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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
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
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
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
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