3 acta2016 macissac - australian clinical trials alliance · evidence to help consumers, clinicians...

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Session S2 How to measure impact on Quality and Cost The Health Service Provider Perspective or A conversation on various points of view ADVANCING CLINICAL TRIALS & REGISTRIES WITHIN THE AUSTRALIAN HEALTH SYSTEM Jane Gray Executive Director HNE Local Health District Director of Partnerships, Innovation and Research Unit Peter MacIsaac Clinical Research Informatics Lead – HMRI & HNE

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Page 1: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

SessionS2HowtomeasureimpactonQualityandCostTheHealthServiceProviderPerspective

orAconversationonvariouspointsofview

ADVANCINGCLINICALTRIALS&REGISTRIESWITHINTHE

AUSTRALIANHEALTHSYSTEM

JaneGrayExecutiveDirectorHNELocalHealthDistrictDirectorofPartnerships,InnovationandResearchUnit

PeterMacIsaacClinicalResearchInformaticsLead– HMRI&HNE

Page 2: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

HealthServiceDeliveryPerspectiveonInvestigator-initiatedclinical‘publicgood’trials

Studiesconductedintheabsenceofcommercialinterestanddesignedtoanswerimportantclinicalquestions,providingunbiasedscientificevidencetohelpconsumers,cliniciansandpolicymakersmakedecisionsaboutwhichtreatments,testsandservicesaremosteffectiveorofferthebestvalueforthehealthcaresystem.

• Individualinvestigators• LocalResearchPrograms• ClinicalTrialNetworks• ClinicalQualityRegistries.

Page 3: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

HunterNewEnglandHealth

• AnnualBudget>$2billion• Population– 1million(approx.)• AreathesizeofEngland• 80facilities– notjusthospitals

• Mixoftertiary,generalandlocalhospitalsandhealthfacilities• PartnershipsbetweenLHD,GPs,Communityhealth,Ambulance

• Eachfacilityhaslocalmedical,nursing,alliedhealthdepartments– withvaryingdegreesoflocalautonomy

• 12Clinicalnetworks• Muchofthedecisionmakingaboutlocalmanagementincludingresearchactivityisdevolved.

Page 4: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

Whatmakeshealthservicestick?• Frameworkandpolicydriven• Budget– costsandservicesdelivered• ContextoftheAustralian“healthsystem”• Traditionalvalues:Servicequality,efficiency,researchandteaching• Guidingprinciples.- TripleAim• 4th Aim- researchengagementsupportsinnovationandchangecultureandwehopeisan“attractor”forourmajorresource– goodclinicians.

Page 5: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

ThisisthecontextwithinwhichhealthresearchsitsPrioritiesFlowFromPremiertoLocalHealthDistrict

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Page 7: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

Goonlineanddownload

KeySections&performancemeasures

Page 8: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

Ministryof

Health

NSWHealthPlan(3-5years)

LocalH

ealth

Distric

t

HNEHealthStrategicPlan/s(3-5years)

HNEHealthOperationalPlan(12Months)

Network/PortfolioOperationalPlan(12Months)

Network

Portfolio

Individu

al

Service/FacilityOperationalPlan(12Months)

IndividualPerformanceDevelopmentReview(PDR)

State

Governmen

tService

Facility

StatePlan- 2021(10yearhorizon)

HNE Health Planning and Accountability Framework

90DayActionPlan

ServiceAgreement

MonthlyAccountabilityMeetings

Individuallevel

Facilitylevel

LHDlevel

Page 9: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

EachinitiativeinourOperationalPlandrillsdowntoameasurewhichflowstoindividualleaders–allofwhomhave90dayactionplans

Numberofoverweightchildren7-13

Page 10: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

“Research”performancemeasuresrelatetoresearchgovernanceeffectiveness.However,researchcanalsohelpusdeliveronotherKPIs.

Note:with23%ofNSWAboriginalpopulation,wealsovalueresearchthathelpsClosetheGap

Page 11: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

ExamplesofResearchsupportingLHDpriorities

• GoForFun- aresearchprojectfocusingonincreasingphysicalactivityinschools.Thisaddressesakeypopulationhealthstrategy–reducingchildhoodobesityandalsomeetsoneoftheKPIsunderourserviceagreement

• DiabetesAlliance- partnershipwithourlocalPrimaryHealthcareNetwork,HunterPrimaryCareLtdandCalvarytoimproveprimaryType2diabetescare– keepingcareclosetohomeandfreeingscarcetertiaryresourcesforthemostcomplex,high-needsDiabetespatients.

• +++

Page 12: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

Evidencemeetsexperience

• Framekeystepsforresearchthroughaprogram- logicframeworkNeeds– Aims– Process– Outcomes– Implementation– Impact

• Targetissuesofimportancetoendusers- upfront

ProjectRetrosight – BrunelUniversity.Wodding etalUnderstandingfactorsassociatedwiththetranslationofcardiovascularresearch..ImplementationScience2014,(:47.FAIT– HMRI.SearlesA,etal.

Page 13: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

FrameworktoAssessImpactfromTranslationalhealthresearch– FAIT

• ModifiedPayback• Definedomainsofbenefit• Determinerelevantimpactmetrics• Inclusionofprocessmetrics.

• SocialReturnonInvestment• Costbenefit- $$return– supportsanalysisofmultiplebenefits,canbeextendedtoasocietalperspective

• $benefitfor$ofcost– alignswithcorporatethinking• Canbeincorporatedintotrialsandhealthservices

research• CaseStudies

• Providecontextandrelatetoeconomicanalysis• SummarizeasScorecard

• Prospectivelyintheplanningphase• Communicationtool

Page 14: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

EngagementwithLHDs.

• Whatwouldsuccesslooklike?• StartwiththedriversoftheLHDinmind.• Becautious:modelsofchangebasedprimarilyonfinancialincentivescanhaveunintendedoutcomesashasoccurredwith“payfortraining”ofmedical,nursingandalliedhealthstudents.

• HeterogeneityinLHDsize,structureandfunctionacrossthecountry &needtothinkregionalandincludePrimaryHealthcareNetworks- achallengeforengagement– uselocalnetworks

• Registries:Creatingaglobalpushforimprovedinformationmanagementsystemswillimprovepatientcare,efficiencyandbearesourceforresearch– oncetechnologymatures

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Researchrelatedactivity- HNE

• Research&InnovationAdvisoryCommittee(RIAC)- CEisamember• Partnerships,InnovationandResearchUnit- ledbyJaneGray• ResearchgovernanceandHealthResearchEthics- NicoleGerrand• RegionalResearchHub– ProfessorChrisLevi• Innovationandawardsprogram• HunterMedicalResearchInstitution– ProfessorMichaelNilsson• Communityengagement- Alliance(PHN&HNE)• Datawarehouseandimprovedaccesstodataforresearch,qualityimprovementandlinemanagement.

Page 17: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

Iftimepermits– diabetescasestudy

Page 18: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

What is the Diabetes population and workforce across Hunter and New England?

• ~60,000 patients with diabetes• 7700 patients with Type 1 Diabetes• 297 GP practices• 1032 GPs

• 27,000 patients in Newcastle cluster

• 2.75FTE Endocrinologist (public)

• 0.5FTE General Physician at Mater

• 3FTE Endocrinologist (private)

• 9.6FTE Diabetes educators

• ~1000+ New referrals/year at JHH

• ~4,500 follow ups

• 30Day and 3 month KPI not being met

• 33,000patients• 1FTE endocrinologist (recently changed to VMO in Tamworth

• 12 people employed by HNE to provide diabetes education

(unknown FTE diabetes time)

Page 19: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

Poorglycaemia

Hypoandhyperglycaemic

Diabeticemergencies,IncreasedLOS

IHD,CCF,CABG,Stroke

Retinopathy,maculopathyandblindness

ChronicKidneyDiseaseandDialysis

dependence,Transplants

PeripheralNeuropathy,Peripheral

Vasculardiseaseandamputations

Pregnancycomplications

Increasedmalformationsintheoffsprings

Psychosocialconsequences

suchasdepression

Mostaspectsofdiabetescomplicationsareeitherpreventableorreduciblebyearlyoptimaltherapy.1%HbA1creductionreducesmicrovascularcomplicationby40%asperUKPDSdata

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• Diabetes and its complications in the top 5 (COPD, CCF, Cellulitis, UTI) that contributed to 47% of preventable admissions and took

62% of bed days nationally

• Significant variation across the nation, rural and remote regions and those with low socioeconomic regions higher rates of admission

• Hunter and New England 2413 preventable admissions related to Diabetes

Page 21: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

• No of patients completing annual care cycles with eye and feet check, recommendations

implemented

• HbA1c at least 2 times a year (Optimal <7%, >9% very poor control, >11% immediate risks of

hospitalisation)

• Annual kidney function, lipids, urine for proteinuria (ACR)

• Those with high urine ACR on ACEI/ARB medications

• Those with absolute CV risk>10% be on statin therapy to prevent MI/Stroke/PVD

• Timely treatment escalation for those who are failing (HbA1c >7%)

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• Sub-optimalprocess:• 12.15%diabeticpatientsdon’tevengetasingleHbA1c>12months

• 33%patientsnotscreenedfornephropathy

• 12%nocholesterolrecorded

• Sub-optimaloutcomes:• 10.5%haveHbA1c>9%

• 6.5%withdocumentedabnormalmicroalbuminuriadonotreceiveACEI/ARB

• 31.5%withcholesterol>4mmol/lnotonmedication

• Problemmaybe– cliniciansnotunderstandingthe‘bigpicture’andperformancefeedbackinadditiontoknowledgeandskillsrequiredtomanageDiabetes

0102030405060

<=7% 7-8% 8-9% 9-11% >11% Missing

%DM

PatientsinPractice

HbA1c

HbA1c 6300 pts at very high risk of immediate

complications

Wouldweaccept6300breastcancerpatients

12.5%

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0

10

20

30

40

50

60

<=7% 7-8% 8-9% 9-11% >11% Missing

%DM

PatientsinPractice

HbA1c

HbA1c6300 pts at very high risk of

immediate complications

Wouldweaccept6300breastcancerpatientsnotbeingoptimallytreatedinourregion?

Whydowehaveinertiatowardsdiabetes?

12.5% don’t seem to get even 1 HbA1c annually

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• Creationofaregionaldiabetesqualityregistry

• Specialistteamstoupskill,supportandmonitorGPstoprovidethemajorityofcare

forpatientswithType2DiabetesMellitus

• Developadistrict-wideDiabetesServicethatprovidesSpecialistsupportto GP

practicesacrossallclusterswithinHNELHDusingamixedfacetoface+telehealth

model

• Improvetimelyaccesstothosewhowouldmostbenefitfromtertiaryservices

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First analysis showed

• 92%neededmedicationchanges

• 65%appropriatelyreferredashighrisk,resthigheducationalvalueforGPs

• 14%ofpatientsatveryhighriskofhospitaladmissionandcomplicationsreducedto5%by6months

• Ofthe65%appropriatelyreferred75%improvedtheirdiabetescontrol

• 51%ofthepatientslostweight

• Activitylevelincreasedfrom30%(>30mins/day)to75%(>30mins/day)

• 88%ofpatientsreportedimprovedknowledge,confidenceandskillsinselfmanagement,

• 100%involvedcliniciansfeltexperiencesatisfying/verysatisfying

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• At6monthsinterimfollow-upacross109patientsshowedHbA1cimprovedfrom60.2 ±15.9to55.1±12.5mmol/mol (p=0.0006);weightimprovedfrom100.1±20.6to98.7±21kg(p=0.02);totalcholesterol4.5±1.2to4.4±1.2mmol/l(0=0.04);systolicBP139±19to133±17mmHg(p=0.0003).

• 100%ofinvolvedcliniciansfelttheexperiencewas"satisfyingorverysatisfying".

MultiMillion$$$drugtrial

HunterAllianceproject

0.5%HbA1creduction

• 0.5%HbA1creduction

• Weightreduction

• Cholesterolreduction

• BPreduction

• 1500follow-upsaved

• Evidencethatbenefitsflowedto

other Diabetespatientsinthe

practice

• UpskillGPsandPracticenurses

• 68GP’seligiblefor40category1

pointsfromRACGP

=

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• 6 monthly feedback on performances, report + NPS portal access

• Regular feedback to each practice about HbA1c levels, urine ACR, BP, Lipids, Appropriate medications, foot and eye screening

• Ability to re identify high risk patients at practice levels to improve health

• Mentoring and integration of services 0

10

20

30

40

50

60

<=7% 7-8% 8-9% 9-11% >11% Missing

%DM

PatientsinPractice

HbA1c

05101520253035404550

AlbuminuriaonACEi/ARB

HypercholesterolaemiaonStatin

%DM

PatientsinPractice

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• Specialiststobeallocatedgeographicalclusterstofosterpartnershipsandresponsibleformonitoringofperformance

• BenchmarkagainstHNEaverageandoptimalperformance

• Identifythoserequiringsupport,frequentreferrers

• IdentifyGPchampions

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Supplementaryslides:

• FAIT• HNEResearchrelatedactivity• HunterNewEnglandCentralCoastMidNorthCoastResearchHub• RICHworkshops• HunterMedicalResearchInstitute

Page 32: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

QualityofCareRegistries– somethoughts• Thereisevidenceofeffectivenessandcosteffectivenessfrominternationalstudies– butbasedinafewcountrieswhohaveinvestedheavilyinthisapproachacrossthewholehealthsystem

• Registriestendtobe“singleissuefocused”notconnectedtoeachotherandduplicateresourcesandcouldbeseentobepotentiallyfragmentingthepatientrecord.

• Largeeffortindatacollectionatthelocallevel- aretherealsoresourcesforlocalinterpretationofdataandimprovementefforts.

• Clearlyusefulfornotonlyoutcomesresearch,butalsobenchmarkingwhensufficientdataisavailabletoallowformeaningfulcomparisons.

• Issues• Lackofinformationsystemsrelatingtoclinicalcare- makingdatacollectionaburden,ratherthanby-productofclinicalcare.Canweaffordtohaveanextensivenetworkofclinicalqualityregistrieswithoutunderpinningclinicalinformationsystems?

• Registriesshouldnotbeseenasanalternativetoeffectiveoperationalclinicaldatamanagement.• Timelinessofdataandfeedback– balancingexcellenceindataqualitywithtimelinessforimprovement

• Canweaccessourowndata,oftenseemstobedifficultonceitleavesourcontrol?• Opt-inconsentmodelsfor‘registries”addcomplexityandreduceuptake.

Page 33: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

ExamplesofwhatmightinterestLHDexecutives?• Balancingthebudget

• Newtechnology- whatislowvaluecarethatcanbeimprovedorremoved?• NeedforHealthTechnologyAssessmentthatiscontextaware- localised

• Qualityofcare• Meetingaccreditationstandards• Meetingqualityofcarestandards– increasingchallenge(especiallyinfaceoflackofclinicalinformationsystems)

• Safety– preventingandrespondingtoclinicalincidents

• Planningandprioritisation– servicedeliveryandresearch• Wherecanweputourresourcesandimpactofdemographicchanges.• Aclearapproachtoprioritisation-• Engagementofhealthservicesindefiningtheproblemsthatneedtobetackled.

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Research– Isitmakingadifference

• FrameworktoAssessImpactfromTranslationalhealthresearch• Encourageandmeasurebothresearchtranslation&researchimpact• StepsinTranslation

• Knowledgegeneration• Sharingofknowledge• Applicationtopractice• Multidirectionalandnonsequentialprocess

• ResearchImpact

Searlesetal.Anapproachtomeasuringandencouragingresearchtranslationandresearchimpact.HealthResearchPolicyandSystems(2016)14:60,DOI10.1186/s12961-016-0131-2

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• Joiningthedots-programlogicmodelfortacklingaproblem

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FAITKeyelements• ModifiedPayback

• Definedomainsofbenefit• Determinerelevantimpactmetrics• Inclusionofprocessmetrics.

• SocialReturnonInvestment• Costbenefit- $$return– supportsanalysisofmultiplebenefits,canbeextendedtoasocietalperspective

• $benefitfor$ofcost– alignswithcorporatethinking• Canbeincorporatedintotrialsandhealthservices

research• CaseStudies

• Providecontextandrelatetoeconomicanalysis• Scorecard

• Communicationtool

Page 37: 3 ACTA2016 MacIssac - Australian Clinical Trials Alliance · evidence to help consumers, clinicians and policymakers make decisions about which treatments, tests and services are

Researchrelatedactivity- HNE

• Research&InnovationAdvisoryCommittee(RIAC)- CEisamember• Partnerships,InnovationandResearchUnit- ledbyJaneGray• ResearchgovernanceandHealthResearchEthics- NicoleGerrand• RegionalResearchHub– ProfessorChrisLevi• Innovationandawardsprogram• HunterMedicalResearchInstitution– ProfessorMichaelNilsson• Communityengagement- Alliance(PHN&HNE)

• Diabetes– collaborativecare• AgedCare- primarycarephonesupportforRACF• EndofLifeCare• ChronicLungDisease

• Datawarehouseandimprovedaccesstodataforresearch,qualityimprovementandlinemanagement.

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• LocatedoncampusofHNEtertiaryreferralcentre– JohnHunter

• Fullresearchspectrum• basictoappliedscience• Widerangeofdiseases,socialdeterminantsofhealth,

healthservices• Engagementpatientcommunities,healthservices,healthpolicymakers,academicandclinicalresearchers

• Supportsresearch• Facilitiese.g.labs,MRI• Skills– epidemiology,studydesign,statistics,

informaticsandhealtheconomics• Funding(primaryandsecondary)

HunterMedicalResearchInstitute(HMRI)

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ResearchHub

• Leadresearchculture• 3LHDs,oneprivatehospital,&2universities

• 6RICHworkshops• 13researchissuesdeveloped• SeedfundingfromLHDandHMRI

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Clinicalnetworksandstreams

• 10yearsinthemaking• Bringclinicalcommunitiestogether• Keyexamples:

• Cardiac- standardisationofmodelsofcare,pre-hospitalthrombolysis• Stroke- regionalstrokeunitdevelopment

• Weareexploringnetworklevelapproachestoresearch– linkingresearchtotheissuesthatmattermosttoourcommunityandlocalclinicians

• DespiteAustralia’ssomewhatfragmentedhealthsystem(Commonwealth/State,Public/Private)wehavecreatednewpartnershipsthatkeepthehealthneedsoflocalcommunitiesasthefocus

e.g.ShouldosteoporosisandfracturepreventionbedeliveredwithahospitalbasedmodeloronethatengageswithcommunityresourcessuchasPHNsandGPs?