Challenges in Pulmonary and Critical Care: 2013

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NATIONAL ASSOCIATION FOR CONTINUING EDUCATION Pulmonary Hypertension: A Disease in Evolution Final Outcome Report Presented at: Cleveland Clinic Florida Weston, Florida Challenges in Pulmonary and Critical Care: 2013 December 7, 2013 Report Date: January 2, 2013

Course Director Franck Rahaghi, MD, MHS, FCCP Director, Pulmonary Hypertension Clinic Director, Pulmonary Education and Rehabilitation Cleveland Clinic Florida Weston, FL Course Accreditation The National Association for Continuing Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The National Association for Continuing Education designates this live activity for a maximum of 7 AMA PRA Category 1 Credits. Physicians should only claim the credit commensurate with the extent of their participation in the activity. National Association for Continuing Education is approved as a provider of nurse practitioner continuing education by the American Association of Nurse Practitioners. AANP Provider Number 121222. This program has been approved for 7.0 contact hours of continuing education (which includes 0.75 pharmacology hours).

Commercial Support Challenges in Pulmonary and Critical Care: 2013 CME activity was supported through educational grants from the following companies: Actelion Baxter Healthcare Boehringer Ingelheim Pharmaceuticals, Inc. Boston Scientific CSL Behring Genentech Grifols

Agenda 7:00-7:45 Continental Breakfast and Registration 7:45-8:00 Welcome Remarks Franck Rahaghi, MD, MHS, FCCP 8:00-9:00 Pulmonary Hypertension: A Disease in Evolution Murali Chakinala, MD, FCCP 9:00-10:00 Update in Interventional Bronchoscopy 2013 Eduardo C. Oliveira, MD 10:00-10.15 Break/Exhibits 10:15-11:15 COPD: New Developments, New Treatment Horizons Anas Hadeh, MD, FCCP 12:15-1:00 Lunch Break/Exhibits 1:00-2:00 Update in PE and CTEPH Charles D. Burger, MD 2:00-3:00 Idiopathic Pulmonary Fibrosis: What have we learned and where are we going? Franck Rahaghi, MD, MHS, FCCP 3:00-3:15 Break/Exhibits 3:15-4:15 Lung Cancer: State of the Art 2013 Jinesh Mehta, MD 4:15-4:30 Concluding Remarks Franck Rahaghi, MD, MHS, FCCP 11:15-12:15 Alpha-1 Antitrypsin Deficiency: 50th Anniversary of a Disease Robert A. Sandhaus, MD, PhD

Levels of Evaluation Consistent with the policies of the ACCME, NACE evaluates the effectiveness of all CME activities using a systematic process based on the following model: 1. Participation 2. Satisfaction 3. Learning A. Declarative Knowledge B. Procedural Knowledge 4. Competence 5. Performance 6. Patient Health 7. Community Health Moore DE Jr, Green JS, Gallis HA. Achieving desired results and improved outcomes: integrating planning and assessment throughout learning activities.j Contin Educ Health Prof. 2009 Winter;29(1):1-15.

Level 1: Participation 129 attendees 76% Physicians; 7% NPs; 11% PAs; RNs; 7% Other Over 46% in community-based practice 45% PCPs, 33% Pulmonologists; 3%Rheumatology; 3% Dermatology; 16% Other or did not respond 8 7 76% 6 5 4 3 1 11% 7% 7% N =57 MD NP PA RN Other Did we reach the right audience? Yes!

Level 2: Satisfaction 10 rated the activity as very good to excellent 98% indicated the activity improved their knowledge 96% stated that they learned new strategies for patient care 79% said they would implement new strategies that they learned in their practice 10 said the program was fair-balanced and unbiased Were our learners satisfied? Yes!

Level 2: Satisfaction Upon completion of this activity, I can now Discuss the pathophysiology of pulmonary arterial hypertension (PAH); Explain criteria for diagnosis and accurate assessment of disease severity in patients with PAH; Address therapeutic options in the management of patients with PAH and effective use of targeted treatment options for PAH. 8 7 6 7 5 4 3 1 3 Yes Somewhat Not at all Did learners indicate they achieved the learning objectives? Yes! 10 believed they did.

Outcome Study Methodology Goal To determine the effect this CME activity had on learners with respect to competence to apply critical knowledge, confidence in treating patients with diseases or conditions discussed, and change in practice behavior. Dependent Variables 1. Level 3-5: Knowledge, Competence, and Performance Case-based vignettes and pre- and post-test knowledge questions were asked with each session in the CME activity. Identical questions were also asked to a sample of attendees 4 weeks after the program to assess retention of knowledge. Responses can demonstrate learning and competence in applying critical knowledge. The use of case vignettes for this purpose has considerable predictive value. Vignettes, or written case simulations, have been widely used as indicators of actual practice behavior. 1 2. Practitioner Confidence Confidence with the information relates directly to the likeliness of actively using knowledge. Practitioner confidence in his/her ability to diagnose and treat a disease or condition can affect practice behavior patterns. 3. Level 5: Self-Reported Change in Practice Behavior Four weeks after CME activity, practitioners are asked if they changed practice behavior. 1. Peabody, J.W., J. Luck, P. Glassman, S. Jain, J. Hansen, M. Spell and M. Lee (2004). Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med14(10): 771-80.

Outcome Study Methodology (Cont.) 4. Readiness to Change Behavior (Prochaska and DeClemente Model) CME activities can motivate providers to move through different stages of change which can ultimately lead them to take action and modify their practice behavior in accordance with the objectives of the education. Movement through these stages of change is an important dependent variable to consider in evaluating the impact of CME. Participants were asked to evaluate their stage of change with respect to specific topics being presented. Pre-contemplation stage: I do not manage (PAH), nor do I plan to this year. Contemplation stage: I did not manage (PAH) before this course, but as a result of attending this course I'm thinking of managing it now. Pre-contemplation/confirmation stage: I do manage patients with (PAH) and this course confirmed that I do not need to change my treatment methods. Preparation for action stage: I do manage patients with (PAH) and this course helped me change my treatment methods. Prochaska, et al (1988). Journal of Consulting and Clinical Psyhcology., 56, 520-528.

Pulmonary Hypertension: A Disease in Evolution Faculty Murali Chakinala, MD, FCCP Associate Professor of Medicine Director, Pulmonary Hypertension Center Co-Director HHT Center Washington University School of Medicine St. Louis, MO Learning Objectives Discuss the pathophysiology of pulmonary arterial hypertension (PAH) Describe the workup of patients suspected of having PAH Explain criteria for diagnosis and accurate assessment of disease severity in patients with PAH Address therapeutic options in the management of patients with PAH and effective use of targeted treatment options for PAH

Key Findings Pulmonary Hypertension: A Disease in Evolution Knowledge/Competence Confidence Intent to Perform Change of Practice Behavior N=61 Learners demonstrated improvement in their answers from pre to post-testing on four of the four case-based questions regarding Pulmonary Arterial Hypertension. Whereas the majority of learners rated themselves as having very low confidence in their understanding of treating Pulmonary Arterial Hypertension before the education most of the learners showed gains in confidence after the program. As a result of this program, 5% of learners who did not manage Pulmonary Arterial Hypertension before are considering doing so, while 32% indicated that they will change their treatment methods 84% of learners who responded to our four week survey indicated that they had changed their practice behavior to implement the learning objectives of this program within four weeks after they attended the activity.

Case Vignette Knowledge and Competence Assessment Questions (Presented before and after lecture. Boxed answer is correct.) 6 5 Which of the following underlying conditions do NOT cause Group 1 pulmonary hypertension? P Value: >0.011 - Sign 52% 4 44% 3 29% 1 17% 15% 3% 7% 7% Scleroderma Portal hypertension Congenital systemic-topulmonary shunts 7% Human immunodeficiency virus Chronic thromboembolic disease N =60 Green highlight indicates significant difference between pre and post testing.

Case Vignette Knowledge and Competence Assessment Questions (Presented before and after lecture. Boxed answer is correct.) Which hemodynamic alteration confers the worst prognosis in PAH? 6 5 P Value: <0.001 - Significant 53% 4 3 33% 1 7% 13% Rising pulmonary artery pressure 15% Rising pulmonary vascular resistance 17% 7% Declining systemic vascular resistance 24% Rising right atrial pressure 19% 13% Increasing transpulmonary gradient N =58 Green highlight indicates significant difference between pre and post testing.

Case Vignette Knowledge and Competence Assessment Questions (Presented before and after lecture. Boxed answer is correct.) Which item is NOT part of the REVEAL risk score calculation? 10 9 P Value: <0.003 - Significant 93% 8 7 73% 6 5 4 3 1 7% 12% 2% 3% Uric acid BNP Diffusing capacity for carbon monoxide (DLCO) 2% 7% 2% Right atrial pressure Six Minute Walk Distance N =59 Green highlight indicates significant difference between pre and post testing.

Case Vignette Knowledge and Competence Assessment Questions (Presented before and after lecture. Boxed answer is correct.) Which clinical endpoint was NOT part of the definition of clinical worsening in the SERAPHIN trial of macitentan? 35% 3 P Value: <0.097 - Significant 32% 25% 15% 21% 18% 1 13% 5% 9% 7% 6% Death Transplantation Hospitalization of PAH Disease progression N =56 Green highlight indicates significant difference between pre and post testing.

Change in Practice Behavior Question Presented after lecture. Which of the statements below describes your approach to diagnosing and treating patients with Pulmonary Hypertension? Pre-Contemplation Stage Contemplation Stage Preparation for Action Stage Pre-Contemplation/ Confirmation Stage 6 5 56% 4 3 32% 1 I do not manage patients with pulmonary hypertension, nor do I plan to this year. N = 57 5% I did not manage patients with pulmonary hypertension before this course, but as a result of attending this course I'm thinking of managing it now. I do manage patients with pulmonary hypertension and this course helped me change my treatment methods. 7% I do manage patients with pulmonary hypertension and this course confirmed that I don't need to change my treatment methods.

Changes in Confidence from Pre to Post-Testing Pulmonary Hypertension: A Disease in Evolution On a scale of 1 to 5 please rate how confident you would be in treating patients with this condition. 45% 4 35% 3 25% 28% 39% 34% 15% 16% 21% 18% 1 5% 11% 7% 6% Not at all confident Slightly confident Moderately confident Pretty much confident Very confident N =64

Intention to Change Practice Behavior and Implement Learning 6 5 56% 4 3 23% 1 Very likely Somewhat likely Unlikely Not applicable 1% N =119

Discussion and Implications Pulmonary Hypertension: A Disease in Evolution Pulmonary arterial hypertension (PAH) is a serious and often progressive disorder that may be idiopathic or associated with various underlying medical conditions. PAH causes right ventricular dysfunction and impaired activity tolerance, and can lead to right-heart failure and death. With the development of new therapies for PAH screening, prompt diagnosis, and accurate assessment of disease severity become increasingly important. However, PAH patients continue to be referred too late in the disease process, at a time when hemodynamic abnormalities are at an advanced stage. Many patients are referred on potentially harmful calcium channel blockers therapy without adequate prior evaluation for pulmonary vasoreactivity. The objective of this activity was to explain the pathophysiology of PAH, discuss how to work up a patient with suspected PAH, explain the diagnostic criteria, and implement appropriate therapies. Knowledge/Competence: Attendee knowledge was assessed at two points for this activity prior to the activity and immediately following the activity using the case vignettes and knowledge questions described earlier. The results indicated improvement in knowledge as measured by positive changes in pre to post-test scores on all four questions asked, with statistical significance achieved in four out of four. Readiness to Change: Thirty-seven percent of attendees claimed they would either start diagnosing and treating PAH now or would change their practice after having been exposed to the information taught in the course Confidence: Participants indicated a shift in self-reported confidence levels in treating patients with PAH. Attendees who reported that they felt very confident rose from 6% to 18%

Intention for Change in Practice Behavior: Fifty-six percent of participants reported that they were very likely to utilize information learned from this activity in their practice. Summary: Seventy nine percent of the attendees suggested they were going to change their practice patterns as a result of this program. This activity was successful in the goal of improving understanding about evaluating patients suspected of PAH and managing their disease. The activity had a positive impact in terms of self-reported improvement in confidence and the likelihood of practice change. Future programming should continue to educate clinicians on current guidelines as well as effective therapies for PAH.