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AHA Scientific Statement

A Taxonomy for Disease Management


A Scientific Statement From the American Heart Association
Disease Management Taxonomy Writing Group
Harlan M. Krumholz, MD, FAHA; Peter M. Currie, MHS; Barbara Riegel, DNSc, RN, CS, FAHA;
Christopher O. Phillips, MD, MPH; Eric D. Peterson, MD, MPH; Renee Smith, MPA;
Clyde W. Yancy, MD, FAHA; David P. Faxon, MD, FAHA
Background—Disease management has shown great promise as a means of reorganizing chronic care and optimizing
patient outcomes. Nevertheless, disease management programs are widely heterogeneous and lack a shared definition
of disease management, which limits our ability to compare and evaluate different programs. To address this problem,
the American Heart Association’s Disease Management Taxonomy Writing Group developed a system of classification
that can be used both to categorize and compare disease management programs and to inform efforts to identify specific
factors associated with effectiveness.
Methods—The AHA Writing Group began with a conceptual model of disease management and its components and
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subsequently validated this model over a wide range of disease management programs. A systematic MEDLINE search was
performed on the terms heart failure, diabetes, and depression, together with disease management, case management, and
care management. The search encompassed articles published in English between 1987 and 2005. We then selected studies
that incorporated (1) interventions designed to improve outcomes and/or reduce medical resource utilization in patients with
heart failure, diabetes, or depression and (2) clearly defined protocols with at least 2 prespecified components traditionally
associated with disease management. We analyzed the study protocols and used qualitative research methods to develop a
disease management taxonomy with our conceptual model as the organizing framework.
Results—The final taxonomy includes the following 8 domains: (1) Patient population is characterized by risk status,
demographic profile, and level of comorbidity. (2) Intervention recipient describes the primary targets of disease
management intervention and includes patients and caregivers, physicians and allied healthcare providers, and
healthcare delivery systems. (3) Intervention content delineates individual components, such as patient education,
medication management, peer support, or some form of postacute care, that are included in disease management.
(4) Delivery personnel describes the network of healthcare providers involved in the delivery of disease management
interventions, including nurses, case managers, physicians, pharmacists, case workers, dietitians, physical therapists,
psychologists, and information systems specialists. (5) Method of communication identifies a broad range of disease
management delivery systems that may include in-person visitation, audiovisual information packets, and some form of
electronic or telecommunication technology. (6) Intensity and complexity distinguish between the frequency and
duration of exposure, as well as the mix of program components, with respect to the target for disease management.
(7) Environment defines the context in which disease management interventions are typically delivered and includes
inpatient or hospital-affiliated outpatient programs, community or home-based programs, or some combination of these
factors. (8) Clinical outcomes include traditional, frequently assessed primary and secondary outcomes, as well as
patient-centered measures, such as adherence to medication, self-management, and caregiver burden.
Conclusions—This statement presents a taxonomy for disease management that describes critical program attributes and
allows for comparisons across interventions. Routine application of the taxonomy may facilitate better comparisons of

The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside
relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required
to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest.
This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on June 16, 2006. A single reprint
is available by calling 800-242-8721 (US only) or writing the American Heart Association, Public Information, 7272 Greenville Ave, Dallas, TX
75231-4596. Ask for reprint No. 71-0371. To purchase additional reprints: Up to 999 copies, call 800-611-6083 (US only) or fax 413-665-2671; 1000
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call the Copyright Clearance Center, 978-750-8400.
The online-only Data Supplement can be found at http://circ.ahajournals.org/cgi/content/full/CIRCULATIONAHA.106.177322/DC1.
Expert peer review of AHA Scientific Statements is conducted at the AHA National Center. For more on AHA statements and guidelines development,
visit http://www.americanheart.org/presenter.jhtml?identifier⫽3023366.
Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express
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© 2006 American Heart Association, Inc.
Circulation is available at http://www.circulationaha.org DOI: 10.1161/CIRCULATIONAHA.106.177322

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Krumholz et al Taxonomy for Disease Management 1433

structure, process, and outcome measures across a range of disease management programs and should promote
uniformity in the design and conduct of studies that seek to validate disease management strategies. (Circulation. 2006;
114:1432-1445.)
Key Words: AHA Scientific Statements 䡲 disease management 䡲 chronic disease
䡲 delivery of health care 䡲 classification 䡲 heart failure

T he past decade has witnessed increasing prevalence of


chronic disease in the United States. This trend has
contributed to skyrocketing healthcare costs and highlighted
system for disease management. The work of the AHA
Writing Group builds on the previous efforts of the AHA’s
Expert Panel on Disease Management to establish core
the fragmented nature of care available to chronically ill principles for the application of disease management to
patients.1 Consequently, many public policy makers and cardiovascular disease and stroke (Table 1).3 The taxonomy
organizations have embraced disease management as a means outlined in the present statement provides a conceptual
of reorganizing medical treatment for chronic illness, shifting framework that can be used both to compare the diverse range
the emphasis toward an integrated, patient-centered approach of disease management programs and to inform efforts to
to care. The purported benefits of disease management identify specific factors associated with effectiveness.
include improved health outcomes, greater patient satisfac-
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tion, better quality of life, and reduced healthcare costs.2 Background


Despite the promise offered by disease management pro- The challenge in identifying a precise definition for disease
grams, questions remain about their potential for widespread management lies partially in its complex origins and histor-
application. Randomized trials of disease management have ical evolution. Although the term disease management was
demonstrated improved outcomes for conditions such as heart first coined in the early 1990s, many of its components were
failure, diabetes mellitus, and chronic kidney disease, but used informally throughout much of the history of medical
these studies generally have been conducted at single sites, practice.4 Common attributes of disease management, such as
and it is not known how successfully their results can be formal and informal best practices and multidisciplinary care
generalized to larger patient populations. In addition, many teams, had long been used to identify and treat patients.
disease management programs are multidimensional, and the However, these techniques were inconsistently applied. In
essential program elements that are associated with efficacy addition, throughout most of the 20th century in the United
have yet to be established. These challenges are further States, disease management components were implemented
complicated by a lack of standardization: The term disease in a healthcare system characterized by fragmentation and
management has entered into common usage without a poorly aligned reimbursement priorities.5 The shift toward a
shared, specific understanding of its meaning. Instead, mul- model of care organized around the principles of disease
tiple definitions of disease management and a variety of management, with an emphasis on coordinated care,
related models exist. Although disease management programs evidence-based practice, and outcomes evaluation, has been a
generally share core elements such as risk management and relatively recent phenomenon.
coordination of care, individual program components are Managed care organizations were among the first to adopt
highly variable. This variability presents difficulties in com- disease management concepts, in part because of their struc-
paring and contrasting models, programs, outcomes, and ture for sharing economic risk.6 Because hospital costs
effectiveness. The heterogeneity also impedes the develop- represent a significant portion of patients’ overall healthcare
ment of policies that will provide incentives for the provision resource utilization, disease management strategies to reduce
of disease management. hospitalization rates and length of stay offered attractive
In response to these challenges, the American Heart Asso- financial incentives to these organizations.
ciation (AHA) formed an interdisciplinary Disease Manage- Other early disease management initiatives included pharma-
ment Taxonomy Writing Group to develop a classification ceutical company programs developed in response to concerns

TABLE 1. Principles and Recommendations From the AHA’s Expert Panel on Disease Management3
1. The main goal of disease management should be to improve the quality of care and patient outcomes.
2. Scientifically derived, peer-reviewed guidelines should be the basis of all disease management programs. These guidelines should be evidence based and
consensus driven.
3. Disease management programs should help increase adherence to treatment plans based on the best available evidence.
4. Disease management programs should include consensus-driven performance measures.
5. All disease management efforts must include ongoing and scientifically based evaluations, including clinical outcomes.
6. Disease management programs should exist within an integrated and comprehensive system of care in which the patient–provider relationship is central.
7. To ensure optimal patient outcomes, disease management programs should address the complexities of medical comorbidities.
8. Disease management programs should be developed for all populations and should particularly address members of underserved or vulnerable populations.
9. Organizations involved in disease management should scrupulously address potential conflicts of interest.
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that health maintenance organizations (HMOs) might decrease TABLE 2. Medicare Disease Management Initiatives
payments for drugs.7 Pharmaceutical companies began identify- 1.Medicare Coordinated Care Demonstration15
ing patients with chronic illnesses, determining their level of
2.Disease Management Demonstration for Severely Chronically Ill Medicare
risk, and offering educational services to promote medication Beneficiaries With Congestive Heart Failure, Diabetes, and Coronary Heart
adherence and behavior change. By bundling prescription drugs Disease16
with these ancillary services, companies sought to add value to 3.Physician Group Practice Demonstration17
their products and to increase the likelihood that they would be
4.Capitated Disease Management Demonstration for Beneficiaries with
included on HMO formularies.8 Chronic Illnesses18
It was not until the mid-1990s that disease management
5.End-Stage Renal Disease—Disease Management Demonstration19
strategies were adopted by the healthcare industry on a wider
6.Care Management for High-Cost Beneficiaries Demonstration20
scale, though still principally as a means of controlling costs.
This widespread adoption coincided with a period of signif- 7.Disease management initiatives authorized by the Medicare Modernization Act:
icant transition within the US healthcare delivery system: The ● Pilot Project for Consumer-Directed Chronic Outpatient Services21
promise of long-term cost savings offered by HMOs had ● Medicare Care Management Performance Demonstration22
begun to wane, and consumer dissatisfaction with managed ● Voluntary Chronic Care Improvement Programs23
care was high.9 At the same time, the chronic disease burden
continued to drive healthcare spending and utilization rates.10
disease management as an important new tool for moderniz-
In response to these conditions, disease management emerged
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ing the Medicare program.14 As part of the 2003 Medicare


in the healthcare marketplace as an attractive new model for
Modernization Act, Congress authorized Medicare Health
controlling costs.5
Support, which constitutes the largest randomized evaluation
A body of medical literature evaluating disease management
of disease management to date.23 Under this pilot program,
also began to emerge in the mid-1990s. In 1995, Rich et al11
approximately 160 000 Medicare beneficiaries with conges-
published a landmark article that reported results of a prospec-
tive heart failure and complex diabetes among their chronic
tive, randomized trial of a nurse-directed, multidisciplinary
conditions will be randomized to either an intervention or a
intervention on the rates of readmission within 90 days of
control group; those assigned to the intervention group will
hospital discharge, quality of life, and costs of care for high-risk
be able to accept or decline participation. Eligible beneficia-
patients ⱖ70 years of age who were hospitalized with heart
ries will be identified through a population-based approach
failure. Readmissions for heart failure were reduced by 56%, and
that uses Medicare claims data. Patients in the intervention
the program saved almost $500 for each person enrolled. The group will receive guidance to promote medication adher-
study provided strong validation for the concept of disease ence, self-management, and access to covered healthcare
management and was soon followed by many other trials of services. Disease management interventions will be delivered
disease management interventions. Phillips and colleagues,12 in by private healthcare organizations, which must guarantee
a review of this literature, studied 18 trials and found that during effective management of comorbidities, reduced healthcare
a pooled mean observation period of 8 months, the risk of costs, improved quality of care, and improved provider and
readmission was reduced by 25%. patient satisfaction. After 2 years, pending successful interim
Once the disease management trend took hold, it spread results, this pilot may be expanded nationally.
rapidly.13 Numerous healthcare companies—including HMOs, These initiatives represent a landmark effort to determine
pharmaceutical manufacturers, pharmaceutical benefits manag- whether disease management programs can be effective in
ers, medical groups and hospitals— organized quickly to meet improving health and cost outcomes for selected subgroups of
the demand for comprehensive initiatives that would improve chronically ill Medicare beneficiaries. Collectively, the dem-
chronic disease care while reducing expenditures. By 1999, onstration and pilot projects comprise the largest evaluation
some 200 disease management programs were in place for of disease management to date, and their outcomes will
conditions such as congestive heart failure, diabetes, and asth- undoubtedly influence future public and private sector ap-
ma.13 These disease-specific programs shared certain common proaches to disease management.
features, including an integrated approach to care, patient edu- States also have been permitted to develop disease man-
cation, and the collection of outcomes data. Ultimately, though, agement programs for their primary care case management
the proliferation of disease management programs was charac- and fee-for-service Medicaid populations; to date, 28 states
terized by variety rather than uniformity. Market forces encour- have done so.24 These programs may be designed and
aged companies to develop proprietary treatment algorithms and operated by health plans or state Medicaid agencies, or they
unique component packages in an effort to gain a competitive may be contracted out to disease management organiza-
advantage. As a result, private sector disease management tions.25 Because of this flexibility, state disease management
developed as a diverse field exhibiting a wide range of program- programs vary widely in their scope and impact. Many are
matic features. still at an early stage of development, so effectiveness cannot
Government interest in disease management also evolved be evaluated.26
during this period. Motivated in part by private sector
developments, in the late 1990s Congress authorized several Disease Management Definitions and
demonstration projects to evaluate disease management strat- Related Models
egies under fee-for-service Medicare (see Table 2). President Numerous definitions of disease management exist. They have
Clinton’s 1999 Medicare Modernization proposal named evolved over time in response to the changing conditions
Krumholz et al Taxonomy for Disease Management 1435

TABLE 3. Selected Disease Management Definitions


1. “关disease management兴 refers to the use of an explicit systematic population-based approach to identify persons at risk, intervene with specific programs
of care, and measure clinical and other outcomes.”4
2. “䡠 䡠 䡠 disease management is generally defined as a comprehensive, integrated approach to care and reimbursement based on a disease’s natural course.
The goal of disease management is to address the illness or condition with maximum effectiveness and efficiency regardless of treatment setting(s) or
typical reimbursement patterns.”5
3. “䡠 䡠 䡠 disease management typically refers to multidisciplinary efforts to improve the quality and cost-effectiveness of care for selected patients suffering
from chronic conditions. These programs involve interventions designed to improve adherence to scientific guidelines and treatment plans.”3

outlined above, and they feature varying levels of specificity, nated care, and multidisciplinary care have been used inter-
ranging from the highly conceptual to the highly detailed. A changeably with disease management, but their unique charac-
sample of published definitions is provided in Tables 3 and 4 to teristics are rarely enumerated. Because disease management
illustrate the diversity of opinion that exists in the field. Each of programs have historically provided narrowly tailored medical
these definitions shares a common theme—the transition from a solutions focused on one dominant health problem, several of
traditional system of care, characterized by fragmentation and these alternative models have arisen in an attempt to provide a
resource-intensive acute care, to a more integrated model— but more integrated approach to care, directing attention to the wide
their specific points of emphasis differ significantly. Epstein and range of patient comorbidities.29 Boundaries between models
Sherwood4 reference risk-based patient identification and out- have increasingly blurred, however, as disease management
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comes measurement, whereas Zitter5 discusses organization of programs have started to evolve to encompass both comorbid
care and reimbursement practices. Faxon et al3 draw attention to conditions and a greater constellation of outpatient services.
quality of care, the use of science-based guidelines, the manage- Below is a discussion of the most commonly referenced disease
ment of comorbid conditions, and the role of the physician. management–related models.
Given this degree of divergence, it is challenging to identify
specific components that truly define a disease management Case management is characterized by intensive post-
program. discharge monitoring by a case manager (usually
The Disease Management Association of America a nurse) who connects patients to community-based,
(DMAA), a nonprofit trade association representing stake- nonmedical support services.30 (It is important to distin-
guish between case management services provided by
holders in the disease management industry, responded to this
nurses or physicians and those provided by nonlicensed
problem by publishing a comprehensive definition that has personnel. Described both as case managers and care
gained widespread acceptance in recent years (Table 4). managers, this latter group typically provides functional
However, the DMAA definition is not used universally, and assistance to patients who are incapacitated and facili-
many programs that fail to meet its standards are nonetheless tates communication among patients, caregivers, and
described as disease management programs in the medical providers. However, these individuals may not possess
literature.28 It is also not clear that this definition can be the training and expertise necessary to address the
supported empirically, as the optimal mix of ingredients for a complex physiological issues associated with conditions
successful disease management program is not yet known.6 such as heart failure or diabetes.) Case management
For these reasons, the AHA Writing Group believes that a programs provide individually tailored care plans for
patients who are at high risk socially, financially, and
broad definition is necessary as research continues to define
medically. These plans frequently include education
the key components associated with positive outcomes. designed to reduce harmful behaviors and promote
The development of alternative care management models, beneficial ones. Because many high-risk patients’ prob-
many of which are considered under the overarching heading of lems are social or functional in nature, coordinating
disease management, has further complicated the search for a access to community resources and social support ser-
standard definition. Terms such as case management, coordi- vices—such as respite care, home-delivered meals, and

TABLE 4. DMAA Definition of Disease Management27


Disease management is a system of coordinated healthcare interventions and communications for populations with conditions in which patient
self-care efforts are significant. Disease management:
supports the physician or practitioner/patient relationship and plan of care;
emphasizes prevention of exacerbations and complications through the use of evidence-based practice guidelines and patient empowerment strategies; and
evaluates clinical, humanistic, and economic outcomes on an ongoing basis with the goal of improving overall health.
Disease management components include:
population identification processes;
evidence-based practice guidelines;
collaborative practice models to include physician and support-service providers;
patient self-management education (may include primary prevention, behavior modification programs, and compliance/surveillance);
process and outcomes measurement, evaluation, and management; and
routine reporting/feedback loop (may include communication with patient, physician, health plan, and ancillary providers, and practice profiling).
Full-service disease management programs must include all 6 components. Programs consisting of fewer components are disease management support services.
1436 Circulation September 26, 2006

transportation assistance—is integral to the case man- Instead, it aims to coordinate activities within primary care
agement approach. Family and caregivers are often systems to improve organizational and health outcomes.40
engaged to provide social support, and the majority of
patients’ interaction with the healthcare system is A Taxonomy for Disease Management
through case managers.30 Some case management pro- The AHA’s Disease Management Taxonomy Writing Group
grams—particularly those deployed in the Medicaid supports the effort to establish a comprehensive, theory-based
environment— create a more prominent “gatekeeping” definition of disease management. However, the group also
role for the primary care provider.31 Traditionally a recognizes that many, if not the majority, of existing disease
physician, this individual is responsible for approving management interventions fail to meet the full range of criteria
referrals and other non–primary-care service utilization required under the comprehensive approach advocated by
in an effort to contain costs.32 Primary care case man-
DMAA. By adopting an empirical approach based on published
agement usually operates as a blended fee-for-service/
capitation model: All medical services are paid on a reports of disease management, we aimed to develop a taxon-
fee-for-service basis, but the primary care provider also omy that could account for this diversity. Consequently, al-
receives an additional per capita management payment though aspects of the DMAA definition and the AHA taxonomy
to cover administrative expenses. Physician case man- are in agreement, our different methodologies also produced
agement may also involve nurse care coordinators who divergent results. For example, the DMAA requires full-service
assume many of the standard case management duties disease management programs to incorporate routine reporting
described above.31 and feedback, which roughly corresponds with our “Method of
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Coordinated care involves the development and implemen- Communication” domain. However, the AHA taxonomy ex-
tation of a therapeutic plan designed to integrate the efforts pands this category to describe different options for communi-
of medical and social service providers.33 Care coordina- cation format (one on one, in a group setting, or electronically
tion programs may designate a specific individual to mediated), medium (face to face, by telephone, or through the
manage provider collaboration, similar to the gatekeeping Internet), and function (symptom monitoring, patient education,
case management role discussed above.34 Traditionally,
or pharmacological management). Moreover, no evidence sug-
coordinated care initiatives have targeted the healthcare
gests that all features of any one definition need be satisfied for
system in an attempt to reduce inappropriate utilization of
resources, rather than explicitly aiming to improve health the intervention to be effective. Among the studies reviewed for
outcomes. the present statement, positive outcomes were associated with
Multidisciplinary care mirrors the holistic approach of case simple, single-intervention designs41 as well as with highly
management by adapting treatment plans to the medical, complex programs.42 Thus, the need remains for a broad-based
psychosocial, and financial needs of each patient. It differs, taxonomy that can adequately classify all types of disease
however, by involving a greater range of medical and management programs, from the most comprehensive to those
social support personnel. Multidisciplinary disease man- that are more selective in what they offer. Such a taxonomy
agement typically draws on the expertise of physicians would facilitate the description and comparison of different
(including the primary care provider), nurses, pharmacists, programs.
dietitians, social workers, and others to facilitate the The taxonomy that follows is designed to meet this need
transition from inpatient acute care to long-term, outpatient through both descriptive and prescriptive analysis. It is based on
management of chronic illness.6 Some multidisciplinary a conceptual model developed by the AHA Writing Group that
disease management programs have incorporated a “health
was refined through a review of published reports of disease
coaching” approach, in which health professionals promote
patient empowerment to achieve behavior modification management strategies for heart failure, depression, and diabe-
and treatment compliance.35 Other multidisciplinary pro- tes. A complete listing of these published reports is available as
grams have also sought to improve patient access to home an online Data Supplement. The conditions of heart failure,
health care, hospice care, and palliative care.36 depression, and diabetes were chosen because of their lengthy
The chronic care model (CCM) is the most comprehensive history as targets for disease management intervention and
of the disease management–related models included here.37 because of the relative abundance of published studies evaluat-
Originally developed by Wagner et al,38 the CCM is ing those interventions. Beyond this focus, however, the taxon-
founded on an understanding and appreciation of the omy is intended to be applicable to disease management pro-
overlapping domains in which health care occurs. These grams across myriad chronic disease states and to both current
domains include (1) the entire community, (2) the health- and future models. The AHA Writing Group strongly encour-
care system, and (3) the provider organization. The CCM ages researchers and publishers to report the results of disease
further identifies 6 essential elements within these domains management trials according to the taxonomic framework de-
that are necessary to ensure optimal chronic care: (1)
scribed here. Although detailed reporting requirements may vary
community resources and policies, (2) healthcare organi-
by study design or disease state, at a minimum, every article on
zation, (3) self-management support, (4) delivery system
design, (5) decision support, and (6) clinical information disease management should include information addressing the
systems.39 These elements are intended to provide a prac- 8 domains (and respective subdomains) of the taxonomy.
tical guide for restructuring the management of chronic
care, incorporating sufficient flexibility to allow customi- Methods
zation for different treatment settings. In contrast to models The AHA Writing Group began by establishing a conceptual
such as case management or multidisciplinary care, the model that categorized common disease management compo-
CCM does not focus on the roles of specific personnel. nents into categories of increasing specificity. The initial model
Krumholz et al Taxonomy for Disease Management 1437
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Figure. Disease management taxonomy.

consisted of 4 domains, selected because of their broad relevance review was able to accommodate a heterogeneous mix of
to disease management programs: target population, intervention interventions and study designs. Indeed, these broad inclusion
design, method of communication, and intensity. This model criteria were deliberately established to encourage the assess-
was then refined through an iterative process of comparison with ment of a wide range of interventions to best capture the full
a wide range of disease management protocols drawn from the spectrum of disease management–related activities.
academic literature. Published reports of disease management
programs were deconstructed, and an inductive analytical ap- Taxonomy
proach was used to identify additional categories of program On the basis of our conceptual model and subsequent refine-
components. After further discussion, we conceptualized these ment, the Writing Group developed a taxonomy that includes
categories into an expanded disease management taxonomy, the following 8 domains: (1) patient population, (2) interven-
with our original model of disease management components tion recipient, (3) intervention content, (4) delivery personnel,
used as the organizing framework. (5) method of communication, (6) intensity and complexity,
(7) environment, and (8) clinical outcomes. Within each of
Search Strategy these domains, additional levels of detail, or subdomains,
To identify study protocols for evaluation, a MEDLINE were identified. For example, intervention design can be
literature search was performed on the terms heart failure, more precisely specified according to subdomains such as
patient education, medication management, and peer support
diabetes, and depression in tandem with disease manage-
care. A graphic representation of the taxonomic structure is
ment, case management, and care management. The initial
found in the Figure, and the taxonomy is used to compare 2
search was limited to articles published in English between
heart failure disease management programs in Table 5.
January 1995 and January 2005. However, further screening
Because the taxonomy was refined through comparison
of the reference list of each article yielded several additional
with reports from the academic literature, its content and
relevant publications, some of which fell outside of the
structure reflect the attributes of programs described in those
original date range. The reference screening process was reports. However, the taxonomy was constructed to accom-
continued until no new articles were identified, resulting in a modate future developments in the field. The domains and
final date range of December 1987 to April 2005. subdomains outlined below represent a framework for the
Articles were selected according to the following criteria: content that reports of disease management should include, as
(1) They described interventions designed to improve out- well as the level of detail with which that content should be
comes and/or reduce medical resource utilization in patients described. This framework incorporates sufficient flexibility
with heart failure, diabetes, or depression; and (2) they used to accommodate the evolving nature of disease management
clearly defined protocols incorporating at least 2 prespecified and novel approaches that may be developed in the future.
components traditionally associated with disease manage-
ment (such as patient education, involvement of nonphysician 1. Patient Population
personnel, or intensive follow-up). Because study outcomes To classify disease management interventions, or to compare
were not formally evaluated or statistically compared, the disease management programs, it is critical that their target
1438 Circulation September 26, 2006

TABLE 5. Comparison of 2 Disease Management Programs


Taxonomic Domain Disease Management Program A43 Disease Management Program B42
Intervention recipient Patients Patients
Patient population Diagnosis of heart failure or cardiomyopathy Diagnosis of severe heart failure; eligible for elective heart
transplantation
Mean age: 80.3 years Mean age: 52 years
NYHA class III or IV NYHA class III or IV
Patients were excluded if any of the following applied: Mean left ventricular ejection fraction: 0.21
● need for permanent nursing home care, Mean V̇O2max: 11.0
● serious or life-threatening illness, or
● communication problem.
Unspecified demographic and psychosocial information was
collected.
Intervention content Patient meeting with study nurses Detailed baseline evaluation
Development of individual patient care plans Medication therapy optimized for each patient
Treatment based on established guidelines Treatment based on established guidelines
Patient education on weight monitoring, medication adherence, Patient/caregiver education on diet, exercise, self-monitoring, and
symptom recognition, and diet symptom recognition
Regular updates to patients’ primary care providers or home
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health staff
Delivery personnel Specialty-trained research nurses Heart failure clinical nurse specialist
Home health nurses (for select patients) Study cardiologists
Physicians Referring physician
Method of Face to face: individual Face to face: individual
communication Telephone: in person Face to face: group
Telephone: in person
Intensity and complexity Patients were followed up for 6 months. Patients were followed up for 6 months.
Frequency of contact was variable because patients were Patient contact occurred:
responsible for initiating contact with study nurses. ● within 3 days of hospital discharge,
At a minimum, all patients were contacted at baseline, week 1, ● weekly until criteria for clinical stability were met,
and monthly thereafter. ● 2 to 3 days after any major medication change, and
Program featured a high level of complexity. ● at routine intervals between weeks 2 and 8.
Program featured a high level of complexity.
Environment Hospital based, outpatient Hospital based, outpatient
Clinical outcomes Percentage of patients who did not visit the study nurse Patient functional status
Change in NYHA class No. of hospital readmissions
No. of hospital readmissions Estimated hospital costs
If readmitted, length of hospital stay
V̇O2max indicates peak exercise oxygen consumption.

patient populations be clearly defined. Although narrowly priate comparisons between interventions. For example, we
tailored selection criteria may facilitate the conduct of re- could draw few meaningful conclusions about the relative
search, this approach fundamentally limits our ability to efficacy of 2 programs by comparing the outcomes of the
understand the impact of disease management in the broader 52-year-old heart transplantation candidates studied by Fon-
population of chronically ill patients. The following subdo- arow et al42 with those of the 80-year-old patients with
mains should be addressed in a patient population definition. chronic heart failure examined by Ekman and colleagues.43
Risk Status
Medical Comorbidities
The patient populations included in the review differed
All studies included in the review identified a primary
widely in their levels of risk. In disease management inter-
condition targeted by the disease management interven-
ventions for heart failure, this included variability in such
tion. However, few of the reports explicitly discussed the
important factors as age, degree of left ventricular dysfunc-
management of comorbid conditions in addition to the
tion, and NYHA class. Among diabetes programs, patients
differed in their diabetes type, degree of glycemic control, primary diagnosis.44 – 48 The remainder either excluded
and the presence of complications. The impact of disease patients with comorbidities from participation or noted
management can vary widely depending on the fit between their presence without taking steps to manage those
the intervention and the risk status of the patient population. conditions. A large proportion of patients with chronic
High-risk groups—such as older patients, patients with a illness suffer from medical comorbidities, and some of the
history of prior hospitalizations, and patients with significant greatest challenges in caring for these patients involve the
comorbidities—may experience fewer hospitalizations in re- complex interactions of different disease states. As disease
sponse to disease management. Failure to account for the risk management evolves to meet the full range of medical
status of the target population can therefore lead to inappro- needs experienced by chronically ill patients, programs
Krumholz et al Taxonomy for Disease Management 1439

and interventions may similarly evolve to address comor- significantly to the variety found among disease management
bidities more comprehensively. programs.
Patient education is the cornerstone of all disease manage-
Nonclinical Characteristics ment programs, and the majority of those reviewed incorpo-
In addition to defining the clinical parameters of the target
rated patient education on topics such as the consequences of
population, researchers must consider other nonclinical char-
illness in daily life. For heart failure patients, this included
acteristics when describing a disease management interven-
recognition of warning signs of deterioration; advice on diet,
tion. A number of studies in the review identified potentially
fluid, and sodium management; and the importance of daily
significant patient characteristics such as education level,
weighing. Diabetic patients received education about weight
annual income, literacy, and marriage status. Riegel and
and caloric intake control, blood glucose self-monitoring, and
LePetri6 have noted that the specific role played by these
foot measurement and care. Educational interventions also
factors is unclear; it may vary with the nature of the disease
addressed behavioral strategies to improve patient compli-
management intervention. Patients with higher levels of
ance with prescribed diet, exercise, and medication regimens.
education and greater self-efficacy may be more responsive
A smaller number reinforced educational messages with
to self-management strategies while exhibiting no difference
ancillary materials, such as brochures or videos.
in their response to medication management. A more system-
Peer support was one component that was regularly present
atic attempt to document and report nonclinical characteris-
in disease management programs for depression but has been
tics of the target population will improve the comparability of
used less frequently as part of cardiac disease management.59
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study results and may facilitate elucidation of the specific


In disease management for depression, peer support was
mechanisms underlying improved outcomes.
provided by trained individuals, linked with study subjects of
similar age and sex, who had experienced an episode of major
2. Intervention Recipient
depression. These individuals were expected to make tele-
The patient population that is expected to benefit from
phone or in-person contact with the patient for at least 6
disease management (see Patient Population above) should
months; during these encounters, peer supporters were sup-
be differentiated from the individuals who are targeted by the
posed to model and share their successful coping skills,
intervention. In most studies these 2 groups overlapped: Heart
provide emotional support, and encourage self-monitoring
failure patients who received education about diet, exercise,
and continued medical treatment.
and weight monitoring were also intended to receive direct
Though less structured than the peer support intervention
benefit as a result. However, the literature also describes
described above, disease management programs for diabetic
disease management interventions designed to benefit pa-
patients routinely educated participants in a group set-
tients indirectly by influencing provider behavior. Under this
ting.46,48,60 – 63 Groups ranged in size from 4 to 28 patients, and
alternative strategy, healthcare providers receive instruction
their educational content was similar to that offered in studies
(often developed from evidence-based guidelines) about op-
that used one-on-one sessions. Group education sessions were
timal care for the target population, are given feedback on the
reinforced by encouraging patients to interact between ses-
results of care received by their patients, or alter the organi-
sions and by follow-up nurse contact.
zation of care processes. In our review, the provider educa-
tion approach was used less frequently in the heart failure
4. Delivery Personnel
studies reviewed49 –51 but was common in disease manage- The type of delivery personnel is another key domain.
ment programs for depression52 and diabetes.53–58 Programs with similar patient populations and intervention
content may vary substantially in the qualifications of the
3. Intervention Content
individuals who deliver the content, which may in turn
Intervention content is another key domain in describing any
influence program effectiveness.
disease management program. Disease management interven-
The programs reviewed generally emphasized a multidis-
tions range widely from a single educational session to
ciplinary approach to care; however, the specific disciplines
remote electronic monitoring to comprehensive programs
represented, as well as the number of personnel involved,
involving multidisciplinary care teams. This variety reflects
varied significantly across programs. It has been noted
the perspective of those providing the intervention (eg,
elsewhere64 that the optimal mix of program delivery person-
physician, nurse, or pharmacist), issues specific to the patient
nel is not yet known: Small teams may be as likely to improve
population, and the goals of the funding organization. Spe-
outcomes as large ones, and alternative models (involving
cifically, the content of a disease management program led by
personnel such as health educators) have yet to be thoroughly
a clinical pharmacist will probably address pharmacological
explored. The following list therefore includes a range of
therapy, whereas that led by a nurse may emphasize patient
delivery personnel commonly represented in disease manage-
education to improve self-care. A disease management pro-
ment programs, but we do not claim the list to be exhaustive.
gram for heart failure would likely aim to reduce hospital-
ization costs, whereas the program for a patient with diabetes Nurses
might emphasize glucose control. The content of a program Nursing staff were integral to nearly all of the disease
funded by a hospital may address ways to shorten hospital management strategies included in the review. Their duties
stays, but an intervention paid for by an HMO would want to were broad in scope, consisting of patient education, inpatient
limit readmissions. These different perspectives contribute and outpatient evaluations, and making treatment or patient
1440 Circulation September 26, 2006

support recommendations to physicians. Among these, the Dietitians


most common theme was reliance on nurse expertise to Multidisciplinary heart failure disease management programs
provide patient education and frequent follow-up to relay routinely included dietitians who provided individualized
clinically relevant findings to the patient’s physician, thereby dietary assessment and instruction. Dietitians were also a
effecting more intensive management of the disease. In some regular feature in diabetes disease management because of
studies, nurses also made home visits to optimize medication the importance of weight and blood glucose control for
management, identify early signs of deterioration, and inten- diabetic patients.
sify medical follow-up as needed.65– 67
Physical Therapists
Case Managers Patients were offered a physical therapy assessment in both
A subset of studies also cast nurses in the role of case heart failure and diabetes studies, and physical therapists
manager. The precise duties associated with this title were not designed personalized exercise programs to improve patients’
always clearly articulated, though it generally connoted a strength and endurance.
more supervisory role in patient care. Case managers assessed
Psychologists
patients in person and via telephone; monitored and partici- Although many depression disease management studies aug-
pated in education sessions for patients and caregivers; mented physician services with nursing support, a smaller
relayed information to patients about symptoms and medica- number also included psychologists among the members of
tion side effects; collected information about medication use, the care team.74,75 Psychologists were not specifically identi-
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symptoms, and vital signs; discussed patients’ status with fied in any of the heart failure or diabetes studies reviewed.
treating physicians; and coordinated care with ancillary pa-
tient services, such as physical therapy or social work Information Systems Specialists
consultations. Some qualified case managers independently A subset of disease management programs used electronic
managed patients’ medication. devices or automated telephone messages to deliver content
to patients.41,76,77,79 – 81 In addition to monitoring clinical
Physicians information such as blood pressure, weight, and blood glu-
Physician involvement tended to be greatest during the early cose, these programs offered programmed education in areas
stages of disease management intervention. Specialist physicians such as medication adherence and behavior change.
(cardiologists, psychiatrists, or endocrinologists) routinely con-
ducted an initial consultation with each patient, involving a 5. Method of Communication
comprehensive assessment of the patient’s status, with follow-up The methods used to deliver disease management interventions
review as required. This was followed by the establishment of are increasingly important to consider, particularly as informa-
individualized treatment plans, with particular attention to the tion technology has become a more prominent feature in many
optimization of medication. Ongoing evaluation of patients’ disease management programs. In most studies, care providers
progress was performed by a combination of different personnel, communicated directly with patients through face-to-face inter-
including specialist physicians, nurses, and primary care physi- action. However, a significant number either replaced or aug-
cians. Despite their inclusion in many of the interventions, mented face-to-face contact with a mediated form of communi-
however, the role of the primary care physician was variable and cation. Remote electronic monitoring systems were used in a
often ill defined. In some cases, they were encouraged to subset of heart failure studies41,76,77,79,80 to record measurements
conduct regular patient monitoring and to modify the treatment of patients’ weight, blood pressure, heart rate, and oxygen
plan as needed; in others, they were merely kept apprised of their saturation. These systems required the installation of electronic
patients’ status. equipment in patients’ homes to transmit data to a central
location via telephone or the Internet. Telephone monitoring was
Pharmacists
A small number of studies48,66,68 –71 evaluated the addition of a more common than remote electronic monitoring in heart
pharmacist to the care team. In these studies, the pharmacist failure, diabetes, and depression interventions. Disease manage-
reviewed patient histories and medication regimens and pro- ment interventions that closely monitored symptoms and vital
vided recommendations to physicians to optimize drug therapy. signs also tended to emphasize intensive management of pa-
The pharmacist also communicated directly with patients, dis- tients’ pharmacological therapy.
cussing medication changes, emphasizing the importance of Telephone contact also provided an opportunity for care
adherence, and conducting telephone follow-up. providers to reinforce educational content, offer encourage-
ment, and respond to patient questions. In one study of
Social Workers diabetes, an automated telephone care program was used as
Social workers participated in both heart failure and depres- the primary method of patient education, with additional
sion interventions to help coordinate social services. This telephone reinforcement by a nurse educator.81
included assessment of patients’ living arrangements, eco- Only one study82 specified the use of the Internet as a means
nomic status, cognitive abilities, and existing sources of of transmitting educational information to patients; however, the
social support. Social workers also helped connect patients to use of advanced technology is expected to increase.
legal resources, meal delivery services, therapy, and live-in
caregivers.72 In one study of depression, a psychiatric social 6. Intensity and Complexity
worker screened volunteers who had expressed interest in Disease management programs differ both in the intensity with
providing structured peer support for subjects.73 which interventions are delivered and in their structural complexity.
Krumholz et al Taxonomy for Disease Management 1441

A recent systematic review of disease management interventions for disco and colleagues41 involved only electronic transmission of
depression found that patient outcomes were improved by complex patients’ weight and symptoms, with daily review by a nurse.
strategies incorporating clinician education, nurse case manage- Finally, programs of intermediate complexity could be recog-
ment, and greater interaction between primary and secondary care. nized by the incorporation of some, but not all, of the interven-
However, the same review also identified improved outcomes tion components and delivery personnel described in the preced-
associated with simpler, less expensive interventions such as tele- ing sections of the taxonomy. Krumholz and colleagues86
phone medication counseling.83 If a basic program is able to deliver investigated a program of intermediate complexity in which
the same benefits as a more costly one, it is more likely to be heart failure patients received a nurse-led hour-long education
implemented on a wider scale. It is therefore critical that disease session shortly after discharge, followed by telephone-based
management interventions are reported and analyzed not only in reinforcement for 1 year. Although the program did not provide
terms of their individual components, but also in terms of the individualized care plans, nurses could encourage physician
relationship between these components and the intensity with which contact during the telemonitoring phase if patients’ status
they are delivered. deteriorated.
Finding a reliable coding system for complexity may be
Duration challenging, but any adequate description of a disease man-
The duration of patient participation in the disease management
agement program should provide a description of the opera-
interventions reviewed varied significantly. Most programs typ-
tional aspects of the program. Program complexity may
ically involved structured intervention (some combination of
significantly affect clinical outcomes, intervention costs, and
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education, medication management, and counseling) for no


overall costs of care; however, few analyses have examined
more than a 6-month period. A few provided less intensive
the association between program complexity and these fac-
telephone follow-up ranging from 3 months to 2 years.
tors. This is an area for further exploration, as it is important
Frequency/Periodicity to identify the types of disease management program struc-
For hospital-based programs, patient–provider interaction oc- ture that optimize chronic care at the level of individual
curred most frequently during the inpatient phase. However, patients or targeted patient communities.
outpatient interventions could also be intensive and time con-
suming: Ledwidge et al84 required heart failure patients to 7. Environment
complete 3 scheduled clinic visits and 10 separate clinic-led The environment in which disease management interventions
consultations during the 3 months immediately after discharge. are delivered also has the potential to affect both patient and
Home-based interventions and telephone support programs in- financial outcomes, though it is not yet clear which environmen-
volved significantly less face-to-face contact. Stewart and tal factors are associated with success. The majority of studies
Horowitz85 found evidence of reduced hospital readmissions for included in the review implemented disease management inter-
heart failure patients after only 1 home visit by a cardiac nurse ventions in the outpatient setting, incorporating a mix of
with reinforcement by a community pharmacist, and Krumholz hospital-based clinic visits and telephone contact. In some cases
et al86 required only 1 in-person education session. Structured (particularly those involving patients with more advanced pro-
telephone contact tended to take place weekly during the gression of disease or limited mobility), disease management
immediate postdischarge period, with the frequency decreasing interventions were delivered in patients’ homes, either electron-
over time. ically or by program staff (see Method of Communication
above). Other programs specifically targeted the hospital-to-
Complexity home transition, reinforcing inpatient education and medication
The individual components of disease management contribute to management with subsequent outpatient contact and monitoring.
overall program structure, such that disease management pro- Program environment also varied with the disease being
grams can also be characterized by their complexity. On the targeted. Heart failure programs were significantly more likely
basis of their mix of individual components, programs were to incorporate an inpatient component because of the high
quite heterogeneous in this respect. Highly complex programs hospitalization rate for patients with heart failure. Alternatively,
maximized the application of many different disease manage- disease management interventions for depression and diabetes
ment components, involved a wide variety of delivery personnel, were more often administered from primary care clinics.
and were more likely to tailor the application to the individual In addition to the physical location of a disease management
needs of each patient. For example, Naylor et al87 evaluated a program, organizational factors may have a significant environ-
highly complex hospital discharge protocol administered by mental impact. Organizations responsible for funding and exe-
advanced practice nurses in conjunction with patients’ physi- cuting disease management programs range widely, including
cians, caregivers, and other home-based service providers. Pro- government agencies, health insurers, physician groups, hospi-
gram components included individualized discharge planning; tals, and private disease management companies. It is not yet
assessment of functional, cognitive, and emotional health; ex- known whether these different organizational environments, and
tensive self-management education; and regularly scheduled the different financial motivations that accompany them, impact
home visits and telephone contact. By contrast, the least com- the cost or efficacy of disease management programs.
plex programs were characterized by far fewer disease manage-
ment components, with fewer disciplines represented among 8. Clinical Outcomes
delivery personnel and a more uniform approach to patients. A A description of a disease management program should also include
simple home-based telemonitoring intervention studied by Cor- a clear description of its goals—that is, the outcomes it is designed
1442 Circulation September 26, 2006

to influence. Although interventions to improve patient satisfaction with treatment, symptoms of depression, and general
and/or caregiver knowledge, self-care behavior, medica- mental and physical functioning. Diabetes disease management
tion adherence, and overall quality of life were common programs generally reported change in glycosylated hemoglobin
components of disease management programs, outcomes value as the primary outcome measure, though secondary outcome
specific to these interventions were not assessed or re- variables, including weight, blood pressure, lipid profile, eye and
ported with consistency in the heart failure literature foot examinations, diabetes knowledge, and health-related quality of
reviewed. Instead, patient mortality and hospital readmis- life were also reported with regularity.
sion rates were often the primary outcomes assessed and
reported with consistency. This trend reflects a design bias Conclusion
in favor of programs targeting costs Reductions in read- Conceptually, disease management should include key
elements such as a coordinated system of care, delivery
mission rates tended to reduce their costs while producing
system support, support for patient self-care, identification
economic loss for hospitals charged with implementing
of at-risk populations, a continual feedback loop between
disease management programs. For payers, there may be
patients and care providers, measures of clinical and other
little enthusiasm for implementing disease management if
outcomes, and the goal of improving overall health. In
it results in economic loss to the system. Few other
practice, however, disease management programs contain
interventions in medicine are required to be cost saving. myriad different elements and vary significantly in their
However, a shift in the domains of program evaluation comprehensiveness. The taxonomy outlined in this statement
toward patient-centered outcomes such as quality of life,
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is intended to advance the field by providing a system to


changes in caregiver burden, and overall societal costs may classify these diverse elements and programs. It does not
facilitate a change in perspective by hospital systems attempt to certify which particular programs or components
through increased demands by patients for these beneficial qualify as disease management, but rather establishes a
programs and a change in reimbursement priorities by framework for understanding the programs that exist. The
private and public payers. taxonomy represents a first step toward establishing a com-
Non–hospital-based programs for depression and diabetes mon language for evaluation of disease management and
tended to report on a wider range of outcomes. For depression, these should ultimately facilitate more rapid identification of effec-
included medication adherence, frequency of mental health visits, tive program components.

Disclosures

Writing Group Disclosures


Consultant/
Other Speakers’ Advisory
Writing Group Research Research Bureau/ Ownership Board
Member Employment Grant Support Honoraria Interest Member Other
Harlan M. Krumholz Yale University None None None None None None
Peter M. Currie Georgetown University None None None None None None
Law Center*
David P. Faxon University of None None None None None None
Chicago
Eric D. Peterson Duke University Millennium Bristol Myers None None Millennium None
Pharmaceuticals,† Squibb/Sanofi† Pharmaceuticals‡
Schering Plough†
Christopher O. Phillips Cleveland Clinic None None None None None None
Barbara Riegel University of American Heart None None None Pfizer‡ None
Pennsylvania Association, Pfizer‡
Renee Smith None* None None None None None None
Clyde W. Yancy University of GlaxoSmithKline,‡ Scios, Inc.‡ GlaxoSmithKline,‡ None AstraZeneca,‡ CHF None
Texas Southwestern Medtronic, Inc.,‡ Medtronic,‡ Solutions,‡ GlaxoSmithKline,†
Medical Center Nitromed,‡ Novartis,‡ Scios, Inc.‡ Medtronic,‡ Nitromed,‡
Scios, Inc.‡ Scios, Inc.‡
This table represents the relationships of writing group members that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure
Questionnaire, which all members of the writing group are required to complete and submit. A relationship is considered to be “significant” if (a) the person receives $10 000
or more during any 12-month period, or 5% or more of the person’s gross income; or (b) the person owns 5% or more of the voting stock or share of the entity, or owns
$10 000 or more of the fair market value of the entity. A relationship is considered to be “modest” if it is less than “significant” under the preceding definition.
*Dr. Currie and Ms. Smith were employed at the American Heart Association during the writing of this statement.
†Significant.
‡Modest.
Krumholz et al Taxonomy for Disease Management 1443

Reviewer Disclosures
Other Research Speakers’ Ownership Consultant/Advisory
Reviewer Employment Research Grant Support Bureau/Honoraria Interest Board Member Other
Debra K. Moser University of R01 from NIH, None None None None none
Kentucky National Institute of
Nursing Research,
Biobehavioral
Intervention in Heart
Failure
Michael Rich Washington None None None None None None
University
School of
Medicine
W.H. Wilson Tang Cleveland None None Takeda None Medtronic Inc, None
Clinic Pharmaceuticals, Neurocrine
Foundation Medtronic Inc Biosciences,
MedImmune,
F-Hoffman La Roche
Randall Williams Pharos None None None Pharos ResMed Sleep Williams Heart
Downloaded from http://circ.ahajournals.org/ by guest on November 24, 2017

Innovations, Innovations Foundation Foundation—Director


LLC; Midwest
Heart
Specialists
This table represents the relationships of reviewers that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure
Questionnaire, which all reviewers are required to complete and submit.

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A Taxonomy for Disease Management: A Scientific Statement From the American Heart
Association Disease Management Taxonomy Writing Group
Harlan M. Krumholz, Peter M. Currie, Barbara Riegel, Christopher O. Phillips, Eric D.
Peterson, Renee Smith, Clyde W. Yancy and David P. Faxon
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Circulation. 2006;114:1432-1445; originally published online September 4, 2006;


doi: 10.1161/CIRCULATIONAHA.106.177322
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