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Treatment Options for Severe Asthma in African-Americans and Hispanics/Latinos

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Slide presentation from the Ad Hoc Workgroup Meeting held March 1, 2013.

Slide presentation from the Ad Hoc Workgroup Meeting held March 1, 2013.

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  • 1. Treatment Options for Severe Asthma in African-Americans and Hispanics/Latinos Ad Hoc Workgroup Meeting March 1st, 2013 1
  • 2. Welcome and Introductions 2
  • 3. Joe V. Selby, PCORI Romana Hasnain-Wynia, PCORI 3
  • 4. Housekeeping: Providing Input Today’s webinar participants can provide input via email (asthma@pcori.org); via Twitter (using #PCORI); the webinar “chat” feature; through our webpage “Submit a Question on our Targeted Topics for Research Funding;” and during the upcoming public comment period, by telephone. Please submit questions today as they occur to you. We will collect and synthesize these for discussion at 1:00 pm ET. If you want to comment by phone, we’ll open the lines during the comment period at 12:45 ET and provide instructions at that time. We welcome additional input through 5 pm ET March 15 via the webpage noted above and email (asthma@pcori.org). 4
  • 5. Introductions: Chair and Moderator James Kiley, MS, PhD, Chief of the Airway Biology and Disease Program in the Division of Lung Diseases at The National Heart, Lung, and Blood Institute, National Institutes of Health (NHLBI) 5
  • 6. Introductions: Researchers Andrea Apter, MD, MSc, MA, Chief and Program Director, Section of Allergy & Immunology, University of Pennsylvania Jean Ford, MD, Chair, Department of Medicine, The Brooklyn Hospital Center Elliot Israel, MD, Director of Clinical Research, Pulmonary and Critical Care Division, Brigham & Women’s Hospital Susan Sommer, MSN, RNC, NP, AC-E, Nurse Case Manager, Children's Hospital Boston Community Asthma Initiative Stanley J. Szefler, MD, Director, Pediatric Clinical Trials Center; Head, Pediatric Clinical Pharmacology Training Program; Director, Allergy and Immunology-Pediatrics, National Jewish Health 6
  • 7. Introductions: Patients Vernal Branch, Patient Advocate Charryse Johnson, Patient Advocate Perry W. Payne, Jr., MD, JD, MPP, Advisor, Asthma and Allergy Foundation of America Nancy Sander, President and Founder, Allergy & Asthma Network/Mothers of Asthmatics 7
  • 8. Introductions: Other Stakeholders Michael Foggs, MD, President-Elect, American College of Allergy, Asthma and Immunology. Sandra McKinney, MS, RN, CCM, Board Member, National Black Nurses Association. Lois Wessel, RN, CFNP, Associate Director, Programs, Association of Clinicians for the Underserved. 8
  • 9. Background on Ad hoc Workgroups 9
  • 10. Joe V. Selby, PCORI Romana Hasnain-Wynia, PCORI 10
  • 11. About PCORI An independent non-profit research organization authorized by Congress as part of the 2010 Patient Protection and Affordable Care Act (ACA). Committed to continuously seeking input from patients and a broad range of stakeholders to guide its work. 11
  • 12. PCORI’s Mission and Vision Mission The Patient-Centered Outcomes Research Institute (PCORI) helps people make informed health care decisions, and improves health care delivery and outcomes, by producing and promoting high integrity, evidence-based information that comes from research guided by patients, caregivers and the broader health care community. Vision Patients and the public have the information they need to make decisions that reflect their desired health outcomes. 12
  • 13. PCORI’s First Targeted Research Topics Identified five high-priority, stakeholder-vetted topics. Jumpstarts PCORI’s long- term topic generation and research prioritization effort. Builds on similar, earlier efforts by others. Allows us to build on our engagement work. 13
  • 14. Targeted PFA Workgroup Goals 14 Provide summary of findings to Board of Governors
  • 15. Workgroup Objectives: A Narrowing Process Consider the broad range of research questions provided by researchers, patients, and other stakeholders. Narrow questions to determine which are most critical. Narrow further by identifying a concise list of high- priority questions. 15
  • 16. Criteria for Knowledge and Research Gaps Knowledge gaps should:  Be patient-centered: Is the proposed knowledge gap of specific interest to patients, their caregivers, and clinicians?  Assess current options: What current guidance is available on the topic and is there ongoing research? How does this help determine whether further research is valuable?  Have potential to improve care and patient-centered outcomes: Would new knowledge generated by research be likely to have an impact in practice?  Provide knowledge that is durable: Would new knowledge on this topic remain current for several years, or would it be rendered obsolete quickly by subsequent studies?  Compare among options: Which of two or more options lead to better outcomes for particular groups of patients? 16
  • 17. Questions External to PCORI’s Mandate Cost effectiveness: PCORI will consider the measurement of factors that may differentially affect patients’ adherence to the alternatives such as out-of-pocket costs, but cannot fund studies related to cost-effectiveness, costs of treatments or interventions. Medical billing: PCORI cannot fund studies about an individual’s insurance coverage or about coverage decisions from third party payers. Disease-processes and causes: PCORI cannot fund studies that pertain to risk factors, origin and mechanisms of diseases. 17
  • 18. How PCORI Gathers Input The researchers, patients and stakeholders who’ve been invited to this workgroup give input during the workgroup. The broad community of researchers, patients and other stakeholders can give input via our website – for the past four weeks and for the next two. Webinar participants can provide input via email (asthma@pcori.org); Twitter (hashtag #PCORI); the webinar “chat” feature; the “Submit a Question on our Targeted Topics” webpage; and, during the upcoming public comment period, by phone. 18 PCORI distinguishes “input” to the PFA development process from “involvement” in the process. Input is information that may or may not be considered or used in crafting The PFA. Involvement is the activity of determining what will be in the PFA.
  • 19. How PCORI Manages the Potential for Conflict of Interest Participants in this workgroup will be eligible to apply for funding if PCORI decides to produce a funding announcement on treatment options for severe asthma in African-American and Hispanic/Latino patients. The Chair of this workgroup will not be eligible. Input received during the workgroup deliberations are broadcast via webinar, and the webinar is then archived and available to other researchers, patients or stakeholders on the website. PCORI does not have subsequent discussions with the presenters after this workgroup. Presenters have been explicitly instructed and are expected to address a set of questions we’ve asked – not to tell us about their research. There should be no “influence advantage” to being a workgroup member, nor any knowledge advantage as to what will eventually be requested in the PFA. 19
  • 20. Setting the Stage 20
  • 21. James Kiley, MS, PhD National Institutes of Health 21
  • 22. Overview Asthma in African-Americans and Hispanics/Latinos Objectives for Workgroup Types of Research Questions Collaborative Workgroup Discussion 22
  • 23. Asthma in African-Americans & Hispanics/Latinos: Disparities in Prevalence 23 Modified from Akinbami, LJ et al. Trends in Asthma Prevalence, Health Care Use, and Mortality in the United States, 2001–2010, NCHS Data Brief No 94, May 2012 Asthma Prevalence in the United States, Annual Average 2008-2010 Asthma affects 25.7 million Americans
  • 24. Asthma in African-Americans & Hispanics/Latinos: Disparities in Outcomes 24 Asthma deaths Healthcare utilization: Hospitalizations & ED Visits
  • 25. Asthma in African Americans and Hispanics/Latinos Factors that contribute to disparities in outcomes:  Lack of access to quality care: ongoing comprehensive treatment.  Genetic factors that influence response to treatment.  Low health literacy and self-management skills.  Patient preferences and health beliefs.  Environmental exposures: allergens & pollutants; psychosocial (chronic stress, violence).  Lack of community capacity to identify and reach patients most at risk. 25
  • 26. Goal and Objectives for Workgroup Goal: Identify high-priority research questions that, when answered, will help African-American and Hispanic/Latino patients with uncontrolled asthma, their caregivers, and clinicians make better informed health and health care choices and improve outcomes. 26
  • 27. Goals and Objectives for Workgroup (cont.) Objectives: Identify 3 to 5 major gaps in our knowledge about factors that contribute to disparities and interventions to address them; and Identify 3 to 5 priority research questions to close the key knowledge gaps and improve outcomes. 27
  • 28. Types of Research Questions on Asthma in African Americans and Hispanics/Latinos with Uncontrolled Asthma Compare interventions (pharmacologic or behavioral) to improve patient-centered outcomes (eg., health care utilization, clinical measures and patient-reported outcomes). Compare strategies to overcome patient-, provider-, or system-level barriers to quality asthma care (eg., language, culture, transportation, environmental exposures, lack of family/caregiver/school or workplace support). Evaluate different segments of the African-American and Hispanic/Latino populations. 28
  • 29. Collaborative Workgroup Discussion Focus: Provide targeted input. Honor timelines: Provide brief and concise presentations and comments. Participate: Encourage exchange of ideas among diverse perspectives that are present today:  Researchers  Patients  Other Stakeholders  Webinar Guests 29
  • 30. Coordinating Federal Activities to Reduce Disparities 30
  • 31. Coordinating Federal Activities to Reduce Disparities 31 Research Needs to Build Capacity to Deliver Comprehensive Asthma Care: Evaluate models of partnerships that empower communities to identify and target disparate populations and provide comprehensive, integrated care at the community level. Examine the relative contribution and cost-effectiveness of different components of a system-wide partnership program. Assess added value of different interventions such as home visits, exposure reduction, housing policies, social services and care coordination to optimal pharmacologic management.
  • 32. Researcher Presentations 32
  • 33. Andrea J. Apter, MD, MSc, MA University of Pennsylvania 33
  • 34. Critical Gaps in Evidence Asthma, a chronic treatable disease, affects 25.7 million Americans, 18.7 million US adults. Asthmatic adults who are poor, African-American or Puerto Rican have heavier asthma burden:  Black persons have persistently higher ED visit, hospitalization, and death rates than white persons.  There is less data on morbidity and mortality data for Hispanic/Latino groups.  Disparities have persisted despite efficacious therapies.  Poverty is pervasive; which elements of poverty should be addressed first?  There is less research on adults than children.  Adults have comorbidities.  In adults, asthma is more prevalent in women; they often have family responsibilities. 34
  • 35. Interface Health Policies •Regulations at State & Federal Levels Insurance Status Reimbursement Levels Operation of the Health System •Cultural Sensitivity •Work Force Diversity •Use of Evidence-Based Care Provider/Clinician Factors •Stereotyping, attitudes of minority groups •Clinician’s training •Prescription Practices •Diagnosis of Severity •Provider/Patient Interaction Social/Environmental Context •Poverty •Indoor/Outdoor Allergens •Pollution •Environmental Stress Process of Care •Access to treatment •Quality of Care Differential Treatment/ Outcomes •Prevalence •Asthma control •Quality of life •# ED and Hospitalization Health Care System Individual/Community System Legal, Economic, and Socio-cultural Parameters Individual/Family Context Inherent factors •Genetics & biological factors •Race/ethnicity Modifiable factors •Beliefs •Health literacy •Illness Management = Points where we could potentially intervene MULTILEVEL ASTHMA DISPARITIES MODEL Canino G, McQuaid EL, Rand CS. JACI 2009;123:1209-17 = Patient-centered outcome
  • 36. Gaps in Evidence: How to address multilevel parameters associated with PCORI’s priorities Access to care  ED and PCP  Transition in care; continuity in care; care coordination  Electronic health record Patient-provider-practice communication  Formats  Primary language  Literacy Patients’ individual/family context Social/environmental context Operation of the health system/practice Therapeutics 36
  • 37. Research Formats Comparisons Qualitative research  Interviews  Focus groups Administrative data EHR Natural comparisons New research designs Board of Governors Meeting, November 2012 37
  • 38. What Can Be Done for the Home Environment that Would Reduce Asthma Morbidity? Compare ways to improve the physical environment: ETS, water damage, pollutants, allergens. Reduce social burdens: family burdens, work, neighborhood. Improve neighborhood physical/built environment. Improve availability and use of community/neighborhood resources: peers, CHW, family, also community and religious organizations, schools, transportation, retail resources. Explore ways information on the home/neighborhood be transmitted to medical providers. How can healthcare providers help at home? 38 Morgan WJ et al . NEJM 2004;351:1068-80 Wright R et al Am J Public Health 2004;94:625-32. Krieger J et al. Am J Public Health 2005;95: 652-59 Apter et al J Allergy Clin Immunol 2010;126:552-7 Crocker DD et al Am J Prev Med 2011;S5-32 Bryant-Stephens T et al. Am J Public Health 2009;99: S657-65
  • 39. Compare communication facilitators  Patient Advocates  Peers  Community Health Workers  Health professionals: nurses, social workers, nurses aids, etc. Compare communication techniques  Shared decision making  Motivational interviewing  Problem solving How do we best engage patients and providers? How do we overcome cultural and language barriers? What are the Best Ways to Promote Patient- Provider Communication in Appointments? Wilson S et al Am J Respir Crit Care Med 2010; 181:566-77 Long JA et al. Ann Int Med 2012; 156:416-24. Peretz PT et al. Am J Public Health 2012;102:1443-6.
  • 40. How do Providers Best Communicate with Patients for whom English is not their Primary Language and for those with Low Literacy? The prevalence of Spanish-speaking Americans is increasing. How do clinicians communicate with patients for whom English is not their primary language? Compare innovative methods. Compare innovative uses of translating services. Compare training given to providers. Compare ways clinicians can take account of cultural differences to improve communication. Half of US adults have no more than basic reading and numerical skills. Compare innovative methods for improving and assessing communication with patients with low literacy. Compare ways in which information technology is used. 40
  • 41. How can the EHR Help Patient-Provider Communication? CMS is instituting incentives for providers and health centers to use the EHR to improve health care: Meaningful Use. Two aspects focus particularly on patient-provider communication and access to care:  The After Visit Summary  The Patient Portal Can patients access and use these? Compare innovations to EHR for patient education and patient-provider communication. How would patients, particularly minority and poor patients, best be introduced to these? Can we ensure access to the web? How can IT be used to assist patients for whom English is not the primary language or for patients with low literacy? 41
  • 42. How Can We Improve the Transitions in Care and Provide Continuity? There is a shortage of PCPs. EDs are overwhelmed. How can outpatient practices be organized so that patients will return for ongoing care with continuity? eg., compare the Patient-Centered Medical Home with Neighbor with other models. Are there ways outpatient practices can better serve patients needing urgent care? Compare innovative methods of communication between ED, PCP, specialist. What resources do outpatient clinicians need to prevent ED use and hospitalizations and promote continuity of care? Compare methods for transitioning care for adolescents from pediatric to adult practices. 42 Liu T et al. Pediatrics 2004;114:e102-10 Lowe R et al. Med Care 2005; 43:792-800
  • 43. Stanley J. Szefler, MD University of Colorado School of Medicine
  • 44. Disclosure Consultant: Aerocrine, Boehringer Ingelheim, Genentech, Glaxo Smith Kline, Merck, Novartis and Roche Grant support: NHLBI Childhood Asthma Management Program, Asthma Clinical Research Network, Childhood Asthma Research and Education Network, and AsthmaNet, NIAID Inner City Asthma Consortium. NIEHS/EPA Childhood and Environmental Health Center Grant 44
  • 45. Disclosure Grant support (continued): CDPHE Colorado Cardiovascular, Cancer and Pulmonary Disease Program Caring for Colorado Foundation Seasons for Sharing, a McCormick Foundation Glaxo Smith Kline - Building Bridges program 45
  • 46. How Do We Reorganize the Health Care System to Identify Populations at Risk for High Asthma Burden and Mortality?
  • 47. Primary Goal of Therapy: Achieving and Maintaining Asthma Control Primary goal of asthma therapy is to enable a patient to achieve and maintain control over their asthma.  Eliminate impairments including symptoms, functional limitations, poor quality of life, and other manifestations of asthma.  Reduce risk of exacerbations, ED visits, and hospitalizations. Treatment goals are identical for all levels of asthma severity. NHLBI. National Asthma Education and Prevention Program. Full report of the Expert Panel: Guidelines for the Diagnosis and Management of Asthma (EPR-3). Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm. Accessed August 31, 2007.
  • 48. NIAID ICATA Study Omalizumab reduced fall exacerbations Ref, Busse and NIAID ICAC, NEJM 2011
  • 49. How Can We Change The Asthma Guidelines to Improve Asthma Control in African-American and Hispanic/Latino Patients? Questions
  • 50. N Engl J Med 2010;362:975-985.
  • 51. LABA ICS Primary Outcome: Probability of BEST Response Based on Composite Outcome* LTRA 0 0.1 0.2 0.3 0.4 0.5 0.6 Probability of Best Response *Covariate adjusted model Ref. Lemanske R and CARE Network NEJM 2010; 362:975-985. © [2010] Massachusetts Medical Society. All rights reserved. LABA step-up was more than 1.5 times as likely to produce the best response (p = 0.002) (p = 0.004)
  • 52. p = 0.006 p = 0.005 p = NS LTRAICSLABA
  • 53. What makes the African American and Hispanic/Latino Populations different in regards to response to conventional therapy? What factors contribute to the high risk for greater morbidity and mortality in these two populations? Questions
  • 54. Steroid Insensitivity: Potential Mechanisms Poor adherence to treatment plan. Persistent inflammation. Steroid-insensitive pathways. Vitamin D insufficiency. Genetics. Structural changes.
  • 55. Are there unique pathophysiologic mechanisms that drive the disease and alter the response to conventional therapies in this population? Do we need to alter current treatment strategies to more effectively achieve asthma control in this high risk population? Questions
  • 56. NHLBI AsthmaNet B-PRACTICAL PROTOCOL: Research Questions Do Blacks inadequately controlled on low dose ICS respond better to increases in ICS than adding a LABA? In Blacks, is a lack of response to low dose ICS/LABA due to inadequate dosing of the ICS component? Are genetic analyses using degree of African vs. European ancestry useful in predicting responsiveness to the different therapies? Do Black adults and children differ from one another with regard to responsiveness to ICS or LABA add-on therapies?
  • 57. How do we achieve trust and collaboration to overcome cultural social determinants that might influence the management of these high-risk individuals with severe asthma? Question
  • 58. Future Directions In order to succeed at reducing gaps in asthma care: Clinicians must agree on principles of management. Guidelines must continue to evolve with new information and efforts for standardization and better communication. We must now place the focus on wellness. Patient-centered outcomes must direct future care. Asthma guidelines must be required reading for those who take care of asthma patients.
  • 59. Break 59
  • 60. Researcher Presentations 60
  • 61. Susan Sommer, MSN, NP, AE-C Boston Children’s Hospital Community Asthma Initiative 61
  • 62. Potential New Research Area #1: Incorporating Asthma Home Visits in PCMH In context of health care reform, how does the integration of a tailored asthma case management and home visiting model into the patient-centered medical home (PCMH) change patient and provider experience of asthma care, asthma control and patient-provider communication, comparing a variety of practice settings (inner-city health center/hospital-based, private practice)? • Research to date indicates large improvements in health outcomes, Quality of Life, and positive ROI with asthma home visiting models, reduced disparities among AAs and Latinos. [ Woods et al. Pediatrics 2012;129:465-472, Bhaumik, et al. J Asthma 2013, in press] • Studying this area would provide much-needed information about patient experience with the changing health care system, while seeking to gain experience with home visiting models embedded in PCMH. • Measures of asthma-specific patient experience need further development to expand patient-centered research. [Sawicki et al. International J of Person Centered Med 2012; 2, 391-399 ] 62
  • 63. 63 Justification for Incorporating Asthma Home Visiting in PCMH Question In the context of health care reform, how does the integration of a tailored asthma case management and home visiting model into the PCMH change patient and provider experience of asthma care, asthma control and patient-provider communication, comparing a variety of practice settings? Population • African American and Latino families of children with severe or poorly-controlled asthma. Research Need • Focus groups with patients/caregivers to assess what services they want/need in the clinic vs. home setting, what outcomes they believe are most important to their lives. • Focus groups with providers to assess the gaps they see in current health care model. • Development of an asthma specific patient experience survey. • Integration of the Community Health Worker/Patient Navigator role into the medical home team. • Measure changes in patient and provider experience of asthma care in the medical home. Proposed Study • Continuous quality improvement process to evaluate the effectiveness of the integration of the medical home model with the home visiting component. • Pilot study that compares a private practice, Community Health Center, and hospital-based clinic needs for care coordination, home visiting and case management. • Compare programs in terms of improved health outcomes, patient experience and quality of life in different practice settings. Timeline • 3 to 5 years. Cost • $500,000 – 750,000 per year.
  • 64. Potential New Research Area #2: Clinical Tools for Shared Decision-Making Can shared decision-making around asthma medications and asthma control goals be facilitated by patient-centered clinical tools that elicit patient/caregiver’s health beliefs (about the nature of asthma, asthma medications, asthma control expectations and goals, and barriers faced in carrying out asthma plans), as compared to usual care?  Evidence is available that families have low expectations and personal health beliefs around asthma and treatment options that may interfere with controller medication use. [Smith L et al. Pediatrics, (2008) 122 (4) 2, 760-769]  Patients often don’t share how they are actually taking medications with their providers and, therefore, don’t have impact on plan.  If accepted by patients and providers, tools could lead to improved patient satisfaction, improved adherence to the plan they helped create, as well as be adaptable to other health conditions. 64
  • 65. 65 Justification for Clinical Tools for Shared Decision-Making Question Can shared decision-making around asthma medications and asthma control goals be facilitated by patient-centered clinical tools that elicit patient/caregiver’s health beliefs (about the nature of asthma, asthma medications, asthma control expectations and goals, and barriers faced in implementing asthma plans), as compared to usual care? Population • African American and Latino families of children with severe or poorly-controlled asthma. Research Need • Low expectations and individualized health beliefs need to be better understood and appreciated by providers. • Tools that allow patient/caregivers to express asthma health beliefs with providers are needed to identify areas where a more patient-centered approach to education and decision-making may yield greater investment and adherence to agreed-upon plan. Proposed Study • Development of patient-centered, culturally and linguistically appropriate questionnaires about health beliefs, attitudes, low expectations and use of control medications that can be applied in a clinic setting. • Develop shared decision-making approaches and tools. • Measure patient and provider experiences, asthma control expectations, and self-efficacy, quality of life, and use of controller medications. Timeline • 3 to 5 years. Cost • $300,000 to 500,000 per year.
  • 66. Potential New Research Area #3: Technological Approaches Does patient experience, self-efficacy and asthma control improve among patients/caregivers who engage with interactive technology, such as video storytelling or social media, for communication about their asthma, compared to usual care?  Increasing usage of technology, especially mobile media, among low-income AAs and Latinos with severe asthma [pewinternet.org]  In-home video story-telling re: adolescents’ asthma experience has been tested with participants finding it useful to understanding their asthma and health behaviors [Rich J Adolescent Health 38 (2006), Wylie SA et al. J Telemed Telecare 2012;18:392-398].  Assess acceptability and feasibility of new technologies for asthma- related communication and self-expression in these two populations, as well as effectiveness in increasing self-awareness and confidence in controlling asthma, improving asthma outcomes. 66
  • 67. 67 Justification for Technological Approaches Question Does patient experience, self-efficacy and asthma control improve among patients/caregivers who engage with current technologies, such as video storytelling or social media, for communication around their asthma, compared to usual care? Population • African American and Latino youths and families of children with severe or poorly-controlled asthma. Research Need • Access to technology and accessible modalities. • Feasibility and acceptability of different technologies. • Use of technologies in asthma and other chronic care management. • Access to virtual communities for information and support. Proposed Study • Develop an intervention with a menu of patient-centered technologies that can be used to help patients/caregivers and providers better communicate around the asthma experience and home management, promote shared decision-making. Timeline • 3 to 5 years. Cost • $500,000 per year.
  • 68. Conclusions  There are important gaps in community-based research that would improve patient experience, asthma control expectations and quality of life and reduce health disparities.  There is a need to develop interventions and tools that encourage patient-provider communication and a sense of self-efficacy and ability to control asthma for AA and Latino families living with asthma.  Health care reform and primary care re-design provide opportunities to explore more patient-centered approaches to asthma care, incorporating successful elements of asthma home visiting models. 68
  • 69. Jean G. Ford, MD The Brooklyn Hospital Center
  • 70. Pillars of Comprehensive Asthma Care NAEPP, EPR-3 Pharmacologic treatment. Education to improve self-management skills of patient and family. Reduction of environmental exposures. Monitoring the level of asthma control.
  • 71. Preventable Factors That Contribute to Asthma Disparities Barriers to implementation of guideline-based asthma care. Lack of capacity to deliver community-based comprehensive care. Gaps in capacity to identify and reach high-risk populations. http://www.epa.gov/childrenstaskforce/federal_asthma_disparities_action_plan.pdf, 2/27/13
  • 72. Patterns and Predictors of Frequent ED Visits During the Prior Year (N = 3151) Predictors of 6+ visits: Nonwhite race. Medicaid, other public or no insurance. Markers of chronic asthma severity. Griswold SK et al., Chest. 2005; 127:1579-86.
  • 73. What Causes Health Disparities? Community Norms and Lifestyles Physical & Social Environment BROADER SOCIAL/POLITICAL ENVIRONMENT: Historical/Current Patterns of systemic Racial/Ethnic inequalities Historical/Current Patterns of systemic SES, gender, age inequalities Federal, State, and Private Financing & Organizational Social Location Race/Ethnicity, SES, Gender, Age Cumulative Lifetime & Current Exposure to Individually Modifiable Behavioral Risks Cumulative & Lifetime Exposure to Social, Environmental, & Genetic Risks Differential Health Care Quality and Access Usual source of care Primary treatment Health risk management Screening adherence Secondary treatment Co-morbid condition care Complete diagnosis Adjuvant therapies Benefits coordination Follow-up care R/E Health Outcome Disparities Mortality Morbidity Quality of Life Satisfaction with health care Community Differences in Health Care Availability
  • 74. Geographic social risk index predicts reutilization (ED visit or hospitalization) Beck AF et al., 2012. AJPH; 102: 2308-2314.
  • 75. Systematic review: interventions that address racial/ethnic asthma disparities Education appears effective. Few culturally tailored interventions. System redesign shows promise. Team-based specialty clinics. Long-term follow-up after acute care visits. Evaluate tailoring, patient-centered education, follow-up and/or team-based approaches. Press VG et al., 2012. J Gen Intern Med; 27:1001–15.
  • 76. Question 1 Among asthma patients with frequent emergency department visits, compared to an educational intervention in the context of usual care, does the addition of a team- based, patient-centered and culturally and socially tailored care management intervention improve asthma outcomes?
  • 77. Question 2 In primary care practices located in socially disadvantaged neighborhoods, compared to an educational intervention in the context of usual care, does a health system-level intervention to promote patient-centered asthma care (provider education, care coordination, medication reconciliation) improve asthma outcomes?
  • 78. Question 3 In socially disadvantaged neighborhoods, compared to a standard asthma education program, does a participatory intervention design improve population-level asthma control?
  • 79. Elliot Israel, MD Brigham & Women’s Hospital 79
  • 80. Critical Gaps in Evidence Related to the Severity of Asthma in Blacks/Hispanics/Latinos Exposure to Allergens  Are there remediable exposures that will improve outcomes? Differential Medication Effects  Are current asthma guidelines appropriate for Blacks/Hispanics/Latinos? Contribution of Pollution  Does smoking have a differential effect in B/H/L?  Does pollution have a differential effect? Interaction with Genetic Ancestry  Can genetics/ ancestry informative markers identify patients who would benefit from aggressive intervention? 80
  • 81. Rosenstreich et al., N Eng J Med, 336: 1356-1363, 1997 Hospitalizations p=0.001 Unscheduled Medical Visits p<0.001 Change in Care Giver’s Plans p=0.006 Hospitalizations inPastYear No.ofVisitsin PastYear DaysWithChanged PlansinPastYear neg skin test, low allergen exposure neg skin test, high allergen exposure* pos skin test, low allergen exposure pos skin test, high allergen exposure* * Bla 0 0.1 0.2 0.3 0.4 0 1 2 3 0 5 10 15 20 neg skin test, low allergen exposure neg skin test, high allergen exposure* pos skin test, low allergen exposure pos skin test, high allergen exposure* * Bla g 1 > 8 U/gram HOME Cockroach Allergen Exposure and Asthma Morbidity in Inner City Children Rosenstreich et al., N Eng J Med, 336: 1356-1363, 1997
  • 82. Morgan et al., N Eng J Med, 351: 1068-1080, 2004 Reductions in cockroach and dust mite allergens highly correlated with reduced asthma morbidity Inner City Asthma Study (ICAS) HOME Multi-Component Intervention Morgan et al., N Eng J Med, 351: 1068-1080, 2004
  • 83. School Vs. Home Allergen Levels Sheehan WJ, Phipatanakul W Ann Allergy Asthma Immunol. 2009;102:125-30 Permaul P, Phipatanakul W Peds Allergy Immunol. 2012 ;23(6):543-9
  • 84. Allergen Exposure Unpublished data in populations that were 35% Black and 35% Hispanic suggest that in allergic individuals, asthma symptoms are proportional to the level of allergen in the schools.
  • 85. Remediating Allergens 85 Question Are there remediable allergenic exposures that will improve outcomes, eg., school-based and workplace remediation? Population • Blacks/Hispanics/Latinos. Research Need • Determining whether reducing in the schools or workplace will reduce asthma morbidity in Blacks/Hispanics/Latinos. Proposed Study • Studies in which PCO are compared in schools/workplaces which have undergone allergen remediation vs. those that have not. Timeline • Two years of intervention.
  • 86. Blacks vs. Caucasians Treatment Failures in Subjects Taking LABA’s Wechsler et al, AJRCCCM, 2011 Wechsler et al, AJRCCCM, 2011
  • 87. Effect of Race for LABA Add-On vs. ICS or LTRA (KIDS) Lemanske, 2010
  • 88. 89 Examining Differential Response to Medications Question • Are current asthma guidelines for initiation and escalation of medications appropriate for Blacks/Hispanics/Latinos? Research Need • Multiple lines of evidence suggest that Blacks/Hispanics/Latinos may respond differently to than Caucasians to asthma medications. • Comparative studies of asthma medication and step-ups are necessary to optimize treatment guidelines for these populations. Proposed Study • Determination of best initial controller agents for Blacks/Hispanics/Latinos. • Performing “real-life” studies that examine effectiveness of alternative medications, as opposed to efficacy.
  • 89. Predicted FEV1 decline by smoking- ancestry strata in Puerto Ricans Current smokers are represented by the ▴ symbol and former smokers by the • symbol. Low African ancestry groups are represented by a solid line and high African ancestry by a dashed line. Aldrich MC, 2012
  • 90. 91 Smoking/Pollution Intervention Studies in Blacks/Hispanics/Latinos Question • Does smoking disproportionately increase asthma morbidity in Blacks/Hispanics/Latinos? • Is pollution a cause of disproportionate morbidity? Research Need • More than 25% of asthmatics continue to smoke. • Data suggest that the genetic degree of “Blackness” in Puerto Ricans increases the adverse effects of smoking in asthma. • Blacks/Hispanics/Latino are frequently live in areas with high levels of pollutants. • Asthma symptoms have been shown to be proportional to these pollutants. Proposed Study • Smoking - Comparing different smoking cessation programs effectiveness in Blacks/Hispanics/Latinos. • Pollution - Comparing effects of pollution interventions (eg. particulate air filters) in the schools.
  • 91. Genetics In a mixed population, polymorphisms at ADRB2 Arg16Gly did not affect AM PEF responses to regular LABA/ICS. However, in the Blacks in the study, Arg16Arg subjects appeared to have minimal response to the addition of LABA to the ICS in contrast to their Black Gly16Gly counterparts.
  • 92. 280 320 360 400 440 480 Arg/Arg Gly/Gly Placebo/ICS LABA/ICS 280 320 360 400 440 480 Arg/Arg Gly/Gly Placebo/ICS LABA/ICS AM and PM PEF (Black Subgroup, n= 8 vs. 8) P = 0.5662 P = 0.0130 P = 0.09 AM PEF (L/min) PM PEF (L/min) P = 0.9223 P = 0.0005 P =0.07
  • 93. Percentages of African Ancestry in Puerto Rican Asthma Cases and Control Subjects Stratified by Socioeconomic sStatus (SES) Choudry S, 2007
  • 94. Differences in Admixture Between Mexican Americans and Puerto Rican Americans Choudry, 2007
  • 95. 96 Genetics/Biomarkers/Ancestry Informative Markers Question • Can genetics/ ancestry informative markers identify patients who would benefit from aggressive intervention? Research Need • Multiple studies suggest that Blacks/Hispanics/Latinos are genetically heterogeneous and that genetic heterogeneity associates with wide differences in asthma morbidity within apparently similar groups. • It is important to identify those groups of patients who may most need personalized and/or aggressive interventions and conversely to identify those who might benefit most. Proposed Study • Studies that enroll an adequately heterogeneous population to test hypotheses related to differential responses based on genetic polymorphisms or genetic ancestry.
  • 96. Critical Gaps in Evidence Related to the Severity of Asthma in Blacks/Hispanics/Latinos Exposure to Allergens  Are there remediable exposures that will improve outcomes? Differential Medication Effects  Are current asthma guidelines appropriate for Blacks/Hispanics/Latinos? Contribution of Pollution  Does smoking have a differential effect in B/H/L?  Does pollution have a differential effect? Interaction with Genetic Ancestry  Can genetics/ ancestry informative markers identify patients who would benefit from aggressive intervention? 97
  • 97. Patient and Stakeholder Perspectives on Information Gaps 98
  • 98. Lunch 99
  • 99. Comments from Public 100
  • 100. How to Provide Comments Today Email (asthma@pcori.org). Twitter (hashtag #PCORI). The webinar “chat” feature. The “Submit a Question on our Targeted Topics” page on our web site. By telephone. Our operator will now tell you how to let us know if you have a question or comment. 101
  • 101. Discussion of Critical Gaps in Asthma Research and Key Research Questions 102
  • 102. Criteria for Knowledge and Research Gaps Knowledge gaps should:  Be patient-centered: Is the proposed knowledge gap of specific interest to patients, their caregivers, and clinicians?  Assess current options: What current guidance is available on the topic and is there ongoing research? How does this help determine whether further research is valuable?  Have potential to improve care and patient-centered outcomes: Would new knowledge generated by research be likely to have an impact in practice?  Provide knowledge that is durable: Would new knowledge on this topic remain current for several years, or would it be rendered obsolete quickly by subsequent studies?  Compare among options: Which of two or more options lead to better outcomes for particular groups of patients? 103
  • 103. Major Areas Discussed by Workgroup Participants James Kiley, MS, PhD Moderator 104
  • 104. Major Areas Contributing to Disparities in Treatment of Asthma Communication Integration of Care Systems Standardization (Guidelines) and Importance of Local Issues Quality of care Behavior 105 Knowledge, Health Literacy Response to Therapy Home Environment/Exposures Barriers Patient-Centered Outcomes Methodology
  • 105. Medical Factors: Communication What are the best ways to overcome language barriers between patients and clinicians? Is there time for meaningful communication? What is the best communication technique? SDM, MI, situation How can the EHR help patients & providers communicate? Social tailoring: Delivering culturally appropriate interventions using knowledge we have 106
  • 106. Medical Care: Integration of care Among asthma patients with frequent emergency department visits, compared to an educational intervention in the context of usual care, does the addition of a team- based, patient-centered and culturally and socially tailored care management intervention improve asthma outcomes? Compare models for team based care with different team members (nurse case manager, community health worker, pharmacist, physicians) and linking clinical care with home visits How does integration of tailored case management and home visit model in patient centered medical home change patient and provider experience? Integrate services in clinic vs. home settings 107
  • 107. Medical Care: Integration of care What is the best use of home visit? How is home visit and clinic information communicated/coordinated? Importance of nurse in medication reviews and comorbidities Transitions in Care; care coordination  Organize care for continuity  Better serve patients who need urgent care  Transition from teenage to adult care  Shortage of PCPs and overwhelmed EDs 108
  • 108. Medical Care: Systems Need for interface between health care system and individuals/community How do we re-organize healthcare system to identify populations at high risk for asthma burden and mortality? Can healthcare redesign address the need to involve community and home environments? Do we have system to address disparities? What has worked locally and how can it be applied/disseminated? 109
  • 109. Medical Care: Systems How can we evaluate the use and benefits of community participatory interventions? What is sustainable? Are group visits useful? How can we identify “hot spots” of disparities? Especially using EHR 110
  • 110. Medical Care: Standardization (guidelines) and importance of local issues Is what “works” local? Cost of services like home visits; how are most costly interventions integrated into treatment algorithm Should the algorithms be the same in all ethnic groups? How should guidelines be modified?  Are ICS better in AA?  Under-dosing in specific populations Are one size fits all guidelines possible? 111
  • 111. Medical Care: Quality of care Differences in quality of care based on race/ethnicity? Are there evidence based approaches to improve asthma outcomes in all populations? What are the differences between providers? 112
  • 112. Medical Care: Behavior How can we change the behaviors of care providers to improve use of guidelines/evidence based care? How do PCPs get updated on latest in asthma research? How do we change organizational behaviors? Does patient experience, self-efficacy and asthma control improve among patients/ caregivers who engage with current technologies, such as video storytelling or social media, for communication around their asthma, compared to usual care? 113
  • 113. Medical Care: Behavior How do we consistently induce behavior modification in minority populations with asthma and change their locus of control from external to internal? How do low self-efficacy, unemployment, beliefs about lack of medication efficacy, expectations for control, powerlessness? Could patient centered approaches improve this? 114
  • 114. Medical Care: Knowledge, health literacy Patient understanding of asthma as a chronic disease, knowledge of asthma diagnosis How do we help families or support who are willing to do anything to help but do not know what to do? 115
  • 115. Response to Therapy Are current asthma guidelines for initiation and escalation of medications appropriate for Blacks/Hispanics/Latinos at all levels of severity? Why has there been negligible improvement in asthma morbidity in African Americans over the past few decades? What makes the African American and Hispanic/Latino Populations different in regards to response to conventional therapy? What factors contribute to the high risk for greater morbidity and mortality in these two populations?  Potential factors that account for steroid resistance? 116
  • 116. Response to Therapy Why are asthma prevalence, morbidity, and mortality so high in African American women and in Puerto Ricans and what are the most important variables that negatively impact their poor asthma outcomes, (e.g., obesity, stress, vitamin D deficiency, etc.)? Can genetics/ ancestry informative markers identify patients who would benefit from aggressive intervention?  How important is admixture? 117
  • 117. Response to Therapy Are there unique pathophysiologic mechanisms that drive the disease and alter the response to conventional therapies in this population? Do we need to alter current treatment strategies to more effectively achieve asthma control in this high risk population? Why are Puerto Rican individuals more affected than Mexicans? What are the gender interactions with ethnicity? Lack of data on Hispanic/Latino groups Safety and efficacy of drugs, need for new drugs 118
  • 118. Environment: Home environment/ exposures 119 What can be done for the home environment that would reduce asthma morbidity? Are there remediable allergenic exposures that will improve outcomes? E.g. School-based and workplace remediation In socially disadvantaged neighborhoods, compared to a standard asthma education program, does a participatory intervention design improve population- level asthma control? How does patient let provider know if medication is not working? Are exposures different and does this identify remediable exposures?
  • 119. Environment: Home environment/ exposures Is reaction to environmental exposures different? Significant differences in home vs. school environment (e.g. mouse in schools) and asthma outcomes; greater opportunity in schools to impact many children? Is pollution a cause of greater morbidity in minority populations? What roles do stress, violence, and psychosocial dysfunction play in the expression of asthma and how what can be done to neutralize their effects while they are still operative? 120
  • 120. Community: Barriers Poverty how can we reduce social burdens (family burden, work , neighborhood)? What are we doing about barriers (transportation)? Do we understand all of the barriers? Not only education 121
  • 121. Community: Patient centered outcomes What do patients think is important? 122
  • 122. Methodology Is RCT needed to find factors we have not considered ? EHR or real world Need clinician agreement Guidelines must evolve Patient centered outcome to direct future care Challenges to informed consent Immigration status Are there patient centered approaches (e.g. for choice of medications)? Develop questionnaire to capture patient experience in asthma care? 123
  • 123. Break 124
  • 124. Continued Discussion of Critical Gaps in Asthma Research and Key Research Questions 125
  • 125. High Level Research Gaps Communication  Compare/evaluate tools that could impact provider and patient communication; eg tools that address language barriers, continuity of care, cultural differences, and social barriers. Integration of care  Compare models that integrate care; eg team based care with different team membersmembers (nurse case manager, community health worker, pharmacist, physicians) and linking clinical care with home visits  Evaluate models to improve transitions in care; eg from ED to outpatient, from pediatrics to adult care 126
  • 126. High Level Research Gaps Systems  Evaluate models that use data integration to identify and target high risk communities and provide comprehensive care in those communities that links systems for healthcare, home, school/workplace to support that care. Response to Therapy  Can evidence based guidelines be adapted to sub-populations?  Identify modifiable mechanisms that underlie differential responses to therapy?  How do African American and Hispanic/Latino Populations respond differently to pharmacologic therapy?  What factors contribute to the high risk for greater morbidity and mortality in these two populations? Including environment and genetic markers to identify patients who would benefit from aggressive intervention? 127
  • 127. High Level Research Gaps Behavior  Compare interventions to facilitate patient engagement  Compare innovative education methods (eg: current technologies such as video storytelling or social media) to tailor the education to varying patient characteristics (health beliefs, literacy level, levels of self-efficacy Environment  How can we mitigate the effects of stress, violence, psychosocial dysfunction play in asthma, particularly in those who cannot get out of the environment?  Which environmental changes (e.g., home visits, school, work) are sustainable?  Among patients failing pharmacologic therapy does the addition of an environment intervention impact the outcome? 128
  • 128. Recap and Next Steps 129
  • 129. We Still Want to Hear From You • We welcome your input on today’s discussions or our process in general. • We’re accepting comments and questions for consideration on this topic through 5 p.m. ET, on Friday, March 15, via: • Email (asthma@pcori.org) • Our “Submit a Question on our Targeted Topics for Research Funding” web page. • We’ll take all feedback into consideration. 130
  • 130. Connect with PCORI • Visit us at www.pcori.org • Follow @PCORI on Twitter • Watch our YouTube channel PCORINews
  • 131. Thank You for Your Participation 132