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

Treatment Options for
Severe Asthma in African-Americans
and Hispanics/Latinos
Ad Hoc Workgroup Meeting
March 1st, 2013
1

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

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.

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
LTRAICSLABA

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.

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.

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.
Cost • $300,000 to 500,000 per year.

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.
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 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

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
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

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

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.

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

91
Smoking/Pollution Intervention Studies in
Blacks/Hispanics/Latinos
Question • Does smoking disproportionately increase asthma morbidity in
• 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/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

Percentages of African Ancestry in Puerto Rican
Asthma Cases and Control Subjects Stratified by
Socioeconomic sStatus (SES)
Choudry S, 2007

Differences in Admixture Between Mexican
Americans and Puerto Rican Americans
Choudry, 2007

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.

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
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

Patient and Stakeholder
Perspectives on Information
Gaps
98

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

Discussion of Critical Gaps in
Asthma Research and Key
Research Questions
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

Major Areas Discussed by Workgroup
Participants
James Kiley, MS, PhD
Moderator
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

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

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

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

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?
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

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

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

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

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

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

Connect with PCORI
• Visit us at
www.pcori.org
• Follow @PCORI on
Twitter
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channel PCORINews

Thank You for Your Participation
132

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