Treatment Options for

Severe Asthma in African-Americans

and Hispanics/Latinos

Ad Hoc Workgroup Meeting March 1st, 2013

1

Welcome and Introductions

2

Joe V. Selby, PCORI

Romana Hasnain-Wynia, PCORI

3

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

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

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

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

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

Background on

Ad hoc Workgroups

9

Joe V. Selby, PCORI

Romana Hasnain-Wynia, PCORI

10

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

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

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

Targeted PFA Workgroup Goals

14

Provide summary

of findings to

Board of

Governors

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

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

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

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.

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

Setting the Stage

20

James Kiley, MS, PhD

National Institutes of Health

21

Overview

Asthma in African-Americans and Hispanics/Latinos

Objectives for Workgroup

Types of Research Questions

Collaborative Workgroup Discussion

22

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

Asthma in African-Americans &

Hispanics/Latinos: Disparities in Outcomes

24

Asthma deaths Healthcare utilization:

Hospitalizations & ED Visits

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

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

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

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

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

Coordinating Federal Activities to Reduce

Disparities

30

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.

Researcher Presentations

32

Andrea J. Apter, MD, MSc, MA

University of Pennsylvania

33

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

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

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

Research Formats

Comparisons

Qualitative research

Interviews

Focus groups

Administrative data

EHR

Natural comparisons

New research designs

Board of Governors Meeting, November 2012 37

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

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.

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

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

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

Stanley J. Szefler, MD

University of Colorado

School of Medicine

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

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

How Do We Reorganize the Health Care System to

Identify Populations at Risk for High Asthma Burden

and Mortality?

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.

NIAID ICATA Study Omalizumab reduced fall exacerbations

Ref, Busse and NIAID ICAC, NEJM 2011

How Can We Change The Asthma Guidelines to

Improve Asthma Control in African-American and

Hispanic/Latino Patients?

Questions

N Engl J Med 2010;362:975-985.

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)

p = 0.006

p = 0.005

p = NS

LTRA ICS LABA

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

Steroid Insensitivity: Potential Mechanisms

Poor adherence to treatment plan.

Persistent inflammation.

Steroid-insensitive pathways.

Vitamin D insufficiency.

Genetics.

Structural changes.

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

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?

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

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.

Break

59

Researcher Presentations

60

Susan Sommer, MSN, NP, AE-C

Boston Children’s Hospital

Community Asthma Initiative

61

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

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.

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

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.

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

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.

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

Jean G. Ford, MD The Brooklyn Hospital Center

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.

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

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.

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 AccessUsual 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

DisparitiesMortality

Morbidity

Quality of Life

Satisfaction with health care

Community

Differences in

Health Care

Availability

Geographic social risk index predicts

reutilization (ED visit or hospitalization)

Beck AF et al., 2012. AJPH; 102: 2308-2314.

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.

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?

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?

Question 3

In socially disadvantaged neighborhoods, compared to a standard asthma education program, does a participatory intervention design improve population-level asthma control?

Elliot Israel, MD

Brigham & Women’s Hospital

79

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

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

Ho

sp

ita

lizatio

ns

in P

ast Y

ear

No.

of

Vis

its in

Past Y

ea

r

Days W

ith C

hanged

Pla

ns in P

ast Y

ear

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

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

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

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.

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.

Blacks vs. Caucasians

Treatment Failures in Subjects Taking LABA’s

Wechsler et al, AJRCCCM, 2011 Wechsler et al, AJRCCCM, 2011

Effect of Race for LABA Add-On vs. ICS or

LTRA (KIDS)

Lemanske, 2010

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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.

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

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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.

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.

280

320

360

400

440

480

Arg/Arg Gly/Gly

Placebo/ICSLABA/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

Percentages of African Ancestry in Puerto Rican

Asthma Cases and Control Subjects Stratified by

Socioeconomic s\Status (SES)

Choudry S, 2007

Differences in Admixture Between Mexican

Americans and Puerto Rican Americans

Choudry, 2007

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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.

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?

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Patient and Stakeholder

Perspectives on Information

Gaps

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Lunch

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Comments from Public

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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.

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Discussion of Critical Gaps in

Asthma Research and Key

Research Questions

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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?

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Major Areas Discussed by Workgroup

Participants

James Kiley, MS, PhD

Moderator

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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

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Knowledge, Health

Literacy

Response to Therapy

Home

Environment/Exposures

Barriers

Patient-Centered

Outcomes

Methodology

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

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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

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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

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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

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

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

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?

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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?

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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

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

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

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

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

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?

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

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

Community: Patient centered outcomes

What do patients think is important?

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

Break

124

Continued Discussion of

Critical Gaps in Asthma

Research and Key Research

Questions

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

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

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

Recap and Next Steps

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

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www.pcori.org

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Twitter

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channel PCORINews

Thank You for Your Participation

132