1. Comparison of Patient Satisfaction and Time Spent in Therapeutic Range in Two Different Clinic Models Ashley Pokallus, PharmD PGY1 Pharmacy Resident—Ambulatory Care Mission Hospital and Mountain Area Education Center (MAHEC) Asheville, North Carolina

2. Disclosure Statement None of the following individuals involved in this project have anything to disclose concerning possible financial or personal relationships with commercial entities (or their competitors). –Resident: Ashley Pokallus, PharmD –Project Advisor: Bill Hitch, PharmD, BCPS, CPP –Statistician: Shelley Galvin, MA

3. Background 1-5 20 million US patients are using warfarin Narrow therapeutic index makes monitoring essential –Bleed rate 1-3% per patient year –Thromboembolism rate 2% per patient year SPORTIF III and V demonstrated patients with time in therapeutic range (TTR) <60% had poor outcomes Trials have shown that management of anticoagulation by hospital- based clinics is better than that in primary care offices

4. Mountain Area Health Education Center

5. MAHEC Clinic Structure—Silo Approach Anticoagulation Clinic – 2 half days a week – 2 primary providers – POC monitoring – 20 minute appointment slots – Pharmacy resident involvement Pharmacotherapy Clinic – 7 half days a week – 2 primary providers – 20 minute appointment slots – Pharmacy resident involvement Pharmacotherapy Clinic Anticoagulation Clinic

6. MAHEC Clinic Structure—Integrated Approach Pharmacotherapy Clinic (including anticoagulation management) – 9 half days a week – 4 primary providers – POC monitoring – 20 minute appointment slots – Pharmacy resident involvement Pharmacotherapy Clinic

7. Purpose To compare impact of clinic structure change in terms of efficacy of anticoagulation management, by evaluating TTR, and patient satisfaction.

8. Objectives Primary –Compare TTR between the two clinic structures Secondary –Consider change in patient satisfaction between the two clinic structures –Evaluate rate of bleeding and thromboembolism between the two clinic structures –Assess the variability in providers between the two clinic structures

9. Methodology Study Design: IRB-approved, retrospective, longitudinal chart review –Silo Approach—May 2014-November 2014 –Integrated Approach—May 2015-November 2015 –TTR calculated based on Rosendaal Method –Provider Consistency Anonymous Patient Satisfaction Survey –8 questions relating to clinic changes and quality of care –Administered between October 2015-November 2015

10. Methodology Inclusion Criteria –Being treated with warfarin at Biltmore Clinic prior to May 2014 Exclusion Criteria –Gap in care >8 weeks –Initiation of therapy after May 2014 –Completion of therapy prior to November 2015 –Transfer of care during study period –Managed at a MAHEC clinic site other than Biltmore Clinic

11. 59 patients identified from Coumadin Registry TTR Study Analysis of TTR for 32 patients 27 patients excluded (14 initiated therapy during study period 13 gap in care >8 weeks) Patient Satisfaction Survey Administered to 19 patients during appointment

12. Baseline Characteristics n=32 Age—median (range)77 (52-96) Medications—median (range)8 (2-20) Gender—female, n (%)18 (56.3) Race, n (%) White/Non-Hispanic Black Unknown 24 (75.0) 1 (3.1) 7 (21.9) History of stroke, n (%) History of major bleed, n (%) 5 (15.6) 1 (3.1) n=32 Indication for warfarin therapy, n (%) Atrial fibrillation Deep vein thrombosis (DVT) Pulmonary embolism (PE) Mechanical valve Other 28 (87.5) 4 (12.5) 1 (3.1) 3 (9.6) INR Goal, n (%) 2 to 3 2.5 to 3.5 Other 29 (90.6) 2 (6.3) 1 (3.1)

13. Results—TTR Analysis n=32 Silo ModelIntegrated Model p-value TTR (Median)71.3%71.9%0.638 Composite Thromboembolism, n (%)2 (6.1%)0 (0%)0.5 Composite Bleeding, n (%)1 (3%)0 (0%)1.00

14. Results—TTR Analysis p=0.791 Number of Patients, n=32

15. Results—Patient Satisfaction n=19

16. Results—Patient Satisfaction n=19 Percentage of Patients 8 7 3 1 8 10 7 9 12 1 8 9

17. Results—Provider Consistency Provider Consistency n=32SiloIntegratedp-value Median (min-max)44.4% (12.5-83.3%) 38.1% (20-85.7%) 0.226

18. Results—Provider Consistency

19. ↑TTR ↑Provider Consistency ↓ TTR ↓ Provider Consistency ↑ TTR ↓ Provider Consistency ↓ TTR ↑ Provider Consistency

20. Discussion Primary endpoint –TTR did not significantly change between the two clinic structures Secondary endpoints –Patients are satisfied with the care they are receiving for their anticoagulation at MAHEC’s Biltmore Clinic –Provider consistency did not change significantly between the two clinics Association between decreased provider consistency and decreased TTR –Nonsignificant composite outcome

21. Limitations Small sample size Large number of patients excluded from the study Relatively short time frame Different subset of patients in each arm Possibility of social desirability bias

22. Conclusion Current clinic model seems to be effective and safe, and patients are satisfied with care.

23. Self-assessment question Question –What is one thing that can be learned by comparing these patient care structures? Answer –TTR did not change despite change in clinic structure –Perceptions of wait times and clinic availability improved –Both models have value

24. Patient Satisfaction Survey

25. References 1.Carlson B. Declaring war on warfarin misdosing. Biotechnol Healthc 2008; 5(2): 54- 55. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2706162/http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2706162/ 2.Pokorney SD, Simon DN, Thomas L, Fonarow GC, Kowney PR, Chang P, et al. Patients’ time in therapeutic range on warfarin among US patients with atrial fibrillation: Results from ORBIT-AF registry. Available from: http://www.ahjonline.com/article/S0002-8703(15)00192-1/fulltext http://www.ahjonline.com/article/S0002-8703(15)00192-1/fulltext 3.Rosendaal Method. INRPRO. Accessed 8/25/2015. Accessed from: http://www.inrpro.com/rosendaal.asp http://www.inrpro.com/rosendaal.asp 4.White HD, Gruber M, Feyzi J, et al. Comparison of outcomes among patients randomizeed to warfarin therapy according to anticoagulant control results from SPORTIF III and V. Arch Intern Med, 167 2007, pp. 239-235. 5.Palareti G. Direct oral anticoagulants and bleeding risk (in comparison to vitamin K antagonists and heparins), and the treatment of bleeding. Semin Hematol. 2014 Apr;51(2):102-11.

26. Comparison of Patient Satisfaction and Time Spent in Therapeutic Range in Two Different Clinic Models Ashley Pokallus, PharmD PGY1 Pharmacy Resident—Ambulatory Care Mission Hospital—1 Hospital Drive Asheville, North Carolina 28801 Ashley.Pokallus@msj.org