Registry-based Quality Improvement in Anticoagulation Geoffrey Barnes, MD Cardiovascular and Vascular Medicine University of Michigan, USA 1 st Qatar Conference on Safe Anticoagulation Management February 28, 2015

Outline What is Quality Improvement (QI) in Anticoagulation? The case for QI in Anticoagulation Clinics (ACSs) Potential targets for QI efforts Example QI projects Resources for QI projects

Outline What is Quality Improvement (QI) in Anticoagulation? The case for QI in Anticoagulation Clinics (ACSs) Potential targets for QI efforts Example QI projects Resources for QI projects

Quality Improvement High Quality Anticoagulation Appropriate Drug Selection In-range INRs Reliable Follow Up Fewer Unwanted Outcomes Bleeding Events Strokes Emergency Department Visits

Quality Improvement High Quality Anticoagulation Fewer Unwanted Outcomes Time in Therapeutic Range (TTR)

Time in the Therapeutic Range Rosendaal Method (aka linear interpolation) Rosendaal Thromb Haemost 1993

TTR and Clinical Outcomes Rose AJ Circ:CVQO 2011 Wallentin L Lancet 2010

Outline What is Quality Improvement (QI) in Anticoagulation? The case for QI in Anticoagulation Clinics Potential targets for QI efforts Example QI projects Resources for QI projects

The case for QI Common medications – Warfarin – Direct oral anticoagulants (DOACs) Highly effective Potentially devastating side effects

Adverse Drug Events Anticoagulants – Up to 10% of all adverse drug events in US – Warfarin  #1 cause Call for tools to improve care delivery – National Quality Forum US Dept of Health and Human Services “National Action Plan for Adverse Drug Event Prevention” (2014) National Quality Forum’s 34 Safe Practices (2013)

QI and Cost-Savings Rose AJ Circ:CVQO 2011

QI and DVT/PE Poor Anticoagulation  VTE Recurrence – Hospitalization costs – Post Thrombotic Syndrome risk Better Anticoagulation   Post Thrombotic Syndrome – Economic burden: ~$200 million/year Kachroo Am J Health Syst Pharm 2012;69:567 Lin J Manag Care Pharm 2014;20:174

Quality Improvement High Quality Anticoagulation Appropriate Drug Selection In-range INRs Reliable Follow Up Fewer Unwanted Outcomes Bleeding Events Strokes Emergency Department Visits

Outline What is Quality Improvement (QI) in Anticoagulation? The case for QI in Anticoagulation Clinics (ACSs) Potential Measures of QI efforts Example QI projects Resources for QI projects

Quality Measures Key Criteria – Commonly occurring events – Linked to important clinical outcomes – Able to be measured Two Types – Patient-centered – Provider-centered

Quality Measures Patient-Centered Rose AJ Jt Comm J Qual Patient Saf 2009 Witt D J Thromb Thrombolysis 2011 Ibrahim S J Thromb Haemost 2013 Witt DM Thromb Research 2013 Patients Intermediate Measures TTR % INR In-Range % Missed INR Draws # Extreme INRs Clinical Outcome Bleeding Event Stroke Emergency Room Visit

Quality Measures Provider-Centered Process of Care – # INRs in first 2 weeks – Time from initiation to therapeutic INR – Time from out of range INR to patient contact Population-focused – % of patients receiving appropriate anticoagulation Guideline-based care Appropriate drug choice/dose – % of patients with appropriate INR target range – % receiving appropriate education Rose AJ Jt Comm J Qual Patient Saf 2009 Witt D J Thromb Thrombolysis 2011

Potential QI Targets Use guidelines to guide targets (CHEST 2012) – Compliance with specific recommendations Other targets in the Literature – Dose adjustment Agreement between providers Agreement with nomograms – Time between INR checks – Workload evaluation Holbrook A CHEST 2012 Witt D J Thromb Haemost 2011

Outline What is Quality Improvement (QI) in Anticoagulation? The case for QI in Anticoagulation Clinics (ACSs) Potential targets for QI efforts Example QI projects Resources for QI projects

Michigan Anticoagulation Quality Improvement Initiative Six Anticoagulation Management Services BCBSM Sponsored CQI Any indication for warfarin Oct 2009-present ~9200 patients

Atrial Fibrillation 1852 AF patients – 24 (1.3%) with CHADS-VASc=0 and no Cardioversion/Ablation Potential for harm with overtreatment? Barnes GD J Thromb Thrombolysis 2014

Atrial Fibrillation Screen all AF patients for appropriate anticoagulation – CHADS-VASc=0 – No cardioversion or ablation procedure – No other indication for anticoagulation Intervention – , phone call to referring provider – Verify risk elements – Education about guidelines – Ask if warfarin should be discontinued

Provoked DVT Patients Surgically Provoked Unprovoked Non-surgically Provoked Baglin T Lancet 2003

Provoked DVT Patients Patients treated for DVT for 3+ months – Recent surgery (6 wks) – Recent immobilization (6 wks) – No other indication for warfarin Intervention – , phone call to referring provider – Verify provoked nature of DVT – Education about guidelines – Ask if warfarin should be discontinued

Adverse Events Review Goal: – Review adverse events in a systematic format Structure: – Monthly meeting – MD, RN, PharmD – 2-4 cases Format: – Root-cause analysis

Adverse Events Review 84yo woman – Paroxysmal AF on warfarin (CHADS 2 =2) – INR always well controlled (3 yrs) Ophthalmology evaluation for “spots in eyes” – Age-related macular degeneration – Treated with AREDS Vitamins to slow progression of disease No feedback to ACS 3 weeks later, groin pain – ED eval: retroperitoneal hematoma – INR 10.4

Adverse Events Review AREDS – High dose vitamins/minerals – A, C, E, zinc, copper Vitamin E potentiates warfarin Reviewed by committee Feedback to Ophthalmology Department – Updated printout given to patients Education to all Anticoag RN/PharmDs

Extended INR Testing Interval CHEST Guidelines suggests up to 12 week testing intervals (Grade 2B) – Stable patients 12 weeks INR in range No warfarin dose change Our clinics – Allow 6-12 week intervals between INR checks Initial 6 month data – 222/889 (25%) of eligible patients were “extended” – No difference in safety outcomes Holbrook, CHEST 2012;144:e152S-184S Schulman, Ann Int Med 2011; 155:

Direct Oral Anticoagulants Inappropriate use  Bleeding Risk – Up to 25% of dabigatran and rivaroxaban patients – Need adjustment for renal function Anticoagulation Clinic Support – Verify dose, drug – Education for patient 17% without education at Hamad General Hospital – Follow up dosing changes (especially VTE) Harper P, NEJM Larock AS, Ann Pharmacother 2014 Steinberg BA, JAHA Khudair Saudi Med J 2010;31:672

Middle East Example Only 60% Angiology 2014:1-8

Outline What is Quality Improvement (QI) in Anticoagulation? The case for QI in Anticoagulation Clinics (ACSs) Potential targets for QI efforts Example QI projects Resources for QI projects

QI Resources Published Guidelines – CHEST 2012 Guidelines – AC Forum Delivery of Optimized Anticoagulant Therapy Online References – AC Forum Centers of Excellence Website – MAQI 2 Anticoagulation Toolkit Holbrook A CHEST 2012 Garcia DA Ann Pharmacother 2008

QI Resources

QI Resources Need for anticoagulation? – AF Risk assessment tools – VTE Risk assessment tools Which anticoagulant to select? – FDA approval list – Comparison between classes – Patient factors that influence choice How to initiate warfarin – Dosing algorithms – Educational tools – Other considerations – Drug-drug interactions – Dietary interactions DOAC initiation – Conversion to/from warfarin – Drug-drug interactions – Educational tools Long-term warfarin management – Dose adjustment algorithms – Periprocedural management – Key follow up questions All available via PDF Interactive tool and iPhone app

QI Resources

Excellence.acforum.org

Questions