Reducing External Barriers to Reducing External Barriers to Acute Stroke CareAcute Stroke Care

The INSTINCT TrialThe INSTINCT Trial

NIH / NINDS R01 NS050372

BackgroundBackground

Stroke patients, properly treated with tPA, Stroke patients, properly treated with tPA, have an 11% absolute greater chance of have an 11% absolute greater chance of a normal outcome compared to untreated a normal outcome compared to untreated patients.patients.

Current Treatment Rates are 1-3% of all Current Treatment Rates are 1-3% of all ischemic strokesischemic strokes

Optimized systems demonstrate Optimized systems demonstrate treatment rates of 8-15%treatment rates of 8-15%

ObjectivesObjectives

Review INSTINCT trial methods for Review INSTINCT trial methods for identification of local barriersidentification of local barriers

Understand taxonomy of barriers to Understand taxonomy of barriers to increasing tPA use in strokeincreasing tPA use in stroke

Enhance awareness of Enhance awareness of local externallocal external barriers to tPA use in strokebarriers to tPA use in stroke

Develop methods to address selected Develop methods to address selected barriersbarriers

The INSTINCT TrialThe INSTINCT Trial

To test whether hospitals receiving the To test whether hospitals receiving the educational intervention have a ≥ 4% educational intervention have a ≥ 4% increase in appropriate tPA use compared increase in appropriate tPA use compared to matched controlsto matched controls

To test whether the intervention enhances To test whether the intervention enhances EP knowledge, beliefs and attitudes EP knowledge, beliefs and attitudes regarding tPA use in strokeregarding tPA use in stroke

INSTINCT HospitalsINSTINCT Hospitals

Trial SpecificsTrial Specifics

Multi-center, randomized, controlled trial Multi-center, randomized, controlled trial testing a multi-level, systems-based, testing a multi-level, systems-based, educational intervention educational intervention Intervention based on adult education Intervention based on adult education and behavior change theoryand behavior change theoryTailored to local needs by identifying Tailored to local needs by identifying local barrierslocal barriersBased on clinical pilot dataBased on clinical pilot data

12 Matched Pairs of Michigan Hospitals ( n = 24 )

Champions Meeting (Ann Arbor) Protocol review with teams

Treatment Barrier Discussion Intervention Description

On-site Barrier Assessment Acute stroke tx process evaluation

Focus groups/Interviews with stakeholders (EM, Radiology, Neurology, Admin)

Local Champion development

Educational Intervention 1 Mock stroke code (EMS & ER)

Offer tailored CME lectures (2 hours) Offer stroke tPA-expert access (telephone)

Anonymous site performance feedback (email) Stroke reminder feedback (email)

Critical Incident debriefing for any complications

Educational Intervention 2 Mock stroke code (EMS & ER)

Offer tailored CME lectures (2 hours) Continue stroke tPA-expert access (telephone)

Continue site performance feedback (email) Continue stroke reminder feedback (email)

Continue CID for any complications

Outcome Assessment Monthly assessment of rt-PA use Quarterly ICD-9 stroke d/c data

Proportion of tPA treated strokes Emergency Physician Survey

Outcome Assessment Monthly assessment of rt-PA use Quarterly ICD-9 stroke d/c data

Proportion of tPA treated strokes Emergency Physician Survey

Control Intervention

Baseline

3 months

6 months

9 months

CROSSOVER

Outcome MeasuresOutcome Measures

∆ ∆ % of tPA-treated stroke patients% of tPA-treated stroke patients

∆ ∆ % of “appropriately” tPA-treated stroke % of “appropriately” tPA-treated stroke patientspatients

∆ ∆ % of tPA-treated stroke patients pre- % of tPA-treated stroke patients pre- and post-interventionand post-intervention

Pre- and post-intervention change in Pre- and post-intervention change in physician knowledge, beliefs and attitudesphysician knowledge, beliefs and attitudes

General measures of effectiveness of txGeneral measures of effectiveness of tx

What Barriers Prevent Physicians from What Barriers Prevent Physicians from Following Guidelines?Following Guidelines?

Screened 5,658 articles describing barriers Screened 5,658 articles describing barriers to guideline adherenceto guideline adherence

76 selected based on focus on clinical 76 selected based on focus on clinical guidelines and examination of at least 1 guidelines and examination of at least 1 barrierbarrier– Contained 120 different surveysContained 120 different surveys– Evaluating 293 potential barriersEvaluating 293 potential barriers

Interrater reliability for selection, k = 0.93Interrater reliability for selection, k = 0.93

Cabana et al: Why Don’t Physicians Follow Clinical Practice Guidelines? JAMA. 1999;282:1458-1465

Cabana, M. D. et al. JAMA 1999;282:1458-1465.

Barriers to Physician Adherence to Practice Guidelines in Relation to Behavior Change

External Barriers: OverviewExternal Barriers: Overview

Guideline relatedGuideline related– Difficult to useDifficult to use– InconvenientInconvenient– Confusing / contradictoryConfusing / contradictory

Patient relatedPatient related– Time to arrivalTime to arrival– Patient expectations vs. realityPatient expectations vs. reality

EnvironmentalEnvironmental– Lack of timeLack of time– Lack of resourcesLack of resources– Organizational constraintsOrganizational constraints– Lack of reimbursementLack of reimbursement– Medical-legal issuesMedical-legal issues

Cabana et al: Why Don’t Physicians Follow Clinical Practice Guidelines? JAMA. 1999;282:1458-1465

Stroke Treatment StakeholdersStroke Treatment Stakeholders

Patients and CommunityPatients and CommunityEMSEMSEmergency department staffEmergency department staffRadiologyRadiologyNeurologyNeurologyIntensive care staffIntensive care staffPrimary care physiciansPrimary care physiciansAdministratorsAdministrators

Overcoming BarriersOvercoming Barriers

Data QuestionsData Questions

EffectivenessEffectiveness

Delivery Delivery SystemsSystems

Specialist Specialist SupportSupport

External Barriers: LocalExternal Barriers: Local

Insert customized data from INSTINCT Insert customized data from INSTINCT Barrier Assessment process for each Barrier Assessment process for each intervention siteintervention site

Local External Barriers: Local External Barriers: Emergency Physician SurveyEmergency Physician Survey

Insert customized data from INSTINCT Insert customized data from INSTINCT Barrier Assessment process for each Barrier Assessment process for each intervention siteintervention site

Local External Barriers: Local External Barriers: Qualitative AssessmentQualitative Assessment

Insert customized data from INSTINCT Insert customized data from INSTINCT Barrier Assessment process for each Barrier Assessment process for each intervention siteintervention site

Group Discussion: SolutionsGroup Discussion: Solutions

Tailor remaining discussion and slides to Tailor remaining discussion and slides to specific external barriers identifiedspecific external barriers identified

Examples followExamples follow

Transforming Acute CareTransforming Acute Care

Recognize stakeholders in Recognize stakeholders in treatment and find treatment and find agreementagreement

Improve “Detection-Door-Improve “Detection-Door-Data-Decision-Drug” Data-Decision-Drug” process process – Outpatient / EDOutpatient / ED– InpatientInpatient

Napoleon greeting Baron Larrey,his Surgeon-in-Chief at Waterloo

EP ABILITY TO Dx STROKEEP ABILITY TO Dx STROKE

Variable reportsVariable reports

Kothari 1996 - 100% sensitivity, 98.6% Kothari 1996 - 100% sensitivity, 98.6% specificityspecificity

Alder 1999 - 6/70 patients misdiagnosed Alder 1999 - 6/70 patients misdiagnosed (UK)(UK)

Libman 1996 - 19% stroke “mimics”Libman 1996 - 19% stroke “mimics”

Impact of Stroke System Impact of Stroke System DevelopmentDevelopment

StudyStudy LocatioLocationn

NN % % TreatedTreated

YearYear

Grond et alGrond et al CologneCologne 100100 22%22% 1996 -1996 -19971997

Lindsberg Lindsberg PJ et alPJ et al

HelsinkiHelsinki 7575 2.14%2.14% 1998-20011998-2001

Rymer et alRymer et al Kansas Kansas CityCity

142142 18.2%18.2% 2000-20032000-2003

HeuschmanHeuschmann et aln et al

German German stroke stroke registryregistry

384384 3%3% 20002000

NEUROLOGYNEUROLOGY

<50% neurologists treating with t-PA<50% neurologists treating with t-PA

Significant number are skepticalSignificant number are skeptical

Lack of reimbursementLack of reimbursement

Lack of neurologistsLack of neurologists

RADIOLOGYRADIOLOGY

Who can interpret CT’s?Who can interpret CT’s?

Availability of radiology interpsAvailability of radiology interps

What about early hypodensity?What about early hypodensity?

ECASS dataECASS data

Schriger studySchriger study

ICH ManagementICH Management

Suspecting ICHSuspecting ICH

Stat Head CTStat Head CT

LabsLabs– CBC, Plts, Coags, CBC, Plts, Coags,

Fibrinogen, T&SFibrinogen, T&S

PreparePrepare– 6-8 units cryoprecipitate6-8 units cryoprecipitate– 6-8 units platelets6-8 units platelets

ConsultationConsultation– NeurosurgeryNeurosurgery– HematologyHematology

149

137

58

52

48

14

17

168

84141

113163* 161*120*

ToolsTools

ProtocolProtocol

NIHSSNIHSS

Triage toolsTriage tools

EMS toolsEMS tools

Informed consentInformed consent

Post-treatment care guidelinesPost-treatment care guidelines

Brain Injury Group AccessBrain Injury Group Access

Contact informationContact information

Telemedicine: ResultsTelemedicine: Results

24 patients evaluated over 2 years24 patients evaluated over 2 years

50% with Telestroke consultation50% with Telestroke consultation

75% of eligible patients treated with tPA75% of eligible patients treated with tPA

Mean consult-to-drug time = 36 minMean consult-to-drug time = 36 min

Avoided transfer in 46% of patientsAvoided transfer in 46% of patients

Decision: tPA ExcludedDecision: tPA Excluded

Benefit still occurs – for patients and systemBenefit still occurs – for patients and system

Start stroke management pathway in EDStart stroke management pathway in ED

Orders to begin now:Orders to begin now:– AspirinAspirin– ThermoregulationThermoregulation– Glucose regulationGlucose regulation– NPO - until swallowing evaluatedNPO - until swallowing evaluated– DVT Prophylaxis DVT Prophylaxis – Rehab/SW consults initiatedRehab/SW consults initiated

Larger Systems of Stroke CareLarger Systems of Stroke Care

Market forces / local Market forces / local interestinterest

GIS analysis GIS analysis

Optimum locations for Optimum locations for stroke centersstroke centers

Maximum coverage with Maximum coverage with minimum costsminimum costs

Combines modelsCombines models

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Michigan

Wisconsin

Illinois

OhioIndiana

Minnesota

Iowa

±0 130 26065 Miles

Population Coverage with 81 Hospitals

The Current National Stroke RealityThe Current National Stroke Reality

A Vision of the Future…A Vision of the Future…

The ImpactThe Impact

(T.E. Dec 2003, 37 yo female RN)

SummarySummary

Thrombolytic treatment rates remain below those reported in optimized systemsMultiple barriers exist to changing system behavior toward strokeA multi-level educational intervention creates the optimal chance for system change If successful, INSTINCT may serve as a model to enhance delivery of other complex medical therapies

Changing Stroke SystemsChanging Stroke Systems