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1
The Time for Change Has Come
In March 2001, the Institute of Medicine (IOM) released the report Crossing the Quality Chasm.
A New Health System for the 2Ist Century, calling for fundamental-change in the health care system
(institute of Medicine, 200Ib). Responding to widespread and persistent, systemic shortcomings in
health care quality, that report challenges the nation to undertake a major redesign of both the health
care delivery system and the policy environment that shapes it. The recommendations in the Quality
Chasm report did not come altogether as a surprise. The safety and quality of health care in the
United States had been brought to the forefront with a renewed sense of urgency starting in 1998
through the release of three major reports on the quality of care. The IOM's National Roundtable on
Health Care Quality had concluded that "the burden of harm conveyed by the collective impact of all
of our health care quality problems is staggering" (Chassin and Galvin, 1998, p. 1004~. The Advisory
Commission on Consumer Protection and Quality in the Health Care Industry (1998, Chapter 1)
called for a national commitment to improve quality after concluding that "today in America, there is
no guarantee that any individual will receive high-quaTity care for any particular health problem."
And the conclusions of both of these national panels had been supported by the results of an exten-
sive literature review conducted by researchers at the RAND Corporation, which encompassed publi-
cations in peer-reviewed journals between 1993 and mid-1997 and revealed evidence of systemic
quality problems throughout the health care sector (Schuster et al., 1998~. Moreover, these findings
had been corroborated by studies that looked in more detail at the treatment of specific diseases (e.g.,
cancer) or focused on particular types of quality problems (e.g., errors) (Institute of Medicine, 2000;
Institute of Medicine and National Research Council, 1999; Leatherman and McCarthy, 2002~.
In an effort to chart a direction for health system improvement, the Quality Chasm report identi-
fied six national quality aims: health care should be safe, effective, patient-centered, timely, efficient,
and equitable (see Box 1-~. These aims address not only the serious quality challenges noted above,
but also the need to use resources more wisely.
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The Time for Change Has Come
1.
BOX 1-1 Quality Aims for the 21st-Century Health Care System
Sate avoiding injuries to patients from the care that is intended to help them.
Effective providing services based on scientific knowledge to all who could
benefit and refraining from providing services to those not likely to benefit
(avoiding underuse and overuse).
Patient-centered—providing care that is respecffu! of and responsive to individual
patient preferences, needs, and values and ensuring that patient values guide all
clinical decisions.
Timely reducing waits and sometimes harmful delays for both those who receive
and those who give care.
Efficient avoiding waste, in particular waste of equipment, supplies, ideas, and
energy.
Equitable providing care to all who could benefit that does not vary in quality
because of personal characteristics such as gender, ethnicity, geographic location
and socioeconomic status.
SOURCE: Institute of Medicine (2001b, p. 39~0~.
i,
In the 2 years since the release of the Qual-
ity Chasm report, the challenges confronting the
health care system have probably worsened.
Overall, national health spending has increased
as a portion of gross domestic product and is
expected to continue to do so for the remainder
of the decade- from 13.2 percent in 2000 to
approximately 17 percent in 201 ~ (He filer et al.,
2002~. Employers are expected to see a 13 to 15
percent increase in their health care premiums
in 2002, which will be the sixth straight year of
rising premiums (Alliance for Health Care
Reform, 2002; Center for Studying Health
System Change, 20011. Medicaid is also experi-
encing cost increases an average of 25 percent
over the 2 years between 2000 and 2002
(Alliance for Health Care Reform, 2002~.
These rising costs, in combination with the
recent economic downturn, are expected to have
a number of consequences. Increases in employ-
ers' health care premiums are likely to result in
employers narrowing benefits and/or shifting a
larger portion of costs to workers in the form of
premiums or copayments. More employees may
choose not to participate in employer-sponsored
~3
plans, and more employers, especially small
businesses, may choose not to offer health
insurance altogether.
Overall the number of uninsured people in
the United States has been increasing for more
than a decade about one in six Americans is
without coverage today (Institute of Medicine,
2001a). The uninsured do not receive the heath
services they need, and this gap has serious
health, financial, and other consequences for
both the uninsured individuals and their families
(Institute of Medicine, 2002a, 2002b). More-
over, the growing numbers of uninsured place
increased demand on public hospitals, academic
health centers, community health centers, and
other safety net providers that offer a sizable
proportion of services to those who lack health
insurance and cannot afford to pay.
There are also serious inequities in health
care. A significant body of research reveals
disturbing disparities in health care access and
quality, especially for racial and ethnic minori-
ties (Institute of Medicine, 2002c). Minorities
receive a lower quality of health care than non-
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The Time for Change Has Come
minorities, even after controling for such factors
as insurance status and income.
The Quality Chasm report calls for changes
at four levels patient experiences, smaTi-
practice settings or Microsystems that deliver
care (e.g., provider groups, multidisciplinary
teams), health care organizations that house the
Microsystems (e.g., hospitals), and the health
care environment (e.g., payment policies, legal
liability, regulatory processes) (Berwick, 2002~.
There is little doubt that change of this magni-
tude will be difficult to accomplish, but it is
imperative that the process begin. This report
sets forth a strategy for health system reform in
which states are used as laboratories for the
design, implementation, and testing of alterna-
tive redesign strategies. The set of demonstra-
tions called for by this strategy addresses criti-
cal leverage points at each of the above four
levels.
ORIGINS OF THIS REPORT
.,
The disturbing trends in health care summa-
rized above have not gone unnoticed by health
care leaders. In June 2002, the Secretary of
Health and Human Services met with represen-
tatives of The National Academies and
expressed his concerns about the need to reverse
these trends. It was agreed that workable solu-
tions must be found quickly. Almost immedi-
ately, the IOM initiated a fast-track study with
the objective of identifying interventions and
approaches that showed promise for solving key
problems, and recommending a set of demon-
stration projects to test these solutions. The
Secretary expressed a strong interest in demon-
stration projects that might be conducted in
collaboration with states starting in 2003.
To conduct this study, the {OM established
the Committee on Rapid Advance Demonstra-
tions in June 2002. The committee began by
developing a set of criteria for use in selecting
potential demonstration projects. Working
groups for each of the five categories of demon-
strations (enumerated below) were then
convened to delineate the specifics of the poten-
tial demonstration projects. The full committee
then met to finalize the set of proposed demon-
strations.
CRITERIA FOR SELECTION OF
DEMONSTRATIONS
The committee went through a multi-step
process to identify potential demonstration
projects. Each committee member was asked to
identify potential demonstration categories.
These categories were then discussed with over-
lapping or related areas being combined, result-
ing in a list of seven categories. Small working
groups were formed to develop detailed descrip-
tions of these seven categories. The full
committee then discussed the seven categories
further and narrowed the list to five. Categories
that were considered, but not selected, are dis-
cussed later in this chapter.
The committee concluded that the demon-
stration projects as a set, and individually if
possible, must be bold and transformational.
Recognizing the gravity of the problems
confronting the health care sector, as well as the
need for a major redesign of health care proc-
esses, the committee focused on projects that
would address the fundamental building blocks
of the health care system.
To guide its work, the committee generated
a list of criteria encompassing factors that
would lead to a successful demonstration initia-
tive (see Box 1-2~. These criteria fall into two
categories: those related to the intended results
of demonstrations and those related to the likeli-
hood of successful implementation.
The demonstration projects are intended to
produce four results:
.
Improved health status for patients and
populations The health care system of the
2ISt century should maximize the health and
functioning of both individual patients and
communities. To accomplish this goal, the
system should balance and integrate needs
for personal health care with broader
community-wide initiatives that target the
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f The Time for Change Has Come
Box 1~2 Criteria for Selecting
Bold anc! Transformational
Demonstrations
Criteria relater! to intenciec! results
of clemonstrations
. /mprovec! health status of patients
and popu/ations
. System improvements
. Reduced waste
. Stimulus for continued innovation
Criteria related to likelihood of
successful implementation
Resonates with public and policy
makers
Broad base of support
Recognizes and addresses barri-
ers
Builds on existing compelencies
.
entire population (e.g., prevention initiatives
to address obesity). The health care system
must have well-defined processes for
making the best use of limited resources.
System improvements In the 20~ century,
"bricks and mortar" constituted the basic
infrastructure of the health care delivery
system. To deliver care in the 2iSt century,
the system must have a health information
and communications technology (ICT)
infrastructure that is accessible to all
patients and providers. Over the past several
decades, the health care needs of the popu-
lation have been shifting from acute to
chronic care (The Robert Wood Johnson
Foundation, 1996~. Although infectious
diseases and acute care are still important,
the vast majority of health care resources
are now devoted to the ongoing manage-
ment of chronic conditions. The processes
used by the health system must be redes-
igned to emphasize the prevention and
ongoing management of such conditions,
and this redesign will require integration
across sites of care and more sophisticated
interfaces between the health care and
social service sectors. Ready access to elec-
tronic medical records will be essential as
well.
.
.
Reduced waste The 20-century health
care system is extremely wasteful, charac-
terized both by clinical waste (e.g., unneces-
sary procedures, redundant laboratory tests)
and administrative waste (e.g., compliance
with the requirements of multiple insurance
programs, which have not been standard-
ized). Waste in the system must be reduced
so resources can be rechanneled to meet the
needs of patients and populations.
Stimulus for continued" innovation- The
2ISt-century health care system must have
the buiTt-in capacity to continuously change
and accommodate innovations in knowi-
edge and technology.
The change process will not be easy, and
the demonstrations must be able to withstand
many challenges. In identifying promising
demonstration projects, then, attention must be
paid to implementation issues, including the
need to:
.
.
Resonate with the public and! policy
makers The demonstration projects must
be understandable to the lay public and pol-
icy makers and must address their immedi-
ate concerns. The demonstrations should be
structured to produce some tangible results
in the short run.
Develop a broad base of support- While a
start-up investment may be necessary to
assist in initiating change, most demonstra-
tions should be budget neutral to the federal
government over the long term or at least
budget conscious. Careful thought should
be given to the benefits and costs of the
demonstrations to each of the major stake-
holders, including patients, payers, and
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The Time for Change Has Come
providers. Financial and other incentives
should be offered to key stakeholders,
recognizing that major change is difficult to
initiate and to sustain over long periods of
time. Both the public sector (i.e., federal
and state governments) and the private sec-
tor (e.g., philanthropic foundations) should
provide up-front support for the conduct of
the demonstrations.
Recognize and address barriers There
will be many bamers to change political,
cultural, organizational, regulatory, and oth-
ers. To be successful, demonstrations must
identify and eliminate (or at least mitigate)
these barriers.
Build on existing competencies—There is
no time to lose. The set of demonstration
projects initiated in 2003 should produce
the building blocks of a model 21 St-century
community health care system by 2006. The
DeparDnent of Health and Human Services
should select demonstration sites that have a
high likelihood of making rapid progress.
The~committee identified five major catego-
ries of demonstrations—chronic care, primary
care, ICT infrastructure, state health insurance,
and liability. These demonstration categories are
discussed in turn in Chapters 2 through 6. For
each category, multiple demonstration projects
or sites are proposed for two reasons. First,
within any given category, there would likely be
a good deal of variability in design characteris-
tics, which in turn will influence the likelihood
of success or failure. For example, an ICT
demonstration project in a predominantly rural
state would likely have different characteristics
than one in a large metropolitan area. Much can
be learned from assessing the variability in
design characteristics across different types of
demonstration sites, and the effects of different
designs on impact. Second, a sizable number of
sites will be needed for this strategy to begin to
have a measurable impact on the health system
overall.
SUPPORTING AND EVALUATING
THE DEMONSTRATIONS
As the demonstrations are launched, there
must be comprehensive parallel efforts to
support exchange among organizations under-
taking the projects within a given demonstra-
tion, to evaluate the effectiveness of the
approaches and interventions being practiced,
and to broadly disseminate best practices thus
identified. Such efforts are critical so that the
demonstrations can achieve their full potential,
and those that show the most promise can be
rapidly replicated across the country.
The committee believes that learning
coliaboratives are the best mechanism for
providing support for the demonstrations, and
that such collaboratives should be formed for
each of the five areas enumerated above. The
learning collaboratives would be modeled after
similar efforts at both the national and state
levels, in which provider organizations have
defined common goals and related performance
measures and collaborated
.
successfully-
excnang~ng ~ueas and information to improve
clinical care for patients with diabetes, heart
disease, and other conditions (Institute for
Healthcare Improvement, 2002; Oswald, 2002~.
In the process, these organizations have
successfully reengineered delivery systems to
meet their quality improvement targets. These
demonstration-specific collaboratives which
would exist virtually but would need some staff
support would be created by various organiza-
tions, depending upon interest and existing
capacity. For example, the Health Resources
and Services Administration might take respon-
sibility for establishing the primary care
collaborative, and the Centers for Medicare and
Medicaid Services the chronic care collabora-
tive. Of course, either or both agencies might
choose to conduct the collaborative directly or
to contract with a private-sector organization.
In addition to the learning coilaboratives,
the committee believes there needs to be a
national evaluation and dissemination effort that
would span all five demonstration categories
and would include an advisory council with
representatives from each of the areas. Given
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~ The Time for Change Has Come
the previous, related work of the Agency for
Healthcare Quality and Research (AHRQj, it
would be logical for this agency to take the lead
in creating and nurturing such an effort. There
would need to be adequate support to carry out
this critical activity. Planning for the evaluation
should begin at the same time as planning for
the demonstrations. The criteria, performance
measures, and data to be used in assessing pro-
gress must be defined in advance. Those
involved in the effort would, over time, rigor-
ously review quantitative and qualitative
performance data from all of the demonstrations
to assess effectiveness, and then extensively
disseminate the best practices identified. They
also would be able to discern how the five
demonstration categories—potential building
blocks for a reformed health care system—
might fit together in the future. In addition, they
would be well poised to identify the specific
environmental obstacles that need to be
addressed if demonstrations that prove success-
fu! are to be replicated on a larger scale.
Learning ColIaboratives
As the demonstrations were being designed
and initiated, the learning collaboratives would
play an important supporting role in enabling
the sharing of information about strategies,
tools, and techniques (see Box 1-3~. Such ar-
rangements allow implementing organizations
to benefit from the creativity and experiences of
others, help guard against reinventing the wheel,
and foster continuous learning. Learning
collaboratives rely on regular contact, mainly
electronic, and regular reporting of agreed-upon
performance measures and qualitative progress
reports. The colIaboratives for these demonstra-
tions would also provide informal and, to a
lesser degree, formal technical assistance to the
projects.
Once performance could be assessed, the
collaboratives would provide a venue for
discussions about what does and does not work
generating information necessary for midcourse
corrections. This kind of transparency and
accountability across the demonstration organi-
zations could help foster a culture of change in a
health care system that has firmly entrenched
interests and has over the decades stubbornly
resisted reform.
Evaluation and Dissemination
A cntical step, whether earned out by
AH[RQ or another organization, is to identify up
front what would constitute success in each of
the five demonstration categories and to ~ans-
Box 1-3 Components of a Learning Collaborative
Multiple organizations that make a commitment, signed by the top leader, to
achieve measurable improvements on a given set of metrics and to support staff in
their efforts to do so
Shared goals and related performance measures
Education and training on how a collaborative functions
A coordinated, supportive network through which demonstration project staff can
actively learn from each other
Informal coaching for project staff
Reporting of performance measures back to the collaborative and to the larger
evaluation effort
SOURCE: Adapted from Oswald (20021.
~11
_
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The Time for Change Has Come
late these ideas into quantifiable measures and
associated data requirements. This effort is
important because limited documentation exists
on approaches that represent alternatives to the
traditional ways in which care is delivered and
financed. With such measures, a rigorous
evaluation can be performed, including, where
possible, a business case and economic analysis.
This business case would help determine
whether the demonstration benefits—as meas-
ured by clinical quality indicators and other
measures—outweigh the costs, after accounting
for up-front investment, particularly in the case
of the ICT infrastructure demonstrations. It is
essential to identify the interventions that are
and are not successful and to understand what
factors contributed to their success or failure.
Such an evaluation can go a long way toward
convincing powerful stakeholders about why
and how they need to change.
The evaluative measures should help
provide a strategic focus for the participating
organizations that emphasizes the objectives of
enhancing quality of care and reducing waste.
To the extent possible, these clinical measures
should be aligned with the process and outcome
measures included in the National Health Care
Quality Report, which is to be published by
AHRQ in September 2003. As a conceptual
framework, the National Health Care Quality
Report will use the six quality aims enumerated
earlier (i.e., safety,
. . .. ..
effectiveness, patient-
centereclness, timeliness, efficiency, and equity).
Specific measures falling into one or more of
these domains have been selected for exam-
ple, the percentage of diabetics with hemogio-
bin Ale under control and the percentage of
heart failure patients prescribed an angiotensin-
converting enzyme (ACE) inhibitor at discharge
are measures of effectiveness (Agency for
Healthcare Research and Quality, 2002~. AHRQ
is also developing the National Disparities
Report, and measures from this report might be
highly useful in assessing efforts to address
racial, ethnic, and geographic disparities. [f
demonstration sites apply some or all of the
same measures, it will be possible to gauge their
progress in comparison with that of the nation
as a whole.
At the close of the demonstrations, when it
is clear which approaches and interventions
have yielded best practices and on what specific
dimensions, it will be time to get the word out
to the broader community. The information dis-
seminated should include all the documentation
and analysis generated over the course of a
project, including costs incurred, gains realized
(particularly in the clinical realm), and opera-
tional issues confronted and overcome.
This would also be an appropriate time to
identify environmental obstacles that must be
confronted for best practices to take hold,
including those that cut across a number of
different demonstrations and therefore necessi-
tate priority action. It is clear that future wide-
scale implementation of the best practices
resulting from the demonstrations will require
more than Medicaid waivers, Medicare demon-
stration authority, or communities and states
that are uniquely supportive of a given demon-
stration.
Those individuals involved in evaluating
and disseminating demonstrated best practices
will have an important vantage point. They will
understand not only which of the demonstration
building blocks are effective, but also how to
combine them into a more comprehensive,
synergistic redo model. They will understand
where gaps exist and how to Fiji them. Finally,
they will have detailed knowledge about envi-
ronmental obstacles that need to be overcome
and areas in which new ground rules need to be
articulated for the seeds of the successful
demonstrations to be sown and to take hold
across the country, transforming the landscape
of the health care system in the process.
OTHER POSSIBLE
DEMONSTRATION AREAS
The committee believes that the five
demonstration categories enumerated above rep-
resent a reasonable starting point from which to
stimulate fundamental change in the health
system, but they are not the only promising
areas. The following are summaries of the two
other areas that were seriously considered but
_
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The Time for Change Has Come
not selected, which may also represent good
candidates:
· Making America's hospitals safe and effec-
tive and a clecent place to work- Many if
not most of the country's hospitals were
built decades ago. Since that time, a great
deal has been learned about how best to
design work environments to promote
patient and worker safety and improve effi-
ciency. There have been many advances in
information technology and medical devices
that have specific space and other physical
requirements. There have also been innova-
tions in architectural design that result in
environments more conducive to the provi-
sion of patient-centered care and workforce
satisfaction. it should be noted that although
the committee did not ultimately choose this
category, some of the categories selected
particularly TCT infrastructure—could well
lead to improvements in hospital care and
environments.
· Evidence-baseci, patient-centerecipharmacy
management Medications, both prescrip-
tion' and over-the-counter represent one of
the fastest-growing components of heath
care services. Safety is a serious concern,
with many suffering preventable adverse
drug events that could have been avoided
through the use of computerized medication
order entry systems (Bates et al., 1999~.
Cost Is a mayor Issues given that Medicare
and some other insurance plans provide
little or no insurance coverage for prescrip-
tion drugs. Numerous options exist for
promoting evidence-based prescribing of
medications and improving efficiency.
Although pharmacy management was not
selected as one of the five categories, the
committee believes that projects in some of
the selected categories including chronic
care, primary care, and ICT infrastructure-
will have a highly positive impact in this
area.
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~r~
_
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Representative terms from entire chapter:
care quality