1. 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

2. 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

3. 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

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

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

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

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

8. 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

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

10. 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) www.hfap.org/pdf/patient_safety.pdf

11. QI and Cost-Savings Rose AJ Circ:CVQO 2011

12. 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

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

14. 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

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

16. 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

17. 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

18. 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

19. 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

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

21. 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

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

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

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

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

26. 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

27. 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

28. 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; 155:653-659

29. 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 - 2008 – Follow up dosing changes (especially VTE) Harper P, NEJM 2012. Larock AS, Ann Pharmacother 2014 Steinberg BA, JAHA 2013. Khudair Saudi Med J 2010;31:672

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

31. 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

32. 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

33. QI Resources www.anticoagulationtoolkit.org

34. 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

35. QI Resources

37. Excellence.acforum.org

38. Questions