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Highlights from the COPD Foundation COPD7usa Conference Byron Thomashow, M.D. Jo-Ann LeBuhn Center for Chest Disease, New York Presbyterian Hospital New York, New York Barbara P. Yawn, MD, MS, FAAFP University of Minnesota, Minneapolis, MN. Fabiana Talbot, COPD Foundation The COPD7USA conference featured 3 tracks to address specific areas of interest for each learner. Tracks included Clinical, Research, and Care Delivery options. The next 2 articles highlight the Care Delivery and Research Tracks. For audio of sessions presented at COPD7usa, please visit the conference website: www.copdconferencesusa.org. he COPD7usa Care Delivery track featured 4 sessions: Care Delivery, 2-Transitions of Care, 3-Comparative Effectiveness Research, 4Care Payment. T Dr. Barbara Yawn, family physician from the Olmsted Medical Center and University of Minnesota moderated the first delivery of care session. Joining her to present two illustrative individual cases was pulmonologist Dr. Antonio Anzueto from the University of Texas at San Antonio, respiratory therapists and educators Gerilynn Connors, BS, RRT, FAACVPR from Inova Fairfax Hospital, and Jane Martin, BA, LRT, CRT from the COPD Foundation. The first case illustrated the broad support required to introduce a person with newly diagnosed COPD to the disease, their medications and future expectations. Dr. Yawn pointed out that most patients are diagnosed during or shortly after an exacerbation and therefore only ready for limited education and early return visit(s). Dr. Anzueto recommended that diagnostic spirometry may have to be delayed for 6 to 12 weeks to obtain an accurate baseline of COPD severity. Both Ms. Connors and Martin suggested help from respiratory therapists to teach and follow up on inhaler technique and provide basic education which could be done at the follow up visit for spirometry. All participants agreed that initial messages need to be simple and straightforward, emphasizing how, when and why to use medications and the importance of regular return visits. Of course smoking cessation must be part of every visit for anyone continuing to smoke. The panel went on to discuss the need for metrics to assess the effect of medical therapy, the decision when the patient has recovered from the exacerbation sufficiently to attend 28 LUNG HEALTH PROFESSIONAL MAGAZINE • VOLUME 3 I NUMBER 1 I 2012 pulmonary rehabilitation, and when to enhance medication treatments. Spirometry may or may not improve with therapy, but is useful to help patients see the impact of its use. The six minute walk test may be useful to demonstrate improved functional status. The COPD control test may be helpful in determining when additional treatment is needed. Of course counting exacerbation also works, but all panel members preferred to be able to prevent exacerbations rather than wait for the next one as a marker of treatment failure. For patients with confusing spirometry, such as a combined restriction and obstruction pattern referral for full pulmonary function testing from an experienced RT, an interpretation and consultation from a pulmonologist is needed. The ideal setting is one in which the respiratory therapist, COPD educator, the primary care physician and a consulting pulmonologist can interact to provide the person with COPD (and their family) the medical home that they need. Realizing the strengths and limitations of each health professional and their setting can improve their ability to focus care on the patient. Respect for each individual member of the team comes from this working together across care sites and disciplines. Learning when, where and how to ask for help and support is not limited to the patient and their family but a task for all health professionals when working to improve the lives of people with COPD. Dr. Jerry Krishnan chaired the Comparative Effectiveness Research Session and was joined by Dr. Joe Selby of the Patient-Centered Outcomes Research Institute; Dr. Tony Punturieri of the National Heart, Lung, and Blood Institute; and John Walsh of the COPD Foundation. Dr. Krishnan initiated the session and discussed the role of comparative effectiveness research (CER) in COPD. Refinements to clinical trials in the past 250 years have increased the ‘signal to noise’ ratio, which has affected participant selection, randomization of treatment allocation, research infrastructure, and overall planning. Efficacy trials are likely to have great direct benefits, utilize practice settings with low rates of complications, and have specific yet costly experimental intervention. However, they may exclude many, if not most, real-world patients, as research conditions do not mimic delivery of care in clinical settings. Conversely, comparative effectiveness research (CER) synthesizes the benefits and harms of different interventions in real world settings. CER improves health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decisionmakers by responding to their expressed needs. These considerations determine which interventions are most effective for specific patients and circumstances. CER is underdeveloped in the U.S. and needs infrastructure to support collaboration between stakeholders who generate, disseminate, and use new knowledge. Continued involvement of stakeholders is required to ensure the validity, feasibility, timeliness, and relevance of study protocols. CER is also utilized to determine Medicare coverage and reimbursement. When Medicare decides to cover a new healthcare item or service, evidence of superior comparative clinical effectiveness determines usual pricing (payment based on existing formulas). It also provides evidence of comparative clinical effectiveness, or reference pricing (payment equal to that for equality effective alternative). Insufficient evidence to judge comparative clinical effectiveness leads to dynamic pricing (payment based on existing formulas, with effectiveness reevaluated after three years). Dr. Selby discussed The Patient-Centered Outcomes Research Institute’s (PCORI) role in developing national priorities and research agenda related to COPD. PCORI’s purpose in defining legislation: “Assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence…[relevant to] the manner in which diseases, disorders and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis.” (Affordable Healthcare Act, 2010) To ensure research outcomes remain patientcentered, studies must understand the choices patients face through patient engagement, align research questions and methods with patient needs, and provide patients and providers with information for better decisions. Patient-centered outcomes research is considered CER as it incorporates the patient voice to ensure research questions are practical, outcomes are important to patients are identified, those studied are representative of those who require information from specific settings, and heterogeneity in effectiveness is carefully examined. Frequently cited priority areas include: prevention and screening; acute care; chronic disease care; palliative care and pain management; care coordination; patient engagement; and health information technology. PCORI’s national research priority areas draw from the frequently cited areas, and frame five draft national priorities: implementing comparative clinical effectiveness, improving healthcare systems, streamlining communication and dissemination, improving fairness/addressing disparities, and accelerating patient-centered research. Dr. Punturieri, Program Director of the Division of Lung Diseases at the National Heart, Lung and Blood Institute (NHLBI), discussed the role of CER in lung research. Accurate, timely data remains a constant need in the field; nearly 50% of recommendations are based on expert opinion, yet 11% are based on multiple randomized trials. Effective CER requires full use 29 of broad range of study designs, utilizing observational studies to conduct CER and for needs assessment, encourage researchers to collect information on a range of outcomes, promote interest in CER among the scientific community, increase efforts to engage stakeholders, and invest in development of databases and infrastructure supporting CER. As an individual with Alpha-1 related genetic COPD and founder of the COPD and Alpha-1 Foundations, Mr. John Walsh concluded with insights on CER from the patient perspective. Patients’ two main priorities are survival and quality of life, with serious concerns about costs associated with multiple co-morbidities and medications. He explained that a clear distinction of “comparative effective” versus “cost effectiveness” research must be made to the patient. The CER process must be transparent, involving all stakeholders in the research process to enhance the credibility of studies. For research to be clinically meaningful, it must impact one’s quality of life, family life, and functional capacity. When studies focus on the totality of healthcare delivery system, they are more likely to improve health outcomes. This requires researchers to go beyond drugs and biologics and into prevention services, diagnostic tests, medical procedures, and health management programs. Dr. Robert Sandhaus chaired the “Addressing Cost of COPD” session, and was joined by Dr. Tangita Daramola of Competitive Acquisition Ombudsman Group; and Drs. Howard Garber and Scott Berkowitz of Johns Hopkins University School of Medicine. Dr. Sandhaus reviewed the roll that a well designed and effectively administered Health Maintenance/Disease Management can play in reducing the cost of COPD. He presented the Alpha-1 Disease Management and Prevention Program (ADMAPP) and reviewed the outcome data documenting its improvement in healthcare utilization and quality of life for participants. Alpha-1 Antitrypsin Deficiency (AATD) is the major genetic cause of COPD. AlphaNet, a notfor-profit health management organization, developed ADMAPP as a way to improve the lives and reduce the healthcare costs for its 3,000 30 LUNG HEALTH PROFESSIONAL MAGAZINE • VOLUME 3 I NUMBER 1 I 2012 members with AATD. The ADMAPP program centers on the patient-aimed Big Fat Reference Guide to Alpha-1 (the BFRG) and includes nurse training and certification, telephonic coordination of patient education and follow-up, and continuous monitoring of patient outcomes. The disease management coordinators who each follow between 100 and 150 patients are all patients with AATD themselves. The program has been functioning since 2003 and outcome data has confirmed that patients in the program has seen a reduction in their healthcare utilization including decreased ER visits, decreased hospitalizations, decreased physician visits, decreased frequency and severity of exacerbations, and decreased steroid and antibiotic usage. At the same time they have demonstrated a stabilization of their quality of life, both in terms of general health and respiratory-specific measurements. Dr. Daramola discussed issues related to Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) competitive bidding program and the Competitive Acquisition Ombudsman (CAO). The Medicare Competitive Acquisition Ombudsman was created in an effort to support the Competitive Bidding Program in responding to individual and supplier inquiries, issues, and complaints. It is also responsible for reporting to Congress annually. The DMEPOS Medicare program reduces out-of-pocket expenses for beneficiaries, saves the Medicare program while ensuring beneficiaries quality products and qualified suppliers. CAO core functions promote fairness and access by responding to suppliers’ and beneficiary complaints and inquiries regarding DMEPOS Competitive Bidding Program; communicating with Congress by providing an annual report that details CAO activities; identifying potential challenges to successful implementation and offer mitigation strategies; and facilitate understanding through regular communication with partner organizations. Dr. Garber’s presentation addressed a pressing issue currently among the most discussed in COPD – the effort to decrease re-hospitalization following an admission with a COPD continued on page 32 continued from page 30 exacerbation. He presented the data obtained from the Johns Hopkins Medical Center regarding efforts to address the issues that lead to readmission. After reviewing the identified issues that are associated with early readmission, he discussed the benefits of a COPD Home Health Care Clinical Pathway approach to addressing and resolving these issues. Dr. Berkowitz, Medical Director for Accountable Care at Johns Hopkins University, described chronic conditions and their associated costs. The total U.S. annual cost of COPD is $40 billion. Americans living with chronic conditions will increase by 46 million between 2000 and 2030, with 4x greater healthcare costs per condition and 25x greater costs with five or more. He described the Affordable Care Act (ACA) as a framework for improving care by: expanding coverage; reducing federal deficit; emphasizing quality; reducing fraud and waste; funding comparative effectiveness research; reducing burdensome paperwork; and focusing on prevention and wellness. He went on to explain the ACA’s role in promoting ACOs, a providerbased arrangement where the providers are accountable for the quality, cost and overall care of a set of patients. ACOs organize and coordinate the end-to-end delivery of services for each participant across the care continuum. Dr. Byron Thomashow chaired the Transitions of Care track; he was joined by Dr. Richard Cassaburi from. Harbor-UCLA Medical Center, Dr. Ravi Kalhan from Northwestern University, Dr. Jill Ohar from Wake Forrest University, and Dr. Scott Conard from ACAP Health and GOH Medical. Dr. Thomashow began the discussion by reviewing the increasingly important issue of hospitalizations and re-hospitalizations. The cost of COPD care in this country now stands at almost 50 billion dollars a year: almost 70% are due to care related to exacerbations, mostly reflecting cost for hospitalizations. Hospital readmissions have been singled out for improvement by CMS National Strategy by Quality Improvement in Health Care. The goal of the CMS strategy is a 20% reduction in hospital readmission rates by end of 2013, potentially preventing 1.6 million hospitalizations and saving an estimated 15 billion dollars. Combining financial incentives and penalties the Affordable Care Act (ACA) seeks to promote coordination across the continuum of care. The Hospital Readmission Reduction Program (HRRP) is 32 LUNG HEALTH PROFESSIONAL MAGAZINE • VOLUME 3 I NUMBER 1 I 2012 designed to reduce all cause readmissions by aligning payments to outcomes. The outcome measurement proposed is hospital specific, risk stratified all cause 30 day excess readmission ratio following index admission for acute myocardial infarction, congestive heart failure, or pneumonia. Underperforming hospitals will incur a reduction of Medicare based reimbursements for inpatient services starting fiscal year 2013 and increasing over the next several years. In addition, HRRP will require expansion of public reporting and will supplement the initial three readmission measures. COPD exacerbation hospitalizations are a likely target. In 2003-2004 the 30-day readmission rate among patients hospitalized with COPD was 22.6%, accounting for 4% of all 30-day readmissions. In 2007, the Medicare Payment Advisory Council listed COPD as number four of the seven conditions associated with the most costly potentially preventable readmissions. Recently released data from 2008 across 15 states and over 190,000 index COPD admissions documented a 20.5% 30-day all cause readmission rate. Costs were consistently higher for readmissions than for the index hospitalizations. Dr. Thomashow reviewed data from a chart review of COPD admissions in 2005-2006 in 5 city hospitals and 4 community hospitals in the New York-Presbyterian Healthcare System (Yip et al JCOPD 2010;7;85-92) This study, which reviewed over 2000 COPD hospitalizations, suggested that while in-hospital care generally followed suggested guidelines with combination of systemic steroids, antibiotics, and bronchodilators, most patients were not receiving the suggested maintenance regimens. Dr Thomashow also reviewed a recent article in Thorax (Hopkinson et al Thorax 10.1136/thoraxjnl-2011-200233) which described a discharge bundle. This bundle consisted of smoking cessation assistance for active smokers, assessment for pulmonary rehabilitation, a written COPD patient information plan, teaching of appropriate inhaler use, arranging a phone call check within 48-72 hours of discharge, and setting up an outpatient appointment shortly post discharge. Dr. Thomashow stressed that his institution and others are working on similar discharge plans. He also emphasized that the financial incentives and penalties that are being put into effect should allow hospitals and institutions to partner with physicians and patient groups so as to develop better care plans for COPD. Dr. Casaburi reviewed a recent meta-analysis from the Cochrane Database. The paper looked at the effect of pulmonary rehabilitation after COPD exacerbation on rehospitalization and included five studies involving 250 subjects with follow up ranging from 12 to 76 weeks. Research showed that pulmonary rehabilitation significantly decreased readmission rates. Three studies, involving 110 subjects, looked at the effect of rehabilitation on mortality, and here too pulmonary rehabilitation appeared to have real benefit. Dr. Casaburi stressed that these studies had limitations including small sample sizes in individual studies, the analysis being based on a small number of events, the impossibility of blinding the intervention, dissimilarities among programs and follow-up, and the possibility of publication bias. Having said that, these initial results are extremely impressive. If ongoing studies confirm these preliminary results, all centers will need to consider post COPD hospitalization pulmonary rehabilitation as a possible option to improve care and decrease readmissions. Dr. Ohar and Dr. Kahan reviewed their experiences regarding the readmission issue. Dr. Ohar emphasized the importance of comorbidities adding to the complexity of COPD hospitalizations quoting data, which shows a 40% incidence of hypertension, a 22% incidence of diabetes, and an 18% incidence of fluid and electrolyte disturbances. She also presented data suggesting impressive increased risk of cardiovascular complications post COPD exacerbations, ranging from a risk ratio of 2.76 for heart failure to 4.37 for atrial fibrillation/flutter, to 4.34 for ventricular arrhythmias, and 15.6 for renal failure. She stressed the potential impact of a selfmanagement program including a single 1-1.5 hour education session, an action plan for selftreatment of exacerbations, monthly nurse follow-up calls and a 24-hour nurse hotline. She reviewed data suggesting that this type of self-management program could decrease emergency room visits, hospital readmissions, and cost. Dr. Ohar also reviewed her institutions experience with pneumonias, another core measure monitored by CMS. She described a 6 step discharge plan used for pneumonias that could potentially be adapted for COPD use. This plan includes a phone call to patient within first 24 hours of discharge, a visiting nurse visit within 1-3 days, a 30 day supply of all medications at discharge, a follow-up clinic visit within 7 days, transportation provided for the clinic visit if needed and a palliative care consult in hospital if the Charlson score which estimates mortalities were significantly elevated. Dr. Conard reviewed the experience of his group in Texas. He described the basis of establishing a successful patient centered medical home dependent upon access, communication, patient tracking and registry, care management, patient self-management support, electronic prescribing, test tracking, referral tracking, performance reporting and improvement. He stressed that advanced electronic communication systems were a critical component allowing management of over 2.4 million active patients, merging data from 64 electronic medical servers daily, and processing hundreds of millions of diagnoses, procedures, lab results, medications, vital signs, and other key clinical indicators. He described their patient medical home summary which included not only patient demographics, diagnoses, vital signs, medications, lab results and procedure history but also a list of all other healthcare providers the patient had seen, protocol recommendations, and patient goals. He also described individualized clinician dashboards depicting how the provider was performing regarding cardiac care, diabetes care, preventative care including vaccinations and provided an ongoing feedback regarding patient satisfaction. Dr. Conard pointed out the importance of external quality recognitions, peer comparisons, and care analysis. He described an appointment reminder program, which contacted all patients 24-48 hours prior to scheduled appointments to confirm and a chronic notification program that automatically reached out to patients if they appear to be out of compliance with evidence based guidelines. Besides the importance of a robust electronic network, Dr. Conard stressed that this process only works with a team approach increasing the input and value of every team member. In this scenario the physician tasks include reviewing data provided by the team, assessing the patient and providing clinical management 33 continued from page 33 recommendations according to approved guidelines. The nurse practitioner or physician assistant tasks include dealing with acute visits, seeing patients on alternate chronic disease visits, and coordinating care for high acuity patients. The RN, LPN, Medical Assistant tasks include medication reconciliation on all patients, working with the patient on adherence. compliance issues, and care management. In this system, the patient too has tasks including defining their own goals in discussion with the team, keeping a current medication list, updating their medical information, and participating in visit planning. Dr. Conard closed by describing a patient care pathway, that maps the patient experience through this new and evolving healthcare system. He felt that this type of core coordination carried tremendous impact reducing emergency room visits, hospital admission and readmission rates, and overall reducing healthcare costs while increasing reimbursement for primary care physicians, thus improving satisfaction of physicians, non physician team members, and patients. COPD7usa received unrestricted educational grants from Boehringer Ingelheim Pharmaceuticals, CSL Behring, Forest Laboratories, Inc, Grifols, and Pfizer Pharmaceuticals. Author disclosures and audio of the COPD7usa sessions are available on the COPD7usa conference website: www.copdconferencesusa.org. Presenters: Dr. Jerry Krishnan: 1. Thorpe KE, CMAJ, 2009. 2. Halpin D, Prim Care Resp J 2010. 3. Austin Bradford Hill, 1984. 4. US Recovery Act Spend Plan, Office of the Secretary, DHHS, 11/09 Mularski RA et al Comp Eff Res 2012 (in press). 5. Pearson S, Health Affairs 2010. 6. Thorpe KE, CMAJ, 2009. 7. Rothwell PM. Lancet 2005; 365: 82–93. Dr. Joe Selby Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010. Dr. Tony Punturieri 1. IOM Report 2009. 2. Tricoci P et al. JAMA 2009;301:831-41. 3. ALLHAT Officers. JAMA 2002;288:2981-7. 4. http://www.iom.edu/CMS/3809/63608/71025.aspx 5. Am J Respir Crit Care Med Vol 184. pp 848–856, 2011. 6. National Emphysema Treatment Trial Research Group. N Engl J Med. 2003;348:2059-73. Dr. Robert Sandhaus 1. www.alphanet.org Dr. Tangita Daramola 1. www.cms.gov/dmeposcompetitivebid 2. www.cms.gov/Partnerships/03_DMEPOS_Toolkit.asp 3. www.cms.gov/DMEPOSCompetitiveBid/01A3_Monitoring.asp 4. www.dmecompetitivebid.com 5. www.medicare.gov/navigation/help-and-support/competitive-acquisition-ombudsman.aspx 6. www.medicare.gov/Supplier/Include/DataSection/Questions/SearchCriteria.asp 7. www.medicare.gov/contacts/search-results.aspx?customresult=AllSHIP 34 LUNG HEALTH PROFESSIONAL MAGAZINE • VOLUME 3 I NUMBER 1 I 2012 Dr. Scott Berkowitz 1. “The Cost Conundrum” by Atul Gawande (New Yorker, 2009) N Engl J Med 2011; 364:e12. Feb 17, 2011. Dr. Byron Thomashow 1. Yip et al JCOPD 2010;7;85-92, Hopkinson et al Thorax 10.1136/thoraxjnl-2011- 200233. Dr. Richard Casaburi 1. Pulmonary Rehabilitation Following Exacerbations of Chronic Obstructive Pulmonary Disease. Puhan MA, Gimeno-Santos E, Scharplatz M, Troosters T, Walters EH, Steurer J. Cochrane Database Syst Rev. Oct 5, 2011. Dr. Jill Ohar 1. Coventry, PA. BMC Pulm Med 2011. 2. Khawaja FJ, Arch Int Med 2011. 3. Lindenauer PK Annals of Int Med 2006 p896. 4. Tashkin-ERS poster 2010. 5. Rice KL AJRCCM 2010 p29. 6. Rice KL AJRCCM 2010 2. Sedeno MF COPD 2009. 7. Effing T Thorax 2008. 8. Borbeau J CHEST 2010. 9. Mannino D, MMWR Morb Mortal Wkly Rep 2002 p1. 10. Mannino DM, Respir Med. (2009) p224. http://www.sdfmc.org/ClassLibrary/Page/Information/DataInstances/293/Files/1948/ASHHC_P atient_Action_Plan_fpr_COPD_signs_and_symptoms.pdf. Accessed September 2010. Dr. Scott Conard 1. National High Blood Pressure Education Program (NHBPEP)/National Heart, Lung, and Blood Institute (NHLBI) and American Heart Association (AHA) working meeting on blood pressure measurement. Summary report. Bethesda, MD: National Institutes of Health; April 19, 2002. 2. Handler J. Permanent J. 2009;13:51-54 Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Washington, DC: US Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute; August 2004. NIH Publication No. 04-5230. 35