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Transcript
Understanding Options to Reduce Disparities in
Cardiovascular Disease through Comparative
Effectiveness Research
Landscape Review
Prepared for PCORI by
LaShawn Glasgow, Mahima Ashok, Deborah Porterfield, Lindsay
Morris, and Zhi-Jie Zheng
December 2013
This report was prepared under PCORI RFQ # PCO-CVDLDSR2013 for the Addressing
Disparities Program
Acknowledgments
The authors would like to thank PCORI colleagues, Romana Hasnain-Wynia, Ayodola
Anise, and Katie Lewis for their guidance and input throughout the landscape review
process. Additionally, we acknowledge RTI Library and Information Services staff Mark
Howell Elizabeth Bedini for providing literature search support.
DISCLAIMER
All statements, findings, and conclusions in this publication are solely those of the
authors and do not necessarily represent the views of the Patient-Centered Outcomes
Research Institute (PCORI) or its Board of Governors. This publication was developed
through a contract to support PCORI’s work and is being made available free of charge
for the information of the scientific community and general public as part of PCORI’s
ongoing research programs. Questions or comments may be sent to PCORI at
[email protected] or by mail to Suite 900, 1828 L Street, NW, Washington, DC 20036.
Overview
The Addressing Disparities Program at the Patient-Centered Outcomes Research
Institute (PCORI) commissioned this landscape review to assess gaps in evidence for
addressing cardiovascular disease (CVD) in populations at risk for experiencing
disparities. This landscape review also identifies opportunities for PCORI to grow the
evidence base for interventions designed to reduce or eliminate CVD disparities by
conducting comparative effectiveness research (CER) in this area. Consistent with
PCORI’s focus on CER and the Addressing Disparities Program’s focus on linking
clinical care and the community, this task was limited to a review of secondary and
tertiary prevention approaches implemented in a clinical setting or as a joint clinical–
community-based effort. Reviewed studies must also have tested either a disparities
intervention or a targeted intervention, which are defined as follows for the purposes of
this review:
 Disparities interventions explicitly aim to address disparities (i.e., differences
between segments of the population) in CVD-related patient-centered or
patient-level outcomes.
 Targeted interventions explicitly aim to address CVD in a single population
group that experiences disparate health outcomes.
Applying these criteria and other basic search parameters described in Appendix A, we
identified 37 articles describing 36 CVD interventions (7 disparities and 29 targeted).
From a social-ecological perspective, interventions targeted 3 levels: systems (n=3),
patient-provider (n=2), and patient (n=31). As summarized in Appendix A, we also
reviewed selected websites to identify additional interventions meeting the inclusion
criteria and research gaps related to addressing CVD disparities.
Through our targeted literature and website review, we identified several opportunities
for future research. In general, there is a need for more research directed to developing,
testing, and assessing the comparative effectiveness of disparities interventions
designed to narrow differences in health outcomes between two groups, as opposed to
targeted interventions that focus on improving health outcomes for a single group.
There is also an opportunity to better integrate health disparities and patient-centered
outcomes research.
Beyond these broader gaps in the evidence for addressing health disparities in general,
there are several research gaps specific to identifying effective strategies for reducing
and eliminating CVD disparities. For example, future studies are needed to help answer
the following research questions:
i
 Are health system quality improvement (QI) interventions effective at reducing or
eliminating CVD disparities? If so, which QI interventions are most effective?
 Are interventions that deliver provider and patient education to improve quality of
care and adherence to disease management guidelines effective at reducing or
eliminating CVD disparities? If so, are these patient and provider level
interventions more effective than those that include only a patient education
component?
 Do self-management support interventions effectively address CVD disparities? If
so, what levels of intervention intensity and duration are necessary to achieve
intended outcomes? What is the comparative effectiveness of different selfmanagement support interventions on CVD disparities (e.g., interventions with
different delivery modes)?
ii
Acronyms
Acronym
Full Term
AHRQ
Agency for Healthcare Research and Quality
CDC
Centers for Disease Control and Prevention
CER
Comparative Effectiveness Research
CFIR
Consolidated Framework for Implementation Research
CVD
Cardiovascular Disease
CVH
Cardiovascular Health
FOA
Funding Opportunity Announcement
IOM
Institute of Medicine
LDL
Low-Density Lipoprotein
LGBT
Lesbian, Gay, Bisexual, and Transgender
NCCAM
National Center for Complementary and Alternative Medicine
NHLBI
National Heart, Lung and Blood Institute
NIH
National Institutes of Health
QI
Quality Improvement
SEM
Social-Ecological Model
SES
Socioeconomic Status
iii
Contents
Overview .......................................................................................................................... i
Acronyms ........................................................................................................................ iii
Introduction ..................................................................................................................... 1
Burden on Society ........................................................................................................... 3
Options for Addressing the Issue .................................................................................... 5
Description of interventions ......................................................................................... 5
Relative Benefits ........................................................................................................ 11
Relative Harms .......................................................................................................... 12
Opportunities for New Research ................................................................................ 12
Recent Innovations .................................................................................................... 15
Pace of Research ...................................................................................................... 16
Potential for New Information to Rapidly Improve Care and Patient-Centered
Outcomes ...................................................................................................................... 17
Summary of the Factors that Would Affect the Translation of New Research
Findings to Practice ................................................................................................... 17
Discussion of Likelihood of New Research Findings Being Immediately
Implemented in Practice ............................................................................................ 18
Durability of Information ................................................................................................ 21
Conclusion .................................................................................................................... 22
References .................................................................................................................... 23
Appendix A: Methods Highlights ..................................................................................... 1
Appendix B: At-a-Glance Summary of Interventions ....................................................... 1
Appendix C: Glossary...................................................................................................... 1
iv
Introduction
Cardiovascular disease (CVD) is a leading cause of death and disability in the U.S.
(CDC 2011), and CVD-related health disparities are well documented. However,
evidence for approaches to effectively address CVD disparities is limited. In their
national action plan, the National Prevention Council highlighted the need to develop,
monitor, and evaluate community-based interventions to reduce health disparities
(National Prevention Council 2012). A systematic review of health care systems
interventions concluded that “virtually no literature specifically addressed disparity
reduction” (Davis et al. 2008,1). Notably, since 2007 the National Institutes of Health
(NIH) has issued consecutive funding opportunities for research to understand the
causes of health disparities (in a number of areas, including CVD) and to test
interventions to reduce or eliminate disparities (NIH 2007).
Addressing health disparities is one of PCORI’s five national research priorities (PCORI
2012). PCORI’s Addressing Disparities Program aims to identify “potential differences in
prevention, diagnosis or treatment effectiveness, or preferred clinical outcomes across
patient populations and the health care required to achieve best outcomes in each
population” (PCORI 2012, 8). In April 2013, the Advisory Panel on Addressing
Disparities selected hypertension and cardiovascular disease as priority areas for future
research (PCORI 2013). Developed to support the work of the Addressing Disparities
Program and the Advisory Panel, this landscape review describes current evidence for
CVD disparities interventions, illuminates the evidence gaps, and identifies opportunities
for PCORI-funded comparative effectiveness research (CER).
Although this landscape review examines evidence for interventions that target a very
inclusive list of potentially disparate populations, it is restricted to a subset of
intervention types and settings consistent with PCORI’s central focus on CER. This
landscape review summarizes evidence, and gaps in evidence, for a subset of
interventions as follows:
 We focused the review on CVD secondary prevention (e.g., screening and
diagnosis) and tertiary prevention (e.g., tobacco use cessation or hypertension
control in persons with diagnosed CVD).
 We focused the review on interventions that took place in a clinical setting; those
that were based in a clinical setting but extended into a community setting (e.g.,
a senior center, the patient’s home); and those that involved organizational
linkages or partnerships between clinical and community organizations.
 We excluded studies that focused on home blood pressure monitoring as this
was the subject of a recent AHRQ review (Uhlig et al., 2012).
Reduce Disparities in Cardiovascular Disease
1
Finally, this review was limited to disparities and targeted interventions, which are
defined as follows for the purposes of this review:
 Disparities interventions explicitly aim to address disparities (i.e., differences
between segments of the population) in CVD-related patient-centered or patientlevel outcomes.
 Targeted interventions explicitly aim to address CVD in a single population group
experiencing disparate health outcomes.
Further details on landscape review methods are provided in Appendix A.
Within this scope, this document provides an overview of types of interventions
addressing CVD disparities and reported patient-centered and patient-level outcomes.
The interventions identified through this landscape review can be characterized, from
the social-ecological model (SEM) perspective, by intervention level. We adopted this
approach to typifying interventions because addressing health disparities in CVD and
other conditions requires comprehensive, interdisciplinary approaches that operate at
multiple levels of the SEM (Mensah 2005; CDC n.d.; NIH 2012). Studies meeting the
criteria for this landscape review tested interventions at the systems level, patientprovider level, and patient level. This landscape review highlights evidence gaps for
these disparities interventions. Furthermore, this review proposes the potential role of
PCORI in further developing the evidence base through CER and supporting research
translation in order to both improve health outcomes for populations experiencing CVD
disparities and reduce and eliminate CVD disparities.
Reduce Disparities in Cardiovascular Disease
2
Burden on Society
The term CVD, also called heart disease, refers to pathological conditions involving the
heart and blood vessels, such as coronary heart disease, hypertension, and stroke.
CVD is a leading cause of death and disability in the U.S. (CDC 2011), and high rates of
hypertension, high cholesterol, and smoking—preventable CVD risk factors—contribute
to the CVD burden. Approximately one in three U.S. adults have one or more types of
CVD (Go et al. 2013). Exhibit 1 lists prevalence estimates by population group and
CVD condition. Each year, approximately 610,000 U.S. adults will have a new coronary
attack, which is defined by Go et al. (2013) as first hospitalized myocardial infarction or
coronary heart disease death.
Exhibit 1. Age-adjusted Prevalence Estimates for Diagnosed CVD Conditions
Population group
(adults ≥ 18 years of
age)
Heart Disease
Coronary Heart
Hypertension
Disease
Stroke
African Americans
10.7%
6.9%
33.4%
4.5%
American Indians or
Alaska Natives
12.7%
7.2%
25.8%
4.6%
Asians
7.4%
4.3%
18.7%
2.7%
Hispanics or Latinos
8.6%
5.9%
22.2%
2.8%
…
…
21.8%
…
6.3%
23.3%
2.3%
Native Hawaiians or
other Pacific Islanders
Whites
11.1%
Source: Go et al. 2013
Note: Data are not available for empty cells.
CVD poses a significant burden on public health, the health care system, and the
economy. By 2030, total direct medical costs of CVD are expected to top $800 billion
(Heidenreich et al. 2011). Heart disease, stroke, and hypertension are among the top 15
conditions that cause functional disabilities among Americans, which include challenges
with daily living, inability to do housework, and inability to work at a job or business (Go
et al., 2013). Stroke is a leading cause of long-term disability among U.S. adults, and
post-stroke depression is experienced by nearly one-third of stroke survivors (Go et al.,
2013).
During the period from 1999-2009, the rate of death attributable to CVD declined by
approximately 33%. However, despite advances in addressing this leading cause of
death in the U.S., CVD-related disparities persist among populations defined by
race/ethnicity; socioeconomic status (SES), including income and education; health
insurance status; geographic location; disability status; gender; and sexual orientation.
Reduce Disparities in Cardiovascular Disease
3
 Heart disease and stroke incidence and mortality rates continue to be higher
among African Americans and Hispanics, adults with low SES, and those living in
the southeastern part of the country (Go et al. 2013)
 The prevalence rate of hypertension in African American adults is the highest in
the world (Go et al. 2013).
 During the period from 1995 to 2002, Puerto Rican Americans had a higher
hypertension-related mortality rate than non-Hispanic whites and all other
Hispanic subgroups (Go et al., 2013).
 In all years of National Health and Nutrition Examination Survey administration
starting in 1988 (1988–1994, 1999–2002, 2003–2006, 2007–2010), Mexican
Americans were less likely than whites to have their blood pressure under control
(AHRQ 2012a).
 In 2007, African American men were 30% more likely to die from heart disease
compared to non- Hispanic white men (CDC 2013).
 CVD has been the leading cause of death among U.S. women since 1984,
resulting in more CVD-related deaths compared to men (Beth Israel Deaconess
Medical Center 2003).
 During most of the period 2001–2009, residents of the lowest area income
quartile had significantly higher inpatient heart attack mortality rates than
residents of the highest area income quartile (AHRQ 2012a). Women had higher
rates of inpatient heart attack deaths compared to men, and uninsured patients’
rates of inpatient heart attack deaths were higher than privately insured patients.
 Adults living in rural environments in the U.S. are more likely to be diagnosed
with coronary heart disease compared to adults living in urban areas (O’Connor
& Wellenius 2012).
With regard to lesbian, gay, bisexual, and transgender (LGBT) health, it is important to
note that research on CVD in this population has focused primarily on increased risk
among LGBT persons infected with HIV and among transgender persons taking
masculinizing hormones (Institute of Medicine [IOM] 2011). However, IOM concluded
that there was insufficient research supporting these risks. IOM recommends additional
research on CVD among all LGBT adults. Reducing and eliminating health disparities is
a critical component of addressing the CVD burden. However, more evidence is needed
to determine the best approaches for intervening on CVD disparities. As a key step in
growing the evidence base in this area, and, in turn, informing health care decisions
related to addressing CVD disparities or improving CVD outcomes among population
groups that experience disparate outcomes, this landscape review will illuminate
evidence gaps and identify opportunities for PCORI-funded CER.
Reduce Disparities in Cardiovascular Disease
4
Options for Addressing the Issue
Description of interventions
As noted in the Introduction, disparities and targeted interventions were included in this
landscape review, and interventions identified through this landscape review targeted
one of three SEM levels: systems, patient-provider, or patient. In this section, which is
organized by intervention level, we provide brief descriptions of the studies, including
intervention aim (i.e., disparities or targeted), followed by a high-level summary of
reported results. Appendix B provides an at-a-glance summary of the interventions
included in this landscape review.
Systems-level interventions: study descriptions. Three pre-post studies tested
health care quality improvement (QI) interventions: (1) a statewide ST-segmentelevation myocardial infarction (STEMI) regionalization program designed to reduce
treatment times among women, minorities, and the elderly (Glickman et al. 2010); (2) a
registry and performance-improvement program intended to improve quality of care and
outcomes for African Americans hospitalized with heart failure (Yancy et al. 2008); and
(3) a heart failure disease management program, which provided a standardized
algorithm of care to eliminate disparities in hypertension care for African American and
Hispanic patients in an urban and a rural safety net hospital (Hebert et al. 2011). All
three interventions were disparities interventions (i.e., explicitly aimed to address
differences between segments of the population on CVD outcomes) and were
implemented in the clinical setting. It is important to note that Herbert et al. (2011) did
not provide a detailed description of the disease management intervention, but
statements included in the paper imply that the primary components of the intervention
involved systems-level changes to “ensure that the best practices known to medical
science are incorporated with minimal variation over the entire continuum of
care”(Hebert et al. 2011, 567).
Systems-level interventions: study results. Glickman et al. (2010) reported a
significant decrease in baseline care differences of door-to-treatment times in women
versus men. However, with the exception of this indicator, the intervention did not
improve disparities in STEMI treatment times. Yancy et al. (2008) concluded that
African American heart failure patients exposed to the performance-improvement
program had better-than-previously observed treatment with evidence-based therapies.
Additionally, African American heart failure patients had similar or better outcomes
compared with non–African American patients. However, the researchers acknowledge
that further research is needed to assess the effect of a performance-improvement
intervention on health care disparities among African Americans with CVD. Herbert et
al. (2011) reported significant reductions in mean systolic and diastolic blood pressure,
but also reported a “persistent” health disparity for blood pressure control: whites were
Reduce Disparities in Cardiovascular Disease
5
more likely to reach blood pressure control goals than African Americans or Hispanics
(2011, 571).Study objectives did not include assessment of rural versus urban safety
net disparities.
Patient-provider level interventions: study descriptions. Two randomized trials
tested interventions that included patient and provider education: (1) a study to compare
the effectiveness of physician communication skills training and patient coaching on
hypertension among underserved primary care patients (Cooper et al. 2011); and (2) a
study to compare the effectiveness of physician education, patient education, and both
on improving blood pressure control in African American patients (Johnson et al. 2011).
Both interventions were targeted interventions (i.e., explicitly aimed to address CVD in a
single population group experiencing disparate health outcomes) and both were
implemented in the clinical setting but included some community linkage. For example,
community health workers provided patient coaching in Cooper et al.’s trial, and
American Society of Hypertension certified hypertension specialists provided lectures to
physicians in Johnson et al.’s trial.
Patient-provider level interventions: study results. In Johnson et al.’s study, the
patient and physician education group achieved a significantly better decrease in
systolic blood pressure compared with the usual care group. Cooper et al. (2011) found
no improvements in patient adherence to medication; however, they reported
suggestive (i.e., not statistically significant but potentially practically important)
improvements in systolic blood pressure among patients with uncontrolled hypertension
in the patient and physician education intervention group.
Patient-level interventions. The remaining 32 papers reported on 31 patient-level
interventions designed to support patients in managing their blood pressure and CVD.
These interventions varied widely by content or types of services provided, mode of
service delivery, and service provider; descriptions are grouped by similar intervention
approach.
Integrative medicine interventions: study descriptions. Two randomized trials tested
integrative medicine interventions; that is, they incorporated non-mainstream health
care approaches (National Center for Complementary and Alternative Medicine
[NCCAM] 2013): (1) a study to determine the comparative effectiveness of patient
education versus patient education with positive-affect induction and self-affirmation
among hypertensive African American patients from two primary care practices
(Ogedegbe et al. 2012); and (2) a study of a secondary CVD prevention intervention for
African Americans that involved transcendental meditation versus health education
(Schneider et al. 2012). Both interventions were targeted interventions and included
support or services provided beyond the clinical setting. For example, in Ogedegbe et
al.’s study, research assistants provided regular telephone-based support, which
Reduce Disparities in Cardiovascular Disease
6
allowed patients to receive services outside of the clinical setting. The transcendental
meditation technique was taught by an external instructor certified by Maharishi
Foundation USA.
Integrative medicine interventions: study results. Ogedegbe et al. (2012) reported that
the integrative medicine intervention had a significant impact on medication adherence,
but not on blood pressure reduction. Schneider et al. (2012) reported a significant
reduction in systolic blood pressure as well as significant reductions in anger expression
and a 48% risk reduction in the composite of all-cause mortality, myocardial infarction,
or stroke.
Enhanced lifestyle interventions: study descriptions. We classified four patient-level
interventions as “enhanced lifestyle” interventions because they provided in-person selfmanagement support paired with supervised exercise sessions and/or interactive
sessions related to healthy eating/cooking. These pre-post studies were designed to (1)
examine the relative effectiveness of a multisite cardiac lifestyle intervention program
(MCLIP) for male and female coronary heart disease (CHD) patients of lower SES
compared to patients with higher SES (Govil et al. 2009) (MCLIP included in-person
education, nurse case management, and supervised exercise); (2) assess the
effectiveness of a 12-week community-based education and physical activity
intervention on blood pressure control among African American adults (Rigsby 2011);
(3) assess the feasibility of a culturally tailored behavioral intervention to lower blood
pressure in Latino adults (Rocha-Goldberg Mdel et al. 2010); and (4) evaluate a
community-based, culturally tailored nutrition and physical activity program designed to
improve the CVH of African American women (Rodriguez et al. 2012). One of the four
interventions was a disparities intervention (Govil et al. 2009); the remaining three were
targeted interventions,
Enhanced lifestyle interventions: study results. Govil et al. (2009) found improvements
in patient-reported well-being across all SES levels. Patient-reported improvements in
diet, stress management, and physical activity were also documented, and exercise
capacity improved to more than 10 metabolic equivalents, across all educational and
income levels. Rocha-Goldberg Mdel et al. (2010) reported clinically significant
decreases in systolic blood pressure among participants. Rigsby found improvements in
participants’ knowledge and blood pressure control, but significance of results was not
reported. Rodriguez et al. (2012) reported a significant reduction systolic blood pressure
from baseline to the end of the intervention period.
Traditional self-management interventions: study descriptions and results. Studies of 14
patient-level interventions (9 randomized trials, 1 nonrandomized trial, 2 pre-post
studies, 1 observational study, and 1 study involving post-hoc analysis of data from a
randomized trial) involved the provision of in-person education and/or counseling,
Reduce Disparities in Cardiovascular Disease
7
services by phone, or through a mix of both methods by clinical staff (e.g., nurses), nonclinical health workers (e.g., promotoras, community health workers, and health
educators), or research staff. All of these self-management interventions were clinicalcommunity linkage interventions in that they extended the services provided by a clinical
setting and/or were implemented through considerable partnering with communitybased health workers and organizations.
Two of the self-management interventions were disparities interventions. (Jackson et al.
2012, Noureldin et al. 2012). Jackson et al. (2012) conducted a randomized trial to
compare the effect of a telephone-based, nurse-delivered medication management and
behavioral self-management support intervention on change in blood pressure among
African American and non-Hispanic white U.S. Department of Veterans Affairs primary
care patients. This intervention included services that extended beyond the clinical
setting, including home blood pressure monitoring and telephone-based selfmanagement support. Jackson et al. (2012) reported significant improvement in mean
systolic blood pressure at 12 and 18 months among African American patients receiving
the combined medication management and behavioral self-management support
intervention compared to African American patients receiving usual care. No
comparable changes in blood pressure were found for non-Hispanic white patients. In
post-hoc analysis of data from a randomized trial, Noureldin et al. (2012) compared the
effect of a pharmacist intervention, including patient education, therapeutic monitoring,
and communication with primary care providers, on medication adherence among heart
failure patients with limited versus adequate health literacy. Researchers reported that,
in general, the intervention improved medication adherence, and in patients with limited
health literacy, adherence was increased to levels similar to baseline adherence among
patients with adequate health literacy.
The remaining 12 traditional self-management interventions were targeted interventions
(Anderson et al. 2010, Balcazar et al. 2009, Cene et al. 2008, Cook et al. 2010, DeWalt
et al. 2012, Evans-Hudnall et al. 2012, Han et al. 2010, Gross et al. 2013, Kim et al.
2011, Mosca et al. 2010, Pezzin et al. 2011, Shaya et al. 2013, Zarate-Abbott et al.
2008). The evidence is mixed as to the effectiveness of traditional self-management
interventions for addressing CVD in subgroups experiencing disparities.
Anderson et al. (2010) found no significant benefit on key clinical and behavioral
outcomes for a randomized trial of a telephone-based disease management intervention
designed to improve CVD outcomes for community health center patients with diabetes.
In a randomized trial to test an in-person and phone-based intervention delivered by
promotoras to improve hypertension control among Mexican Americans, Balcazar et al.
(2009) reported significant differences in diet-related heart-healthy behaviors between
the intervention and control groups. Cene et al. (2008) reported no group differences in
Reduce Disparities in Cardiovascular Disease
8
mean risk factor levels at 5 years for their randomized trial to compare the effectiveness
of community-based care provided by a nurse practitioner/community health worker
team versus enhanced usual care on CVD risk among high-risk African American
families. Based on results of their randomized trial to compare the effectiveness of a
single session literacy sensitive training to improve self-care among patients with heart
failure versus the single session plus ongoing telephone-based support provided by a
health educator, DeWalt et al. (2012) concluded that patients with low health literacy
may benefit more from interventions that involve multiple sessions compared to those
with higher health literacy. However, DeWalt et al. found no differences between
intervention groups on clinical outcomes, including all cause hospitalization and all
cause death. Evans-Hudnall et al. (2012) reported significant increases in stroke
knowledge and decreased secondary stroke risk factors among underserved
racial/ethnic minorities for their randomized clinical trial of a secondary stroke self-care
pilot program. Mosca et al. (2010) conducted a randomized trial of an education and
counseling intervention provided by a prevention facilitator/educator during
hospitalization and by phone following discharge to improve adherence to secondary
CHD prevention guidelines among women. The researchers reported no difference
between the intervention and usual care groups on a summary score of prevention
goals met, but found that minority women in the intervention group were about twice as
likely to reach blood pressure goals at 6 months compared to minority women receiving
usual care. In a randomized clinical trial of the effect of a nurse and health educator
counseling intervention on blood pressure control among high-risk African American
home care adults, Pezzin et al. (2011) found significant improvements in blood pressure
control. Kim et al. (2011) and Han et al. (2010), whose publications are based on a
randomized trial of the same intervention, compared the effectiveness of more-intensive
versus less-intensive nurse-provided telephone counseling on hypertension
management among Korean American patients with high blood pressure. Improvements
in medication adherence and blood pressure were found in both intervention groups
with no significant group differences.
Results from Cook et al.’s (2010) observational study of a nurse-delivered educational
intervention designed to address health care disparities among Native Hawaiians
include improvements in adverse events following percutaneous coronary interventions
for Native Hawaiian patients and a decrease in readmissions that occur within 30 days
among patients admitted with myocardial infarction and heart failure. Study limitations
notwithstanding, Gross et al. (2013) reported that the 10 African American community
clinic patients who participated in a culturally sensitive education program to support
lifestyle changes and medication adherence demonstrated diet, exercise, and
medication adherence improvements. Shaya et al. (2013) conducted a non-randomized
trial to assess the effectiveness of nurse-led group education sessions on hypertension
Reduce Disparities in Cardiovascular Disease
9
control among African American adults in urban communities. Researchers reported a
significant decrease in blood pressure among the intervention group at 18-month followup. Zarate-Abbott et al. (2008) conducted a pre-post study to determine the effects of a
nurse-led workplace education program for low-income, immigrant Hispanic women on
blood pressure control and heart-healthy behaviors. Study findings showed a significant
reduction in blood pressure over the 17-month intervention.
Alternative modes of service delivery: study descriptions and results. Nine of the 31
patient-level interventions (5 randomized trials, 3 nonrandomized trial, and 1 pre-post
study) used alternative modes of service delivery, including self-management provided
by DVD (Eckman et al. 2012, Houston et al. 2011), text message (Nundy et al. 2013),
telehealth kiosk (Resnick et al. 2012), website/computer (Bove et al. 2011, Martin et al.
2011, Migneault et al. 2012), illustrated medication schedules (Kripalani, Schmotzer,
and Jacobson 2012), and a mix of visual, written, aural and kinesthetic strategies based
on patients learning styles (Giuse et al. 2012). All of these interventions were targeted
interventions.
Eckman et al. (2012) conducted a randomized trial to compare the effectiveness of a
VHS/DVD plus printed booklet educational intervention versus only the printed booklet
on coronary artery disease knowledge among patients with low health literacy. The
researchers concluded that results trended towards increased improvement on
knowledge scores among patients in the VHS/DVD plus printed booklet group, but
found no significant differences in knowledge score improvements or clinical outcomes
between patients with low health literacy and those with higher health literacy. Houston
et al.’s (2011) randomized trial to test the impact of an interactive storytelling
intervention, delivered via DVD, on blood pressure improvement among African
American adults found significant improvements in blood pressure among patients with
baseline uncontrolled hypertension in the intervention group. Nundy et al. (2013)
conducted a pre-post study to assess the feasibility of a text message-based
intervention on heart failure self-management among African American adults following
hospital discharge. Researchers reported clinically significant improvements in self-care
maintenance and management. Resnick et al.’s (2012) pilot study, a non-randomized
trial on the effect of nurse-monitored telehealth kiosks placed in community-based
senior centers on blood pressure, reported lower blood pressure levels and improved
blood pressure control among the telemonitoring group. However, the pilot was not
powered or designed for hypothesis testing, so no inferential statistics were provided.
With regard to website/computer interventions, no intervention effects were observed in
a randomized trial to test the effectiveness of a culturally tailored, automated telephone
system on adherence to medication and other self-management guidelines among
hypertensive African American adults (Migneault et al. 2012). Similarly, Martin et al.’s
Reduce Disparities in Cardiovascular Disease
10
(2011) randomized trial of a multimedia computer-based program designed to improve
medication adherence among low-income hypertensive African American adults found
no intervention-control group differences. Bove et al. (2011) observed significant CVD
risk reduction among medically underserved urban and rural patients in both the
telemedicine and comparison office-based nurse management and education
interventions, which were tested in a randomized trial.
Kripalani et al.’s (2012) randomized trial to evaluate the effect of illustrated medication
schedule and refill reminder postcards on medication adherence among patients with
low health literacy reported no significant improvements in medication adherence.
However, results of post-hoc analyses suggest that illustrated medication schedules
may improve medication adherence among patients with low medication self-efficacy,
those with polypharmacy, or those with non-adherence at baseline. Guise et al. (2012)
conducted a randomized trial to compare the effectiveness of educational materials
tailored to health literacy level versus those tailored to health literacy level and learning
style (e.g., education provided via audio recording for aural learners) on hypertension
knowledge among emergency department patients with high blood pressure.
Participants in both intervention groups demonstrated improvements in post-test scores
for hypertension knowledge with increased improvements among those receiving
materials tailored to health literacy level and learning style.
Unique providers: study descriptions and results. Two patient-level interventions, both
tested in randomized trials, involved non-traditional providers of self-management
support services. Turner et al. (2012) evaluated the effectiveness of phone-based
counseling provided by peer patients with well-controlled hypertension paired with
office-based counseling provided by trained practice staff on CHD risk among African
American patients with uncontrolled hypertension. Researchers concluded that risk
reduction favored the intervention group; however, results were not statistically
significant. Victor et al. (2011) conducted a randomized cluster trial to determine
whether a blood pressure monitoring and referral program administered by barbers in
community barber shops led to improved blood pressure control among patrons with
high blood pressure. Results indicate that the hypertension control rate increased more
in intervention barbershops than in comparison barbershops.
Relative Benefits
As detailed in the previous section, this landscape review found that studies of
interventions that explicitly addressed disparities in CVD health outcomes and those
that addressed CVD in populations experiencing disparate health outcomes reported
statistically significant and suggestive improvements in patient-level and patientcentered outcomes (see Appendix C for definitions adopted for the purposes of this
Reduce Disparities in Cardiovascular Disease
11
landscape review). Patient-level outcomes commonly reported across all reviewed
studies include improvements in
 patient knowledge, attitudes, and behaviors related to CVD management;
 physiological measures (e.g., blood pressure); and
 medication adherence.
Quality of care improvements were also reported in two systems-level intervention
studies (Glickman et al. 2010; Yancy et al. 2008) and in one patient and provider-level
intervention (Cooper et al. 2011).
Patient-centered outcomes were less commonly reported than patient-level outcomes.
Two studies reported health-related quality of life benefits, including improvements in
depression scores, following patient-level self-management support interventions (Govil
et al. 2009; Kim et al. 2011). Reduction in risk for CVD (Bove et al. 2011), inpatient
mortality (Yancy et al. 2008) and composite morbidity and mortality (Schneider et al.
2012) were also reported. Based on results from an observational study, Cook et al.
(2010) reported improvements in 30-day hospital readmissions for myocardial infarction
and heart failure patients.
Relative Harms
None of the papers reviewed included information about the relative harms of the
interventions. However, the recent NIH funding opportunity announcement (FOA)
identified through the web scan, Behavioral and Social Science Research on
Understanding and Reducing Health Disparities, notes that interventions focused on
improving the absolute level of a single group’s health may not improve the group’s
relative health and instead could result in maintaining or exacerbating disparities (NIH
2013a).
Opportunities for New Research
In general, PCORI can advance health disparities research by increasing the inclusion
and reporting of patient-centered outcomes and by funding intervention studies that
focus on reducing disparities (i.e., differences in health outcomes between two groups),
in addition to studies of targeted interventions:
 Enhance the inclusion and reporting of patient-centered outcomes. About
one-quarter of the papers included in full-text review covered chief patientcentered outcomes. A recent AHRQ funding opportunity identified through the
web scan, Closing the Gap in Healthcare Disparities through the Dissemination
and Implementation of Patient Centered Outcomes Research, reflects the
importance of integrating health disparities and patient-centered outcomes
research (NIH 2013b). However, the cooperative agreement focuses on health
Reduce Disparities in Cardiovascular Disease
12
care disparities in racial and ethnic minority populations in under-resourced
health care settings. PCORI research could complement AHRQ research by
broadening an integrated approach to health disparities and patient-centered
outcomes research to other groups experiencing disparities (i.e., beyond racial
and ethnic populations) and by focusing on CVD disparities.
 Focus on measurement of disparities between or among two or more
groups. In general, there is a need for more research aimed at developing
interventions, and assessing the comparative effective of interventions, designed
to reduce or eliminate disparities in CVD health outcomes, as opposed to
research that aims to improve CVD-related outcomes in a single population
experiencing disparities. This research gap is reflected in the small number of
disparities studies found through this landscape review (Glickman et al. 2010;
Govil et al. 2009; Eckman et al. 2012; Hebert et al. 2011; Jackson et al. 2012;
Yancy et al. 2008; Noureldin et al. 2012). And the recently released NIH Funding
Opportunity Announcement (FOA) for research on understanding and reducing
disparities, which stresses that “applied research under the FOA should be
aimed at narrowing the differential between groups,” underscores the importance
of addressing this research gap (NIH 2013a, 4).
There is an opportunity for PCORI to complement NIH disparities research by
funding studies that compare the effectiveness of various disparities interventions
developed and tested under the NIH R01. A patient-level self-management
support intervention determined to be effective at reducing disparities versus
usual care can be further examined in comparative effectiveness studies to
determine, for example, which intervention components are critical for achieving
intended outcomes. It is worth noting that the NIH FOA is “restricted health
disparities among populations defined by race/ethnicity, SES, and/or rural-urban
residence” NIH 2013a, 3), and the National, Heart, Lung and Blood Institute “will
only support research project (R01) that test interventions, not observational
studies, [rather]…projects…employing randomized designs” (NIH 2013a,11).
Therefore PCORI can also complement NIH research by funding studies that
compare the effectiveness of interventions designed to reduce health disparities
between groups not covered under the R01 and/or studies that employ nonrandomized, yet rigorous designs (e.g., regression discontinuity).
In addition to these broader gaps in evidence for addressing health disparities, there are
several gaps in research specific to CVD disparities. To help address these evidence
gaps, this landscape review suggests three types of studies that PCORI could fund:
those that assess the effectiveness of QI interventions; those that explore the added
value of provider education; and those that compare the effectiveness of various selfmanagement support intervention models, including within model studies that compare
effectiveness at different levels of intervention intensity and duration.
 Studies that assess the effectiveness of QI interventions. PCORI can help
address gaps in CVD disparities research by funding studies that compare the
Reduce Disparities in Cardiovascular Disease
13
effectiveness of QI interventions on reducing disparities and improving patientcentered outcomes. In following with AHRQ’s definition (AHRQ 2012b), QI
interventions would include any multidisciplinary, systems-focused, data-driven
methods applied to improve the efficiency, effectiveness, and reliability of health
processes and outcomes of care. As described in the previous section, we found
only three studies of QI interventions designed to address disparities between
two or more groups (Glickman et al. 2010; Yancy et al. 2008; Hebert et al. 2011).
As a recent AHRQ report identified through the web scan notes, although QI
interventions have proven effective for improving health and health care, it is
unclear whether they are effective at reducing disparities (AHRQ 2012b). The
Community Preventive Services Task Force recommendations for CVD
prevention and control align with the AHRQ findings. The Task Force
recommends clinical decision-support systems (CDSS) for prevention of CVD
and team-based care to improve blood pressure control (Community Preventive
Services Task Force 2013). However, evidence gap summaries highlight the
need for more evidence around the impact of CDSS on reducing health
disparities and more assessment of the effectiveness of team-based care for
groups experiencing health disparities, including patients from low-SES groups
and racial and ethnic minorities other than African Americans. The Task Force
also concludes that more information is needed about the patient-centered
outcomes of these QI interventions.
 Studies that explore the added value of provider education. PCORI can
expand the evidence for CVD disparities interventions by funding studies that
compare the relative impact of (a) provider education, (b) patient education, and
(c) provider and patient education on patient-centered and patient-level CVD
outcomes, including quality of care. As summarized in the previous section, this
landscape review identified only two studies that compared the relative
effectiveness of provider education, patient education, and provider and patient
education interventions to address disparities in hypertension control (Cooper et
al. 2011; Johnson et al. 2011). One of the studies found that the dual provider
and patient education intervention yielded significantly better reduction in blood
pressure compared to the usual care group (Johnson et al. 2011). Both studies
suggest that more research is needed to identify the intervention components
and levels of intensity required to improve patient outcomes. Research to identify
the subgroups of clinicians and patients who are most likely to benefit from
education interventions was also recommended (Johnson et al. 2011).
 Studies that compare the effectiveness of various self-management
support intervention models. PCORI can help develop the evidence base for
CVD disparities interventions by funding studies that compare the effectiveness
of various self-management support models, including studies designed to
identify which intervention components are critical for achieving intended
outcomes. As described in the previous section, most (31 of 37) of the studies
reviewed tested patient-level interventions designed to support patients in
managing their blood pressure and CVD. Interventions varied widely by the
provider of services, types of services provided, service delivery mode, and
Reduce Disparities in Cardiovascular Disease
14
setting. The diversity of self-management support interventions offers many
options for CER within and between intervention models. Indeed, most papers
included a recommendation to compare the intervention’s effectiveness at
different levels of intensity and duration. Researchers suggested that this withinintervention CER is necessary to identify essential elements of the intervention,
which could, in turn, facilitate translation of research findings into real world
practice.
Two patient-level interventions were integrative medicine interventions
(Ogedegbe et al. 2012; Schneider et al. 2012). Under the NIH FOA, the National
Center for Complementary and Alternative Medicine identifies “comparative
effectiveness studies of combined pharmacological/non-pharmacological
integrative health interventions” as an example research area (NIH 2013a,9).
However, CVD is not listed as a specific area of focus, and this is a research gap
that PCORI can address.
We classified three patient-level interventions as enhanced lifestyle interventions
because they provide in-person self-management support paired with supervised
exercise sessions and/or interactive sessions related to healthy eating/cooking
(Govil et al. 2009; Rigsby 2011; Rodriguez et al. 2012). Future research should
compare the effectiveness of enhanced lifestyle interventions to more basic
patient education and counseling services on patient-centered and patient-level
outcomes and assess whether effectiveness varies across different groups
experiencing CVD disparities.
Recent Innovations
Current innovations and contextual events are important for PCORI to consider as it
plans its portfolio of CVD disparities research. Electronic health records and health
information exchange are the key innovations that may facilitate CER related to
addressing CVD disparities and/or improving patient-centered and patient-level
outcomes in groups experiencing disparities. For example, health information
technology may minimize or altogether remove the burden of abstracting patient data
from registries or paper medical charts, making it easier for researchers to gather data
on health indicators and outcomes of interest at baseline, during the intervention, and at
follow-up. The Office of the National Coordinator (ONC) for Health Information
Technology has concluded that “health IT has potential to impact the health of
populations experiencing health disparities” (ONC 2013, 2).ONC’s future work in this
area may present additional opportunities for PCORI research.
Reduce Disparities in Cardiovascular Disease
15
Pace of Research
Number of Publications
Based on publication trends and
Exhibit 2. Number of Articles Meeting Landscape
recent FOAs, we expect a steady
Review Inclusion Criteria by Publication Year
pace of research related to
14
addressing CVD disparities. Our
12
assessment of publication trends is
10
limited to those papers that met the
8
inclusion criteria for this landscape
6
review. The number of articles for
4
2013 includes projections based on
2
0
seven published study protocols
2008 2009 2010 2011 2012 2013
that have not yet published results,
Publication Year
but abstracts suggest that planned
studies and those in progress align
Note: 2013 includes actual (n = 3) and expected number
with the focus of this landscape
of articles (n = 7) based on published study protocols
identifed through this landscape review.
review (Cabassa et al. 2011;
LeBlanc et al. 2012; Lee et al. 2012;
Ogedegbe et al. 2013; Schoenthaler et al. 2011; Warner et al. 2013; Willard-Grace et al.
2013).
The NIH and AHRQ FOAs posted in summer 2013 will support new behavioral and
social science research on reducing health disparities. Because these FOAs are not
specific to CVD and do not cover all groups experiencing disparities—the NIH FOA is
restricted to racial/ethnic, socioeconomic status, and rural-urban health disparities and
the AHRQ FOA focuses on racial/ethnic disparities in under-resourced settings—there
is an opportunity for PCORI to complement and expand on research projects funded
through the NIH and AHRQ FOAs and ensure that patient-centered outcomes research
is integrated with health disparities research.
Reduce Disparities in Cardiovascular Disease
16
Potential for New Information to Rapidly Improve Care and PatientCentered Outcomes
Summary of the Factors that Would Affect the Translation of New Research
Findings to Practice
Interventions that have been shown to be effective in the research setting have often
failed when translated to practice (Damshroder et al. 2009). Adoption rates for
innovations vary considerably; some are adopted and spread rapidly, while others fail to
gain traction (Greenhalgh et al. 2004). To understand which research findings are likely
to be quickly adopted and effectively implemented, researchers and organizations
seeking to fund new research opportunities should examine the potential for successful
translation. In this section, we discuss factors that impact the potential of interventions
to be effectively translated into practice. We then examine the research opportunities
identified in this landscape review, and described in the previous section, through the
lens of these factors.
The implementation science literature offers multiple translation-related theories but with
a significant amount of overlap. To overcome the issue of redundancy between various
existing theories, and to develop a practical, usable, and comprehensive metaframework that can assist in identifying which interventions may work in practice,
Damshroder et al. (2009) developed the Consolidated Framework for Implementation
Research (CFIR). The CFIR consists of a set of 37 total constructs, or factors, grouped
by domains. We have selected and adapted five constructs that we believe provide
PCORI with the answer to the question at hand: What factors affect translation of new
research findings to practice?
Exhibit 3 presents selected CFIR domains, or major areas that impact implementation
of interventions, as well as brief descriptions of five factors that are useful in evaluating
the potential of interventions to be effectively translated into practice.
Reduce Disparities in Cardiovascular Disease
17
Exhibit 3. Factors that Impact Translation of Research Findings into Practice
Domain
Factors

Adaptability: the extent to which the intervention can
be modified to suit local needs

Trialability: whether the intervention can be tested on
a small scale before large-scale implementation and
whether course can be reversed easily if desired

Complexity: the difficulty of implementation, including
the extent to which it disrupts current operations and
systems, number of stages in implementation, scope,
and duration of implementation
Outer Setting: The environmental
factors that may affect
implementation.

External policies: incentives, mandates, and
insurance-related issues that may affect effective
translation
Inner Setting: Features of the
organization, system, or community
in which in the intervention is being
implemented in practice

Readiness for implementation: commitment of staff,
involvement of staff, level of resources dedicated to
implementation, accessibility of information for staff
regarding implementation and sustainability
Intervention Characteristics:
Characteristics of the intervention
being implemented in practice
Source: Adapted and modified from Damshroder et al. 2009.
The domains and factors described in Exhibit 3 provide a structure to evaluate the
potential of interventions identified in this landscape review to be effectively translated
and adopted. This potential varies based on the interventions themselves and the
contexts in which they are implemented (Damshroder et al. 2009). In the following
section, we provide a brief discussion of the likelihood of the research findings identified
in this landscape review being implemented in practice, using the factors listed in
Exhibit 3 as a guide.
Discussion of Likelihood of New Research Findings Being Immediately
Implemented in Practice
In previous sections, we identified opportunities for PCORI to help address research
gaps around interventions to reduce or eliminate CVD disparities. In this section, we
examine these research opportunities with a focus on factors that impact likelihood of
translation (Exhibit 4). We designated the likelihood of translation as being low,
intermediate, or high based on our expertise and on qualitative examination of the each
of the constructs described in Exhibit 4. In addition, we considered each intervention’s
characteristics across the translation constructs relative to the others. A description of
our qualitative assessment follows.
Reduce Disparities in Cardiovascular Disease
18
 Assess effectiveness of QI interventions. Overall, we rate QI interventions as
having an intermediate likelihood for immediate implementation based on the
following considerations outlined in Exhibits 3 and 4:
 The adaptability and complexity of QI interventions will vary with the context
and scope of the intervention itself. For example, if clinics in a health system
are all part of a QI initiative, they will all have common goals, but the Plan-DoStudy-Act (PDSA) cycles in each clinic should be tailored appropriately. QI
interventions typically do well on the trialability factor because starting on a
small scale and expanding is an essential feature of QI initiatives, making it
easier to reverse course or correct errors in implementation. Complexity
depends on context, but QI interventions can be very complex, particularly
when interfacing with electronic health records.
 External policies depend on contextual factors, but generally speaking,
insurance coverage for QI initiatives is not common, although health systems
themselves may sponsor these initiatives based on the promise of increased
future efficiencies.
 Internal to the organization, leadership support for QI interventions that
improve quality of care and efficiency of services can generally be expected
to be strong. However, for effective implementation, resources need to be
guaranteed prior to beginning the process of operationalization. Similarly,
staff support within organizations for these initiatives is typically broad as long
as the initiatives do not impact negatively on staffing or compensation.
 Explore the added value of provider education. We suggest that effective
patient and provider education interventions designed to improve quality of care
and self-management of CVD have a high likelihood for immediate
implementation based on the following considerations:
 We assess dual patient-provider education interventions as being adaptable
to contextual needs (e.g., physician training requirements and patient
language barriers) and less complex (e.g., compared to the QI interventions
described above). Additionally, these interventions do well on the trialability
factor because they generally do not require commitment of large-scale
resources for implementation.
 Provider education is required and encouraged by licensing boards and
health systems. However, provider education components are more likely to
be adopted by providers if the education program aligns with these external
forces.
 Readiness of implementation can be expected to be high for these
interventions. For example, staff can be trained and prepared using online
trainings, webinars etc.
Reduce Disparities in Cardiovascular Disease
19
Exhibit 4. Translatability Considerations for Opportunities to Address CVD Disparities through CER
Translatability Considerations
CER
Opportunities
Intervention
Characteristics
(Adaptability)
Intervention
Characteristics
(Trialability)
Intervention
Characteristics
(Complexity)
Outer Setting (External
Policies)
Inner Setting (Readiness of
Interventions)
QI
Depends on
context
Yes
Depends on context
Unlikely that insurance will
cover staff time on QI in the
future, but it is possible that
health systems themselves
will self-fund QI
Generally, strong leadership
support can be expected, but
commitment of resources prior to
implementation is required; staff
require training on QI
Patient and
Provider
Education
Adaptable to
contextual needs
Yes
Less complex
Alignment with institutional
and board requirements will
influence provider adoption
Readiness may be easily achieved
with webinars and other online
training
SelfManagement
Adaptable to
contextual needs
Yes, but less so Complexity varies
than other
interventions
described above
Most likely to be covered by
insurance in the future
Staff availability may be a concern
Reduce Disparities in Cardiovascular Disease
20
 Compare the effectiveness of various self-management support
intervention models. We rate patient self-management interventions as having
an intermediate likelihood for immediate implementation based on the following
considerations:
 Adaptability to patient needs is a primary requirement for self-management
models and is usually built into the design. The complexity of the interventions
varies significantly. For example, technology that interfaces with electronic
health records tends to be more complex. Increased complexity also
contributes to greater difficulty in implementing the intervention and reversing
course if needed.
 Of the three kinds of research areas discussed here, patient selfmanagement interventions are most likely to be covered by insurance in the
future.
 Availability of staff to train patients on using the self-management model may
be a concern for these interventions.
Durability of Information
The interventions identified in this literature review, and in particular, those identified as
having a high likelihood of being implemented in practice, are relatively durable.
Concerns regarding durability are pressing in interventions where medical devices or
other technological innovations are a major component because these technologies are
replaced with improved versions, often on a continual basis (PCORI 2012). Medical
devices and other technological solutions are not primary components of the
interventions identified in this landscape review. However, QI interventions that have a
major technological innovation component may be less durable than other interventions
identified here. Although provider and patient education as well as patient-directed selfmanagement programs may include software-components (such as interactive
education applications), the core of these interventions is the education and selfmanagement content, which is highly durable.
Reduce Disparities in Cardiovascular Disease
21
Conclusion
This landscape review revealed several opportunities for new research designed to
identify effective strategies for addressing CVD disparities and improving CVD
outcomes among populations experiencing disparities. Generally, there is a need for
more research directed at developing, testing, and assessing the comparative
effectiveness of disparities interventions (i.e., interventions explicitly aimed at
eliminating differences in CVD outcomes between segments of the population). In
addition, there is an opportunity to better integrate health disparities and patientcentered outcomes research (few studies included in this review incorporated patientcentered outcomes of high importance to PCORI).
Specifically, within the context of interventions to address CVD disparities, studies are
needed to (1) assess the effectiveness of health systems quality improvement
interventions on reducing disparities and improving patient-centered outcomes, (2)
compare the relative impact of provider education versus patient education versus
provider and patient education on patient-level and patient-centered outcomes, and (3)
compare the effectiveness of various self-management support intervention models.
Based on our expertise and qualitative examination of key translatability constructs for
these recommended studies, we conclude that findings from new research have an
intermediate to high likelihood of swift translation into practice. Considering recent
publication trends and AHRQ and NIH FOAs, we expect a steady pace of research
related to addressing CVD disparities. However, because these FOAs are not specific
to CVD and do not cover all groups experiencing disparities, there is an opportunity for
PCORI to complement and expand on research projects funded through the NIH and
AHRQ FOAs and ensure that patient-centered outcomes research is integrated with
health disparities research. We also expect that electronic health records and health
information exchange will facilitate new research on reducing disparities in CVD.
Reduce Disparities in Cardiovascular Disease
22
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Appendix A: Methods Highlights
We conducted a non-systematic literature review as well as a grey literature search
(scan of websites of relevant organizations) to identify interventions to address CVD
disparities and related research gaps. Our goal was to identify interventions of the
following two broad types:
 clinical and clinical-community linkage interventions aimed at addressing
disparities in health outcomes associated with cardiovascular disease (CVD),
including hypertension; and
 clinical and clinical-community linkage interventions aimed at addressing CVD in
populations experiencing disparate health outcomes.
Literature Review
To identify relevant articles, we conducted a literature search using three databases:
PubMed, CINAHL, and the Cochrane Library. To guide our search in these databases,
we identified medical subject heading (MeSH) terms and keywords related to CVD,
health disparities or disparate populations, and types of interventions. The search had
the following limits:
 time period: 2008 to present;
 publication language: English;
 population: U.S. adults; and
 abstract available.
We did not limit the abstract literature search based study design. Based on the PCORIRTI team’s expertise in this area, we did not expect to find many randomized controlled
trials on this topic and agreed that insights regarding research gaps could be gained
through studies that span the spectrum from observational to experimental. A team of
four persons conducted single-reviewer review of the abstracts using the inclusion and
exclusion criteria detailed in Exhibit 5. Prior to abstract review, a training and pilot
review of 10 abstracts was conducted to standardize reviews.
Reduce Disparities in Cardiovascular Disease
A-1
Exhibit 5. Inclusion and Exclusion Criteria for Literature Review Component of the
Landscape Review
Category
Population
Intervention
Include



Adults aged 18 and older
Exclusion

Study populations where even a
portion of the population is less
than 18 years of age

No intervention implemented (e.g.,
description of CVD burden and/or
disparities; study protocol or other
description of planned intervention)

CVD not identified as a primary
focus of the intervention (e.g., HIV
intervention that includes blood
pressure monitoring)

Addressing disparities OR CVD in
disparate populations not an
explicit intervention aim

Purely community-based
interventions (e.g., media
campaigns, built or food
environment initiatives)

Interventions that focus only on
primary prevention


Drug or device studies
U.S. population
Populations experiencing disparate
health outcomes associated with CVD
• Racial/ethnic minorities
• Low socioeconomic status
• Uninsured or underinsured
• Limited English proficiency, low
literacy, and/or low numeracy
• Rural
• Living in the southeastern part of
the country
• Medically underserved
• Living with disabilities
• Women
• LGBT

Intervention is present
AND

Intervention explicitly aimed at
addressing disparities in CVD health
outcomes OR addressing CVD in
populations experiencing disparate
health outcomes
AND

Clinical (e.g., health care
setting/system) OR clinical-community
linkage (e.g., community health
workers, community pharmacists,
chronic disease self-management
programs) interventions
AND

CVD secondary prevention (e.g.,
screening and diagnosis) OR tertiary
prevention (e.g., tobacco use
cessation in persons with diagnosed
CVD; treatment/management
interventions)
Reduce Disparities in Cardiovascular Disease
Papers describing trial design but
not including outcome data
A-2
Category
Outcome
Include

Quantitative patient-level (including
patient-centered) outcomes pertaining
to cardiovascular health, including
morbidity and mortality
Exclusion

Studies that report only outputs
(e.g., reach); organizational-level
outcomes; or provider-level
outcomes

Cost or cost-effectiveness
outcomes
Time period

Studies published between January
2008 and August 2013

Studies published before January
1, 2008 or after August 31, 2013
Publication
criteria



English language


Non-English language




No abstract available for review
Admissible
evidence*

Articles in print
Abstract available for review
Original peer-reviewed intervention
studies that include quantitative
patient-level CVH outcomes:
• Descriptive studies
• Cross-sectional studies and trend
studies
• Before-and-after studies and
interrupted time series
• Prospective and retrospective
cohort studies
• Controlled trials
• Systematic reviews/
Comparative effectiveness reviews
• Meta-analyses
• Evidence-based guidelines
Accepted for publication, but not in
print during the review period
Commentaries/editorials
White papers
Policy briefs
Note: Grey literature was reviewed as part of the web scan.
A form containing fields important for abstraction was developed using Microsoft
InfoPath software and piloted by the team prior to proceeding to full-text review.
Following abstract review, the same four-person team conducted single review of fulltext articles (using inclusion and exclusion criteria listed in Exhibit 5). Key data from
articles deemed suitable for inclusion were entered into the abstraction form. During all
phases of review, the team met to discuss questions and resolve issues regarding
potential inclusion of articles. Following full-text abstraction, one team member
consolidated the various abstractions into a single Microsoft Excel document to facilitate
synthesis and report writing.
Exhibit 6 demonstrates the number of abstracts and articles identified through this
literature review, and how many were included and excluded at each step of the
process.
Reduce Disparities in Cardiovascular Disease
A-3
Exhibit 6. Summary of Literature Search and Selection
Reduce Disparities in Cardiovascular Disease
A-4
Grey Literature Scan (Website Review)
We conducted a review of a targeted list of websites to identify additional interventions
meeting our inclusion criteria and/or research gaps related to addressing CVD
disparities. We reviewed the following websites:
 AHRQ
 AHA
 CDC
 NHLBI
 Million Hearts
 The Community Guide
AHRQ and NIH FOAs, Community Guide recommendations, CVD burden data, and
CVD health disparities statistics were identified through the web scan and cited
throughout this landscape review as appropriate.
Reduce Disparities in Cardiovascular Disease
A-5
Appendix B: At-a-Glance Summary of Interventions
SYSTEMS-LEVEL INTERVENTIONS
Citation
Glickman et
al. 2010
Intervention Description
Length of
Intervention*
Study
Design
Length of
Study*
Sample
Size
Summary of Reported Results
Statewide ST-segment-elevation myocardial
infarction (STEMI)
regionalization program
designed to reduce treatment
times among women,
minorities, and the elderly
Pre-post
1.5 years
N=2,063
Patient Level: Women, minorities, and the
elderly received comparable benefits relative
to their counterparts from improved systems
of care that were implemented. The
intervention was also associated with a
significant reduction in baseline care
differences in door-to-electrocardiogram
times in women versus men.
Hebert et al. Heart failure disease
-2011
management program that
provided a standardized
algorithm of care to eliminate
disparities in hypertension
care for African American
and Hispanic patients in an
urban and a rural safety net
hospital
Yancy et al. Registry and performance-2008
improvement program
intended to improve quality of
care and outcomes for
African Americans
hospitalized with heart failure
Pre-post
10 years
N=898
Patient Level: Whites were more likely than
African Americans or Hispanics to achieve a
lower final blood pressure (BP) reading as
well as reaching either the standard or more
intensive BP goal, despite all groups having
similar absolute changes in BP per patient
from baseline.
Pre-post
2 years
N=5,791
Patient Centered: African American patients
had a lower risk-adjusted inpatient mortality
due to heart failure, but a similar adjusted 60to 90-day post-discharge morbidity and
mortality risk due to heart failure.
Patient Level: Among participating hospitals,
the provision of most but not all quality
measures were similar between African
American patients and patients of other
races.
* Estimated value based on information provided in cited paper
-- Unable to determine based on information provided in cited paper
Reduce Disparities in Cardiovascular Disease
B-1
PATIENT-PROVIDER LEVEL INTERVENTIONS
Citation
Cooper et al.
2011
Johnson et
al. 2011
Intervention Description
Physician communication
skills training and patient
coaching interventions
designed to address
hypertension among
underserved primary care
patients
Length of
Intervention*
--
Study
Design
Randomized
trial
Length of
Study*
3 years
Sample
Size
Physicians:
N=41
Patients:
N=279
Physician education, patient
Physicians: 12
Randomized
education, and physician and education
trial
patient education
sessions over
interventions designed to
24 months
improve blood pressure
Patients: -control in African American
patients
* Estimated value based on information provided in cited paper
-- Unable to determine based on information provided in cited paper
2.5 years
Physicians:
N=10
Patients:
N=552
Reduce Disparities in Cardiovascular Disease
Summary of Reported Results
Patient Level: No improvements in patient
adherence to medication were reported.
Positive intervention effects reported
include patient satisfaction with physicians’
decision-making styles, facilitation, and
information exchange, and the clinically
significant, though not statistically
significant, reductions in systolic BP
among uncontrolled hypertensive patients.
The greatest improvements in BP were
seen among patients who received
coaching by a community health worker
and whose physicians also received
patient-centered communication skills
training.
Patient Level: The physician and patient
education intervention group achieved a
significantly better reduction in systolic BP
compared with the usual care group.
B-2
PATIENT-LEVEL INTERVENTIONS
Citation
Anderson et
al. 2010
Balcazar et
al. 2009
Intervention Description
Length of
Intervention*
Study
Design
Telephone-based disease
12 months
management intervention
designed to improve CVD and
other health outcomes for
community health center
patients with diabetes
Randomized
trial
In-person and phone-based
promotora intervention
designed to improve
hypertension control among
Mexican Americans
Randomized
trial
2 months
Length of
Study*
--
Sample
Size
N=295
Summary of Reported Results
Patient Centered: Perceived health status
did not vary between treatment and control
groups.
Patient Level: Results indicated no
significant benefit on a wide variety of
primary and secondary clinical and
behavioral outcomes, including self-reported
rates of physical activity. Interval estimates
for a primary outcome variable, glycemic
control, excluded a clinically significant
difference in HbA1c.
3 years
N=98
Reduce Disparities in Cardiovascular Disease
Patient Level: Results indicated statistically
significant differences between the
intervention and control groups on
perceived benefits of healthy behaviors and
two behavioral outcomes (reduce intake of
salt and sodium, reduce cholesterol and
fat).
B-3
PATIENT-LEVEL INTERVENTIONS
Citation
Bove et al.
2011
Intervention Description
Length of
Intervention*
Nurse management (NM) CVD 12 months
risk reduction program and
NM system augmented with
telemedicine communication
interventions
Study
Design
Randomized
trial
Length of
Study*
1 year
Sample
Size
N=388
Summary of Reported Results
Patient Centered: In both groups, risk score
was reduced, driven by a reduction in
hypertension and hyperlipidemia
prevalence, early in the study and was
sustained throughout the 1-year study.
Patient Level: Total cholesterol decreased
significantly in both groups. There were no
significant differences between groups on
BP response Medication adherence was
similar in both high- and intermediate-risk
subjects.
Cene et al.
2008
Community-based self12 months
management care provided by
a nurse practitioner/community
health worker team and
enhanced usual care
interventions to reduce CVD
risk among high-risk African
American families
Randomized
trial
3 years
Cook et al.
2010
Nurse-delivered educational
-intervention designed to
address health care disparities
among Native Hawaiian
patients admitted with
myocardial infarction and heart
failure
Observational 2 years
study
N=363
Patient Level: No significant differences
were detected between groups in mean lowdensity lipoprotein cholesterol, systolic and
diastolic blood pressure, or in the overall
percentages achieving goal cholesterol,
blood pressure, or smoking status.
N=137*
Patient Centered: All quality indicators for
patients improved; readmissions that
occurred in less than 30 days for patients
admitted with myocardial infarctions and
heart failure decreased to match those for
all other patient populations. There was a
reduction in adverse events following
percutaneous coronary interventions among
the target population.
Reduce Disparities in Cardiovascular Disease
B-4
PATIENT-LEVEL INTERVENTIONS
Citation
DeWalt et al.
2012
Intervention Description
Single session literacy
sensitive self-care training for
clinic patients with heart failure
and single session plus
ongoing telephone-based
support
Length of
Intervention*
Single session:
40 minutes
Study
Design
Randomized
trial
Length of
Study*
2 years
Sample
Size
N=605
Telephonebased support: 1
month
Summary of Reported Results
Patient Centered: There was no difference
between single session and multiple
session intervention groups on all cause
hospitalization or death.
Patient Level: Emergency department visits
not resulting in hospitalization did not differ
between groups.
Eckman et al. Single occurrence VHS/DVD
40 minutes
2012
plus printed booklet
intervention and printed
booklet only intervention
designed to improve coronary
artery disease knowledge
among patients with low health
literacy
Randomized
trial
4 years
N=187
Patient Level: Coronary artery disease
knowledge scores increased significantly in
all groups, and health behaviors improved
for both intervention groups. There were no
significant differences in improvements on
coronary artery disease knowledge scores
between patients with lower and higher
health literacy.
EvansHudnall et al.
2012
Randomized
trial
2 years
N=52
Patient Level: Secondary stroke risk factors
decreased among underserved racial/ethnic
minorities.
STOP (secondary stroke
-prevention program) consisted
of three culturally tailored
information sessions and goalsetting activities that were
delivered in person by a
research assistant
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PATIENT-LEVEL INTERVENTIONS
Citation
Govil et al.
2009
Intervention Description
Length of
Intervention*
Multisite cardiac lifestyle
intervention program (MCLIP)
for male and female coronary
heart disease (CHD) patients
of lower SES
3 months
Gross et al.
2013
Culturally sensitive education
program to support lifestyle
changes and medication
adherence among African
American adults
2 months
Giuse et al.
2012
Han et al.
2010
Study
Design
Pre-post
Length of
Study*
6 months
Sample
Size
N=863
Summary of Reported Results
Patient Centered: Participants at all SES
levels reported improvements in wellbeing
(e.g., depression, hostility, quality of life).
Patient Level: Participants across all
education and income levels reported
reduced dietary fat, improved stress
management, and increased physical
activity. Improvements in exercise capacity
were also reported.
Pre-post
--
N=10
Patient Level: Participants demonstrated
improved adherence to their treatment
routine, including life style changes, diet,
exercise, and medication adherence.
Educational material tailored
-to health literacy level and
educational material tailored to
health literacy level and
learning style designed to
improve hypertension
knowledge among emergency
department patients with high
blood pressure
Randomized
trial
5 months
N=172
Patient Level: Participants in both
intervention groups demonstrated
improvements in post-test scores for
hypertension knowledge with increased
improvements among those receiving
materials tailored to health literacy level and
learning style.
More-intensive and lessintensive nurse-provided
telephone counseling to
improve hypertension
management among Korean
American patients
Randomized
trial
5 years
N=360
Patient Level: Over the 12-month
counseling period, both groups
demonstrated improved medication-taking,
reduced alcohol consumption, and
increased exercise; there were no
significant group differences.
24 months
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B-6
PATIENT-LEVEL INTERVENTIONS
Citation
Intervention Description
Length of
Intervention*
Study
Design
Length of
Study*
Sample
Size
Summary of Reported Results
Houston et al. Interactive storytelling
6 months
2011
intervention delivered via DVD
designed to improve blood
pressure among African
American adults
Randomized
trial
1 year
N=299
Patient Level: Patients with uncontrolled
hypertension who were assigned to the
intervention group experienced an 11–mm
Hg greater reduction in systolic blood
pressure than the comparison group.
Following the intervention, blood pressure
subsequently increased in both groups;
however, the relative advantage for the
intervention group was sustained until the
end of follow-up.
Jackson et al. Three telephone-based
18 months
2012
interventions (nurseadministered and physician
directed medication
management that included use
of a validated
clinical decision support
system; nurse-administered
behavioral management
intervention; and combined
behavioral management and
medication management
intervention) for African
American and white U.S.
Department of Veterans
Affairs primary care patients
Randomized
trial
3 years
N=591
Patient Level: Results indicated significant
improvement in mean systolic blood
pressure at 12 and 18 months among
African American patients receiving the
combined medication management and
behavioral self-management support
intervention compared to African American
patients receiving usual care. No
comparable changes in blood pressure
were found for non-Hispanic white patients.
Reduce Disparities in Cardiovascular Disease
B-7
PATIENT-LEVEL INTERVENTIONS
Citation
Kim et al.
2011
Intervention Description
Length of
Intervention*
Study
Design
Randomized
trial
Length of
Study*
~5 years
Sample
Size
N=360
Summary of Reported Results
More-intensive and lessintensive nurse-provided
telephone counseling to
improve hypertension
management among Korean
American patients
24 months
Patient Centered: Depression scores for
both groups decreased over time with no
statistically significant differences between
the groups.
Kripalani,
Schmotzer,
and Jacobson
2012
Randomized trial to evaluate
the effect of illustrated
medication schedule and refill
reminder postcards on
medication adherence among
patients with low health
literacy reported no significant
improvements in medication
adherence
12 months
Randomized
trial
1 year
N=435
Patient Level: Neither mailed refill reminders
nor illustrated medication schedules
improved adherence overall. Post hoc
subgroup analyses indicated that illustrated
medication schedules may improve
adherence among patients with low
medication self-efficacy, polypharmacy, or
baseline non-adherence.
Martin et al.
2011
Multimedia computer-based
program designed to improve
medication adherence among
low-income hypertensive
African American adults
6 months
Randomized
trial
--
N=434
Patient Level: Participants receiving the
intervention did not differ from individuals in
the control group on medication adherence.
Patient Level: Both groups demonstrated
slight increases in high blood pressure
knowledge questionnaire scores. Perceived
self-efficacy was slightly increased over
time for participants in the more-intensive
counseling group and slightly decreased in
the less-intensive counseling group.
Participants in both groups demonstrated
improvements in adherence to HBP
treatment recommendations.
Reduce Disparities in Cardiovascular Disease
B-8
PATIENT-LEVEL INTERVENTIONS
Length of
Intervention*
Study
Design
Length of
Study*
Sample
Size
Citation
Intervention Description
Migneault et
al. 2012
Culturally tailored, automated
telephone system designed to
improve adherence to
medication and other selfmanagement guidelines
among hypertensive African
American adults
8 months
Randomized
trial
4 years
N=337
Patient Level: No significant intervention
effects were observed at the 4- and 12month assessments. Based on post-hoc
analysis, the intervention was associated
with greater absolute improvements in most
primary and secondary outcomes among
diabetics, but results were not statistically
significant given the small subgroup size
(n=127).
Mosca et al.
2010
Education and counseling
intervention provided by a
prevention facilitator/educator
during hospitalization and by
phone following discharge to
improve adherence to
secondary CHD prevention
guidelines among women
--
Randomized
trial
2.5 years
N=304
Patient Level: Minority women assigned to
the intervention were two times as likely to
achieve the blood pressure goal compared
with minority women who received usual
care.
Noureldin et
al. 2012
Pharmacist intervention,
including patient education,
therapeutic monitoring, and
communication with primary
care providers designed to
improve medication adherence
among heart failure patients
with limited versus adequate
health literacy
9 month
intervention with
3 month followup period
Post hoc
analysis of
randomized
trial data
3 years
N=314
Patient Level: The intervention generally
increased medication taking and scheduling
adherence. In patients with inadequate
health literacy, the intervention increased
adherence levels similar to baseline of
those with adequate health literacy.
Reduce Disparities in Cardiovascular Disease
Summary of Reported Results
B-9
PATIENT-LEVEL INTERVENTIONS
Citation
Intervention Description
Nundy et al.
2013
Text message–based
intervention designed to
improve heart failure selfmanagement following
hospital discharge among
African American adults
Ogedegbe et
al. 2012
Pezzin et al.
2011
Length of
Intervention*
Length of
Study*
Sample
Size
Summary of Reported Results
Pre-post
3 months
N=15
Patient Level: The text messaging
intervention was associated with clinically
significant improvements in self-care
maintenance and management.
Patient education and patient 12 months
education with positive-affect
induction and self-affirmation
interventions for hypertensive
African American patients in
two primary care practices
Randomized
trial
--
N=256
Patient Level: The positive-affect
intervention had a significantly greater
impact on medication adherence compared
to the patient education intervention. The
positive-affect intervention had no
significant effect on BP reduction.
Nurse and health educator
counseling intervention to
improve blood pressure
control among high-risk
African American home care
adults
3 months
Randomized
trial
3 years
N=845
Patient Level: The nurse-led intervention
significantly improved BP control among
patients with stage 2 hypertension as
defined in the Seventh Report of the Joint
National Committee on Prevention,
Detection, Evaluation, and Treatment of
High Blood Pressure.
3 months
Nonrandomized
trial
10 months
N=112
Patient Level: Relative to baseline, mean
blood pressure at 10 months postintervention were lower and the percentage
of participants with controlled BP was higher
in the intervention group. Note that
inferential statistics were not provided
because the pilot study was not powered or
designed for hypothesis testing.
Resnick et al. Nurse-monitored telehealth
2012
kiosks placed in communitybased senior centers to lower
blood pressure levels and
improve blood pressure
control among older adults
1 month
Study
Design
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PATIENT-LEVEL INTERVENTIONS
Citation
Intervention Description
Length of
Intervention*
Study
Design
Length of
Study*
Sample
Size
Summary of Reported Results
Rigsby 2011
Community-based education
and physical activity
intervention designed to
improve blood pressure
control among African
American adults
3 months
Pre-post
--
N=36
Patient Level: Patients experienced an
improvement in both knowledge and BP
control, but significance tests were not
conducted.
RochaGoldberg
Mdel et al.
2010
Culturally tailored behavioral
intervention to lower blood
pressure in Latino adults
1.5 months
Pre-post
study
1.5 months
N=17
Patient Level: The intervention yielded
clinically significant decreases in systolic
blood pressure among participants.
Rodriguez et
al. 2012
Community-based, culturally
tailored nutrition and physical
activity program designed to
improve the cardiovascular
health of African American
women
3 months
Pre-post
study
4 months
N=34
Patient Level: Intervention participants had
a significant reduction in systolic BP, as well
as clinically important reduction in systolic
BPs.
Schneider et
al. 2012
Transcendental meditation
-and health educations
interventions focused on
secondary CVD prevention for
African Americans
Randomized
trial
8 years
N=201
Patient Centered: Based on follow-up data
(average follow-up of 5.4 years), there was
a significant reduction of risk for mortality,
myocardial infarction, and stroke in coronary
heart disease patients in the transcendental
meditation intervention group.
Patient Level: There were significant
reductions of systolic blood pressure and
anger expression among transcendental
meditation intervention participants.
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PATIENT-LEVEL INTERVENTIONS
Citation
Intervention Description
Shaya et al.
2013
Nurse-led group education
sessions designed to improve
hypertension control among
African American adults in
urban communities
Turner et al.
2012
Victor et al.
2011
Length of
Intervention*
--
Study
Design
Length of
Study*
Sample
Size
Summary of Reported Results
Nonrandomized
trial
3 years
N=530
Patient Level: At the 18-month follow up, the
intervention group had a statistically
significant larger decrease in systolic and
diastolic BP and compared with the control
group.
Phone-based counseling
6 months
provided by peer patients with
well-controlled hypertension
paired and office-based
counseling provided by trained
practice staff designed to
reduce CHD risk among
African American patients with
uncontrolled hypertension
Randomized
trial
2.5 years
N=280
Patient Level: Compared to the control
group, more patients in the intervention
group achieved target BP reductions. CHD
risk reduction favored the intervention, but
this result was not statistically significant.
Blood pressure monitoring and 10 months
referral program administered
by barbers in community
barber shops designed to
improve blood pressure
control among patrons with
high blood pressure
Randomized
cluster trial
13 months
N=1,022
Patient Level: The hypertension control rate
increased more in intervention group than in
control group, but a marginal effect was
found for systolic BP change in the
intervention group.
Pre-post
study
1.5 years
N=39
Patient Level: Intervention participants
demonstrated a significant reduction in both
systolic and diastolic BP over the course of
the intervention.
Zarate-Abbott Conducted a pre-post study to 1.5 years
et al. 2008
determine the effects of a
nurse-led workplace education
program for low-income,
immigrant Hispanic women on
blood pressure control and
heart-healthy behaviors
* Estimated value based on information provided in cited paper
-- Unable to determine based on information provided in cited paper
Reduce Disparities in Cardiovascular Disease
B-12
Appendix C: Glossary
Definitions of Key Terms as Developed for the Purposes of this Landscape
Review
Cardiovascular disease (CVD): pathological conditions involving the cardiovascular
system, including the heart, the blood vessels, or the pericardium (hypertension
included)
Cardiovascular health (CVH): The American Heart Association defines cardiovascular
health as the absence of disease and the presence of seven key health factors and
behaviors: blood pressure, physical activity, cholesterol, healthy diet, healthy weight,
smoking status, and blood glucose.
Interventions: includes diagnosis, secondary (e.g., screening) and tertiary (e.g.,
tobacco cessation in persons with diagnosed CVD) prevention approaches, and
treatment; interventions may be implemented in clinical or community settings, or be a
joint community-clinical effort
Health disparities: differences in health outcomes and their determinants between
segments of the population, as defined by social, demographic, environmental, and
geographic attributes
Populations at risk for experiencing CVD disparities:
 racial/ethnic minorities
 low socioeconomic status
 uninsured or underinsured
 limited English proficiency, low literacy, and/or low numeracy
 rural populations
 adults living in the southeastern part of the country
 medically underserved
 living with disabilities
 women
 lesbian/gay/bisexual/transgender
Patient-centered outcomes: outcomes that are important to patients, including
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 new diagnosis, incident disease
 disease-specific morbidity (e.g., amputations, hospitalizations, getting a stent for
CVD)
 disease-specific or all-cause mortality
 health-related quality of life as measured by generally accepted generic healthrelated quality-of-life measures (e.g., short-form questionnaires, EuroQOL) or
disease-specific measures
 symptoms, patient-reported
 activities of daily living as measured by generally accepted standardized
measures of basic and/or instrumental activities of daily living (e.g., Katz, Lawton,
or Bristol instruments) or with instruments that have demonstrated validity and
reliability
 patient satisfaction with care
 work or school absenteeism
 patient and caregiver participation in medical care and decision making
Patient-level outcomes: outcomes patients experience, or that are measured from the
patients’ perspective, including
 quality of care
 patient knowledge, attitudes, and behaviors
 adherence to medications and self-management behaviors
 physiological measures (blood pressure level, HbA1c)
 goals of therapy met
 health care utilization (doctor visits)
Harms: unintended patient-centered, patient-level, or systems level outcomes, including
 patient fatigue
 patient distress
 breach of patient confidentiality
 stigmatization
 perpetuation of disparities in patient-centered or patient-level outcomes
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