ambulatory care organizations: improving diagnosis...dissertation. all my stanford health policy...
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AmbulatoryCareOrganizations:ImprovingDiagnosis
by
KathrynMackMcDonald
Adissertationsubmittedinpartialsatisfactionoftherequirementsforthedegreeof
DoctorofPhilosophy
inHealthPolicy
inthe
GraduateDivisionofthe
UniversityofCalifornia,Berkeley
Committeeincharge:
ProfessorStephenM.Shortell,ChairProfessorHectorP.RodriguezProfessorThomasG.RundallProfessorUrmimalaSarkar
Spring2017
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©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.
References
1. IndustriesataGlance:AmbulatoryHealthCareServices:NAICS621[Internet].BureauofLaborStatistics.[cited2016Oct30].Availablefrom:http://www.bls.gov/iag/tgs/iag621.htm
2. IndustriesataGlance:HealthCareandSocialAssistance:NAICS62[Internet].BureauofLaborStatistics.[cited2016Oct30].Availablefrom:http://www.bls.gov/iag/tgs/iag62.htm
3. NationalCenterForHealthStatistics.NationalAmbulatoryMedicalCareSurvey:2012StateandNationalSummaryTables[Internet].2012[cited2017Apr22].Availablefrom:https://www.cdc.gov/nchs/data/ahcd/namcs_summary/2012_namcs_web_tables.pdf
4. OECDHealthStatistics2016-OECD[Internet].2016[cited2016Oct30].Availablefrom:http://www.oecd.org/health/health-data.htm
5. OECD.Focus-Health-Spending-2015.OECDHealStat.2015;(July):1–8.6. Farrell,Diana;Jensen,Eric;Kocher,Bob;Lovegrove,Nick;Melhem,Fareed;Mendonca,
Lenny;ParishB.AccountingforthecostofUShealthcare :AnewlookatwhyAmericansspendmore.2008.
7. SchoenC.TheAffordableCareActandtheU.S.Economy:AFive-YearPerspective.2016.
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8. WachterRM.IsAmbulatoryPatientSafetyJustLikeHospitalSafety,Onlywithoutthe“Stat”?AnnInternMed.2006Oct3;145(7):547.
9. GandhiTK,LeeTH.PatientSafetybeyondtheHospital.NEnglJMed.2010Sep9;363(11):1001–3.
10. HammonsT,PilandNF,SmallSD,HatlieMJ,BurstinHR.Ambulatorypatientsafety:whatweknowandneedtoknow.JAmbulCareManage.2003;26(1):63–82.
11. SarkarU,WachterRM,SchroederSA,SchillingerD.Refocusingthelens:patientsafetyinambulatorychronicdiseasecare.JtCommJQualpatientSaf.2009Jul;35(7):377–83,341.
12. PanesarSS,DeSilvaD,Carson-StevensA,CresswellKM,SalvillaSA,SlightSP,etal.Howsafeisprimarycare?Asystematicreview.BMJQualSaf.2016Jul;25(7):544–53.
13. SarkarU.Tipoftheiceberg:patientsafetyincidentsinprimarycare.BMJQualSaf.2016Jul;25(7):477–9.
14. Shekelle,PG,SarkarU,ShojaniaK,WachterRM,McDonaldK,MotalaA,SmithP,ZippererLSR.PatientSafetyinAmbulatorySettings.TechnicalBriefNo.27.AHRQPublicationNo.16-EHC033-EF.Rockville,MD;2016.
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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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.
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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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28. Gittell,JH;Edmondson,A;ScheinE.LearningtoCoordinate:ARelationalModelofOrganizationalChange.SanAntonio,Texas;2011.
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51. SinghH,GraberML,TimothyP.MeasurestoImproveDiagnosticSafetyinClinicalPractice.2016;0(0):1–6.
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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
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• 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
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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.
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Figure8.TechnicalInterventionDevelopmentCycle:Example
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Figure9.Socio-TechnicalInterventionDevelopmentCycle:DesignSeedExample
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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.
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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.
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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.
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ConclusionsWecarriedoutamulti-stageresearchprocesswithspecialtyclinicsatanurbanpubliclyfundedhealthsystemtoaddressanimportantevidence-basedsafetygapinambulatorycare:potentiallypreventableandconsequentialdiagnosticandmonitoringdelays.Basedonsurfacingalargenumberofcommonvulnerabilitiesamongtheclinics,wespecifiedandvalidatedkeyattributesforarobustsocio-technicalapproachtoimprovingoutpatientmonitoringthatisgearedtoenablecontext-sensitiveimplementation,utilizingindustrialandhumanfactorsmethodslinkedtoimplementationtheory.
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70. ChaudoirSR,DuganAG,BarrCH.Measuringfactorsaffectingimplementationofhealthinnovations:asystematicreviewofstructural,organizational,provider,patient,andinnovationlevelmeasures.ImplementSci.2013;8:1–20.doi:10.1186/1748-5908-8-22.
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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
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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
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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
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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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29. KellermannAL,JonesSS.Whatitwilltaketoachievetheas-yet-unfulfilledpromisesof
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42. Health,Education,LaborandPensions(HELP)CommitteeHearing.Achievingthepromise
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49. AHRQWorkflowassessmentforhealthITtoolkit.AccessedAug8,2016at
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51. McInnesDK,BrownJ,HayR,etal.DevelopmentandEvaluationofCAHPS®Questionsto
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54. SittigDF,SinghH.Improvingtestresultfollow-upthroughelectronichealthrecords
requiresmorethanjustanalert.JGenInternMed2012;27:1235-7.55. BabbottS,ManwellLB,BrownR,etal.2014.Electronicmedicalrecordsandphysician
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56. ShortellSM,SingerSJ.Improvingpatientsafetybytakingsystemsseriously.JAMA.2008
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CHAPTER5
Paper3—Organizationalinfluencesontimepressurestressorsand
potentialpatientconsequencesinprimarycare
Co-Authors:HectorRodriguez,StephenShortell
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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.
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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
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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,
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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).
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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%,
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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.
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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%
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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%)
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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
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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).
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Table9.Practice-LevelTimePressure(Chaos)Models
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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.
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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
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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
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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)
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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)
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43. SolomonJ.Howstrategiesformanagingpatientvisittimeaffectphysicianjob
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48. ZulmanDM,ShahNH,VergheseA,SS-C,RBP,CAL,etal.EvolutionaryPressuresonthe
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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
1. CommitteeonDiagnosticErrorinHealthCare,NationalAcademyofMedicine.Improving
DiagnosisinHealthCare.BaloghEP,MillerBT,BallJR,editors.ImprovingDiagnosisin
HealthCare.Washington,D.C.:NationalAcademiesPress;2015.
2. SchultzEM,McDonaldKM,Schultz,EllenM;McDonaldKM.Whatiscarecoordination?
IntJCareCoord.2014;17(1–2):5–24.
3. McDonaldKM,MatesicB,Contopoulos-IoannidisDG,LonhartJ,SchmidtE,PinedaN,et
al.Patientsafetystrategiestargetedatdiagnosticerrors:Asystematicreview.Vol.158,
AnnalsofInternalMedicine.2013.p.381–9.
4. McGlynnEA,McDonaldKM,CasselCK.MeasurementIsEssentialforImprovingDiagnosis
andReducingDiagnosticError:AReportFromtheInstituteofMedicine.Jama.
2015;314(23):2501–2.
5. BruceBBElyJW,KanterMH,RaoG,SchiffGD,tenBergMJ,McDonaldKME-KR,Bruce
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
practice.Lancet.2016;6736(16):1–4.
5ThecreativebasisforthisDissertation’slogo,displayedonthededicationpageandafterthischapter.
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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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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.