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

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

33

UMassMemorial Healthcare UMassMemorial Healthcare (UMMHC) Anticoagulation (UMMHC) Anticoagulation Center (ACC)Center (ACC)

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

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

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

77

Greater Rates of TTRGreater Rates of TTR

Health Belief SystemHealth Belief System Patient EducationPatient Education CommunicationCommunication Face-to Face EncounterFace-to Face Encounter

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

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

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

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

1212

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

1313

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

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

1515

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)

1616

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

1717

Active Approved Active Approved DevicesDevices INRatio INRatio

HemosenseHemosense Protime Microcoagulation Protime Microcoagulation

International TechnidyneInternational Technidyne Coaguchek Coaguchek

Roche DiagnosticRoche Diagnostic

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

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

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

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

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

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)

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

UMMHC Anticoagulation UMMHC Anticoagulation ClinicClinic

BRIDGING THERAPYBRIDGING THERAPY

2626

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.

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.

2828

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

2929

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)

3030

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

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

3232

Bleeding RiskBleeding Risk

Low RiskLow Risk– CataractCataract– SkinSkin– EndoscopyEndoscopy– HerniaHernia– GallbladderGallbladder– DentalDental

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

3434

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

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

3636

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

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

3838

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

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

4040

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

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

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

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

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

4545

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.

4646

THANK YOUTHANK YOU