INTRODUCTION

Due to its tremendous clinical and financial impact, managing chronic diseases has become a focus for health-care policymakers and researchers. More than 100 million Americans have a chronic disease, and half of the health-care dollars in the United States are being spent on individuals with chronic illnesses.1,2 These expenditures double when chronic disease produces limitations in physical activity.1 As a chronic condition associated with marked physical debilitation and multiple comorbidities, heart failure (HF) ranks high on the list of chronic diseases in terms of prevalence, morbidity and mortality, and financial costs in the United States and worldwide.1 An increase in the aging population combined with aggressive treatment for and improved survival from acute coronary syndromes has contributed to the dramatic growth in the number of individuals with HF, where HF is expected to reach 10 million cases in the United States alone.

Managing HF is challenging for both health-care providers and patients. The United States has been criticized for providing health care on an episodic, acute illness basis and for the absence of a systematic approach to managing chronic disease. Rightfully so, since the majority of health-care dollars spent on HF result from inpatient care during hospitalization.2 Over the past decade, many pharmacologic and nonpharmacologic treatment strategies have been evaluated in multicenter clinical trials. The good news is that many of these strategies work, giving those with HF an improved prognosis with reduced morbidity and mortality and improved quality of life.3–6 The bad news is that these strategies have dramatically changed HF care over the past decade, making it quite complex as multiple medications, including medications that were previously contraindicated, and biomedical devices are now integral aspects of care.

Based upon the overwhelming evidence and the desire to improve treatment and the quality of care, the American College of Cardiology/American Heart Association published Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult in 2001.6 These guidelines were subsequently updated in 2005.7 Yet even with explicit recommendations for practice, gaps exist between best evidence and clinical practice in implementation of the guidelines. Rapid advances in biomedicine, the tendency to overlook information not used routinely, and learning new information concurrent with relearning forgotten information all contribute to nonadherence. Studies suggest that 30–40% of patients are not receiving care based upon current scientific evidence and that as much as 25% of the care provided to patients with chronic HF is either unnecessary or is potentially harmful.8,9 One approach to bridging the gap between proven therapies and clinical practice has been the development of disease management (DM) programs.

HISTORICAL PERSPECTIVES

As health-care costs continue to soar, everyone seems to be looking for new ways to reduce expenditures while improving patient outcomes and satisfaction. The first programs considered to be DM were introduced by the pharmaceutical industry as a tactic to increase pharmaceutical profits.10 The largest pharmaceutical benefits management (PBM) firms, which process pharmacy claims for employers and health maintenance organizations (HMOs), and negotiate purchasing agreements with pharmaceutical manufacturers, were purchased by pharmaceutical companies in 1993 and 1994.10 On average, patients with a single chronic condition see more than 3 physicians and fill 6 prescriptions annually, while individuals with 5 or more comorbidities have 15 physician visits and fill over 50 prescriptions per year.11 By offering services to assist with managing patients with chronic diseases and/or programs designed to improve patient adherence to medications regimens, PBMs can directly effect drug sales. Thus, through systematic approaches making them providers of care for patients with chronic diseases, pharmaceutical manufacturers influence billions of dollars in revenue from HMOs while also expanding their industry’s volume and profits.10

Other strategies geared toward reducing health-care expenditures have been developed. Critical pathways, guidelines, and care maps attempt to standardize care for individuals hospitalized with a particular disease or condition. These approaches are very effective in reducing length of stay and limiting inpatient resource utilization, but do little to address postdischarge needs or to prevent rehospitalization. For these reasons, more comprehensive approaches, such as DM, have been accepted by health-care institutions and organizations. “Disease management” is used as an umbrella term. The phrase “disease management” means different things to different people, has diverse operationalizations, and encompasses a wide range of concepts. Unfortunately there are no universal standards for DM programs. According to the Disease Management Association of America (DMAA), a voluntary organization formed in 1999 to promote a more scientific approach to measuring success of DM programs, full-service DM programs have six essential components (Table 18-1). Those with fewer components are considered DM support services and far outnumber the full-service programs available.12 DMAA defines DM as “a system of coordinated healthcare interventions and communications for populations with conditions in which patient self-care efforts are significant.”12 Since initial programs focused on reducing expenditures, managed care organizations were early adopters of DM due to the financial attractiveness. However, “true” DM is far more than fiscal in nature. For clarity purposes, the remainder of this chapter will utilize the DMAA definition.

DM programs are population-based approaches concentrating on costly chronic diseases, such as asthma, diabetes, or HF. Even though termed “disease” management, these programs intently focus on managing “patients” and use patient-centered outcomes as measures of success. Because of the significant accomplishments seen in improving outcomes, DM is being increasingly endorsed by policymakers and third-party payers. However, caution must be used when interpreting the findings in many of the articles published on DM. Flaws in the research design and/or data analysis, the lack of guidelines for evaluation, and inconsistencies in reviewing of such articles leave questions about the veracity in reported findings.13–15 This may be one reason the National Committee for Quality Assurance in the United States announced plans in June 2000 to certify DM programs, using criteria based on effectiveness in quality, accreditation, and health improvement.16

Successful DM programs engage in collaborative practice with a multidisciplinary approach, utilizing a health-care team with specialized education and training for that specific chronic condition. Traditional members include physicians, advanced practice nurses (APN), nurses, pharmacists, dietitians, and social workers, to name a few. Membership can be extended on a routine or ad hoc basis to palliative care clinicians, exercise specialists, home care nurses, clergy, psychologists, or others deemed essential. A prerequisite for any program is advanced education in the management of the disease for all team members. Using this approach, care is coordinated throughout the continuum of illness, throughout all providers of care, and throughout the health-care system.

To optimize collaboration, it is imperative that team members respect the unique skills and knowledge base of all members and encourage active involvement by all. Members have a clear vision of their responsibilities in order to achieve the common goals, which are beneficial to both the team and the patient. Examples of common goals include a reduction of the severity of symptoms and the impact of that disease. By working together, care can be extended across the natural course of the illness.

Collaboration between medicine and nursing is integral to success in DM, as physicians and APNs develop a partnership to manage the complex clinical issues associated with chronic illness. While the plan of care is typically established by the physician, the APN typically provides the majority of care and clinical management.

Importantly, this approach bestows the patient with increased access to the APN for both routine and urgent care. The APN works semiautonomously to accomplish medication optimization, symptom management skills, education to the patient and family, and communication between patient, family, and other caregivers. Routine processes of episodic care, with heavy emphasis on the use of hospitals and emergency departments, are broken as patients are instructed to contact the APN with concerns or changes in symptoms. Through proactive surveillance and early intervention, hospitalizations may be avoided, thereby both reducing health-care expenditures and increasing quality of life.17,18

DM endorses and employs evidence-based medicine, based upon the most current science, and cost-effective technology to deliver individualized care to those with specific chronic diseases. Many successful DM programs participate in clinical research, offering patients access to participate in investigations of novel medications or other therapies. Thus, DM is multifaceted and incorporates a variety of strategies and interventions to manage chronic illness. Individual programs determine the actual interventions that are used and how they are operationalized. For the vast majority of programs, patient education, lifestyle modifications to reduce further injury, outpatient monitoring, and self-care management strategies are important aspects of care.

Accurately defining quality care is problematic as well. In The Quality Chasm report, the Institute of Medicine outlined key recommendations to improve the quality of health care in the United States, focusing on health-care delivery and dimensions of health-care performance.19 In this report, the patient’s experience within the health-care system is fundamental to quality. Thus, the value of work, delivery systems, organizations, and policies is judged only by their ability to alleviate suffering, reduce disability, and improve the health of patients.19

Since its inception, DM has been interested in clinical and economic outcomes. While clinical outcomes are important and necessary measurements of success, patients ultimately judge their own health within the context of daily living. Thus comprehensive DM programs routinely evaluate changes in physical limitations and the impact of chronic disease on patients’ lives. This is accomplished through either general or disease-specific health questionnaires, appraisal of physical performance, or standardized surveys. This information can, and should, be used to make individualized treatment decisions.

HEART FAILURE DISEASE MANAGEMENT

Managing HF is challenging and requires the integration of inpatient and outpatient care. The goals of DM are to reduce symptoms and to improve morbidity, mortality, and quality of life in HF. Although guidelines are available to guide and direct the management of patients with HF or at risk for its development, the vast majority of clinicians managing the condition have fallen short of the standards.9,18,24,25

Numerous challenges are associated with managing HF. First, it is a complex disease requiring substantial resources for care. It is difficult for clinicians to keep abreast of the latest research findings, and adherence to published guidelines remains less than ideal. Many patients with HF are not prescribed medications proven to improve morbidity and mortality or are not prescribed evidence-based medications at doses deemed effective in clinical trials.26,27 In addition, most patients have multiple comorbidities, making their care and management more complicated. Common comorbidities include hypertension, coronary artery disease, atrial fibrillation, renal insufficiency, sleep disorders, dyslipidemia, and diabetes.28 Evidence suggests that many patients with HF are undiagnosed, and thus receive no treatment until advanced disease has developed, thereby missing any opportunities to slow or halt disease progression are lost.29

As previously discussed, the majority of health-care dollars in HF are spent during hospitalization. Postdischarge, these patients have readmission rates between 36% and 75% and increased mortality rates.30 Age, gender, coronary artery disease, diabetes, and nonadherence to the medical regimen are risk factors for readmission.31 All of these issues contribute favorably to and support the importance of DM in HF.

The American Heart Association’s Expert Panel recommends the following principles for the development, implementation, and evaluation of DM initiatives:20

* The main goal should be to improve the quality of care and patient outcomes.

* Evidence-based, consensus-driven guidelines should be the basis of care and should be used to increase adherence to the most current evidence.

* DM programs should be within integrated and comprehensive systems. The patient-provider relationship is central.

* DM programs should be developed for all populations and should include under-served or vulnerable populations.

* Organizations involved in DM should be aware of and address potential conflicts of interest.

MODELS OF HEART FAILURE DISEASE MANAGEMENT

The literature is filled with articles describing HF programs and their impact on outcomes. However, because of the diversity in the data measured and reported, it is difficult to discern exactly what intervention was most influential or to replicate the results. It is also difficult to compare programs due to the diversity of interventions used. Riegel and LePetri propose a classification system that can be used for comparison, based upon the provider(s) of the DM intervention: multidisciplinary models, case management models, and clinic models.23 These models are discussed in greater detail below.

Multidisciplinary Models of Care

As previously described, this model involves multiple dedicated health-care clinicians, each approaching the patient from a unique perspective. The first prospective study of a multidisciplinary HF DM program was conducted by Rich et al. in 1993.32 Using interventions that involved intensive education, medication adherence, discharge planning, and enhanced follow-up care, Rich reported significant reductions in HF hospitalizations that were evident 1 year later.

It is important to note that no two DM programs are identical. Similarities seen in the literature include characteristics of transitioning from hospital to home, individualized education and reinforcement, telephone monitoring, promoting self-care abilities, and the role of the 33–36 nurse. Nurses play a critical role as liaisons between the patient and the physician, through telephone monitoring, triage, and advice to patients. Because most HF DM utilize APNs, patients have increased access to care either through frequent follow-up, through the ability to be seen on an emergent basis, or through walk-in appointments. These programs emphasize the role of medications in treating HF and routinely review prescription and over-the-counter drugs to simplify and optimize regimens, utilize treatment protocols to manage changes in symptoms and/or weight, have established education plans for patients and families to enhance self-care, are involved in the discharge process to ease the transition from hospital to home care, and provide routine monitoring and access to care for outpatients. Reported successes include marked reductions in HF hospitalizations and shorter length of stay, higher ACE inhibitor and b -blocker utilization, and improved quality of life and functional capacity.37,38

Case Management Models

In this model, patients receive intense monitoring after hospital discharge. This monitoring may occur via the telephone or home visits, or remotely via electronic scales within the home. Case managers are typically nurses, but may be social workers, pharmacists, or physicians.23 This model provides frequent, individualized education focusing on dietary sodium, medication adherence, and symptom monitoring. Case managers coordinate communication with the health-care clinicians about issues, concerns, or physical examination findings. Decreases in hospitalizations, length of stay, costs, and clinic and emergency department visits have been reported.37,39 In fact, a recent article reported that a home-based model may be most effective for fragile, elderly, or physically impaired patients who cannot travel to clinic appointments.40

Clinic Models of Care

Clinic models for DM in HF are outpatient clinics that are directed by HF specialists who are usually, although not always, cardiologists. Intense follow-up by physicians or APNs provides the basis of care, where emphasis is placed on treating modifiable causes of HF and optimization of medications. Education and reinforcement are major components of care. Flexible diuretic regimens allowing patients to adjust their doses based on daily weights originated in clinic models.33,41 As with the others, reductions in all-cause and HF hospitalizations and emergency department visits are reported in the literature.33,41

ESSENTIALS OF HEART FAILURE DISEASE MANAGEMENT

Adherence to prescribed medical regimens, including both pharmacologic and nonpharmacologic interventions, significantly impacts both the short- and long-term management of HF. Such treatment strategies have been well proven to slow disease progression, reduce hospital admissions, and improve overall symptom control.42 However, despite the importance of these interventions, numerous barriers to adherence exist. Barriers may include lack of understanding of perceived benefit, lifestyle modifications, absence of social support, powerlessness, financial concerns, and time constraints. These barriers complicate patients’ ability and willingness to adhere to the prescribed medical regimen. In addition, in the haste to shorten length of stay and reduce health-care expenditures, clinicians may simply treat the symptoms and fail to identify nonmedical causes for the decompensation. By taking the time to do a thorough assessment to identify barriers and then target problem areas, clinicians can better utilize the time spent with each patient, leading to a more individualized treatment plan and enhanced adherence.

Worsening Signs and Symptoms

Despite advanced warning signs and symptoms of decompensation, many patients either fail to recognize or fail to react. For example, Friedman and Griffin reported 90% of patients hospitalized due to decompensation experienced dyspnea 3 days prior to hospitalization.44 Additionally 35% reported edema and 33% had cough 1 week prior to admission.45 A survey by Carlson and Riegel revealed that most patients had experienced multiple symptoms of worsening HF in the previous year, yet their knowledge of the importance of these signs and symptoms was poor.46 Even though patients who had lived with HF for years were more likely to use appropriate self-care strategies than newly diagnosed patients, they were uncomfortable in evaluating the effectiveness of their own actions.46 Thus when patients fail to recognize or acknowledge worsening signs and symptoms, clinicians lose the chance to intervene and potentially avert hospitalization. Therefore, educating patients and their families on both the signs and symptoms associated with worsening HF and what actions to take provides an excellent opportunity to reduce hospitalizations and ultimately reduce health-care expenditures. Establishing self-efficacy, or belief in the ability to control HF, is essential for patients to participate in their own care and better manage their disease.

Patients experiencing decompensated HF exhibit a constellation of signs and symptoms, including increased dyspnea and/or fatigue, weight gain, orthopnea, and paroxysmal nocturnal dyspnea (PND). Essential aspects of education are presented in Table 18-3. Patients need simple advice on what changes in symptoms are important and clear endpoints that should prompt them to seek help. Whenever special equipment is involved, instruction on proper use and when to seek help are required. For example, daily weights require that the patient owns a scale, that the scale has numbers that can be read by the patient with a stable base large enough for them to stand on, and that the weights be obtained at approximately the same time each day. Education on when to call with weight changes is determined by the clinician and should be provided in written format and then reinforced frequently. In all cases, patients and families should be diligent in monitoring physical signs and symptoms. Establishing plans for notifying health-care providers of any changes are the logical next step and should include the identification of emergency contact numbers for doing so.

“Which program is best?” “What interventions are most effective?” Unfortunately those questions cannot be answered at this time, as no one trial has evaluated single models or interventions against each other. In a meta-analysis of 33 randomized clinical trials of DM in HF, Roccaforte et al conclude that all produced similar effects on outcomes and that the choice for a specific program should be driven by the resources available, patient population, and health-care system.47

FUTURE IMPLICATIONS

Well-designed studies, employing long-term outcomes and a control group, are needed to evaluate the impact of patient management strategies in HF. Because of the variety of DM programs and interventions, a classification system for comparison between programs should be developed.48 As the evidence supporting HF DM continues to mount, steps must be taken to identify those at risk for developing HF followed by aggressive treatment. Improving clinician adherence to the evidence-based treatment guidelines is also an important issue that must be addressed. Research in this area should answer some questions as to why clinicians fail to follow clinical practice guidelines. In doing so, insight may be gained that will direct future work in enhancing adherence and ultimately improving outcomes for individuals with chronic HF.

SUMMARY

DM in HF is very effective in reducing the associated morbidity and mortality, halting or reversing the natural course of the condition, improving quality of life, and reducing overall health-care expenditures. Development of multifaceted programs that stress primary prevention through lifestyle modifications for risk reduction, early aggressive treatment using evidence-based approaches, and enhancing patient self-care may proactively diminish the staggering burden of HF on individuals, families, health-care systems, and society.

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