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UMASS Memorial Health UMASS Memorial Health CareCare
Improving Patient Care Improving Patient Care ManagementManagement
Pamela Burgwinkle APRN-BC, Pamela Burgwinkle APRN-BC, CACPCACP
Presented Presented
November 4, 2008November 4, 2008
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22
Historical PerspectiveHistorical Perspective
Coordinated Anticoagulation Clinics in Coordinated Anticoagulation Clinics in United States Since 1950United States Since 1950
UMass Medical Center (UMMC) UMass Medical Center (UMMC) Established 1970sEstablished 1970s
Point of Care (POC) Testing 1980sPoint of Care (POC) Testing 1980s approximately 250 patientsapproximately 250 patients
Patient Self Testing (PST)/Patient Self Patient Self Testing (PST)/Patient Self Management (PSM) 1980sManagement (PSM) 1980s
14 patients/1 continues with PST/PSM14 patients/1 continues with PST/PSM
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UMassMemorial Healthcare UMassMemorial Healthcare (UMMHC) Anticoagulation (UMMHC) Anticoagulation Center (ACC)Center (ACC)
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44
UMMHC ACCUMMHC ACC
Warfarin /POC TestingWarfarin /POC Testing Peri-Procedure/OperativePeri-Procedure/Operative Patient Self TestingPatient Self Testing Thrombophilia ScreeningThrombophilia Screening High-Risk PregnancyHigh-Risk Pregnancy
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55
UMMC ACCUMMC ACC
Approx 1650 active patientsApprox 1650 active patients
– 65% Point-of-care65% Point-of-care– 23% Lab draw/VNA23% Lab draw/VNA– 12% patient self testers/pending12% patient self testers/pending
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66
UMMC ACCUMMC ACC
Quality MeasuresQuality Measures– Time in Therapeutic Range Time in Therapeutic Range
(TTR)(TTR)
Benchmark: 66%Benchmark: 66%– Thrombotic/Hemorrhagic EventsThrombotic/Hemorrhagic Events– PresGaney-Patient SatisfactionPresGaney-Patient Satisfaction
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77
Greater Rates of TTRGreater Rates of TTR
Health Belief SystemHealth Belief System Patient EducationPatient Education CommunicationCommunication Face-to Face EncounterFace-to Face Encounter
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88
Greater Rates in TTRGreater Rates in TTRHealth Belief SystemHealth Belief System
MotivationMotivation Perceived VulnerabilityPerceived Vulnerability Perceived SeriousnessPerceived Seriousness Perceived Costs/BenefitsPerceived Costs/Benefits Cue to ActionCue to Action
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99
Greater Rates of TTRGreater Rates of TTREducationEducation
IndicationIndication RationalRational INR RangeINR Range Pill Strength/ColorPill Strength/Color Weekly DoseWeekly Dose Generic/Brand nameGeneric/Brand name
Provider Managing Therapy Provider Managing Therapy Writes ScriptWrites Script
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1010
Greater Rates of TTRGreater Rates of TTRCommunicationCommunication
Provider/PatientProvider/Patient– Verbal, Written, Contract, AccessVerbal, Written, Contract, Access
Patient/ProviderPatient/Provider Provider/ProviderProvider/Provider
– Transition inpt/outpt Transition inpt/outpt 1.1. ReferralReferral
2.2. Medication ReconcilliationMedication Reconcilliation
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1111
Greater Rates of TTRGreater Rates of TTRFace-to-Face EncounterFace-to-Face Encounter
AssessmentAssessment Non-Verbal CommunicationNon-Verbal Communication Verbal PromptsVerbal Prompts Real Time ManagementReal Time Management
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Patient Self Testing Patient Self Testing (PST)(PST) Used in Europe since 1980’sUsed in Europe since 1980’s FDA approvedFDA approved Third party reimbursement has Third party reimbursement has
limited progress in United Stateslimited progress in United States
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ObjectivesObjectives
Empower patients to take controlEmpower patients to take control Promote patient satisfactionPromote patient satisfaction Improve quality of lifeImprove quality of life Provide Safe careProvide Safe care Provide mechanism for patients Provide mechanism for patients
to test on a more frequent basis to test on a more frequent basis with less disruption in lifestylewith less disruption in lifestyle
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1414
Insurance TimelineInsurance Timeline
2002-Medicare covers mechanical 2002-Medicare covers mechanical heart valves (MHV)heart valves (MHV)
2002-Blue Cross/Blue Shield (BC/BS) 2002-Blue Cross/Blue Shield (BC/BS) MA covers MHV MA covers MHV
2003-BC/BS anticoagulation to similar 2003-BC/BS anticoagulation to similar levels intensity (INR > 3.0) as MHVlevels intensity (INR > 3.0) as MHV
2006-Harvard Pilgrim and Tufts cover 2006-Harvard Pilgrim and Tufts cover all indicationsall indications
2008-CMS, BCBS MA add Chronic AF, 2008-CMS, BCBS MA add Chronic AF, VTEVTE
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CMS CriteriaCMS Criteria
3 months warfarin therapy for 3 months warfarin therapy for MHV, chronic AF or VTEMHV, chronic AF or VTE
Initial face-to-face education and Initial face-to-face education and demonstrated use of the devicedemonstrated use of the device
Limited to no more than weekly Limited to no more than weekly testingtesting
Face-to-face verification by MD Face-to-face verification by MD minimum of once/year (E/M visit)minimum of once/year (E/M visit)
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Billing CodesBilling Codes
G0248-Demonstration/training at initial G0248-Demonstration/training at initial use use – $299.00$299.00 one time fee one time fee
G0249-Provision of the test G0249-Provision of the test materials/equipment materials/equipment – $280.00$280.00 for 4 test results for 4 test results
G0250-Physician review, interpretation G0250-Physician review, interpretation and patient management and patient management – $9.00$9.00 per 4 tests per 4 tests
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Active Approved Active Approved DevicesDevices INRatio INRatio
HemosenseHemosense Protime Microcoagulation Protime Microcoagulation
International TechnidyneInternational Technidyne Coaguchek Coaguchek
Roche DiagnosticRoche Diagnostic
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1818
Service CompaniesService Companies
Quality Assured ServicesQuality Assured Services www.QualityAssuredServices.comwww.QualityAssuredServices.com
Philips Cardiac Services (Raytel)Philips Cardiac Services (Raytel) www.philips.comwww.philips.com www.inrselftest.comwww.inrselftest.com
Tapestry MedicalTapestry Medical www.coagnow.comwww.coagnow.com
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1919
Private PayPrivate Pay
MonitorMonitor
$1300.00 to $1600.00$1300.00 to $1600.00
SuppliesSupplies
$13 to $25 a test$13 to $25 a test
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2020
Patient CriteriaPatient Criteria
Compliance*Compliance* Physically Capable Physically Capable Mentally CompetentMentally Competent CommunicationCommunication
**Possible patients are non-compliant d/t Possible patients are non-compliant d/t inconvenience of frequent blood testsinconvenience of frequent blood tests
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2121
EducationEducation
FingerstickFingerstick1.1. Proper technique/locationProper technique/location2.2. Increase blood flow (warming/gravity)Increase blood flow (warming/gravity)3.3. ApplicationApplication
DeviceDevice1.1. On/OffOn/Off2.2. Setting DateSetting Date3.3. Correlation StripsCorrelation Strips4.4. Return DemonstrationReturn Demonstration
ContractContract
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2222
UMMHC Anticoagulation UMMHC Anticoagulation Clinic Patient TClinic Patient Totals By otals By
IndicationIndication9/30/07 thru 9/30/089/30/07 thru 9/30/08
AllAll AFAF DVTDVTPEPE
MHMHVV
CVCVAA
TIATIA
MI/MI/
CHFCHFotheotherr
#Pt#Pt 21721700
10210222
531531 225225 8484 4545 263263
%%
TTRTTR8383 84.884.8 80.980.9 81.81.
338585 82.982.9 80.780.7
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2323
UMMHC Anticoagulation UMMHC Anticoagulation Clinic PatientClinic Patient Self Testing Self Testing
(PST)(PST) Program Program
115 patients115 patients 85 pending approval85 pending approval QAS, RaytelQAS, Raytel Protime, Hemosense and Protime, Hemosense and
CoaguchekCoaguchek Education on site (G0248)Education on site (G0248) Provider Interpretation (G0250)Provider Interpretation (G0250)
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2424
UMMHC Anticoagulation UMMHC Anticoagulation Clinic Clinic
TTR ComparisonTTR Comparison
0
10
20
30
40
50
60
0-40% 40-60 60-80 80-100
ACCHome
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UMMHC Anticoagulation UMMHC Anticoagulation ClinicClinic
BRIDGING THERAPYBRIDGING THERAPY
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ObjectivesObjectives
Provide a guideline for assessing Provide a guideline for assessing thromboembolic and hemorrhagic risk.thromboembolic and hemorrhagic risk.
Utilize an algorithm to determine Utilize an algorithm to determine appropriate bridging strategy.appropriate bridging strategy.
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2727
DefinitionDefinition
Bridging anticoagulation refers to Bridging anticoagulation refers to the administration of therapeutic the administration of therapeutic dose anticoagulation therapy with dose anticoagulation therapy with UF Heparin, LMWH or DTI for the UF Heparin, LMWH or DTI for the 8 to 12 day period before and 8 to 12 day period before and after surgery/procedure, during after surgery/procedure, during which time warfarin therapy is which time warfarin therapy is interrupted.interrupted.
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OptionsOptions
Continue Warfarin TherapyContinue Warfarin Therapy Withhold Warfarin TherapyWithhold Warfarin Therapy Temporarily Withhold Warfarin Temporarily Withhold Warfarin
and Provide a Short-Acting and Provide a Short-Acting (Bridge) Anticoagulant(Bridge) Anticoagulant
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ExpertsExperts
Annual risk of thromboembolism is Annual risk of thromboembolism is low, warfarin therapy may be held for low, warfarin therapy may be held for 4 to 5 days before the procedure and 4 to 5 days before the procedure and restarted shortly thereafter. restarted shortly thereafter. (American (American College of Chest Physicians)College of Chest Physicians)
May be held for up to one week. May be held for up to one week. (American College of Cardiology, American Heart (American College of Cardiology, American Heart Association, European Society of Cardiology)Association, European Society of Cardiology)
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Patient SelectionPatient Selection
No Universal GuidelinesNo Universal Guidelines Moderate to High Risk for Moderate to High Risk for
Thromboembolic EventThromboembolic Event Optional for Low Risk PatientsOptional for Low Risk Patients
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3131
Bleeding RiskBleeding Risk
Very High RiskVery High Risk– Intracranial Intracranial
SurgerySurgery– Spinal SurgerySpinal Surgery– CABGCABG– Valve Valve
ReplacementReplacement
High RiskHigh Risk– Pacer/DefibrillatorPacer/Defibrillator– Prostate Prostate
Biopsy/SurgeryBiopsy/Surgery– Bowel Bowel
PolypectomyPolypectomy– Total KneeTotal Knee– Total HipTotal Hip– Bladder TumorBladder Tumor
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Bleeding RiskBleeding Risk
Low RiskLow Risk– CataractCataract– SkinSkin– EndoscopyEndoscopy– HerniaHernia– GallbladderGallbladder– DentalDental
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3333
Venous Venous ThromboembolicThromboembolicRisk ScaleRisk Scale Low RiskLow Risk
– DVT/PE >6 months without inherited DVT/PE >6 months without inherited thrombophilia or other risk factorsthrombophilia or other risk factors
– Factor V Leiden/ProthrombinG Factor V Leiden/ProthrombinG 20210A gene mutation without prior 20210A gene mutation without prior eventevent
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Venous Venous Thromboembolic Risk Thromboembolic Risk ScaleScale Intermediate RiskIntermediate Risk
– Factor V Leiden/ProthrombinG Factor V Leiden/ProthrombinG 20210A gene mutation with prior 20210A gene mutation with prior thromboembolic event > 12 monthsthromboembolic event > 12 months
– Protein C/Protein S/Antithrombin Protein C/Protein S/Antithrombin deficiency without prior event, but deficiency without prior event, but strong family historystrong family history
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3535
Venous Venous Thromboembolic Risk Thromboembolic Risk ScaleScale High RiskHigh Risk
– DVT/PE <6 monthsDVT/PE <6 months– Antiphospholipid antibody syndrome Antiphospholipid antibody syndrome
with prior thromboembolic eventwith prior thromboembolic event– Factor V Leiden/ProthrombinG Factor V Leiden/ProthrombinG
20210A mutation with prior 20210A mutation with prior thromboembolic event < 12 monthsthromboembolic event < 12 months
– Protein C/Protein S/ Antithrombin Protein C/Protein S/ Antithrombin deficiency with prior eventdeficiency with prior event
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Arterial Arterial Thromboembolic Risk Thromboembolic Risk ScaleScale Low RiskLow Risk
– Atrial Fibrillation (non-valvular)Atrial Fibrillation (non-valvular)– St. Jude Aortic Mechanical Heart St. Jude Aortic Mechanical Heart
ValveValve– Dilated CardiomyopathyDilated Cardiomyopathy
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3737
Arterial Arterial Thromboembolic Risk Thromboembolic Risk ScaleScale Moderate RiskModerate Risk
– Atrial Fibrillation with Valvular Atrial Fibrillation with Valvular DiseaseDisease
– Dilated Cardiomyopathy and Prior Dilated Cardiomyopathy and Prior Thromboembolism (> 3 months)Thromboembolism (> 3 months)
– Anterior MI < 3 Months With No Anterior MI < 3 Months With No Other Risk FactorsOther Risk Factors
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Arterial Arterial Thromboembolic Risk Thromboembolic Risk ScaleScale High RiskHigh Risk
– Aortic St. Jude Mechanical Valve with Aortic St. Jude Mechanical Valve with AF or EF < 35%AF or EF < 35%
– Mitral St. Jude Mechanical ValveMitral St. Jude Mechanical Valve– Cardioversion < two weeksCardioversion < two weeks– History of arterial thromboembolic History of arterial thromboembolic
eventevent– Antiphospholipid Syndrome plus Antiphospholipid Syndrome plus
prior event or additional risk factorsprior event or additional risk factors– Caged Ball Mechnical Heart ValvesCaged Ball Mechnical Heart Valves
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3939
CHADsCHADs
Nonvalvular Atrial FibrillationNonvalvular Atrial Fibrillation– Score calculated based on number Score calculated based on number
of risk factors for strokeof risk factors for stroke– Prior CVA or TIA: 2 pointsPrior CVA or TIA: 2 points– CHF, HTN, Diabetes, age >75: 1 CHF, HTN, Diabetes, age >75: 1
point eachpoint each– Bridging Recommended for score >5Bridging Recommended for score >5– Consider Bridging >2Consider Bridging >2– Optional for < 2Optional for < 2
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CHADS2 CHADS2
CHADS2 CHADS2 ScoreScore
Stroke RiskStroke Risk % Annual % Annual RiskRisk
00 lowlow 1.91.9
11 lowlow 2.82.8
22 moderatemoderate 4.04.0
33 moderatemoderate 5.95.9
44 moderatemoderate 8.58.5
55 highhigh 12.512.5
66 highhigh 18.518.5
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4141
Preoperative AnticoagulationPreoperative AnticoagulationIndication for Warfarin - ArterialIndication for Warfarin - Arterial
Arterial
High Risk
Stop Warfarin4d preop
Check INR1d Preop
Stop Warfarin4d preop
IV HeparinOr SC LMWH
(treatment doses)When
INR <2**
Check INR1d Preop
**Stop Heparin 6h preop
or
LMWH 12 – 24 hr preop
Yes No
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4242
Postoperative AnticoagulationPostoperative AnticoagulationIndication for Warfarin - ArterialIndication for Warfarin - Arterial
Arterial
Start WarfarinImmediately Postop
LowRisk
IntermediateRisk
High/Very HighRisk
Provide DVTProphylaxis
(Unfractionated heparinOr LWMH)
For Hospital Admission
IV Heparin(aPTT 40 – 50 sec)*
OrSC LMWH
(prophylaxis dose)Q12 -24 hr
Until INR > 2.0
Minor Surgery*IV Heparin
(APTT 60 SEC)Until INR
> 2.0*
Major Surgery*IV Heparin
(aPTT 40-50)Or
SC LMWH(prophylaxis dose)
Q12 – 24 hrUntil hemostasis
and bleedingrisk reduced
then IV Heparin(treatment dose)
*Initiate 12 – 24 h postop if clinically acceptable per surgical team
*If not very high risk for thromboembolism and low risk for bleeding
Can consider LMWH (treatment doses) until INR > 2
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4343
Preoperative Anticoagulation Indication Preoperative Anticoagulation Indication for Warfarin - Venousfor Warfarin - Venous
Venous
High Risk
Stop Warfarin4d preop
Check INR1d Preop
Stop Warfarin4d preop
IV HeparinOr SC LMWH
(treatment doses)When
INR <2**
Check INR1d Preop
**Stop Heparin 6h preop
or
LMWH 12 – 24 hr preop
Yes No
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4444
Postoperative Anticoagulation Indication for Postoperative Anticoagulation Indication for WarfarinWarfarinVenousVenous
Venous
Start Warfarin Immediately Postop
Low/Intermediate Risk
LMWH (prophylaxis)Until Discharge*
*Initiate 12 – 24 hr post-op if clinically
acceptable (per surgical team)
*If low risk for bleeding consider LMWH (treatment doses)
High Risk
Has IVC Filter(event < 3 mos)
MajorSurgery
MinorSurgery
LMWH treatment Dose Or
IV Heparin+ (aPTT 60 sec)Until INR > 2.0
IV Heparin aPTT 40 – 50 secOr
SC LMWH (prophylaxis) q12-q24 until Hemostasis securedand bleeding risk reduced,
then IV Heparin (aPTT 60 sec)Until INR> 2.0
Or Treatment Dose LMWH
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CONCLUSIONCONCLUSION
“ “ It must be recognized that no It must be recognized that no alternative therapy has undergone the alternative therapy has undergone the rigorous testing of large randomized rigorous testing of large randomized controlled trials and that judgment controlled trials and that judgment must be made on the basis of available must be made on the basis of available literature, expert opinion, a community literature, expert opinion, a community standard, cost and patient standard, cost and patient preference.”preference.”
Jack E. Ansell M.D.Jack E. Ansell M.D.
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THANK YOUTHANK YOU