecorrectfit.(43)Toapplydesignseedstopatientmonitoringd,wedrawfromasomewhatanalogoussituationstudiedoutsideofhealthcare:intelligenceanalystswhoexperiencetimepressureanddataoverloadastheycullthroughnumerousdocumentstoidentifynationalsecuritythreats.(44)Ourapproachwillinformprototyping,pilotingandfull-scaletestingoftechnicalandorganizationalinterventions,withtheaimofproducingrobustpopulation-levelmonitoringsolutionsforwidespreadimplementation.

MethodsDesignWeconductedformativeresearch,followinga6-stageco-developmentprocessbetweentheresearchteamandfrontlineclinicians(attendingdoctors,residents,nursepractitioners,registerednurses)toidentifysolutionattributesofacomprehensiveinterventionformorerobustmonitoringofhigh-riskcancerconditionsovertime(Figure2).Theresearchteamappliedhumanfactorsstrategiesandorganizationaltheoryaboutcomplexadaptivesystemswithinfivespecialtyclinicstoidentifyvulnerabilitiesandgeneratedesirablesolutionattributesforinterventions.(1,37,45,46)

dPatientmonitoringforcancer,inthispaper,isbroadlyconstruedtoincludeanexpansivesetofdiagnosticopportunities,notjustonedefinitiveandstagedcancerdiagnosis.Ambulatorysafetyriskinthiscontextincludesidentificationofhigh-riskpatients,pre-diagnosistesting,definitivediagnosticprocedures(e.g.,biopsies),andevenlongitudinalpost-diagnosisfollowup(e.g.,keepingtrackofpatientsforwhomtreatmentisdelayedonpurpose,orfollowingpatientsaftertreatmentforcancerrecurrence).

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Ethicalapprovalforsemi-structuredinterviewsandfeedbacksessionswithclinicpersonnelforqualityimprovementpurposeswasreviewedandwaivedbytheinstitutionalreviewboardoftheUniversityofCalifornia,SanFrancisco.Figure2.Co-DevelopmentResearchProcess

KeyQuestionsBasedonNAMImprovingDiagnosisFrameworkPROBLEM:Whatvulnerabilitiesexistinmonitoringoutpatientsforhighriskconditions(e.g.,cancer)?SOLUTION:Whatelementsofworksystemsandthediagnosticprocessareimportanttoproducerobustmonitoring&therebyreducediagnosticerrors?Stage1:Identify5High-riskPopulations

• Reviewliterature• Corroboratewithlocalclinicianstakingcareofthesepatients

Stage2:DevelopJourneyMaps• Identifykeyparticipantstolearnaboutworkflowsforeachhigh-riskpopulation• Elicitwithsemi-structuredinterviewadescriptionofthepatientanddataflowfromworker’s

vantage• Visualizethisinformationintoswimlanesor“clusters”ofactivities• Showswimlanestoparticipantsandrevise(asneeded)• Visitclinicsitestoobservecriticalpartsofprocess(asneeded)

Stage3:GenerateVulnerabilityList• Abstractvulnerabilitiesfrominterviewnotesandjourneymaps• Returntoclinicparticipantstovalidatethelist(oneormoreclinichasindeedexperienced

vulnerability)• Mapvalidatedlistofitemstotheorydomainsfromapplicablepatientsafetyframeworks[1,56]

Stage4:AnalyzeJourneyMapsforCommonalities• Categorizetypesofactivitiesinthejourneyusinghumanfactorsmethodofprocesstracing

(novelextensiontoderivetracingsfromjourneymaps)• Generateprocesstracesequencesforeachclinic’sworkflow[57]• Lookforpatternsofworkflowthataresimilarandvariableacrossthe5populations

Stage5:DevelopDesignSeedsforInterventionsandLinktoImplementationTheory• Statewhatasolutionwouldneedtodotoaddressvulnerabilitiesidentifiedfrompreviousstage• Reducethelisttosolutionattributes(designseeds)thataddresscommonproblemsandneeds

acrossclinics• Aimfordesignseedsthatmeetthegenericneedsofrobustmonitoringandthatenable

evaluation• Hypothesizewhichcontextsarelikelytoaffecttheeffectivenessoftheimplementationofthe

interventionsemanatingfromthedesignseedsusingTayloretal’scontextualdomainsandfeatures[37]

Stage6:SeekReactionsfromClinicsonDesignSeeds• Assessanticipatedimpact(improvedmonitoringofpatients,reducedtimespentbyclinicteam)

andrelativepriorityofeachdesignseed(seeAppendix1and2forscriptanddatacollectionusedineachclinic)

SettingTheSanFranciscoHealthNetworkisapubliclyfunded,integratedhealthnetworkoperatingundertheauspicesofSanFrancisco’sDepartmentofPublicHealthandincludes14primarycareclinics,urgentcare,andspecialtycareatZuckerbergSanFranciscoGeneralHospital.

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Patientsseenwithinthenetworkarediverse:ofthoseseenatthenetwork’smainclinicandhospital,18%areAfricanAmerican,31%areLatino,22%areWhite,and21%areAsian.Servicesareprovidedinover20languages.Basedonoutpatientdays,only1%ofthepopulationhascommercialinsurance,14%uninsured,16%HealthySanFrancisco(acitywideslidingscalehealthaccessprogram),42%Medi-Cal,17%Medicare,andtheremaining10%coveredbyothermostlypublicsources.(47)Othershavecategorizedhospitalsaccordingtosafety-netburden,withhigh-burdenrangingfrom33or36%to100%ofpatientsasthosewithMedicaidornocoverage.(48,49)Likemanysafety-netsystemsandambulatorypracticesnationwide,thehealthsystemdoesnothaveacomprehensiveelectronichealthrecordsystemandstruggleswithinformationtransferaswellasfragmentationofhealthinformationacrossover50electronicplatforms.DespitesomeoftheHITchallengesandknownworkaroundstypicalofthesesafety-netsettings,theorganizationhasalongstandingcommitmenttobothhuman-centeredstrategies(patient-centeredmedicalhome,plan-do-study-actcycles)andLeanmanagementmethods.(50)Evidence-basedSafetyGapsTargeted(Stage1)Basedonliteratureaboutmissedanddelayeddiagnoses,includingreportsfrommedicalmalpractice,weselectedfivehigh-riskcancersituations—incidentally-discoveredpulmonarynodules,andmonitoringforbreast,colorectal,prostate,andear,nose,andthroat(ENT)cancers—forwhichcoordinationandtimelyuseofdataareimportantforpatientsafetysurveillancebutchallengingtoimplement,particularlyinsafety-netsettings.(4,5,51)Thesechallenginghigh-risksituationsrequirerecurringandtimelyfollow-upcaretopreventharm.(7,9–17,52)Ourteam(GS,SL,KM)conductedaseriesoftheoreticallyinformedsemi-structuredinterviewswithparticipantsfromeachoffivespecialtyclinicsresponsibleforthesehigh-riskpatients:pulmonarymedicine,breastcancer,gastroenterology,urologyandotolaryngology.Aspartoftheseinterviews,wecorroboratedthespecificsafetytargetsbyaskingfrontlineclinicians:“Whatkeepsyouupatnight?”and“Whatareyourclinicalhunchesaboutwhomightfallthroughthecracks?”Althoughproviderstalkedaboutthetypesofpatientslosttofollow-up,noneoftheclinicswereenabledwithastandardizedandefficientmethodforquantifyinghowmanypatientswerelosttofollow-up,whypatientswerelosttofollow-up,orevenwhichpatientswerelosttofollow-up.Manyotherhealthnetworkssharesimilarstruggleswithincompletedocumentationandmeasuringthereal-timescopeofpatientsafetyproblems.(53)MappingandAnalyzingClinicalWorkflows(Stage2through4)Theinterviewsineachofthefivecancerclinicalsettingsfollowedauser-centereddesignapproachcalledjourneymapping,atoolwidelyusedacrossmultipleindustries.(38,54,55)Journeymappingderivesfromuserexperienceinitiativesinindustrythatinformedthe

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improvingdiagnosisframeworkproposedintherecentNAMImprovingDiagnosisreport.(1,34,56)Themethodarticulatesanddocumentsaprocessthroughaspecificpointofview(typically,acustomer).Inthehealthcarefield,ithasbeenappliedtoelicitindividualpatientjourneysthroughtheclinicalworkflow.(40)Ourteam-basedvariationofjourneymappinghasapatientpopulationmanagementview.Weelicitspecialtycaremanagementthroughtheexperiencesoftheclinicalteamastheytrytotrackthehostofpatientdatarequiredtomonitortheirhigh-riskpopulation.Toourknowledge,thistechniquehasseldombeenappliedtotheambulatorysetting,andhasnotbeentargetedtoclinicworkflowefficiencyorpatientsafetyinterventiondevelopment.Wedirectedthesejourneymappingsessionsto:(1)isolatethestepsinthepatientmonitoringjourneythatarethemostcritical,time-intensive,andriskyrelativetothesafetygap,(2)identifycriticaldataelementsneededtoeffectivelyandsafelymonitorpatients,and(3)gatherpotentialattributesoforganizationalandtechnicalinterventionstoameliorateworkflowproblems.Toconstructthejourneymaps,investigatorsprobedclinicalparticipantswithquestionssuchas:“Whatareyouworkingon?”toelicitactionstaken;“Whoisresponsibleforwhichtask?”tolearnaboutmonitoring-relatedactivities;“Arethereexternalstakeholders?”and“Howimportantarethey?”tosurfacecoordinationchallengesoutsideoftheclinic.Basedonwhatparticipantsarticulated,weconstructedajourneymapforeachclinicalpathwaywiththeirreviewandendorsement.Themapsfocusonthetransferofpatientdatathroughoutthepatient’smonitoringexperience,startingwiththeinitialdiagnosticassessmentandendingwiththeongoingfollow-up.Wheneverparticipantsverbalizedelementsofthepathwaythatwereparticularlyvulnerabletoerrororpoormonitoring,wemarkedtheactivitywithabull’seyetarget,alsoreferredtobycliniciansasa‘painpoint’.Fromthejourneymappingsessions,wegeneratedacomprehensivelistofvulnerabilitiesexperiencedbyatleastoneclinic.Toverifythelistandgaugehowmanyoftheclinicsexperiencedeachofthevulnerabilities,wereturnedtotheclinicwithadatacollectioninstrument(Appendix1).Wealsomappedthevulnerabilitiescorroboratedbyatleastoneclinictodomainsfrompatientsafetytheoreticalframeworks.(1,56)Usingstandardprocesstracingtechniquesfromhumanfactors,wecategorizedandsummarizedthesequenceofactivitiesdescribedinjourneymaps.(57)Thetracesequencesareusedtodeterminethesimilarityofactivityflowamongclinicsthatmonitorhigh-riskpopulationsaswellasanydifferencesbetweenclinicstoinformwell-designedinterventions.DevelopingDesignSeedsandLinkingtoImplementationTheory(Stages5)Designseedsandthehumanfactorsapproachesfromwhichtheystemhavebeenusedoutsideofhealthcarefordevelopmentofcomplexsocio-technicalinterventions.(44,58)Theyserveasbridgestotechnicalandorganizationalsolutionoptionsthatcanbedesigneddifferentlydependinguponcontext,butthatusecommonattributes.Assuch,theyofferanappealingadditiontotheimplementationsciencetoolkit.Insimpletermsthisapproachreplacesthe

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typicaltechnicalapproach(Figure3)withatheoreticallybasedsocio-technicalsystemunderstanding(Figure4).AsshowninFigure4,designseedslinkthevulnerabilitiesexperiencedtopotentialsolutionsinaspecificandevaluableway.Thispromotestheevaluationofa“seed”toasolution,ratherthanafull-fledgedsolutionitselfasispracticedinsoftwaredevelopmentcyclesoftenusedinHIT.(59)Byjumpingdirectlyfrom“problem”to“solution,”oneopensthedoortovariousmisdirectedapplicationsthatdonotappropriatelymediatethediverseinstantiationsofaproblem.Theevaluationofdesignseedspriortothedevelopmentofasolutioncreatesanopportunityformorecost-effectiveanduser-customizedsolutions.(44)Sinceadesignseedfeaturesaseriesofevaluablestatements,theapproachenablesinterventiontestingattherightpointinthepathwayforaspecificaction(e.g.,doestheinterventionworkaccordingtothedesignseedcriteria?yes,no,orpartially).Inordertosetuptheory-basedimplementation,we(KM,SL)independentlyusedthesestatementstohypothesizewhichcontextsarelikelytoaffecttheeffectivenessofimplementationoftheinterventionsemanatingfromthedesignseeds.WeusedTayloretal’sfourcontextualdomainsand13specificfeaturesthatatechnicalexpertpaneljudgedashighpriorityforassessment(asopposedtosimpledescription)intheevaluationofavariedrangeofpatientsafetyinterventionimplementations.(37)Figure3.TechnicalInterventionDevelopmentCycle

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Figure4.Socio-TechnicalInterventionDevelopmentCycle:DesignSeedTheory

AssessingClinicianReactionstoDesignSeeds(Stage6)Togaininsightabouttheimportanceofthedesignseeds,wedevelopedandtestedadatacollectionscriptandinstrument(Appendix1and2).Aclinicianparticipantfromeachclinicreviewedeachdesignseed,assessedlikelihoodofimprovedmonitoringandlikelihoodofreducingtimespentmonitoring,andrankedthesetofseedsforrelativeoverallimportance.

ResultsFromJanuary2015toFebruary2016,weconvenedoneormorejourneymappingsessionswithcliniciansandstaffatfivespecialtyclinicstoestablishtheworkflowformonitoringhigh-riskpatients.Asexpected,allclinicsparticipateinteachingalongsidepatientcare,havesimilarsafety-netpatientdemographicswithaccompanyingoperationalchallenges(e.g.,translationservices,transportationneeds),andusethesameunderlyingelectronichealthrecordsystembutworkwithinalargersystemoffragmentedrecord-keepingsystems(e.g.differentspecialty-specificEHRs,electronicsystemsrestrictedtoon-sitedevices,paper-basedsystems).Themappingprocessalsorevealedvariabilityinorganizationalapproachestomonitoringhigh-riskpatients,includingthetypesofpersonnelinvolvedinvariousmonitoring-relatedtasks(e.g.residentversusnurseresponsibilityfortracking)andthespecificstepstakentomonitorhigh-

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riskpatients(e.g.,useofnotebook-basedlistofpatientsversuslackofastructuredtrackingtool).JourneyMaps:HowSpecialtyClinicsMonitorHigh-RiskPatientsForeachclinic,weconstructedajourneymapasshowninFigure5,theabnormalcolonoscopyworkflow,andFigure6,theENTcancerworkflow.Thesejourneymapsfollowthemanagementofpatientswithconcerningconditionsrequiringcancersurveillance,diagnosis,monitoringandtreatment,startingwithreferraltotherespectivesubspecialtyclinic.Eachjourneymapcontainsswimlanes(visualcolumns)togroupsimilaractivities,flowarrowstorepresentpatientandinformationmovement,andtargetstohighlightareasofvulnerabilityformonitoringasexpressedbyclinicpersonnel.Forexample,anabnormalcolonoscopytriggersentryintothegastroenterologyclinicworkflow(Figure5),whichisadjudicatedbytheattendingdoctor.Thefirstswimlaneclusterstheactivitiesrelatedtoreferrals.Thenexttwoswimlanesseparatetwodifferentlevelsofdiagnosticconcernandcoordination–oneforbenignlesionswhichjustrequirenotifyingtheprimarycaredoctor,andtheotherfor“sinister”lesionswhichprecipitateaseriesofactionswithinthespecialtyclinic,aswellascoordinationwithothersbasedonsubsequentfindings(e.g.,pathology,primarycare,oncology).Thebull’seyetargetonthebox--“ifno-show,patientfallsoffthelist”--meansthattheclinicisawareofthisvulnerability,butdoesnothaveanyfurther,regularstepstoreducetheriskoflosingapatienttofollow-up.Thebottomofthediagramillustratesthatpatient-relatedcontactinghappensthroughouttheworkflow;theassociatedtargetconveysthechallengesinreachingpatientsoutsideofclinicandassuringthattheycanmakeittofollow-upencounters.TheENTclinic(Figure6)reportedsimilarchallengescontactingpatientsmonitoredandtreatedforcancer,asdidallotherclinics(Appendix3).TheactivitiesperformedbytheENTclinicforcancermonitoringclusterintofourswimlanes—caseidentificationandreferral,coordination,consultation,andcarepathway.Inthisclinic,thecoordinationactivitiesdonotfollowfromaparticularclinicalscenario(thebenignversussinisterlesion),butinsteadrelatetoaparticularrole,thechiefresident.Asaresult,thisclinicidentifiedfourseparatevulnerabilitiesrelatedtothebusychiefresident’sresponsibilitytokeeppatientsonthe“ENTRadar”withoutanyspecifictoolsbesidespapernotecards,whilealsocoordinatingresourcessuchastransportationforpatients,tumorboardpresentations,andcommunicationoffollow-uprequirementstoprimarycareproviders(PCPs).Thecarepathwayswimlanessketchoutaseriesofdiagnosticactivitiesandpre-treatmentpreparation.Thelaststageofthisclinic’scarepathwayispatientsurveillanceaftertreatment.Nospecificresponsibilityassignmentexistsforpatientswhorequireregularsurveillancetomonitorforcancerrecurrence,sotheongoingsurveillanceactivityboxislabeledwithabull’seyetarget,indicatinganothervulnerability.

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Figure5.AbnormalColonoscopyJourneyMap

Figure6.EarNoseandThroat(ENT)CancerJourneyMap

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Thejourneymapsintentionallytellonlypartofthestoryastheyrepresentthejourneytoldfromasingleclinic’sperspective.Forexample,allofthesubspecialtyclinicshaveinteractionswithPCPs,butonlywhenanindividualclinicspokeaboutdependenciesonthePCPforthepatientsthattheymonitordidweincludethePCPinajourneymap.Forincidentallungnodules,breastcanceroncologynavigationservice,andabnormalcolonoscopies,thespecialtyclinicsrelyonthePCPtoremindpatientstofollow-upatthenecessaryintervalssincetheyhaveminimalcontactwiththesepatients.ChallengesExperiencedintheClinicsBasedontheinterviewnotesandjourneymapsfromallfiveclinicswedevelopedacomprehensivelistofvulnerabilitiesdescribedbyatleastoneclinic(seeTable1).Weidentified45distinctvulnerabilities,andmappedthesetodomainsfrompatientsafetytheoreticalframeworks:36relatetoworksystemfactorsthatareinherenttoenvironment,task,technology,organizationandpeople,while9vulnerabilitiescorrespondtoprocessfactorsthatreflectinteractionsbetweenpeopleorwithsystems.(1,56)Eachclinicreviewedthelistatleastfourmonthsafterjourneymappingtovalidatehigh-priorityvulnerabilitiesthatpersistovertimedespiteongoingorganizationalchangesandtorecorddifferencesbetweenclinics.Onlytwovulnerabilities—1)havetotracksomepatientsinownmindorsidesystem,and2)creatinglistofpatientrequiringmonitoringtakestime–wereexperiencedbyallfiveclinics.Atleasttwoclinics(invaryingcombinations)experiencedmostofthevulnerabilities.Fourofthefiveclinicsverifiedmultipleproblemsrelatedtothetimeexpendedontasksrelatedtomonitoring.Thebreastcancerclinicexperiencedonly7%ofthefulllistofpossiblevulnerabilities,whiletheothersexperienced12%to34%.Thislightervulnerabilityburdenisperhapsbecausethebreastclinichasseparatephilanthropicfundingthatsupportspatientnavigationservices,referredtobyaparticipantasa“humantrackingsystem”.Severalbroadworksystemchallengesemergedfromtheclinicvisits:

• Organizedforvisit-basedcare(asopposedtopatientmanagementovertime)• Rotatingcareprovidersfromvisit-to-visitduetobeingateachingenvironment(as

opposedtohavingdoctorswithlong-termorganizationalknow-how)• Lackofclearownershipforthemonitoring-over-timefunction(asopposedtotask

responsibilityandadequatetimeallocatedforthispopulationmanagementfunction)

• Noaggregatedreal-timelistsofthosewhorequirefollow-upmonitoring(asopposedtosupportivetools)

• Lackofsystematicandtransparentapproachtopatient’scareplan(asopposedtowidelyknownandspecifiedbenchmarksandtimingformonitoringfollow-ups)

• Substantialtimepressurelimitsfrontlineattentiontolearningfrommissedmonitoringincidents(asopposedtoeffortstoanalyzedataaboutmisses,understandvulnerabilitiesanddeveloporganization-widesolutions)

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ThisworkenvironmentanalysisthatutilizestheNAMframeworkunderscoresthelackofinfrastructureandprocessesorganizedtosupportpopulation-leveltrackingofpatientsundergoingdiagnosisofinitialcancer,progressingcancerorrecurringcancer.Onenoteworthyfindingwasthelackofpopulation-leveldescriptionsofthedifferenttypesofmonitoringcarepathwayscommonlyusedwithinagivenclinic.Forexample,theurologyclinicparticipants–anattendingdoctor,aresidentandanurse–describedacompositionbookwheretheresidentlogsallurologicpatientswhohadapathologyresult.Thecompositionbookisastartingpointforpopulation-leveltrackingofthosewhoareatsomeriskforbeinglosttofollow-updespitelikelihoodofneedingit.However,thelistisnotsub-dividedorcategorizedbasedonfindings,conditions,anticipatedfollow-uppathway(e.g.,testing,timingofnextvisit).Theclinicparticipantsnotedthattheypreferredasystemtomonitorforallurologiccancersratherthanrestrictingtoprostatecancermonitoring(journeymapfocus)andthatthecompositionbookre-emergedasaworkaroundafteratechnicalmonitoringsystemwasunsuccessful.Table1.VulnerabilitiesExperiencedbyEachClinic

VulnerabilityfromSpecialtyClinicianPerspective #ofClinicsExperiencing

Clinic+(X=experienced)ClassifiedbyFrameworkDomain* B P GI E UWorkSystem:Task Havetotracksomepatientsinownmindorsidesystem 5 X X X X XCreatinglistofpatientsrequiringmonitoringtakestime 5 X X X X XLookingupeachpatient'sinformationtakestime 4 X X X XMaintaininglistofpatientsrequiringmonitoringtakestime 4 X X X XOutsideofvisit-basedcare,don'talwaysknowwhenpatientsneedfollow-upmonitoring

4 X X X X

Manuallymonitoringpatientsistimeintensive 4 X X X XDon'talwaysknowwhichpatientsneedtobecalledbackformonitoring

3 X X X

Havetospendtoomuchtimescheduling 2 X X Manuallymonitoringpatientsiserror-prone 2 X XWorkSystem:TechnologyandTools Analyzingdatainadhocmanneristimeintensive 4 X X X XInefficientsystemtocreatepersonal,siloedremindersforfollow-up

4 X X X X

Listofpatientsweuseoutdatesquickly 3 X X XCan'tdivertalertstootherproviders 3 X X X Analyzingdatainadhocmanneriserror-prone 3 X X XDon'talwaysknowwhenpatientdataismissing 2 X X Can'tfindmissingdatafromoutsideclinic 1 X Don'talwayswantalertwhenpatientstatuschanges 1 XDon'thaveadequatereal-timedata 1 X Can'teditpatient'scarepathwayasneededbasedonfrontlinedata

1 X

Can'tfindmissingdatawithinclinic 1 X WorkSystem:Organization Systemsdon'ttalktoeachother 4 X X X XDon'thaveasystemthatputspatientsintosubgroupsformoreefficientmonitoring

4 X X X X

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VulnerabilityfromSpecialtyClinicianPerspective #ofClinicsExperiencing

Clinic+(X=experienced)ClassifiedbyFrameworkDomain* B P GI E UCan'tsharepatientlistwithentirecareteam 3 X X XDon'talwayshavethetimetoperformtheassignedrole 2 X X Hardtostratifypatientsintosubgroupsformonitoringduetomanyindividualpatientdifferences

2 X X

Careplanispoorlydocumented 2 X X Don'tknowwhattypesofschedulingchallengesoccurmostoften

1 X

WorkSystem:People Overlappingefforts 4 X X X XDon'talwaysknowwhentheloopcloses 3 X X XEveryoneinputsdatadifferently 2 X X Knowingwhoismanagingateachstageisunclear 2 X XMappingpatienttocareplanrequiresclinicaljudgment 2 X X WorkSystem:Environment Coordinatingschedulingeffortsacrosscareteamsisdifficult 3 X X XLittleornoperformancedataaboutmonitoringsodon'tknowwheretofocusanyimprovementefforts

3 X X X

Stretchedforresourcestoreachouttoallpatientsinneedoffollow-up

3 X X X

Unawareofclinic'sperformanceinpatientmonitoring 2 X X Process:System-PatientInteraction Don'tknowwhenpatientmissesappointment 4 X X X XDon'talwaysknowwhenpatientdoesn'thavePCP 4 X X X XDon'talwaysknowpatient'svulnerabilitiesrelevanttomonitoring(e.g.patient'sworkschedule,can'tgettoclinic,substanceabuse)

3 X X X

Difficultycommunicatingpatientneedswithentirecareteam

2 X X

Don'tknowwhenpatientchangesstatus 2 X X Process:System-ProviderInteraction InconsistentprocessforinformingPCP 3 X X XCan'tusepatientdataforoperationalimprovement 2 X X InvolvingPCPwhennotnecessary 1 X Process:Patient-ProviderInteraction PCPdoesn'thaveoverviewofallpatientinfo/carepathway 3 X X X*AdaptedfromtheNationalAcademyofMedicineImprovingDiagnosisFramework,2015andSarkaretal’sSystem-relatedFactors,2014toclassifyeachreportedvulnerabilityintoWorkSystemversusProcess,aswellassubdomainsofthesetwoframeworkcategories(1,56)+ClinicsdesignatedasB=Breast,P=Pulmonary,G=GI,E=EarNoseandThroat,U=UrologyProcessTraceSequences:FourCriticalActivitiesforMonitoringHigh-RiskPatientsTosimplifythejourneymapsandenablepatternrecognitionacrossclinics(seeAppendix4forcolor-codedjourneymaps),wecategorizedeachactionintooneofthreefunctionalclusters:

• Communicate/coordinate

35

• Patientactivity(contactpatient,patientshowsup)• Revieworenterdata/datasystems

Figure7showstheresultantprocesstracesequencesderivedfromthejourneymapsforeachofthefiveclinics.Theworkflowshavesimilarpatterns:reviewandenteringdataatthebeginningofthejourney;acoupleactivitiestocommunicateandcoordinatewithintheclinicteambeforeseeingapatient,aseriesoftestsandappointmentswherethepatienthastoshowup,andsomepatientcontactoutsidetheappointmentspunctuatingthemiddleofthejourney;andmorecommunicationorcoordinationactionsmarkingtheendofthejourney.Asnotedinthethematicanalysis,afourthcriticalactivityweavesthroughthesequence:

• Trackprogressrelatedtopatientsandtheirfollow-upneeds

Figure7.ProcessTraceSequences

DesignSeeds:ElementsofaComprehensiveandAdaptableInterventiontoSaveLivesandTimeToinforminterventiondevelopment,welookedforleveragepointstoalleviatethevulnerabilityareasthatheldthehighestconsequenceforfailure.Wegeneratedalistof13leveragepoints,calleddesignseeds,whichcorrespondtothecriticalactivitiesforrobustpatientmonitoring,asshowninTable2.Oneoftheclinics,urology,toldusthattheyhadaregistrybutitwasnotused.Thissituationexemplifiesthetypicalsolutionspathway,asshown

36

inFigure8.Incontrast,basedonsocio-technicaltheory,statingsimplythataregistry“isneeded”istoominimalisticandfailstotaketheorganizationalcontextanditspotentialvariationsintoaccount.Figure9providesanexampleofthedesignseeddescriptionforfunctionsneededinapopulationregistryofhigh-riskpatientsrequiringmonitoring.Thedesignseedcommunicatestheintentbehindtherecommendationresultinginamodular-thereforemoreevaluable-setofsolutionattributes.Eachofthefourfunctions(e.g.,groupspatientsbyPCP)showncansupportdifferentcomponentsofanintervention.Inaddition,eachdesignseedfunctionalstatementcaneasilybeconvertedintoanevaluationquestion,suchas“doestheinterventionusedatavisualizationinawaythatenablesrapididentificationofpatientsinneedoffollow-up?”or“doestheinterventionallowourclinictoprioritizeworkinawaythatassuresthatthehighestriskpatientsreceivefollow-upfirst?”(Appendix2hasanexampleofthedetailedfunctionaldescriptionsforonedesignseeds,aspresentedtotheclinicsforfeedback.)Thesedescriptionsalsosupporthypothesis-generationaboutcontextualfeaturesthatmayhavevariableeffectsonwhethertheinterventionisabletoachieveitsintendeddesigngoals(Table2).Table2.DesignSeedsRelationshiptoCriticalActivityCategoriesandImplementationContext

Criticalactivitycategory

Designseed*

RelevantContextDomains(37)SafetyCulture,

Team

work,

Lead

ership

Structural

Organ

izatio

nal

Characteris

tics

ExternalFactors

Implem

entatio

n/

Man

agem

ent

Tools

Communicate/coordinate

Abilitytocontroldataaccess X X X XSchedulingfunctionality X X XAssignrolesandresponsibilities X X XTriggerednotifications X X X X

Patientactivity Patientsupport X X X XCompletepatientinformation X X X

Revieworenterdata

Keepslistup-to-date X X XStandardizeddataentry X XCompletedatacapture X X XPerformancedata X X X X

Trackprogress Populationregistryfunctionalityforhigh-riskpatients

X X

Figureoutwhatpatientsare“onthelist” X X X XCustomizethepatientlist X X X

*Designseedscorrespondtothefourcriticalactivitiesperformedbyclinics.Tomaximizeeffectivenessindiverseanddynamicsettings,designedinterventionsareconsideredwithinthecontextofalargerworksystem,splitintofourmajordomainsbyTayloretal.(37)Hypothesizedrelationshipsbetweencontextfeatures(e.g.,leadershipatunitlevel,localtailoringofintervention)areshowforthefourcontextdomainsandeachdesignseed.

37

37

Figure8.TechnicalInterventionDevelopmentCycle:Example

38

38

Figure9.Socio-TechnicalInterventionDevelopmentCycle:DesignSeedExample

39

Whenclinicparticipantswerepresentedthepreliminaryfindingsfromthisformativeresearch,theywereaskedtoprioritizethedesignseedsandsuggestrevisionsofthedesignseeddescriptions.Twelveofthe13designseedsreceivedrankinginthetop5inatleastoneclinic(Table3).Althoughthedesignseedforschedulingfunctionalitydidnotreceiveatop5ranking,fourclinicsrankeditseventh,rightinthemiddleofthelist,soitwashardlyalowpriority.Thedesignseedforkeepingthelistofpatientswhoneedmonitoringup-to-datereceivedtopthreeorbetterrankingatfourclinics.Threeotherdesignseeds–triggerednotifications,customizethepatientlist,andpopulationregistryfunctionality–wererankedinthetop5bythreeormoreclinics.Asnotedbyoneparticipant,thehighpriorityseedsorsolutionattributes“werethosethatbringtherightinformationtotherightpersonattherighttime.”Somedesignseedshadhighersalienceforonlyoneclinic.Completedatacapture,forexample,ismoreproblematicforclinicswhosepatientsreceivesomeoftheircareatotherinstitutionsthatuseotherrecord-keepingsystemsandEHRs.Intheseinstances,patientdataiseitherinaccessibleormustbefaxedbetweensites.BasedonaverageratingsshowninTable3,aswellasindividualclinicratings,thedesignseedsreceivedagreementthattheywouldimprovemonitoringandsavetimeinmostclinics.Onlyonedesignseed(assigningroles)receiveddisagreementforimprovingmonitoringandreducingtimeinoneclinicbecauseallmonitoringisperformedbya“one-womanshow”(aregisterednurse).Alldesignseedsexceptone(patientsupport)receivedthemostfavorablerating(5)fortimesavedbyatleastoneclinic.Noclinicprovidedverystrongagreement(5)thatthedesignseedforperformancedatawouldimprovemonitoring,althoughrepresentativesofthreeclinics(breast,GIandurology)agreedthatitwouldimprovemonitoring(ratingsof4on5-pointscale).Asonerespondentnoted,“thescopeoftheproblemwouldbegoodtoknow,butsecondarytootherneeds.”Thisviewisconsistentwithotherstudiesshowingfrontlineconcernthatmonitoredactivitieswillbeartificiallyprioritizedovercoreclinicalwork.(60)Designseedsviewedashavinghigherimpactpotentialforsavingtimeandimprovingmonitoringweregenerallyrankedclosertothetopbymoreclinics.Table3.ImportanceRankingofDesignSeedsfromFiveSpecialtyClinics

DesignSeed RankedinTop5*

Rank(Avg)

ImprovedMonitoring(Avg)

ReduceTimeSpent(Avg)

Keepslistup-to-date P,G,E,U 3.4 4.6 4.8Triggerednotifications B,G,E 4.2 4.8 4.8Customizethepatientlist B,P,G,U 5.2 4.2 4.6Abilitytocontroldataaccess E,U 6.2 4.4 4.2Populationregistryfunctionalityforhigh-riskpatients

P,E,U 6.6 4.4 4.2

Completepatientinformation G,E 7.2 4.6 4.6Standardizeddataentry G 7.2 4.2 4.4Performancedata B 7.2 3.6 3.8

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Patientsupport B,P 7.8 4.2 3.6Completedatacapture B 8 3.8 4.2Schedulingfunctionality - 8.4 4 4Figureoutwhatpatientsare"onthelist" P 9.8 4.2 4.2Assignrolesandresponsibilities U 9.8 3.4 3.6

*ClinicsdesignatedasB=Breast,P=Pulmonary,G=GI,E=EarNoseandThroat,U=Urology

DiscussionThisresearchhighlightstheuniqueandinnovativeintegratedapplicationofmethodsdrawnfromhumanfactorsengineering(designseeds,processtracinganalysis)anduserexperiencestudies(journeymapping)toderivecontext-sensitiveandtheory-basedinterventionsatthelocallevel.Suchfocusedandpotentiallyscalableworkisparticularlyneededforpatientswhomaybelosttofollow-upinsystemsthatarestretchedfordollarsandtime.Thisprojectfocusedonhigh-riskpatients,bothclinicallyduetoapotentiallyconcerningfindingduringanoutpatientvisit,andduetochallengesfromasocio-demographicviewpoint.Whenapatienthasawarningsignalforaseriousconditionthathasyettomaterialize,butmayinthefuture,theabilityofaclinicalteamtowatchthepatientcloselyovertimehingesonincrediblevigilanceonthepartofindividualclinicians-hardlyanidealsolution.Thesechallengesmirrorthosereportedinotherhealthsettingswithincompletedocumentationandlimitedknowledgeofthemagnitudeofpatientsafetyproblems.(53)Providerswilloftencreateinformalworkaroundsinresponsetothelackofcomprehensiveandcoordinatedrecord-keepingsystems,whichcanresultinerrorsaswellasredundantefforts.(61,62)Accompaniedbyanunderstandingoftheseworkarounds,safety-netsettingsofferauniqueopportunitytoapplyuser-centeredapproachestoredesignsocio-technicalstrategiesbyintegratinguserandclientneeds,thepossibilitiesoftechnology,andrequirementsforeconomicviability.(63)Throughmappinghowpatientsarecurrentlymonitoredforspecifichigh-riskconditionsaccordingtoevidence-basedpracticeinfivespecialtyclinicsinoursafety-netsetting,weidentified45differentvulnerabilities.Repeatedly,weheardthatcliniciansworryaboutproperlytrackingthesepatients,andaretroubledbythesignificantpersonneltimerequiredincarryingoutpatient-levelmonitoringactivitieswithouttoolsandorganizationalapproachesforpopulation-levelmonitoring.Inaddition,noongoingperformancedatacurrentlyexistsrelatedtothefrequencyofmissedopportunitiestomonitorthesehigh-riskpatients,thougheffortsareunderway.(27)Toamelioratethedifficultiesidentified,weworkediterativelywiththeclinicstodevelopthebasisforasoundapproachtopopulationmanagementofdiagnosticallyhigh-riskpatients.Weadaptedthejourneymappingtechniquetocaptureactivitiesandexperiencesoftheclinicteamastheymanagecohortsofsuchpatients,focusingontheclinician’smonitoringjourney.

41

Previousapplicationshavefocusedonpatientjourneysandexperiences.Whileeachclinichadadifferentjourneymap,allteamscarriedoutthesamefourbasicfunctionswithsomevariationinsequencingandspecifics.Forexample,onefunction,‘patientactivities’,includesschedulingthepatient,assistingpatientswithbarrierstomakingittoacriticaltest,seeingthepatientwhentheycomeintotheclinic,conductinganimagingstudy,andsoforth.Onceweunderstoodtheclinicteams’manyconcerns,particularlythetimeimplicationsofthecurrentmonitoringworkload,aswellasthepotentialforerrors,wedidnotjumpstraighttosolutions.Theuseofdesignseeds,asabridgebetweenproblemsandeffectiveorganizationalinterventions,offersthreeadvantagestoleapingoverthisstep.First,designseedsaresimpledescriptionsthatstatewhatasolutionneedstodo,andcanbedescribedinawaythatallowsvalidationbytheusers,thoseonthefrontlinesattheclinics.Forexample,clinicianscaneasilyimaginescenarioswherepatientsmightnotbemonitoredaccordingtoevidence-basedguidelinesbecauseofambiguityinwhoisresponsiblefortrackinghigh-risksituations(i.e.,addressedbythedesignseedforassigningrolesandresponsibilitiesbetweenprimarycarepractitionerandspecialistforapatientflaggedforfurtherfollow-up).Second,designseedscanbesuppliedtootherclinicstolearnwhethertheyhavefacevalidityoutsideofthisparticularsafety-netsetting.Designseedssupportflexibilityandtailoringtocontext,acriticalfeatureforeffectiveimplementationofpatientsafetyinterventionsindifferentsettings.(37,64)Otherclinicscouldusethefeedbackexercisetodeterminewhetherthe13designseedsareperceivedtoimprovemonitoringandsavetimeintheirsettingpriortoinvestinginasolution.Asaresult,oneorganizationcouldimplementandtestinterventionsbasedononesetofdesignseeds(e.g.,#3,5,and7),whileanothermightchooseanotherset(e.g.,#2,3,4,6)basedondifferingcontextualenablersandbarriers.Third,designseedsare,bydefinition,anassessmenttoolduringtestingofpotentialsolutions.Doesthesolutiondowhatthedesignseedprescribed?SomeofthedesignseedsmayresultinprimarilyHITsolutions(triggerednotifications),whileothersmayneedsignificantorganizationalchanges(patientsupport).Butmost,ifnotall,willlikelyrequirebothtechnicalandorganizationalchange.Theuseofdesignseeds,previouslyappliedforcomplexcognitivelyrichtasksoutsideofhealthcare,isadaptivetoanyorganizationalsettingcoordinatinglayersofcognitivelytaxingactivitiesmeanttoaccomplishaparticularorganizationalgoal.(65,66)Healthnetworksfragmentedbytechnology,location,andorganizationalelementsareripeenvironmentsforthedesignseedmethodasitcapturesdifferencesincontextwhilemovingtowardsacohesiveend-goal:asolutionthatworksacrosssettingswhilealsotargetingspecificneedstoprovidethehighvaluetolocalsettings.Inourcase,wesoughttousejourneymappingcoupledwithprocesstracinganddesignseedstoidentifyfeaturesofpopulationmanagementinterventionsforhigh-riskconditionsandtreatmentstoreducediagnosticerror.Theflexiblestructureofthesetools,anchoredtotouchpointswithendusers,enableageneralizablestrategyforidentifyingleveragepoints,reducingdiagnosticdelaysrelatedtosuboptimalmonitoring,andincreasingorganizationaleffectiveness.

42

LimitationsWhiledesignedforadaptabilityacrosssystems,ourproposedstrategyfordevelopingdesignseedswouldbestrengthenedbyfurtherassessmentwithinotherhealthcaresystems.Atthisstage,weknowfromtestinginmultiplespecialtysettingsthatcommonthemesandvariationsexist.Whileeachoftheclinicsinthisstudyhasitsownleadership,electronicandpaper-basedsystems,andorganizationaldesign,weshowedthatjourneymappingpairedwithprocesstracingcapturedbothdifferencesandsimilaritiesacrossfivesettings.Anadditionallimitationisthatourdesignseedshavenotreceivedfeedbackfromstakeholdersoutsidethespecialtyclinicworkforce(e.g.patients,informationtechnologyproviders,caregivers).Byfocusingonthe“holders”ofthepatientdata–thosestakeholdersthatmostfrequentlyengagewith,andbearresponsibilityfor,patientmonitoringactivities–wehaveestablishedafoundationfromwhichtobuild.Theapproachusedfostersaniterativeprocessfordatacollectionthatwillloopinotherstakeholders.Ouradaptationofjourneymappinganddesignseedssummarizesabroad,butpossiblyincomplete,listofactivitiesrelatedtopatientmonitoringwhenapproachedfromacohortperspective.FutureWorkWesoughttodrawfromorganizationalanalysisusedoutsideofthehealthcaresettingtoinformapracticalandscalableinterventiongearedtoreducemissedanddelayeddiagnosisinhigh-riskpatientpopulations.Ideally,thisapproachwouldbereplicatedinotherspecialtyareasandsites,includingthosethatarebetterresourced.Wewilltranslatethevalidateddesignseedsintoaprioritizedlistofsolutionattributestouseindevelopmentandevaluationofsocio-technicalinterventions.Duringtheorganizationalchangeprocess,weintendtocontinuallyreferenceanditeratejourneymaps.Oneofthedesignseeds–figureoutwhatpatientsare“onthelist”–willrequireworkwithintheclinicsaswellasliteraturereviewstargetedtotriggeralgorithmsforidentifyingpatientsinneedofclose,butnoturgent,follow-upduringtheirdiagnosticjourneys.(67-69)Weanticipatethatinterventionsevaluatedagainstuserneedsthataregeneratedwithintentionandcontextwillbemoresustainable,user-friendly,andimplementedmoresuccessfullythanthosegeneratedwithoutthishumanfactorsapproach.Asanascentareaofresearch,strategiestoclosegapsindiagnosticsafetybuiltfromthegroundup,asinthisstudy,willfirstbefollowedbypilottesting,andultimatelyfull-scaleimplementationevaluationswithadditionalmeasuresrelatedtothepeople(patient,provider),organizational,technologyandstructuralfactorspredictingdesiredimplementationoutcomes.(70)TheNAMImprovingDiagnosisframeworksharesasimilarmulti-levelstructurewiththoseofimplementationscience,anticipatingfutureresearchtoimprovingdiagnosticcareinanorganizationallyeffectiveandsustainableway.

43

ConclusionsWecarriedoutamulti-stageresearchprocesswithspecialtyclinicsatanurbanpubliclyfundedhealthsystemtoaddressanimportantevidence-basedsafetygapinambulatorycare:potentiallypreventableandconsequentialdiagnosticandmonitoringdelays.Basedonsurfacingalargenumberofcommonvulnerabilitiesamongtheclinics,wespecifiedandvalidatedkeyattributesforarobustsocio-technicalapproachtoimprovingoutpatientmonitoringthatisgearedtoenablecontext-sensitiveimplementation,utilizingindustrialandhumanfactorsmethodslinkedtoimplementationtheory.

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CHAPTER4

Paper2—Healthinformationtechnologies,patientsafetycultureandmedicalofficeproblemsthatcouldleadtodiagnosticerrors

Co-Authors:JoanneCampione,RussMardon

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IntroductionAsEHRsareadoptedmorewidelyforambulatorycare,andphysicianclinicscontinuetoHITsystems,itisincreasinglyimportanttoevaluateboththepositiveandnegativeeffectsofHITimplementationonclinicprocessesandcommunicationthatmayimpactpatientsafety.(1-2)InadditiontoEHRs,examplesofHITapplicationsinaclinicincludecomputerizedproviderorderentrysystems,computerizedclinicaldecisionsupportsystems,electronicreportingoflaboratoryorimagingresults,andelectronicexchangeofhealthinformationwithotherhealthcarefacilities.Intheambulatorysetting,thesesystemsarebecomingincreasinglyintegraltoarangeofpatientcare-relatedactivitiessuchastestandmedicationordering,resultsreporting,diagnosis,clinicaldecision-making,careplanning,patientcommunication,andcarecoordinationwithotherproviders.

HIITandPatientSafety

ThereisevidencethateffectiveuseofHITcanimprovehealthcarequalityandsafetyintheinpatientsetting.(3-4)Forexample,Furukawaetalfoundthatcardiovascular,pneumoniaandsurgeryhospitalizedpatientsexposedtofullyelectronicEHRshad17-30percentloweroddsofanadverseevent.(5)However,theevidenceontheimpactofHITonqualityandsafetyinphysicianclinicsismixed,withbothpositiveandnegativeeffectsreported.(6-10)StudieshavepointedtotheimplementationphaseofneworupgradedHITsystemsasaparticularlyriskytimethatcannegativelyimpactofficeprocessesthatcanleadtoHIT-relatederrors.(11-15)

AHIT-relatederroroccurswhendataarelost,incorrectlyentered,displayedortransmitted.(16-17)Theseerrorscanoccurduetosystemmalfunctions,systemorinternetdown-time,userinterfaceerror(poorusabilityand/orlearnability),informationdisplayissues,ornon-interoperabilityacrosssystems.(18-22)Asystematicreviewofambulatorycaresafetypublicationsover10yearsfoundthatHITwasacontributingfactortothethreemostcommonsafetyconcerns:1)medicationerrors,2)diagnosticerrors,and3)patientsintransition.(23)Forexample,inastudythatreviewedcriticalimagingalertnotifications,theresearchersfoundthatnearlyallabnormalresultslackingtimelyfollow-upat4weekswereeventuallyfoundtohavemeasurableclinicalimpactintermsoffurtherdiagnostictestingortreatment.(24)

DiagnosticErrors

Singhetal.haveestimatedthatonein20ambulatorypatientswillexperienceadiagnosticerroreveryyear,andhalfofthoseerrorscouldpotentiallyresultinharm.(25)Diagnosticerrorsmaycauseharmtopatientsbypreventingordelayingappropriatetreatmentorbyprovidingunnecessaryorharmfultreatment.(26)Thereiscurrentlyanationalfocusonaddressingtheproblemofdiagnosticerrors.(27-28)EHRsandelectronicresultsreportinghavethepotentialtoimprovedecisionsupportandtoassistinfinding,exchanging,andanalyzingthedataneeded

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duringthediagnosticprocess.However,thispotentialhasnotbeenwidelymet.(29)Data-gatheringandsynthesisproblems,inaccuraciesandinformationoverloadfromelectronic“copyandpaste”functionality,andtheunintendedconsequencesofalertand/orreminderfatiguearejustafewoftheexamplesofhowHITisnotcurrentlysupportingthediagnosticprocess.(30-31)

PatientSafetyCultureTheNationalPatientSafetyFoundationdescribesacultureofsafetyas“oneinwhichhealthcareprofessionalsareheldaccountableforunprofessionalconduct,yetnotpunishedforhumanmistakes;errorsareidentifiedandmitigatedbeforeharmoccurs;andsystemsareinplacetoenablestafftolearnfromerrorsandnear-missesandpreventrecurrence.”(32)Healthcareprovidersmeasureculturethroughstaffsurveystodetermineareasthatneedimprovement,toconductinternalandexternalcomparisons,andtoevaluatequalityimprovementinitiativesandotherinterventions. Studieshaveshownthatbetterpatientsafetycultureisgenerallyassociatedwithsafercare.(33-35)HowevertheabilityofbettersafetyculturetomitigatethepotentialrisksofHIT,especiallyduringtheimplementationphase,hasnotbeenwellstudied.(36)

ThisstudyaimstobetterunderstandtherelationshipbetweenHITimplementationandofficeproblemsthatcanleadtoadiagnosticerror,andtotestthehypothesisthatcultureisamediatingfactorinthatrelationship.ThemeasuresincludedintheAgencyforHealthcareResearchandQuality’s(AHRQ)MedicalOfficeSurveyonPatientSafetyCulture(MO-SOPS)provideauniqueopportunitytoquantitativelyassesstheassociationsbetweenaclinic’sstaffperceptionsofcultureandthefrequencyofofficeproblemsthatcanleadtodiagnosticerror,andtolinkthoseresultswithcliniccharacteristicsandeachclinic’sHITimplementationlevel.

MethodsDataSourceSince2009,healthcareorganizationshavebeenusingtheMO-SOPStoaskprovidersandstafffortheiropinionsaboutthecultureofpatientsafetyintheirclinics. TheMO-SOPSsurveyinstrumentcanbefoundon-lineathttp://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/medical-office/index.html. Inadditiontoquestionsaboutpatientsafetyculture,theMO-SOPSsurveyincludesquestionsaboutthefrequencyofofficequalityandsafetyissuesrelatedtothediagnosticprocessasdescribedbelow.Furthermore,during2012,thesurveyincludeddataaboutthelevelofimplementationofseveralelectronictypesofHITsystemtoolswithinaclinic.

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Approvalforuseofclinic-levelaggregateddatawasgrantedbyAHRQpursuanttoWestat’sdatauseagreement(DUA)withorganizationsthatsubmitdatatothecomparativedatabase.Thedataprovidedforthisstudywasde-identified--clinicgeographiclocationandotherprovideridentifierswerenotprovided.The2012AHRQMO-SOPSUserComparativeDatabaseReport,presentingdatafrom934U.S.clinicsnationwide,containsdetailedcomparativedataforvariouscliniccharacteristics(numberofproviders,specialty,ownership,andregion)andstaffposition.(37)StudySampleSurveyresultsfrom934clinicswereanalyzedfromdatavoluntarilysubmittedin2012totheAHRQMO-SOPSdatabase.ParticipatingclinicsadministeredtheMO-SOPStotheirstaff(includingdoctors,management,nurses,andotherstaff)betweenNovember2009andOctober2011.Eightclinicswereexcludedfromthisanalysis:fiveclinicswithresponserateslessthan15%andthreethatdidnotanswertheimplementationofelectronictoolsquestion. Amongtheremaining926clinics,responseratesatthecliniclevelrangedfrom18-100%,averaging72%,withatotalof23,597staffrespondentsinthisstudy.MeasuresImplementationofelectronictoolsAlthoughnotpartofthesurveytakenbystaffmembers,in2012,whenaclinicsubmitteddatatothedatabase,theywereaskedaquestionaboutHITimplementation.Thisfive-itemquestionasked:“Towhatextenthasthismedicalofficeimplementedthefollowingelectronic(computer-based)tools?”:a)appointmentscheduling,b)orderingofmedications,c)orderingoftests/images,d)accesstopatients’results,ande)electronichealthrecords.Thefourresponseoptionswere:1)notimplementedandnoplanstoimplementinthenext12months,2)notimplementedbutimplementationplannedinthenext12months,3)implementationinprocess(onlypartialimplementation),and4)fullyimplemented.Wegroupedtheresponsesintothreecategoriesbycombiningthetwonotimplementedresponseoptions.ThisstudyfocusesontwooftheITtoolsrelevanttothediagnosticprocess:accesstopatients’laboratoryandimagingresults(“E-reporting”)andEHRs.E-reportingrepresentscomputer-generatedreportsandimagesthataretransferredelectronicallyfromthelaboratoryandfromradiologists(respectively)tothepatient’sattendingproviders.DatacollectedandstoredinanEHRincludedemographics,progressnotes,problems,medications,vitalsigns,pastmedicalhistory,immunizations,laboratorydataandradiology.OfficeproblemsrelatedtodiagnosticprocessAspartoftheMO-SOPSsurvey,eachclinicstaffrespondentisasked“Howoftendidthefollowingthingshappeninyourmedicalofficeoverthepast12months?”Thelisteditemswere:

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incorrectpatientinformation,nothavingresultsavailablewhenneeded,untimelyfollow-upofabnormaltestresults,andproblemsexchangingaccurate,complete,andtimelyinformationwithotherprovidertypes.Thesixresponseoptionsare:1)daily,2)weekly,3)monthly,4)severaltimesinthepast12months,5)onceortwiceinthepast12months,and6)notinthepast12months.Foreachclinicandeachproblem,wecalculatedthepercentofaclinic’stotalresponsesthatweredailyandweekly(referredtoas“PercentDailyorWeekly”).CulturescoreTheMO-SOPSsurveyincludes38itemsthatmeasuretenpsychometrically-sounddimensionsoforganizationalculturepertainingtopatientsafety.(38)Thequestionswithinaculturedimensionareledwiththeseinstructions:“Howmuchdoyouagreeordisagreewiththefollowingstatements:…?”Anexampleitemis:“Ourofficeprocessesaregoodatpreventingmistakesthatcouldaffectpatients.”Responsesarea5-itemLikertscalewith1=stronglydisagree,2=disagree,3=neitheragreenordisagree,4=agree,5=stronglyagree.Respondentscanalsochoose“Doesnotapply/don’tknow”.Anoverallculturescorewascalculatedbytakingtheaverageofthe10-dimensionmeanscores(range1to5,with5representinghighestlevelofclinicsafetyculture).Clinicswererankedandcategorizedintorelativeequal-sizethirds(“tiers”).ThesurveyitemswithineachdimensioncanbefoundinonAHRQ’swebsiteathttp://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/patientsafetyculture/medical-office/userguide/medoffitems.pdf.Cliniccharacteristics(Table4)andstatisticalanalysisAnalyseswereperformedusingSASversion9.3.Foreachofficeproblem,wecomparedtheadjustedmeansofPercentDailyorWeeklyacrossthethreeimplementationlevelsofEHRandE-Reporting.Wealsoperformedstatisticaltestingandanalysistodeterminemodelcovariates.Forexample,forafewoftheofficeproblems,highersurveyresponseratesatthecliniclevelwerecorrelatedwithPercentDailyorWeeklyfrequencyofclinicproblems.Wefound,uponinvestigation,thathigherresponserateswerecorrelatedwiththepercentofclinicresponsesthatwerefromphysicians(r=12.5;p<.0001).Therefore,wechosetoincludepercentofrespondentswhowerephysiciansinthemodels.Table4.Officecharacteristics(n=926)

Characteristic PercentorMeanEHRImplementationLevel None 25.4%Partial 12.7%Full 61.9%E-ReportingImplementationLevel None 16.2%

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Partial 15.2%Full 68.6%NumberofDoctorsinClinic 1-3 27.7%4-9 41.5%10+ 30.9%Clinicisamulti-specialtypractice 30.9%ClinicmainlyownedbyanAcademicMedicalCenter 5.7%Cliniconlyhasonelocation(vs.morethanone) 59.9%%ofresponsesthatwerephysicians(meanofclinics) 12.6%Overallculturescore* 3.80Meanscoreinlowculturetier(n=308) 3.46Meanscoreinmiddleculturetier(n=309) 3.80Meanscoreinhighculturetier(n=309) 4.13

*Note:Mainmodelincludesanindicatorofaclinic’sculturescoretier,notthescore.RegressionAnalysisForeachofthe8officeproblems,weusedamultivariateregressionmodel(PROCGLIMMIX)toestimatetheeffectofHITimplementationleveloneachofficeproblemPercentDailyorWeeklywhilecontrollingforcliniccharacteristicsandoverallculturetier.Lastly,weranthefullmodelwiththe10culturedimensionscoresreplacingtheculturetier.TheSASGLIMMIXprocedurewithalognormaldistributionwasusedtomodelthedependentvariables(officeproblems)becausethedistributionofthepositivevalueswasskewed.Restrictedmaximumlikelihood(REML)wasusedforvarianceestimation.Themajorityofourdependentvariableshadamixtureofalargespikeatzeroandacontinuousdistribution.Forexample,fortheproblem“resultsfromalaborimagingtestwerenotavailablewhenneeded”,35%oftheclinicshadaPercentDailyorWeeklyvalueequalto0%.However,amongtheremaining65%ofclinics,thePercentDailyorWeeklywasnormallydistributed.Weperformedsensitivityanalysisusingotherregressionmodelssuchastheuseofatwo-stepmodeltopredicttheoddsofnotzerocoupledbyalinearregression(bothwithnormalandlognormaldistributions)ononlynon-zerodependentvariablevalues.Foreachproblem-specificmodel,theresultsofthesensitivityanalysisofvariousregressionmodelsconfirmedthesamedirectionandstrengthofthecovariatesasthosereportedfromtheGLIMMIXlognormalmodel.

ResultsFindingsbeforecontrollingforsafetycultureOfficeproblemsthatarerelevanttothediagnosticprocesswerereportedtohaveoccurreddailyorweeklybyanaverageof1.2%to14.6%ofclinicrespondents,dependingonthespecific

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problem(Table5).Havingtheincorrectpatientrecordwasreportedleastfrequently,whilenothavingtheresultsforalaborimagingtestinatimelyenoughmannerhadthehighestfrequency.Thesereportsvariedwidelywithsomeclinicsatover80%ofstaffsurveyedreportingoneormoreoftheproblemsoccurringdailyorweekly.Table5.MedicalOfficeProblemsMeasuredinMO-SOPS

Problem Ofallresponsesinanoffice…..thePercentDailyorWeekly

Meana

StandardDeviation

Range

1) Theresultsfromalaborimagingtestwerenotavailablewhenneeded 14.6% 15.3% 0–83.3%

2) Patient’smedicalrecordwasnotavailablewhenneeded 10.1% 15.9% 0–88.9%3) Acriticalabnormalresultfromalaborimagingtestwasnot

followedupwithin1businessday. 3.8% 7.5% 0–66.7%4) Medicalinformationwasfiled,scanned,orenteredintothe

wrongpatient’schart 3.1% 6.8% 0–55.6%5) Wrongchart/medicalrecordwasusedforapatient 1.2% 3.5% 0–37.5%6) Informationexchangeproblemswithoutsideimagingorlabs 11.1% 13.2% 0–85.7%7) Informationexchangeproblemswithothermedicaloffices 10.7% 12.8% 0–83.3%8) Informationexchangeproblemswithhospitals 8.0% 11.1% 0–80.0%

aNote:Meanof926clinics’percentoftotalresponsesDailyorWeeklywhenstaffaskedaboutproblemfrequencyoverthepast12months.AsshowninFigure10,forfiveoftheeightofficeproblems,theadjustedmeanPercentDailyorWeeklywassignificantlylowerforEHRfullimplementationincomparisontonoimplementation.Foruntimelyfollow-upofabnormalresults,thePercentDailyorWeeklywashigherforclinicsimplementingEHRs.WithrespecttoE-Reporting(Figure11),forfiveoftheeightofficeproblems,theadjustedmeanPercentDailyorWeeklywashighestforpartialimplementation.However,clinicswithfullimplementationofE-ReportinghadthelowestPercentDailyorWeeklyforchartunavailable,informationinwrongchart,lab/imageresultnotavailable,andinformationexchangeproblemswithotheroffices.

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Figure10.PercentofOfficeStaffthatReportedProblemasHappeningDailyorWeeklybyEHRImplementationLevel

SOURCE:2012MedicalOfficeSurveyofPatientSafetyCultureDatabase(N=926offices)*Theadjustedmeanforfullimplementationissignificantlydifferentthannoimplementation.**TheadjustedmeanforpartialImplementationissignificantlydifferentthanfullimplementation.Meansareadjustedfor#ofphysiciansperoffice,multi-specialtyornot,academicmedicalcenterownershipstatus,oneormorelocations,andthe%ofphysicianresponses.

0% 2% 4% 6% 8%

10% 12% 14% 16% 18% 20% 22%

WrongChart*

ChartUnavailable*

InfoEnteredinWrongChart*

Lab/imageresultnotavailable*

Untimelyfollow-upofabnormalresults**

InformationExchangeProblems

withOutsideLabs

InformationExchangeProblemswithOtherOffices*

InformationExchangeProblemswith

Hospitals

Adjusted

Mean%OfficeRespo

nsesofD

ailyorW

eekly

EHRNoImplementation EHRPartialImplementation EHRFull Implementation

57

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Figure11.PercentofOfficeStaffthatReportedProblemasHappeningDailyorWeeklybyE-ReportingImplementationLevel

SOURCE:2012MedicalOfficeSurveyofPatientSafetyCultureDatabase(N=926offices)*TheadjustedmeanforfullImplementationissignificantlydifferentthannoneandpartialimplementation.**Theadjustedmeansforpartialandfullimplementationaresignificantlydifferentthannoimplementation.***Theadjustedmeanforfullimplementationissignificantlydifferentthanpartialimplementation.****TheadjustedmeanforpartialImplementationissignificantlydifferentthannoneandfullimplementation.Meansareadjustedfor#ofphysiciansperoffice,multi-specialtyornot,academicmedicalcenterownershipstatus,oneormorelocations,andthe%ofphysicianresponses.

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

22%

WrongChart ChartUnavailable*

InfoEnteredinWrongChart**

Lab/imageresultnot

available***

Untimelyfollow-upofabnormalresults****

InformationExchangeProblems

withOutsideLabs

InformationExchangeProblemswithOtherOffices

InformationExchangeProblemswith

Hospitals

Adjusted

Mean%OfficeRespo

nsesofD

ailyorW

eekly

E-ReportingNoImplementation E-ReportingPartialImplementation E-ReportingFullImplementation

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Findingsaftercontrollingforculture:fullmodelMultivariateRegressionResults(Table6)

ThePercentDailyorWeeklyforsevenoutoftheeightofficeproblemswaslowerforclinics

withfullimplementationofEHRs,threeofthemstatisticallysignificantlylower:patientchart

notavailablewhenneeded;patientmedicalinformationfiled,scanned,orenteredintothe

wrongpatient’schart;andlaborimagingresultsnotavailablewhenneeded(p<.0001foreach

problem).ThePercentDailyorWeeklyforsevenoutoftheeightofficeproblemswashigherfor

clinicsundergoingimplementationofE-reportingoflaborimagingresults,oneofthem

statisticallysignificantlyhigher:criticalabnormalresultnotfollowedupwithin1businessday

(p=.006).ClinicswithfullimplementationofE-reportinghadhigherPercentDailyorWeeklyof

patientinformationinwrongpatient’schartincomparisontoclinicswithnoE-reporting

(p=.01).NeitherEHRnorE-reportingimplementationlevelwasassociatedwiththefrequency

ofinformationexchangeproblemsacrossfacilities.Comparedtothemediumculturetierclinics,onaverage,clinicsinthelowesttierhad

significantlyhigherPercentDailyorWeeklyforofalleightproblems,whilethehighesttier

clinicshadsignificantlylowerPercentDailyorWeeklyforalleightproblems.Largerclinicshad

higherPercentDailyorWeeklyforsevenoftheeightproblemsincomparisontosmallerclinics

(i.e.,withlessthan4doctors).Increasedphysicianrepresentationinaclinic’stotalsurvey

respondentswasassociatedwithhigherPercentDailyorWeeklyforthethreeinformation

exchangeproblems(p<.001).

Table6.RegressionResult:PercentDailyorWeeklyProblemFrequency(DependentVariable)

Wrongptchart

Chartnotavail

Infowrongchart

Resultsnotavail

Effect* Estimate Pr>|t| EstimatePr>|t| Estimate Pr>|t| Estimate Pr>|t|

Intercept -8.57 <.0001 -5.13 <.0001 -7.36 <.0001 -4.99 <.0001

EHRFull -0.61 0.0201 -2.75 <.0001 -2.14 <.0001 -0.73 <.0001

EHRPartial -0.54 0.1097 -1.39 0.0049 -1.06 0.0117 -0.30 0.0117

E-reportingFull 0.42 0.1680 0.82 0.0657 0.93 0.0135 0.75 0.0135

E-reportingPartial 0.50 0.1546 0.28 0.5798 0.17 0.7024 1.33 0.7024

10ormoredoctors 0.69 0.0013 1.81 <.0001 1.20 <.0001 0.91 <.0001

4-9doctors 0.55 0.0039 1.08 <.0001 0.69 0.0031 0.95 0.0031

Multispecialty 0.66 0.0004 0.22 0.4041 0.33 0.1510 0.07 0.1510

AMCownership -0.49 0.1413 -0.63 0.1987 -0.30 0.4691 0.73 0.4691

Onelocation -0.13 0.4291 -0.01 0.9724 0.11 0.5705 -0.33 0.5705

%DocResponses -0.29 0.6555 -0.30 0.7567 1.345 0.0972 2.22 0.0972

Highculturetier -0.58 0.0021 -1.60 <.0001 -1.15 <.0001 -1.53 <.0001

Lowculturetier 0.70 0.0002 0.95 0.0005 0.81 0.0004 1.11 0.0004

*Note:ReferencecategoriesincludeEHRnone,E-reportingnone,1-3doctorsandmiddle

culturetier.

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Table6.Continued Untimely

FollowupInfoX

Rad/LabInfoXOffices

InfoXHospitals

Effect Estimate Pr>|t| Estimate Pr>|t| Estimate Pr>|t| Estimate Pr>|t|

Intercept -7.97 <.0001 -6.06 <.0001 -5.84 <.0001 -6.95 <.0001

EHRFull 0.15 0.6570 -0.56 0.1433 -0.64 0.0906 -0.08 0.8323

EHRPartial 0.14 0.7470 -0.67 0.1785 -0.79 0.1086 -0.16 0.7378

E-reportingFull 0.18 0.6523 0.49 0.2739 -0.11 0.8093 0.15 0.7363

E-reportingPartial 1.27 0.0062 1.00 0.0551 0.38 0.4517 0.72 0.1595

10ormoredoctors 1.10 <.0001 1.61 <.0001 2.08 <.0001 1.55 <.0001

4-9doctors 0.07 0.7638 1.12 <.0001 1.16 <.0001 0.76 0.0055

Multispecialty 0.23 0.3289 0.15 0.5781 0.49 0.0670 0.25 0.3472

AMCownership 1.10 0.0101 0.23 0.6356 0.25 0.6046 1.28 0.0077

Onelocation -0.38 0.0702 -0.19 0.4181 -0.23 0.3205 -0.30 0.1927

%DocResponses 1.99 0.0204 4.60 <.0001 3.39 0.0004 3.38 0.0004

Highculturetier -1.27 <.0001 -1.57 <.0001 -1.03 0.0002 -1.42 <.0001

Lowculturetier 0.91 0.0002 0.73 0.0080 1.03 0.0001 1.37 <.0001

Note:pt=patient,avail=available,info=information,InfoX=informationexchange

Sub-AnalysisResultsoftheTenCultureDimensions

Table7showsthemeanscoreforeachsafetyculturedimension,andtheproblemsforwhich

eachdimensionhadasignificant,independenteffectineachproblem-specificregression

model.ThesemodelsincludedalltensafetyculturedimensionsandcontrolledforEHRandE-

reportingimplementationlevelsandcliniccharacteristics.

Table7.CultureDimensionsandRelatedOfficeProblems*

Dimension** MeanScore

SignificantEffectonPercentDailyorWeeklyAhigherscoreonculturedimensionwassignificantlyassociatedwitha……

1) WorkPressureandPace 2.8 • DecreaseinResultsnotavailablewhenneed

(p=.002)

2) OfficeProcessesand

Standardization

3.3 N/A

3) Management/Leadership

SupportforPatientSafety

3.5 • IncreaseinInfoexchangeproblemswithimaging/

labs(p<.0001)

• IncreaseinInfoexchangeproblemswithoffices(p<

.003)

4) CommunicationOpenness 3.5 N/A

5) CommunicationAboutError 3.6 N/A

6) StaffTraining 3.6 N/A

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Dimension** MeanScore

SignificantEffectonPercentDailyorWeeklyAhigherscoreonculturedimensionwassignificantlyassociatedwitha……

7) OverallPerceptionsof

PatientSafetyandQuality

3.7 • DecreaseinWrongchartused(p<.0001)

• DecreaseinInfoenteredinwrongchart(p<.0001)

• DecreaseinInfoexchangeproblemswithhospitals(p

=.0002)

8) OrganizationalLearning 3.7 N/A

9) Teamwork 3.9 N/A

10) PatientCareTracking/Follow-up

4.0 • DecreaseinResultsnotavailable(p<.0001)

• DecreaseinAbnormal-untimelyfollow-up(p<

.0001)

• DecreaseinInfoexchangeproblemswithhospitals

(p=.003)

*RegressionmodelincludedalltendimensionsandcontrolledforHITimplementationlevelsandclinic

characteristics.DependentvariableperproblemwasPercentDailyorWeekly

**MO-SOPSSurveyDimensionmeanscoresrangefrom1-5,with5reflectinghigher/bettersafetyculture

***Significantatp<.005.N/Aisnotapplicable;nosignificantassociationwithfrequencyofaproblem.

LimitationsTheEHRandE-reportingimplementation-levelinformationateachclinicwasnot

independentlyverified,whichmayleadtosomemisspecification.However,itseemsunlikely

thataclinicrespondentwouldhavedifficultyreflectingthesituationaccurately.Inaddition,

possibledifferencesintimingbetweenthecompletionofdataaboutHITimplementationlevel

andstaffresponsesaboutcultureandofficeproblemsmayleadtosomedegreeofmismatching

inthosetypesofresponses.Also,wedidnothaveaccesstoinformationaboutthepatient

populationsattheclinics,whichmayinfluencetherelationshipsstudied.Lastly,althoughwe

foundinourstudythatclinicswithEHRsseemtohavebettercoordinatedcareandmore

reliableofficeprocesses,ourcross-sectionalanalysisdoesnotprovecausation.Itisquite

possiblethatclinicswithbetterprocessesofcarewere“earlyadopters”and,thus,morelikely

tohaveEHRandE-reportingimplementedby2012.

Discussion

TheresultsofthisstudygeneratenewevidenceontheeffectsofHITonpatientsafetyinthe

ambulatorysetting.Wefoundthattheimplementationofelectroniclaboratoryandimaging

resultsreportingwasassociatedwithanincreaseinresultsnotavailableanduntimelyfollow-

upofabnormalresults.Thisassociationmayindicatevulnerabilitiesduringthediagnostic

processthatcancauseseriouslapsesindiagnosisandpatientcare.(30,39)Withsomuch

emphasisontheinpatientsetting,softwarevendorsmaynotoptimizeelectronicreporting

softwareandproductstosupporttheneedsofambulatorycarecliniciansfortimelyand

accuratediagnosisandtreatment.(40-41)However,theseresultsshowthatclinicdiagnostic

61

processesaresusceptibleduringtheimplementationphaseofneworupgradedHIT

systems.(42-44)

Ourstudyshowedthatthatsubscalesofpatientsafetyculturedemonstrateassociationswith

officeproblems,linkagesworthyoffurtherexplorationinambulatorycare.(45)Notably,we

alsofoundthatclinicswherestaffperceivedbettermanagementand/orleadershipsupportfor

patientsafetyalsoreportedmorefrequentinformationexchangeproblems.Theitemsinthis

dimensionaskaboutresourcesforquality,processimprovement,anddoingwhatisbestforthe

patient.Possibly,inaclinicwheremanagementand/orleadershipisstronglyfocusedon

patient-centeredcare,theclinicstaffhashigherexpectationsforcarecoordinationand

informationexchange,orismorelikelytoreportproblemsintheseareas.Notsurprisingly,as

showninTable7,whenstaffperceivedunfavorableworkpressureandpace,clinicswereless

likelytohaveimagingandlabresultsavailablewhenneeded.Patientsafetycultureisoften

viewedasacontextualfactorthatshapesstaffbehaviorsandattitudesinwaysthatmay

influencethequalityandefficacyofhealthcareprocesses.

Pre-implementationriskassessments,monitoringduringimplementation,measurement,and

post-implementationevaluationsarecrucialforthepreventionofHIT-relatederrors.(46)

Frameworks,modelsandtoolkitsareavailabletoHITprofessionalstounderstandandassess

thesafetyimplicationsofEHRimplementation.(47-49)Furthermore,theONC’sSafety

AssuranceFactorsforEHRResilience(SAFER)Guides,thatincludepre-implementation

checklistsandplanningtools,areavailablefortheimplementationofspecificelectronic

technologies.(50)Morespecifically,theTestResultsReportingandFollow-UpSAFERGuidecan

helpassesswhetheranorganization’scommunicationofdiagnostictestresultswithHITworks

asitshouldandisdesignedandimplementedtominimizethepotentialerrors.Practicescan

alsoassesstheimpactofHITontheirpatients’experiencesthroughuseoftheCG-CAHPS

supplementalitems.(51-52)

OurstudyfindingsaddtotheevidencebaseforthreeoftheeightgoalsintheNational

Academies’2015report,ImprovingDiagnosis.(28)First,thecommitteerecommended

establishingaworksystemandculturethatsupportsthediagnosticprocessandimprovements

indiagnosticperformance.Second,thecommitteehighlightedtheimportanceofHITin

enablingpatientsandhealthcareprofessionalsinthediagnosticprocess.Third,thecommittee

recommendedateamworkapproachtodiagnosis.Toachieveallofthesegoals,HITvendors,

clinicians,andpatientsneedanunderstandingoftheinteractionsbetweenorganizational

structures,processesandtoolsthatrelatetoensuringeffectiveandtimelycommunicationof

diagnosticallysalientinformation(e.g.,imagingresults,patientrecords,etc.).Inaddition,our

findingsunderscoretheneedforambulatorycareorganizationstofocusonpromotingaculture

thatvaluesopendiscussionandfeedbackonimpedimentstoimprovingdiagnostic

performance.(32)

ConsistentwithrecommendationsfromtheInstituteofMedicinein2011,theNQF-ledHIT

SafetyCommitteerecommendsbetterclinicaldocumentationandmoretimelytransmissionof

62

high-qualityclinicalinformationaspatientsmoveacrosscaresettings.(1,53)Additionally,

technology-basedinterventionsaimedatidentifyingpotentialpatientsafetyconcernsand

thosethatcanreducediagnosticerrorsshouldbetestedandimproved.(54)Diagnostic

improvementworkneedstoaddressclinicalreasoning,workflow,andsystem-levelsolutions

withinvolvementfromphysiciansandtheirteams,diagnosticserviceproviders,andhealthcare

organizationsinallsettings.(46,55-56)

Conclusions

AsmeasuredbytheAHRQMedicalOfficeSurveyonPatientSafetyCulture,fullimplementation

ofEHRswasassociatedwithlessfrequentofficeproblems,butnotassociatedwithcross-entity

informationexchangeproblems.Theimplementationofelectronicreportingofimagesandlab

resultswasassociatedwithmorefrequentdiagnostic-relatedofficeproblems.Clinicswithlow

patientsafetyculturereportedofficeproblemsmorefrequently.Moreresearchisneededto

understandtheunderlyingrisksandcausesoferrorsthatcanleadtodiagnosticerrorduring

andafterHITimplementationintheambulatorysetting.

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67

CHAPTER5

Paper3—Organizationalinfluencesontimepressurestressorsand

potentialpatientconsequencesinprimarycare

Co-Authors:HectorRodriguez,StephenShortell

68

Introduction

Over900millionpatientvisitsoccurannuallyinambulatorycareclinicsthroughouttheU.S.,

withalmosthalftoprimarycarephysicians.(1)Primarycareteamsfacedailytimepressuresin

attemptingtomeettheneedsoftheirpatients.(2,3)Timeconstraintstressorsoccurbothwithin

apatientencounter,(4,5)andmoregloballyastheclinicalteammanagesworkoutsideof

appointments.(6,7)

Timepressurecanaffectaltruisticbehaviors,asseendramaticallyinaseminallaboratorystudy

onseminarianswhowhenrushedwerelesslikelytostopandhelpamanwhoappearedto

needtogotoanemergencyroom.(8)Ameta-analysisofstudieswithsimilarmanipulationsto

createtimestressconditions(e.g.,pressurefrominstructionstogofaster,adeadlineora

controlledpacefortasks)comparedtonotimepressureshowedmodestdetrimentaleffectson

performance.(9)Despitethesalienceoftimestresstoprimarycarecliniciansandtheirstaff,

scantevidenceexistsabouttypesoftimestress,theorganizationalfactorsthatshapesuch

stressorsinroutinecaresettings,andconsequencesforpatientsandpractitionersalike.

Inresponse,weassesstheextenttowhichtwotypesoftimestressors–encounter-leveland

practice-leveltimepressure—areassociatedwithpoorerpatientreportedexperiencesofcare

andtheroleofselectedorganizationalstrategiesinmitigatingthisrelationship.Aspartofa

studyof16randomlyselectedprimarycarepracticesfromtwolargeAccountableCare

Organizations(ACOs)andtheiradultpatientswithcardiovasculardisease(CVD),diabetes,or

both,(10)weanalyzedteamperceptionsandpatient-reportedeffectsoftimestressorson

patientcare.

TheoreticalModelofTimeStressors,OrganizationalPredictorsandPatientConsequences

Organizationalperformanceofaworkteamisaffectedbythewayithandlesstressorsthat

comefromenvironmentaldemands.ForprimaryclinicsoperatingwithinACOs,thisrelationship

isshowninFigure12,andadaptedfromasynthesisofstressor-stress-performancetheories

appliedtothemilitarycontext.(11)Theenvironmentisoutsidethepicture,butshapes

corporateandclinicresponses,whichinturnresultinhigherorlowerlevelsoftimepressure

stressors,whichwhenexperiencedasstressbytheteam,translatetoeffectsonperformance.

69

Figure12.Stressor-Stress-PerformanceintheAmbulatoryCareContext

Basedonthisbroadtheory,wepositthatprimarycareclinicsrespondorganizationallyto

demandsfromtheenvironmentsuchasnewpaymentandregulatoryrequirementsandfrom

theircorporateparentorganizationtostaysolventandperformwellonqualitymetrics.Clinic

organizationallevelresponsesintermsofstaffingmodels,leadershipapproach,workprocesses

andsupportinfrastructuremaybemoreorlessadaptivetotheenvironmentalpressures,

resultinginhigherorlowerlevelsofstressorexertingforceontheteammembers.Weposit

thatspecificclinicandcorporateresponsestotheenvironmenttranslateintotwotypesof

stressorsrelatedtotimepressure:practice-leveltimepressureandencounter-leveltime

pressure.(12,13)Thestressorconditionissimilartotheweather–determinedbyboth

barometricpressureandtemperature–inpotentiallydifferentways.Wehypothesizethatthe

waysinwhichtheclinicoritscorporateparentorganizationshapethetwodistinctformsof

timepressurediffer,motivatinganexplorationofboththewaystheseconstructsmaybe

distinct,aswellasthewaysinwhichtheymaybemalleableininfluencingaclinic’spotentialto

changestressorlevels.

Greatertimepressureresultingfromactivitiesoutsideoftheindividualpatientencounterisreflectedinhigherlevelsofpractice-levelpace,operationalizedaschaosinpreviousstudiesof

70

clinicworkconditions.(14,15)Previousstudiesrestrictedassessmentstophysicians,andthis

studyextendstheoperationalapproachtoincludeperceptionsofallclinicpersonnel,thereby

reflectingabroaderconceptofpractice-leveltimepressure.Productionpressuretoseemore

patientsmorequicklyisconceptualizedastimepressurewithinencounters.Whileprevious

studieshavesoughtphysicianestimationsoftimeallocatedtoappointmentsversustime

neededtoprovidehighqualitycare,(15,16)ourstudyoperationalizespatientencounter-level

timepressurefortheentireteam,usingameasureofperceivedeffectsoftimepressurewithin

appointmentsonmissingimportantcareopportunitiesforscreening,diagnosisandtreatment.

(12)Thismeasurechoiceprovidesanassessmentofperceivedpatientsafetyeffectsof

encounter-leveltimepressure.Bothformsofthetimepressurestressor–withinandoutsideof

encounterswithpatients—arehypothesizedtocreateastressresponseattheindividualand

teamlevel.Inturn,theirresponsestotimepressure(stress)willaffecttheclinic’sperformance

onpatientreportedexperiences.Insummary,weaddressthreequestions:

1) WhatclinicfactorsareassociatedwithPractice-LevelTimePressure?

2) WhatclinicfactorsareassociatedwithEncounter-LevelTimePressure?

3) AretheseTimePressureconstructsassociatedwithPatient-ReportedExperienceofCare?

Forthefirstquestion,environmentalstressorsexertforceontheclinicasawhole,creating

practice-leveltimepressuretovaryingdegreesthatdependonclinicleadershipandworkgroup

rolewithinthepracticeteam.Wehypothesizethatthoseoccupyinglowerstatuspositionsin

theteam,suchasMedicalAssistants[MA],willreporthigherlevelsofpracticechaosbecause

theymayexperiencemorepractice-leveltimepressurefromcoveringmultipleoperational

taskswithlowcontroltomakepractice-levelimprovements,relativetothoseinhigherstatus

positionssuchasPrimaryCarePhysicians,NursePractitionersandotherNursingpersonnel.

(17–19)Moreleadershipresponsivenesstofrontlineneedsrelatedtochallengesunderway

fromprimarycaretransformationtopatient-centeredmedicalhomes,socalledleadership

facilitation,willbeassociatedwithlesspractice-leveltimepressure.(20,21)

Forthesecondresearchquestion,encounter-leveltimepressuremaybeperceivedbytheclinic

teamtoadverselyaffectpatientcare.AsshowninFigure12,wepositthatpracticesthatare

morepatient-centered,thatcoordinatetheirinterdependentworkbetter(relational

coordination),andthatusemoreHITcapabilitieswillbelesslikelytoreportadversetime

pressureeffectsduringpatientencounters.Solidarityamongteammemberscouldproduce

betterteamflexibilityandbeassociatedwithlessadversetimepressureeffects,orsucha

group-orientedculturecoulddistractattentionawayfrompatientcareandbeassociatedwith

moreadverseencounter-leveleffects.Fromthehumanfactorsandorganizationalsystems

literature,(22–24)perceivedpatientsafetyeffectsoftimepressurearehypothesizedtobe

similarregardlessofwhetherconcernexpressedrelatestomissingimportantdiagnosticandscreeningopportunitiesormissingtreatmentopportunities.

Toaddressthethirdresearchquestion,wetheorizethatpractice-leveltimepressure(as

measuredbypracticechaos)andencounter-leveltimepressureeffects(missedopportunities,

71

asperceivedbytheteammembers)eachadverselyinfluencepatientreportedexperiencesof

care(11-questionPACICinstrument)(25)Adequatetimewithinanencounterandtimecapacity

toorganizesupportiveresourcesarepotentialprerequisitesnecessary,butperhapsnot

sufficientforclinicteamstoprovideallofthenecessaryactionstomeetpatient’schroniccare

needs.Wehypothesizethatpatientsreceivingcarefrommoretimestressedpractices(both

encounter-levelandpractice-level)willreportexperiencinglowerlevelsofsupportfromthe

practiceinmanagingtheirchronicconditions.

Methods

StudyDesignOverview

Weanalyzedcross-sectionalsurveydatacollectedfromprimarycareteamsandtheirpatients,

participatinginthesecondwave(January-August,2016)oftheACTIVATElongitudinalstudyof

16practices.TheACTIVATEparentstudyprotocol,thecharacteristicsofthetwolargeregional

ACOsfromwhichtheclinicsweredrawn,andthefirstwaveofdataanalysisonpatient

engagementandpatient-reportedoutcomeshavebeenpreviouslyreported.(10)Inbrief,16

practiceswereselectedatrandom,evenlysplitfromeachACO’stopandbottomquartileof

clinicsbasedonpatientengagementactivitiesundertakenbythepracticesatbaseline.Patients

wererandomlysampledfromthesubsetofeachclinic’spatientpopulationthatmetinclusion

criteria(adults,EnglishorSpanishorunknownprimarylanguage,atleastonevisittothe

practiceinthepreviousyear,andclinicalevidenceofdiabetesorcardiovasculardiseasebased

onICD-9-CMdiagnosiscodesorprescriptionsfilled).

Thestudyreceivedapprovalpriortodatacollectionbytheinstitutionalreviewboard(IRB)of

theUniversityofCalifornia,Berkeley.

TeamAssessmentPracticeSurveyandTimeStressorMeasures

Allphysicians,nurses,medicalassistants,receptionistsandothersineachclinic’spracticeteam

receiveda20-questionsurveystartingJanuary27,2016,withdatacollectionclosingonApril

25,2016ataresponserateof84.37%(N=353).Thesurveyrepeatedtheinitialwave’sitems

reportedpreviously,(10)includingmultiplequestionsonpatient-centeredness,(26)solidarity

culture,(27)leadershipeffortstofacilitatechangeandsupportthefrontlineworkers,(28)and

relationalcoordinationamongthepeopleontheteamintheirrespectiverolesrelatedto

patientcare.(29)ThesurveyalsoincludedquestionsaboutHITcapabilities,notincludedinthe

firstwave.(14)(SeeAppendix5)

Thesurveyalsoincorporatedadditionalquestionsabouttimestressorsforthecurrentstudy’s

primaryaim.BasedontheworkofLinzeretal,(12,15)weincorporatedquestionsaboutthe

perceptionbypracticemembersoftimepressure(encounter-level)affectingpatientcareand

practicesitechaos(practice-leveltimestressor).

72

AspartoftheMinimizingError,MaximizingOutcome(MEMO)studyofprimarycareclinics,

Linzeretaldevelopedanovelscale(OSPRE-OccupationalStressandPreventableError)to

assessphysicians’self-reportedlikelihoodoffutureerrorscommittedinthemanagementof

commonchronicmedicalconditionsthatincludesmisseddiagnosticandscreening

opportunities,aswellastreatmentgaps.(12)Weadaptedthescaletoassessperceivedtime

pressureeffectsbyallmembersofthepracticeteam,notjustphysicians.Thedependent

variableisaseven-itembatteryassessinghowlikelyitisthattimepressurecausesthe

respondent’scareteamtooverlookaproactiveneedtodiagnoseorscreenapatientfora

healthproblem(5questions),ormissanimportanttreatmentopportunity(2questions).For

example,howlikelywoulditbeto‘overlookadiagnosisofhypertensionforapatientwith2-3

elevatedBPs’or‘notstartanACEinhibitorinadiabeticpatientforwhomitisindicated’?(The

fullscaleisshowninAppendix5.)

Aseparatesingle-itemscaleassessedpracticesitechaos(fromcalmtochaotic).Thechaosscale

wasdevelopedbasedonfocusgroupfindingsfromMEMO,(15)

andhasbeenreportedintwo

subsequentstudies.(30,31)Linzeretalfoundthatphysicianswhoratedtheirpracticeas

chaotic(4ormoreonthe5-pointscale)weremorelikelytoreporthigherstressandburnout.

(15)InamorerecentstudybyPerezetal,clinicswereclassifiedaschaoticifmorethan50%of

physiciansratedthepracticeatmosphereasa4or5.(31)Previousstudieshavenotassessed

chaosamongnon-physicianfrontlineteammembers,sotheextenttowhichrelationships

betweentimepressureandperceptionsofpracticesitechaosdifferforphysiciansandother

primarycareteammembersremainsunclear.

PatientSurveyFromMay16toAugust9,2016,wefieldedasurveybymailwithtelephonefollow-up,andthe

optiontoadministerinEnglishorSpanish.Thesurveyachieveda73.48%responserate

(N=1,291).Aspreviouslyreportedforthefirstwave,wecollecteddemographicinformationand

dataonpatient-reportedoutcomesofcare,(32)patientassessmentofthechronicillnesscare

thattheyreceived(PACIC-11),(25,33)andpatient-reportedactivation(PAM).(34)Inaddition,

thesurveyincludedCollaboRATE,a3-itemmeasureoftheextentthatpatientsbelievethatthe

practiceteamunderstandswhatmatterstothem,andprovidescriticalingredientsrequiredfor

collaborationbetweenthepracticeteamandthepatient(e.g.,listeningtothepatient).(35)

Becausethismeasurereferstotheprimarycaredoctorandothermembersofthepractice

team,thesurveyalsoasksthepatientswhethermembersoftheteaminadditiontothedoctor

playedanimportantroleintheircare.

StatisticalAnalysis

Forprimaryanalyses,werestrictedthesampletothecoreprimarycareteammemberroles

representedinalmostalloftheclinics:primarycarephysicians(N=75),nurses(N=70),medical

assistants(N=110),anddiabeticnurseeducators(N=19).Therewasminimalmissingdatafor

patientvariables(average1.1%,range0to3.4%)andformostteamvariables(average1.9%,

73

range0to9.1%).Asasensitivitytest,analyseswerealsoconductedonthefullsampleofcare

teammemberstoexaminetheconsistencyoftheresults.

Weconductedcorrelationanalysisonthecontinuoustimestressoritems(7itemsfortime

pressureeffectsandonepracticeatmosphereitem).Forallsummarydependentand

independentmeasures,weconductedfactoranalysisandobtainedacceptableCronbachalpha

internalconsistencyreliabilitycoefficientsof.82andabove.(36)

Weexaminedthehypothesizedassociationsbetweenorganizationalfactorsandthetwo

dichotomizedtimestressormeasuresusingmultivariatelogisticregressionmodelsandrobust

varianceestimators.Wealsoranacombinedmodelwithalloftheorganizationalfactorstotest

forhypothesizednullrelationshipsbetweenpredictorsofonetimestressorbutnottheother.

Weexaminedthehypothesizedassociationbetweeneachtimestressormeasuresummarized

atthecliniclevel(averagepercentageofrespondentsratingtheclinicabovethedichotomized

threshold)andpatient-reportedexperiencesofcare.Weestimatedhierarchicallinear

regressionmodelstoaccountforpatientsnestedwithinclinics.(37,38)Thesemodelscontrolled

forpatientcharacteristicsincludingage,educationalattainment,Englishlanguageproficiency,

patientactivation,patientreportedphysical,social,andemotionalhealthstatus.Allhierarchical

regressionanalyseswereperformedwithrestrictedmaximumlikelihood(REML)estimators,

advantageousforasmallnumberofclusters.DatawereanalyzedusingStata14.0(StataCorp

LP,CollegeStation,TX)andregressioncoefficientsatalevelof≤0.05wereconsidered

statisticallysignificant.

Results

PrimaryCareClinicandPatientCharacteristics

Table8showsthedescriptivestatisticsforkeyvariablesbasedonstudyclinicteamrespondents

(n=353)andpatientrespondents(n=1291).Clinicsvaryintheircompositionofoccupations

(receptionistandancillarystaffasapercentageoftotalrangedfrom0%to40%)andsize

(numberofrespondentsperclinicrangingfrom5-81).Forcliniccharacteristics,thecore

primarycareteammembers(primarycare,nursing,medicalassistant,diabeteseducator)

reportedsimilarvaluesastheentireteamofrespondentsforalldependentandindependent

variables.

Theadultpatientswithdiabetesand/orCVDestablishedwiththe16clinicswere57.2%female,

predominantlyEnglishspeaking(82.5%),andover44yearsold(95.9%)withatleastsome

collegeexposure(58.8%).Patient-reportedoutcomesforfunctionalstatusaveragedslightly

higherthanthemidpointofscalesforemotional(mean3.50,SD0.72),physical(mean3.93,SD

0.91)andsocialhealth(mean3.61,SD1.06),andpatientresponsesspannedtheentirescale

frompoorhealthatthelowendtofullfunctioningatthetopendforthepopulation.

74

Table8.DescriptiveStatisticsforKeyVariables

PracticeSurveyVariables MedicalTeam All Cronbachalpha(MedTeam)

N=274 N=353 Encounter-LevelTimePressureEffect,mean,SD[1-6] 4.94(1.14),

N=249

4.96(1.16),

N=280

.95(7items)

Encounter-LevelTimePressure–HighlyUnlikelytoMiss

AllDiagnostic,ScreeningandTreatmentOpportunities

[6]

78/249(31.3%) 94/280

(33.5%)

Encounter-LevelTimePressure,dichotomized(morevs

lesslikely[5+])

95/249

(38.2%)

101/280

(36.1%)

PracticeAtmosphere(calmtochaotic),mean,SD[1-5] 3.29(0.84),

N=272

3.26(0.86),

N=351

Practice-LevelTimePressure:chaos,dichotomized

(more[4+]vsless)

91/272(33.5%) 117/351(33.3%)

Relationalcoordination,mean(SD)[96-336] 256.16(42.62) 264.04(46.46) 0.90(7items)

Patientcenteredness,mean(SD)[0-25] 21.01(4.60) 20.73(4.69) 0.92(5items)

Healthinformationtechnology,mean(SD)[1-4] 3.52(0.55),

N=264

3.52(0.58),

N=323

0.88(8items)

Leadershipfacilitation,mean(SD)[0-35] 26.17(7.49) 26.19(7.71) 0.95(7items)

Solidarityculture,mean(SD)[0-20] 14.92(3.88) 14.78(3.88) 0.82(4items)

WorkgroupRole,N

Physician 75 75

Nurse 70 70

MedicalAssistant 110 110

DiabeticEducator 19 19

Receptionist - 74

Other:SocialWorker,Dietician - 5

ACO(#ofrespondents)

A 185 247

B 89 106

PracticeSites:ClinicAnonymousID#(ACOAorB) MedTeam%1(A) 15 23 65.2%

2(A) 38 53 71.7%

3(A) 8 11 72.7%

4(B) 4 5 80.0%

5(B) 10 12 83.3%

6(B) 19 25 76.0%

7(A) 9 15 60.0%

8(A) 9 13 69.2%

9(B) 10 15 66.7%

10(B) 6 6 100.0%

11(A) 37 37 100.0%

75

PracticeSites:ClinicAnonymousID#(ACOAorB) MedTeam%12(A) 10 14 71.4%

13(A) 59 81 72.8%

14(B) 8 9 88.9%

15(B) 10 11 90.9%

16(B) 22 23 95.7%

PatientSurveyVariables AllN=1291 Range Cronbachalpha

PatientAssessmentofChronicIllnessCare(PACIC),

mean(SD)N=1282

2.73(0.82) 1-4 0.92(11

items)

CollaboRATE,mean(SD)N=1269 3.61(1.08) 1-5 0.91(3items)

PatientActivationMeasure(PAM),mean(std.dev.) 3.25(0.51) 0-4 0.92(13

items)

Patient-ReportedOutcomes(higherscoresàbetter

function)

EmotionalFunctioning(PHQ-4/Depression),mean(std.

dev.)N=1284

3.50(0.72) 1-4 0.89(4items)

Physicalfunctioning,mean(SD)N=1290 3.93(0.91) 1-5 0.93(10

items)

Socialfunctioning,mean(SD)N=1288 3.61(1.06) 1-5 0.96(8items)

Age,years,no.(%)N=1278

18–24 4(0.3%)

25–44 48(3.8%)

45–64 446(34.9%)

65+ 780(61.0%)

Sex,no.(%)N=1282

Female 733(57.2%)

Male 549(42.8%)

Education,no.(%)N=1269

Grade8orless 152(12.0%)

GEDorsomehighschool 371(29.2%)

Four-yearcollegedegreeorsomecollege 573(45.2%)

Morethan4-yearcollegedegree 173(13.6%)

Englishlanguageproficiency,no.(%)N=1285

Yes 1060(82.5%)

No 225(17.5%)

Doctoronly,no.(%)N=1247

Yes(response=0) 561(45.0%)

No(othersplayedimportantrole=1) 686(55.0%)

76

TimeStressors:Encounter-LevelandPractice-Level

One-third(33.3%)ofrespondentsindicatedachaoticpracticeatmosphere.Only31.3%ofthe

coremedicalteamrespondedthatduringpatientencountersitwasveryunlikelyfortheclinic

teamtomissallsevenspecificopportunitiesrelatedtoscreening,diagnosisortreatment.These

encounter-leveltimepressureeffectswerehighlycorrelated(average0.73,range0.63to0.82

inpairwisecomparisonsamongthesevenitems)indicatingcomparablepotentialforpatient

safetyeffectsofmissedscreening,diagnosis,ortreatment.Practice-leveltimepressure,based

onatmospherefromcalmtochaotic,wasnotcorrelatedwithanyoftheencounter-leveltime

pressureeffects(0.02-0.05),supportingthehypothesisthatthesetwoseparatetimestressor

constructsaredistinct.

Figure13displaysthedichotomizedstressorvariables(encounter-leveltimepressureeffect

andpractice-leveltimepressure[chaos])byclinicforallrespondentsandcoremedicalteam

only.Theproportionofpersonnelfromagivenclinicwhoreportedastressorrangedfrom10%

to89%.Fourof16clinicshad50%ormoremedicalpersonnelperceivingachaoticpractice-

leveltimepressure(clinics1,7,12and14).Clinic14fromthechaoticsubgroup,andthree

otherclinics(8,9and10)hadgreaterthan50%ofthemedicalrespondentsreportinggreater

likelihoodofencounter-leveltimepressureeffectsonpatientmanagement.

Figure13.TimeStressorLevelsin16PrimaryCareClinics

77

OrganizationalFactorsAssociatedwithEachTypeofTimePressure

Table9and10eachshowthreemodelsforpractice-level(chaos)andencounter-leveltime

pressureeffects.IntheACO-onlymodels,theACOencounter-leveltimepressureeffectsare

indistinguishable,butrespondentsfromACOBarelesslikelytoreportpractice-levelchaos

(oddsratio(OR)0.52,p=0.03).

Thesecondsetofmultivariatemodelsexaminetheimpactofaddingclinicorganizational

variableshypothesizedtoberelatedtoeachtimestressor.Ashypothesized,encounter-level

timepressureadverseeffectsareassociatedwithlesspatient-centeredness(OR0.85,p<0.001),

lessHITcapability(OR0.46,p=0.003),andlessrelationalcoordinationamongteammembers

(OR0.98,p<0.001).Solidarityculture,however,wasnotassociatedwithencounter-leveltime

pressureeffects.Similarly,supportingthehypothesizedrelationshipsforpractice-leveltime

pressure,medicalassistantsweremorelikelytoreportachaoticpracticecomparedtoprimary

carephysicians,(OR2.30,p=0.03),andgreaterleadershipfacilitationwasassociatedwithlower

oddsofpractice-levelchaos(OR0.92,p<0.001).

Thefinalsetofmodelsincorporatedallindependentclinicvariablestotestwhetherdifferent

organizationalcharacteristicspredictoneofthetwotimestressors,butnottheotheras

hypothesized(nulltheory).ComparedtoreferenceClinic1,nineclinicsweremuchlesslikelyto

havepractice-levelchaos(OR0.05to0.18,p<0.05),andthreeclinicsweremorelikelyto

perceiveadverseencounter-leveltimepressureeffects(OR9.3-14.3,p<0.05).Clinics9and10

werestatisticallydifferentfromClinic1forbothpractice-levelchaos(lesslikely)andencounter-

leveltimepressureeffects(morelikely).Ashypothesized,leadershipfacilitationwasnot

associatedwithencounter-leveltimepressure,andpatient-centeredness,HITcapability,

relationalcoordinationandsolidarityculturewerenotassociatedwiththepresenceofpractice-

levelchaos.Contrarytothehypothesizedrelationship,bothnursesandmedicalassistants

weresignificantlylesslikelytoperceiveadverseencounter-leveltimepressureeffectson

patientcarecomparedtoprimarycarephysicians(OR0.24,p=0.001fornursesandOR0.21,

p<0.001formedicalassistants).

78

Table9.Practice-LevelTimePressure(Chaos)Models

79

Table10.Encounter-LevelTimePressureModels

TwoTypesofTimePressureandPatient-ReportedExperienceofChronicCare

Greaterpractice-leveltimepressure(chaos)wasassociatedwithlowerPACIC-11meanscores

(OR0.719,p<0.05)andremainedsignificantinmultivariateanalysisincludingpatient-reported

characteristicsandotherexperienceswiththeclinic(OR0.743,p<0.01)(Table11.Encounter-

leveltimepressurewasnotassociatedwithPACIC-11scoresineitherunadjustedoradjusted

analyses,thoughtheeffecttrendedintheexpecteddirection.

80

Amongcontrolvariables(Table11,Models3and4),womenreportedlowerPACICscoresthan

men,andthosewithan8thgradeeducationorlesshadhigherPACICscoresthanthosewith

moreeducation.PACICscoresdidnotvarysignificantlybypatientconditionorsymptoms

(patient-reportedfunctioning),ageorEnglishproficiency,allelseequal.Patientswhoindicated

thatteammembersintheprimarycarepracticebesidesthedoctorplayedanimportantrolein

theircarereportedhigherPACICscores.Higherlevelsofcollaborationwiththepracticeteam,

andgreaterpatientactivationlevelswerealsosignificantlyassociatedwithhigherPACICscores.

Wefoundnosubstantivechangestoanyresults(datanotshown)foralternativetimestressor

specifications–continuousinsteadofdichotomousclassification,allrespondentsinsteadof

medicalteamonly.

Table11.PatientExperienceofCare(PACIC)Models

Discussion

Timepressureeffectsforcarewithinanencounterwerenotcorrelatedwithpractice-leveltime

pressure(chaos).Thetwomeasuresusedinthisstudyseemtobecapturingdistinctprocesses

andexperiences,oratleastdifferentperceptionsabouttheclinicenvironmentanditspotential

effectsonpatientcare.Inthisstudyof16primarycarepractices,wefoundeverycombination

–onechaoticclinicwithconsiderableencounter-leveltimepressureeffects,severalchaotic

81

clinicswithoutperceivedencounter-leveltimepressureeffects,severalcalmorlowpractice-

leveltimepressureclinicswithperceivedencounter-leveltimepressureeffects,andfinally

relativelycalmclinicswithoutperceivedencounter-leveltimepressureeffectsofoverlooking

importantopportunitiestodiagnoseortreatpatientsduringtheirvisits.Thesepatterns

highlightthecomplexityofmanagingexperiencesandperceptionsoftimepressureforhealth

caresystemssuchastheACOswestudied.

Individualprimarycareteammembersexperienceencounterandglobalpractice-leveltime

stressorsindifferentwaysandwefoundsystematicdifferencesbyteammemberrole.Medical

assistantsweremorelikelytoperceivepracticechaoscomparedtoprimarycarephysicians,

controllingforothercliniceffects.Partofamedicalassistant’sroleistohelpthedoctorfocus

ondirectpatientcareworkbybufferinganyroughedgesinlogisticsandcommunications

outsidetheexamroom.(17–19)Somemedicalassistantsmaywanttoprotectdoctorsfromthe

chaoticsideoftheclinic.Alternatively,becauseoftheirlowerpositionalstatus,theymaynot

feelcomfortablesharinginformationaboutthechaoticenvironmentwithphysicians,orhave

muchefficacyinaddressingit.Wehypothesizednorelationshipbetweentimepressureeffects

withintheencounterandworkgrouprole.However,primarycarephysiciansweresignificantly

morelikelytoperceiveencounter-leveltimepressureeffectsonpatientcarecomparedto

medicalassistantsandnursingpersonnel.Physiciansmayhavethebestlineofsighttodetect

actualrisksfromtimepressureinanencounter,ortheymaytendtoworrymoreaboutadverse

effects,relativetotheotherteammembers.Iftheformersituationistrue,patientsafety

concernsmeritattentiontobalancingphysicianloads,addingscribes,exploringdelegation

arrangementsandothereffortstomitigateencounter-leveltimepressureeffects.

Ashypothesized,severalorganizationalfactorswereassociatedwitheachtimestressor.Atthe

practicesitelevel,moreleadershipfacilitation–includingmanagementassuringenoughtime

todiscusschangestoimprovecare–wasassociatedwithlesschaos.Attheencounterlevel,

morepatient-centeredness,betteravailabilityanduseofHITcapabilities,andhigherlevelsof

relationalcoordinationwereassociatedwithfewertimepressureeffects.Theprotective

directionforHITonencounter-leveltimepressurewasevenstrongeraftercontrollingforwork

groupandclinicsite,suggestingHIThasapotentiallypivotalroleinalleviatingtimestress

duringpatient-clinicianinteractions.Greatersolidarityamongteammemberscouldeither

increasetimepressureeffectsiftimeforpeersreducedcapacityforpatientcare,ortime

pressureeffectscouldlessengroup-orientedculturemeaningthatteammembersbackedeach

otherupmore,easingworkloads.Thelackoffindinganassociationbetweensolidarityandtime

pressureinourstudycouldmeanthatbothmechanismsoperateandcanceledouteffectsof

eachother.

Previousstudieshaveshownthatpractice-levelchaosisassociatedwithadversephysician

effectssuchaslowerjobsatisfactionandmoreburnout,butresultsaremixedforpatientsafety

andqualityeffects.(15,31)Wefoundasignificantrelationshipbetweenchaosandworse

patient-reportedexperienceofreceivingchroniccaresupport(PACIC-11).Themagnitudeofthe

associationwasconsistentafteradjustingfordemographics,patientengagement,andlevelof

82

patient-teampartnership(CollaboRATEandimportanceofnon-physicianteammembers).This

suggeststhatapracticecharacteristicperceivablebytheteam,especiallymedicalassistants,

maybeanimportantleverineffectivechroniccaremanagement.

LimitationsAlthoughthisstudybenefitsfrommultileveldatacollecteddirectlyfrompatientsandthe

clinicalteamsthatservethematarandomlyselectedsetofprimarycareclinicsintworegions,

ithasseverallimitations.First,encounter-leveltimepressureeffectsonpatientcarearebased

onperceptionaboutlikelihoodofmissingimportantcareneeds,andarenotverifiedbymedical

recordreview.Socialdesirabilitywouldsuggestthatweareunderestimatingthelikelihoodof

adverseeffectsforpatients,butitisalsoconceivablethatclinicians,particularlyphysicians,

worryaboutmissingopportunitiestoprovidenecessarycareandthereforeoverestimatethe

chancecomparedtootherprimarycareteammembers.Second,intheorganizationalfactors

analysis,butnotthepatientexperienceanalysis,independentanddependentmeasurescome

fromthesamesurvey,resultinginpotentialforcommonmethodvariancebiasinflating

correlationsamongthesameindividualsrespondingtoallthequestions,andincreasingthe

chanceofspuriousassociations.(39)Becauseweanalyzetwoseparatedependentvariablesina

fullmodelofallorganizationaldependentvariableswithnullresultsaspredicted,thisconcern

isnotasstrong.Third,thecross-sectionalnatureofthestudyprecludesconclusionsabout

causeandeffectintheassociationsdetected.Finally,thestudyislimitedtoprimarycare

practicesofACOs,andthereforeisnotnecessarilygeneralizabletootherpractice

environments.GiventhetransformationalgoalsofACOsandtheirincreasingroleinhealthcare

delivery,however,ourfindingsproviderelevantinsightintotimepressuresfacedbyprimary

careteammemberswithconsiderableincentivestosimultaneouslyimprovequalityofcareand

patientexperiences,whilealsoreducingtotalcostsofpatientcare.(40,41)

Conclusions

Ourstudybuildsonthelimitedbaseoforganizationalresearchabouttime-relatedstress

amonghealthcareprofessionals,theworktheydo,andtheconsequencesforpatients.This

studyprovidesinitialsupportforthenotionthattherearetwodistincttimestressconstructs

(patientencounter-levelandglobalpractice-level),withdistinctpotentialorganizationdesign

andculturecontributors,aswellasdifferentpossibleconsequencestopatientcare—missed

clinicalcareopportunitiesandlesspatientexperienceofchroniccaresupport.

Organizationscontroltimeallotmentstoworkers,andinturn,thepotentialstressexperienced

bythosedoingtheorganization’sworkifthereareinadequateallocations.Forface-to-face

clinicvisits,patientsaretypicallyscheduledforaparticulartimeallotment(e.g.,10minutes)

83

basedontheworkanticipated(basedonminimalinformationfrompatientswhocallin),the

reimbursementenvironment,andtheorganization’sfinancialcircumstances(e.g.,limited

resourcesforsafetynetproviders,productionpressureinforprofitoperations).(2)Patients

oftendonotknowthetimeallotment,thoughcuessuchasadoctor’smovementtowardthe

doororafullwaitingroommayconveyasenseoftimepressure,whileempatheticlisteninghas

theoppositeperceptualeffect.(42)Somephysiciansignoreappointmenttimelimitsinorderto

enhancetheirjobsatisfaction,eveniftheyanticipateadversefinancialconsequences.(43)

Practicesthataremorepatient-centeredmayprovidemoretimetotheclinicalteamtocarry

outtheirpatient-facingwork.Basedonourstudyresults,primarycarepracticesneedto

considerthepotentialeffectofmalleableorganizationalfactorssuchasHITcapabilityand

patient-centeredcultureontheleveloftimestressthatcouldbeassociatedwithpoorpatient

outcomes.Forlongitudinalchroniccaremanagementwithinthecontextofanadaptive

sociotechnicalsystemsapproach,timepressurebothwithinandoutsideencountersisrelevant

tooptimalpatientcare.(44,45)Givenhighburnoutlevelsofprimarycarecliniciansand

staff,(46)identifyingthedeterminantsandconsequencesofdifferentformsoftimestressin

primarycareiskeytodevelopingmitigatingstrategies.

GiventheincreaseinconsolidationsinambulatorycarewiththeemergenceofACOs,the

findingaboutanACOleveleffectonchaosunderscorestheutilityofdatacollectionand

analysisatmultiplelevels–patient,team,clinic,andparentorganization.WithACOs,the

practicalityofsuchdatacollectionhasimproved.SomeACOsmaybemotivatedtomonitor

practice-level(chaos)andencounter-leveltimepressureasearlywarningsignalsfortheir

workersandpatients,whotogetherareco-producinghealthoutcomes.(47)ACOsarealsoina

goodpositiontoworkcloselywiththeirfrontlineteamstoidentifythespecifictimestressors

thataremostconcerning,andwhetherinterventionstiedtoourfindingsmerittesting.For

example,HITisoftenimplicatedasincreasingclinicianburden,(48,49)yetspecificfeaturesof

HITassessedinthisstudyareassociatedwithperceptionsoflowerlikelihoodofmissing

diagnosesandtreatmentopportunities.Interventionsthataimtomakeaccessiblesomeof

thesecapabilitiessuchaseaseofassessingbasicdata,integratingdata,andcommunication

withotherprovidersandpatientscouldreducetimestressattheencounterlevel,andinturn,

potentialadverseconsequencestopatients.Likewise,thefocusforteamwork(i.e.,patient-

centeredness)andhowworkisorganizedandcoordinated(i.e.capabilitiesforrelational

coordinationamongthedifferentroles)maybeparticularlyimportantforbufferingphysicians

frommissingopportunitiestodiagnosisandtreatpatientsintheexamroom.(50)Intermsof

reducingpractice-leveltimepressure,recentresearchonchaoticpracticessuggeststhatclinic

leadersmightfocusfirstonspecificofficebottleneckchallengessuchasavailabilityof

interpreterservicesandphoneaccess.(31)

84

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CHAPTER6

FinalConclusionsandContributions

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Thethreeresearchpaperstogetheraimedtocontributetotheemergingareaofdiagnostic

safetyandqualityresearchwithaparticularfocusonorganizationalfactors.Byfocusingon

differentbutcomplementarysettingsinambulatorycare,takingqualitativeandquantitative

methodologicaltactics,workingwithintheNAMframework,(1)anddrawingfrom

organizationalscience,thisworkcontributesinsightsaboutwaysforambulatorycare

organizationstoimprovediagnosis.Thethreeprojectsalsocollectivelyprovideexamplesof

interrogatingkeyaspectsoftheNAMframeworkforimprovingdiagnosis,demonstratinghow

thisconceptualframeworkisusefulforpatient-centered,organizationallysensibleresearch.

Therefore,thecontributionsfromthissetofpapersareexpectedtobepractical,

methodologicalandtheoretical,whilealsoinformingfurtherresearch.

InsightsforAmbulatoryCareOrganizations

Asaqualitativefieldstudy,thefirstprojectstartedwithaproblemfacedbyfivespecialtyclinics

operatingunderchallengingcircumstancesfamiliartothosewhocareforeconomically

disadvantagedpopulationswithinsafetynetsettings.Theclinicteamsexpressedworryabout

patientsfallingthroughmetaphoriccracksinasystemofcareprimarilydesignedtohandle

patientsoneencounteratatime,asopposedtoacrosstimeandplace.Whenpatientshave

potentiallysinisterbutinconclusivefindings,theyneedlongitudinalfollow-upandtesting.Ifthe

clinicsareunabletotrack,communicateandseethesepatientsatintervalsdeterminedbytheir

uniqueclinicalsituations,theymayexperienceadelayedormisseddiagnosisofcancerand

otherlife-threateningconditions.Coordinationofcarechallengesacrosssettingsandtimeare

pervasiveandconsideredanationalpriority,butpreviousstudieshavenotrecognizedsuch

challengesforthispopulationofhigh-riskpatients.(2,3)

Thefirstpaperaddressedthatgapinpracticalterms.Theresearchsetuptheabilitytodesign

interventionsforrapidprototypingandtestinginthesafetynetenvironment,withaneyeto

problemsinworkflowandclinicianneedssurfacedfromtheresearch.Inparticular,theproduct

oftheresearch—potentialremediesintheformofdesignseeds–areprioritizedandassessed

fortheiranticipatedeffectsoncliniciantimeandpatientsafety.Commonvulnerabilities

includedshortcomingsinHIT,limitedorganizationalattentiontopopulationmanagementof

high-riskpatients,andextremelytime-crunchedpersonnel.Allthreeofthesevulnerabilities

arelikelypresentatnumerousotherspecialtyclinics.Thedesignseedapproachtodeveloping

keyattributesforrobustpopulation-levelmonitoringsolutionsenablescustomizationtoother

contexts(i.e.,otherspecialtyormulti-specialtyclinics),followedbytestingand

implementation.

Thesecondpaperstartedwithamuchbroadergroupofclinics,bothprimarycareandspecialty

clinicsfromeveryregionoftheU.S.,thatoptedintoagovernment-rundatabaseaboutpatient

safetycultureatmedicaloffices(clinics).Practicescompletingthesurveyrespondedto

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questionsaboutthefrequencyofofficequalityandsafetyissuesrelatedtothediagnostic

processsuchasincorrectpatientinformation,nothavingresultsavailablewhenneeded,

untimelyfollow-upofabnormaltestresults,andproblemsexchangingaccurate,complete,and

timelyinformationwithotherprovidertypes.Theclinicofficesalsoprovidedinformationabout

theirlevelofimplementationofHITsystemtools.

Usingmultivariableregressionmethods,thesecondprojectestimatedtheassociationbetween

office-reportedHITimplementationlevelsandperceivedfrequencyof8officeproblemsthat

couldleadtodiagnosticerrors,withandwithoutincludingstratifiedpatientsafetyculture

scoresattheclinicofficelevel.Separateanalysesofthesubscalesoftheculturesurveyincluded

oneonworkpressureandpace,atime-relatedvariableofinterest,thatdemonstratedan

associationwiththeofficeproblemoftestsnotavailablewhenneeded.Thefindingsalsooffer

partialsupportforthepaper’sthreemainhypothesesrelevanttoambulatorycareclinics:1)a

higherfrequencyofofficeproblemsthatcouldleadtodiagnosticerrorwereassociatedwith

partiallevelsofHITimplementationcomparedtonoimplementation,2)lowerfrequencyof

officeproblemswasassociatedwithfullHITimplementationcomparedtonoimplementation,

and3)worseofficesafetyculturewasassociatedwithmorefrequentofficeproblems.

Thethirdpaperwasmotivatedbyamajorgapintheliteratureabouteffectsoftimepressure

onteamworkintheclinicsetting,includingthepossibilityofmissingconsequentialdiagnoses.

Basedonthisobservation,thethirdprojectincorporatedmeasuresoftimepressureintoan

ongoingstudyofprimarycarepracticesinordertolearnaboutpotentialorganizational

determinantsandpatientconsequencesoftimepressureforteam-basedcare.

Thethirdproject’scross-sectionalobservationalapproachfoundassociationsbetweentime

pressureandorganizationalfactors,suchasHITcapabilities,patient-centeredculture,relational

coordinationamongpracticeteamsandleadershipfacilitationofchange,andinturn,

associationswithadverseconsequencesforpatients.Buttheseassociationsdonotconfirm

whatcomesfirst–theorganizationalfactorsreducingtimepressureeffectsinthetheorized

direction,orlesstimepressuregalvanizingorganizationstobecomemorepatient-centeredand

useHITcapabilitiesmorefrequently.Whileeitherexplanationispossible,theproject’s

measuresoftwotypesoftimepressureexperiencedbypracticeteammembers(i.e.,

encounter-levelandpractice-level)allowedtestingassociationsrelatedtohypothesized

significantdirectionaleffectsandnulleffects.Theanalysesprovidedsomesupportforthe

distinctionofeffectstheorized,wherebychangesintheorganizationalfactorswouldbe

expectedtocausechangesintimepressureeffects,andinturnhaveadverseconsequencesto

patients.Inthefuture,thestudycouldbeextendedwiththeencounter-levelandpractice-level

timepressurequestionsincorporatedinasubsequentsurveyofthesesameprimarycare

practicestoallowlongitudinalanalysisthatmoredirectlyexplorescauseandeffect

relationships.Additionally,examinationofinterviewdatacollectedfromtheprimarycareteam

membersatthese16practicesitesfromconcurrentfieldworkcouldprovidefurtherinsights

intothetimepressurefindings.

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TheoreticalandMethodologicalContributions

Thefirstpaperarticulatesbothtextuallyandvisuallyhowinterventiondevelopmentcanbe

informedbycomplexadaptablesocio-technicalsystemstheory.Thestudyalsolinksthe

researchfindingsofmorethan40vulnerabilitieselicitedfromtheclinicsdirectlytotheNAM

conceptualframework,demonstratingitsutilityasaconceptualmapinthisdomain.(1)Finally,

thefirstprojectdemonstratesanovelintegrationofindustrialandhumanfactorsmethods

(journeymapping,processtracing,designseeds)fororganizationalanalysisandintervention

designwithinthesafetynetsetting.

Akeycontributionfromthesecondpaperisitsfocusonofficeproblemsthatcouldleadto

diagnosticerror.Becausediagnosticsafetyisanemergingareaofconcerninhealthcare,

researchersaresomewhatstymiedbyalackofmeasuresofdiagnosticperformance.(1,4,5)In

themeantime,proxymeasuresareuseful.Thepaperdemonstratesthatofficeproblems,as

assessedinthisnationalsurveymayprovideonereasonablesignalforconcernsabout

diagnosticsafetygapsbecausetheyaresensitivetoHITandofficecultureinwaysthathave

facevalidity.Inaddition,thefindingscontributetotheexistingliteratureontheimportanceof

safetyculture.Thoseinthediagnosticsafetyarenaofresearchhaveaskedwhetheradiagnostic

safetyculturemeasureisneeded,apartfromgeneralsafetyculturemeasures.(1)Thisstudy

showsthattheMO-SOPSissensitivetoaproxymeasureofdiagnosticsafety.Furtherresearch

onthedomainscoveredbyMO-SOPSandotherdiagnosticsafety-relatedmeasureswouldhelp

determinewhetherthisgeneralsafetyculturemeasureforambulatorycaresettingsis

adequatelysensitivetoambulatorycarediagnosticsafetyconcerns.

Sincetheresearchliteratureontimepressureeffectsinactualpracticeisscant,thethird

paper’sobservationalmethodologycomplementswhatisknownfromexperimentalstudies

abouttheseeffects.Inaddition,theadaptationoftheLinzeretalmetriconmissed

opportunities(i.e.,encounter-leveltimepressureeffects)asametricofperceivedtime

pressurepatientsafetyeffects,includingdiagnosticerrors,wasprovenfeasibleinasurveyof

practiceteams.Asapotentialnewmeasure,theencounter-leveltimepressuremeasuregains

initialevidenceofconstructvaliditybasedonthedemonstratedassociationwithhypothesized

organizationally-shapedfactors.

Allthreestudiessetouttoexploretheoreticallyandempiricallyrelationshipsbetweenkey

componentsoftheNAMFramework(i.e.,worksystem,diagnosticprocess,diagnosticteam,

toolssuchasHIT,patientoutcomes,etc.).Forexample,eachstudyexploredsomeaspectof

HIT’sroleinexacerbatingorreducingtimepressurestressanditseffectsondiagnosticquality

andsafety.WithmajorHITinvestmentsunderwayandubiquitousawarenessoftheburdenof

medicaldocumentation,(6,7)findingsfromthistheoretically-informedresearchhasthe

potentialtoinformdecisionsbypolicymakers,innovators,anddeliverysystemsaboutchanging

theHITlandscapeinawaythatisresponsivetotheneedsofdiagnosisintheambulatorycare

setting.Moreimportantly,thecombinedstudyofHIT,timepressure,diagnosticteamworkand

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ambulatorycareorganizationsundertakenforthethreepapers5holdspromiseforimproving

diagnosisforpatients.

References

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DiagnosisinHealthCare.BaloghEP,MillerBT,BallJR,editors.ImprovingDiagnosisin

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2. SchultzEM,McDonaldKM,Schultz,EllenM;McDonaldKM.Whatiscarecoordination?

IntJCareCoord.2014;17(1–2):5–24.

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al.Patientsafetystrategiestargetedatdiagnosticerrors:Asystematicreview.Vol.158,

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BB,El-karehR,ElyJW,KanterMH,RaoG,etal.Methodologiesforevaluatingstrategies

toreducediagnosticerror:reportfromtheresearchsummitatthe7thInternational

DiagnosticErrorinMedicineConference.Diagnosis.Mar82016.2016;3(1):1–7.

6. ZulmanDM,ShahNH,VergheseA,SS-C,RBP,CAL,etal.EvolutionaryPressuresonthe

ElectronicHealthRecord:CaringforComplexity.Jama.2016;88(12):877–82.

7. MartinSA,SinskyCA.Themapisnottheterritory:medicalrecordsand21stcentury

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93

Appendices

Appendix1:ScriptforDataCollectiononDesignSeeds

Script: Thank you for taking the time to meet with me today. We have the opportunity to improve patient monitoring in your clinic. In order to meet your needs for improved monitoring, we’d like to validate our findings and get your feedback. Specifically, we would like to follow-up on the discussion you had with George Su regarding vulnerabilities of monitoring patients with high-risk conditions/ receiving high-risk treatment in your clinic. We’ve found that many other subspecialty clinics are facing similar challenges. We’d like to get your feedback on potential technology and organizational solutions that may alleviate the problems experienced in managing high-risk populations. Did we appropriately capture the problems you experience in your clinic? Do you think our suggested solutions will improve patient monitoring and efficiency? As we go through the exercise, I’d like to remind you that there is no correct or incorrect answer. Your responses allow us to get a better sense of your experiences monitoring high-risk situations in clinic. We expect this feedback collection exercise will take about 30 minutes. Thank you for your input! Instructions: Part I First, we’ll look at a list of the problems we heard about from each clinic. As you look at these problems, make a check next to those that you experience. You can circle problems that are even more relevant and make notes on these cards. Part II We’ll now look at a set of cards that list 13 suggestions to improve patient monitoring. The solutions respond to issues raised by at least one of the clinics we visited. From your vantage point at your clinic, think about patients who are at high-risk of being lost to follow-up and/ or require multiple steps or high effort to track/ monitor.

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We’ll also ask you to prioritize the cards according to importance. If you think a solution characteristic is particularly important, you can mark it with an asterisk so it is easier to rank them at the end of the exercise. We also encourage you to take notes or talk aloud if any other ideas come to mind. This will allow us to both refine our findings and better understand the differences between clinics. Here is the first solution card. All 13 look like this. This (pointing) is a statement from a specialty clinic’s viewpoint that motivates the solution attribute. The summarized solution attribute is in bold (pointing), followed by details related to the solution attribute (pointing). After you read the quoted statement and information in each box, please respond to the statements at the bottom. You can do this after I tell you one more thing. As you go through all the cards, please order them so that you end up with the most important solution card on the top and least important one on the bottom. It is fine to move them around as you go, or to go back through at the end. I will mark the cards 1-13 according to your final order. If we have time after the exercise, I’ll ask you to explain why you ranked in the order that you did. Ask for: Additional comments – reasons for ratings, choices, and thoughts about any of the potential solutions What clinic is participant representing?

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Appendix2:FeedbackFormforDataCollectiononDesignSeeds(examples)

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Appendix3:AdditionalWorkflows(breast,gastroenterology,urology)withTargets

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Appendix4:AllWorkflowsColor-codedasFoundationforProcessTraceSequences

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101

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Appendix5.ExcerptsfromACTIVATETeamSurvey:HITandTimePressure/Stressor

Questions

FromShortell,RodriguezandCHOIRTeamSurvey(questionsadaptedfromworkbyInaSebastion)

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FromShortell,Rodriguez,andCHOIRTeamSurvey;QuestionsareadaptedfromPWS(PhysicianWork-lifeStudy),

MEMO(MinimizingErrorMaximizingOutcome)andHWP(HealthyWorkPlace)studies,projectsdirectedbyMark

Linzer,MD.