Changing the Ambulatory Training Paradigm: The Design and Implementation of an Outpatient Pulmonology Fellowship Curriculum

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1 Online Data Supplement Changing the Ambulatory Training Paradigm: The Design and Implementation of an Outpatient Pulmonology Fellowship Curriculum Stacey M. Kassutto, C. Jessica Dine, Maryl Kreider, Rupal J. Shah Items contained: 1. Appendix A: Sample teaching script 2. Appendix B: Sample survey distributed to fellows 3. Appendix C: Supplemental table of 6 month survey data.

2 APPENDIX A: SAMPLE TEACHING SCRIPT Venous Thromboembolism - Outpatient Management John P. Reilly MD MSCE Educational Objectives: 1. Review the longer term treatment options for acute PE and DVT 2. Discuss the relative benefits and evidence for each anticoagulant 3. Review the contraindications and concerns with each anticoagulant, including the new direct thrombin inhibitors and factor Xa inhibitors 4. Discuss the decision making process for deciding on length of anticoagulation therapy 5. Review the inherited thrombophilias and when to test for them CASE ONE: Mr. S is a 27 year old male professional soccer player with no past medical history who presented to the hospital with acute onset dyspnea and chest pain after a 12 hour flight from a soccer tournament in Asia. On physical exam he is tachycardic, mildly tachypneic, normotensive, and not hypoxic. His right lower extremity has trace to 1+ edema, while his left lower extremity has no edema. CXR is clear. He is subsequently diagnosed via a CT angiogram with an acute PE, as well as a proximal R lower extremity DVT. He is started on LMWH immediately and admitted. The next day he remains stable with improving symptoms and is preparing for discharge. He will follow up in your clinic. Question 1: What anticoagulant should this patient be discharged on? What are your options? What is the evidence? Initial Anticoagulation Choices: Low Molecular Weight Heparin Grade 2B recommendation by ACCP as initial anticoagulation over IV unfractionated heparin. Compared with IV UFH, LMWH results in lower mortality, fewer recurrent thromboembolic events, and less major bleeding. It also has greater bioavailability, more predictable pharmacokinetics, fixed dosing, and a decreased likelihood of thrombocytopenia. Concerns have been raised in obesity and low body weight (less predictable pharmacokinetics) as well as with renal insufficiency. Fondaparinux (SC) Antithrombin III mediated selective inhibitor of factor Xa. ACCP suggests fondaparinux as an alternative to LMWH and over IV UFH for initial anticoagulation. Fondaparinux compared to IV UFH resulted in similar outcomes. LWMH and fondaparinux have only been compared for acute DVT. In 2,205 patients with DVT, mortality, recurrent thromboembolic disease, and major bleeding were similar (Buller et al, 2004). Unfractionated Heparin (IV) IV drip requiring routine monitoring of PTT. Used in several specific situations; (1) Persistent hypotension due to acute PE. (2) Increased risk of bleeding UFH is easily reversed with protamine. (3) Thrombolysis is being considered. (4) Concerns about subcutaneous absorption obesity, anasarca. (5) Renal insufficiency. SC UFH is also reasonable but not commonly used. Rivaroxaban Not currently recommended given lack of experience, but see below. E2

3 Long Term Anticoagulation Choices: All patients with acute proximal DVT of the leg and/or PE (provoked or unprovoked) should be anticoagulated for at least 3 months if not contraindicated (Grade 1B recommendation). Comparisons with shorter durations such as 4-6 weeks have all show higher rates of recurrent VTE and/or extension of VTE. ACCP Guidelines (2012): In patients with DVT of the leg or PE and no cancer, we suggest vitamin K antagonist therapy over LMWH, dabigatran, or rivaroxaban for long-term therapy (Grade 2C). In patients with DVT of the leg or PE and cancer, we suggest LMWH over VKA therapy, dabigatran, or rivaroxaban for long term therapy (Grade 2B). Warfarin Vitamin K antagonist that suppresses the production of the vitamin K-dependent clotting factors (II, VII, IX, and X). Long-term treatment with warfarin has excellent evidence. In a Cochrane review of 8 studies with 2,994 patients long-term treatment of warfarin dramatically reduced recurrent VTE compared to early cessation (Hutten et al. 2006). Limitations include: need to monitor the INR, drug drug interactions, need to overlap with heparin therapy, effects of diet, and warfarin induced skin necrosis. LMWH Preferred therapy for pregnancy and malignancy. RCTs have demonstrated no difference in LMWH versus warfarin in recurrent VTE, bleeding, or mortality, and may have decreased post-thrombotic syndrome. Several RCTs compared LMWH to warfarin in cancer and demonstrated conflicting results. A Cochrane meta-analysis concluded that LMWH was associated with reduced recurrent VTE in cancer and no change in bleeding or mortality (Lee et al. 2003, Hull et al. 2006, Meyer et al. 2002, Deitcher et al. 2006, Akl et al. 2014). Dabigatran Direct thrombin inhibitor. Thrombin (factor IIa) is the final enzyme in the clotting cascade leading to fibrin formation, and is cleaved from prothrombin by factor Xa. The orally administered drug is a pro-drug that is converted in the liver to the active form. Half-life is hours in normal renal function. Pills must stay in their bottle and not in a pill box as the drug breaks down with moisture and only lasts 4 months. Cannot use in renal disease. Interacts with many drugs (Rifampin, ketoconazole, verapamil), and needs acid in stomach to activate (i.e. interacts with PPIs). Cannot be reversed (maybe dialysis). Evidence in VTE: 1. RECOVER I 2539 patients with acute VTE randomized to six months of dabigatran (150 mg BID) vs. warfarin after 7 days of parenteral anticoagulation. Recurrent VTE occurred in 2.4% vs 2.1%, VTE-related deaths 0.1 vs. 0.2, major bleeding 1.6 vs. 1.9, any bleeding 16.1 vs (Shulman et al. 2009, NEJM). 2. RECOVER II 2589 patients with acute VTE very similar results recurrent VTE 2.3% vs 2.2%, major bleeding 1.2% vs 1.7% (Shulman et al. 2014, Circulation). Rivaroxaban Oral direct factor Xa inhibitor, inactivates circulating and clot bound factor Xa. Metabolized by the kidney and interacts with dual inhibitors of CYP-3A4 and P-glycoprotein (azoles, ritonavir). Cases of liver injury have also been reported. Rivaroxaban has been studied as an initial anticoagulant that continues as long-term. E3

4 Evidence in VTE: 1. EINSTEIN-DVT 3449 patients with acute, symptomatic DVT randomized to oral rivaroxaban alone (15 mg BID for 3 weeks, than 20 mg daily) vs. enoxaparin followed by VKA. Recurrent VTE 2.1% vs. 3%, bleeding 8.1% vs. 8.1% (Bauersachs et al. 2010, NEJM). 2. EINSTEIN-PE 4,832 patients with acute symptomatic PE randomized to rivaroxaban versus enoxaparin followed by VKA. Recurrent VTE 2.1% vs 1.8%, bleeding 10.3% vs 11.4%, major bleeding 1.1% vs 2.2% (Buller et al, 2012, NEJM). Apixaban Oral direct factor Xa inhibitor. Similar to rivaroxaban. Evidence in VTE: 1. AMPLIFY 5395 patients with acute VTE randomized to apixaban (10 mg BID for seven days than 5 mg BID for 6 months) vs enoxaparin followed by warfarin. Recurrent VTE 2.3% vs. 2.7%, bleeding 4.3% vs. 9.7% (Agnelli et al. 2013, NEJM). Case Continued: Mr. S was discharged on warfarin therapy with follow up in pulmonary clinic and coumadin clinic. He reports that he takes his warfarin every day as prescribed but in the last two weeks he has had INRs that have been >3.0 and <2.0. His warfarin dose has been adjusted several times since his discharge. He asks you if there are any other options for anticoagulation that are easier for him. Question 2: What are the major concerns with alternative anticoagulants? What is Mr. S s bleeding risk? The major concerns with the newer alternative anticoagulants are the limited experience with their complications. Their anticoagulant effects are not reversible and while bleeding risk may be similar, outcomes from bleeding may be worse. In the case of Mr. S, we should evaluate his bleeding risk prior to switching him from warfarin. Additionally, his renal function, other medications, and compliance with medications should be evaluated. Mr. S s bleeding risk was determined to be low as long as he continues to avoid playing soccer. He was switched to Rivaroxaban and is tolerating it well. He now asks you about the expected duration of his anticoagulation. He wants to get back to playing soccer and has concerns about bleeding if he returns to work on anticoagulation. Question 3: How long should patients be anticoagulated after an acute PE or proximal DVT of the leg? Answer: It depends. Goals: E4

5 1. Continue until the reduction of recurrent VTE no longer clearly outweighs the bleeding risk. 2. Must take into account patient preferences and the risks specific to each patient. Estimates of the Risk of Recurrent VTE without anticoagulation (Baglin et al. 2003, Iorio et al. 2010) VTE provoked by surgery - 1% at 1 year, 3% at 5 years VTE provoked by non-surgical, reversible factor - 5% at 1 year, 15% at 5 years Unproved VTE - 10% at 1 year, 30% at 5 years Cancer - No good estimates, but maybe 15% per year Other factors Distal DVT has ½ the risk of proximal DVT or PE, second or more episode of VTE increase the risk of recurrence by 50%. Hereditary thrombophilias, antiphospholipid antibodies, residual thrombus. ACCP guidelines (2012): We recommend treatment of 3 months over shorter periods (Grade 1B). For first proximal DVT or PE that is provoked by surgery or a non-surgical transient risk factor, we recommend 3 months of therapy (Grade 1B for surgery, Grade 2B for non-surgical transient risk factor). If unprovoked, we suggest extending therapy if bleeding risk if low or moderate (Grade 2B), and recommend 3 months of therapy if bleeding risk is high (Grade 1B). Extended Therapy for VTE: Patients Likely to Benefit: 1. Unprovoked proximal DVT and symptomatic PE Given high risk of recurrence, the risk of extending therapy may be lower than the risk recurrent VTE without extended therapy. RCTs of extended warfarin full intensity (INR 2-3) vs low intensity (INR ) vs placebo demonstrated reduced risk of recurrence 90% for full intensity and 64% for low intensity (ACCP 2012 Guidelines). 2. Recurrent unprovoked VTE Patients with Possible/Unclear Benefit: 1. Recurrent provoked VTE only observational data, but demonstrated increased risk of recurrence if already recurred. 2. Provoked VTE with persistent risk factors particularly malignancy. 3. Unprovoked isolated distal DVT 4. Unprovoked incidental PE Patients Unlikely to Benefit: 1. Provoked VTE with transient risk factor 2. Patients with high risk of bleeding E5

6 Aspirin for Extended Therapy: RCT comparing aspirin to placebo for therapy beyond 1 year for unprovoked VTE (Becattini et al. 2012, NEJM). Demonstrated a 40% reduction in risk of recurrent VTE; however, standard of care is to continue full anticoagulation. Aspirin may be used in select patients, but is not an alternative to full anticoagulation. Question 4: What risk factors for recurrent VTE should be assessed when deciding when to stop anticoagulation? No clear evidence for using any other risk factors to make decision about anticoagulation duration, but inherited and acquired thrombophilias warrant consideration. Virchow s Triad alterations in blood flow, vascular endothelial injury, alterations in the constituents of blood. Inherited Thrombophilias Hypercoaguable states to consider in a patient with VTE include antithrombin deficiency, antiphospholipid antibodies, Factor V Leiden, Factor VIII level, lupus anticoagulant, protein C deficiency, protein S deficiency, Testing for hypercoaguable disorders may be confounded by acute thrombosis, heparin and warfarin. Back to the Case: Mr. S tested negative for all inherited thrombophilias. It is not entirely clear if his VTE was provoked (by air travel) or unprovoked. Given his occupation as a soccer player, a decision was made to stop his anticoagulation after 3 months. He has not had recurrent VTE. Question 5: What is the risk of CTEPH in patients with PE? It is estimated that approximately 3% of patients with acute symptomatic PE will develop CTEPH, and only 1/3 to ½ of CTEPH patients have a history of an acute symptomatic PE. E6

7 References: E1. Kearon C, et al. Antithrombotic therapy for VTE disease, 9 th edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141(2):e419s-e494s. E2. Büller HR, et al. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep vein thrombosis: a randomized trial. Ann Intern Med 2004;140(4): E3. Hutten BA and Prins MH. Duration of treatment with vitamin K antagonists in symptomatic venous thromboembolism. Cochrane Database Syst Rev E4. Lee AV et al. Low-molecular weight heparin versus Coumadin for the prevention of recurrent venous thromboembolism in patients with cancer. NEJM 2003;349(2):146. E5. Hull RD et al. Long-term low-molecular weight heparin versus usual care in proximalvein thrombosis in patients with cancer. Am J Med 2006;119(12):1062. E6. Meyer G et al. Comparison of low-molecular weight heparin and warfarin for the secondary prevention of venous thromboembolism in patients with cancer: a randomized controlled study. Arch Intern Med 2002;162(15):1729. E7. Deitcher SR et al. Secondary prevention of venous thromboembolic events in patients with active cancer: enoxaparin alone versus initial enoxaparin followed by warfarin for a 180-day period. Clin Appl Thromb Hemost 2006l12(4):389. E8. Akl EA et al. Anticoagulation for the long-term treatment of venous thromboembolism in patients with cancer. Cochrane Database Syst Rev E9. Schulman S, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. NEJM 2009; 36(124): E10. Schulman S, et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation 2014; 129 (7): E11. Bauersachs et al. Oral Rivaroxaban for Symptomatic Venous Thromboembolism. NEJM 2010; 363: E12. Buller et al. Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism. NEJM 2012; 366: E13. Agnelli G et al. Oral Apixaban for the Treatment of Acute Venous Thromboembolism. NEJM 2013; 369: E14. Becattini, C et al. Aspirin for Preventing the Recurrence of Venous Thromboembolism. NEJM 2012; 366: E7

8 APPENDIX B: SAMPLE FELLOW SURVEY 1. In what year of fellowship are you currently? 1 st year 2 nd year 3 rd year 4 th year 5 th year Other 2. What is your gender? Male Female 3. Describe your career aspirations at the current time: Basic Science Research Focused Clinical Research Focused Health Services Research Focused Clinically Focused Clinician Education/Medical Education Advanced Clinical Training (Transplant, Interventional Pulmonary, etc) Mix of some combination of the above Unsure at this time 4. Please describe your primary clinical interest: Critical Care General Pulmonary Transplant Interventional Pulmonary Unsure/Undecided at this time 5. Where is/was your primary outpatient pulmonary clinic? Perelman Center/HUP VA Medical Center Other 6. I learn best by: Reviewing sample cases on a topic in a small group setting Hearing a didactic lecture on a clinical topic Self-learning and individual reading One-on-one preceptor to trainee discussions Review of the current literature on clinical practices E8

9 Other Please respond to each statement using the answer scale provided: 1. My outpatient pulmonary clinic has prepared me well for independent pulmonary practice Strongly agree Agree Neutral Disagree Strongly Disagree Not applicable/unable to answer at this time 2. My outpatient pulmonary clinic (as it is currently structured) is a crucial part of my overall pulmonary fellowship education Strongly agree Agree Neutral Disagree Strongly Disagree Not applicable/unable to answer at this time 3. With the current outpatient curriculum structure, I am gaining/have gained appropriate instruction and teaching on clinically relevant topics in ambulatory pulmonary medicine Strongly agree Agree Neutral Disagree Strongly Disagree Not applicable/unable to answer at this time 4. I am satisfied with the current structure and education in my outpatient pulmonary clinic Strongly agree Agree Neutral Disagree Strongly Disagree Not applicable/unable to answer at this time 5. I am likely to attend an outpatient pre-clinic conference Strongly agree Agree Neutral Disagree Strongly Disagree Not applicable/unable to answer at this time 6. The outpatient pulmonary clinic experience is a strength of the program Strongly agree Agree Neutral Disagree Strongly Disagree Not applicable/unable to answer at this time Please describe your current comfort level in the care of patients with the following clinical issues: 1. COPD requiring therapy beyond tiotropium, bronchodilators and inhaled corticosteroids 2. Step up asthma therapy E9

10 3. Approach to bronchiectasis 4. Approach to the initial interstitial lung disease evaluation 5. Pre-operative evaluation 6. Work up of the lung nodule 7. Outpatient management of terminal illness/hospice 8. Connective tissue disease related interstitial lung disease 9. Cystic fibrosis 10. When to order a cardiopulmonary exercise test and how to interpret it 11. HIV-related pulmonary infections 12. Asbestosis 13. Evaluation of cystic lung disease E10

11 14. Approach to allergic bronchopulmonary aspergillosis (ABPA) and other asthma mimics 15. Management of non-tuberculous mycobacterial infections E11

12 APPENDIX C: SUPPLEMENTAL TABLE OF 6 MONTH SURVEY DATA Table 1: A summary of 6 month survey data detailing fellow impressions of the outpatient curriculum. 6 month Interval Survey My outpatient pulmonary clinic has prepared me well 9 (75%) for independent pulmonary practice My outpatient pulmonary clinic (as it is currently 12 (100%) structured) is a crucial part of my overall pulmonary fellowship education With the current outpatient curriculum structure, I am 10 (83%) gaining/have gained appropriate instruction and teaching on clinically relevant topics in pulmonary medicine I am satisfied with the current structure and education 8 (67%) in my outpatient pulmonary clinic The outpatient pulmonary clinic experience is a 10 (83%) strength of the program E12

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