Disease Management Programs

Disease management is "a comprehensive, integrated system for managing patients...by using best practices, clinical practice improvement...and other resources and tools to reduce overall cost and improve measurable outcomes in the quality of care".110 A number of disease management programs have been studied. They fall into 3 broad categories: (1) HF clinics 19,111-126 (2) care delivered in the home or to patients who are at home 18,83,90,105,127-139 and (3) telemonitoring.140-146 Clinics or services designed solely for the administration of intravenous infusions, or which consist of only a single component of HF care, are not considered HF disease management programs and generally have not provided evidence of effectiveness.

HF clinics are disease management programs in which service is provided primarily in an outpatient clinic setting where patients come to receive care from practitioners with expertise in HF. HF clinics provide optimization of drug therapy, patient and family/caregiver education and counseling, emphasis on self-care, vigilant follow-up, early attention to signs and symptoms of fluid overload, coordination of care with other providers, quality assessment, and increased access to the health care provider.

Although some of the studies evaluating disease management in HF clinics were randomized, controlled trials,113,114,119,123,126 most compared data before and after program implementation. These studies consistently show that HF patients receiving care in a HF clinic experience a reduction in subsequent hospitalizations and hospital days, higher quality of life, and an improvement in functional status. This model appears to be cost-effective, because the increased costs of specialty care are offset by fewer rehospitalizations and/or improvements in quality of life endpoints.147-149 Improved survival was seen in one of the randomized, controlled trials.123 The largest study of clinic-based disease management to date, the Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) demonstrated a non-statistically significant 15% reduction in mortality in 1049 patients randomized to a nurse-based HF disease management intervention as compared to usual care. However, no differences between groups were observed in the primary endpoints of all-cause mortality or HF hospitalization, or the number of days lost because of death or hospitalization over 18 months of follow-up.126 The lack of effect on the primary endpoints in this study may have been due to a lower than anticipated event rate, and closer follow-up than anticipated in the usual care group. In a meta-analysis of 29 randomized trials of multidisciplinary HF disease management programs involving 5039 patients, disease management programs were associated with significantly lower mortality and hospitalization rates. The majority of the trials included in this meta-analysis that analyzed cost-effectiveness (15 of 18) demonstrated that the strategies were cost saving.150 Another meta-analysis included 54 studies, 27 of which were randomized and 27 of which were not randomized.151 The findings of this analysis revealed that among the randomized studies, disease management programs were associated with reductions in all-cause hospitalizations, cardiovascular and HF specific hospitalizations, and the combined endpoint of hospitalization or death.151

Another model features HF-specific care delivered in the home or to patients at home. Many of these programs use a case management approach. Included in this group are examples of true multidisciplinary and collaborative HF care.83,90,131,152 Characteristics shared by these programs include patient and family/caregiver education and counseling, emphasis on self-care, vigilant follow-up, early attention to signs and symptoms of fluid overload, coordination of care with other providers, increased access to the health care provider, and attention to social and financial barriers to adherence.

Studies of patients receiving care in the wide variety of home-based programs showed significantly fewer total and HF rehospitalizations, fewer days per hospitalization, improved quality of life, lower health care costs, and improved survival. 83,90,105,127-129,131,133-136,152,153 Several were randomized controlled trials that showed positive results for endpoints such as time to first hospitalization, days in the hospital, unplanned readmissions, and deaths out of the hospital.127,129,131,134,153 In the meta-analysis by McAlister et al, disease management programs that focused on enhancing patient self-care activities reduced HF hospitalizations by 34%, and all-cause hospitalizations by 27%, but they had no effect on all-cause mortality.150

In the third category of disease management programs, computer technology and telephone data transmission are used to monitor patients' weight, blood pressure, heart rate, and in some cases other physiologic parameters. These programs have much less personal contact with a health care provider than the home-based programs, and many lack an educational component. Most of the studies conducted using telemonitoring techniques were small, with one exception.146 Because of these study limitations, findings concerning this category of disease management programs remain equivocal. In the meta-analysis by McAlister et al, disease management strategies using telephone contact were associated with a reduction in HF hospitalizations, but not mortality or all-cause hospitalization.150

Studies of HF disease management using the clinic and home-based care models provide convincing evidence that it is possible to significantly reduce rehospitalization rates and costs and improve functional status and quality of life for HF patients. Although evidence of a clinical benefit was not demonstrated statistically in the COACH trial, a potentially clinically relevant reduction in all-cause mortality was noted, and it is plausible that a higher than expected level of care was provided in the usual care arm, thus limiting the ability to detect significant between-group differences.126 A growing number of adequately powered studies and published meta-analyses have demonstrated a positive effect on survival by HF disease management.123,127,136,150,151 This effect appears to be due to improved patient self-care. Programs focusing on self-care skills demonstrate gains equal to or greater than those seen with programs that improve drug therapy.18,123

Essential Elements of Disease Management. Every successful HF disease management program has a comprehensive education and counseling component. Programs should include intensive guideline-based education and counseling with emphasis on behavioral strategies to increase adherence and counseling to address patients' individual barriers to engaging in self-care. Education should include diet, medications, weighing, symptoms heralding worsening HF, and the importance of seeking early treatment for these symptoms. Promotion of self-care is a fundamental component of successful programs and the foundation upon which disease management is based. Frequent follow-up in some form and increased access to health care providers also appear to be vital components. Optimization of medical therapy is an important aspect. Because the majority of rehospitalizations for exacerbation are the result of fluid overload98 some mechanism for addressing early signs of fluid overload is essential. In many programs, educating patients about flexible diuretic regimens is successful. When patients or their family or caregiver are unable or unwilling to assume significant responsibility, home visits by a nurse or "drop-in" visits to a HF clinic are options. Assistance with social and financial concerns and coordination of care among all agencies involved are additional important components of HF disease management.

A recent meta-analysis examined randomized controlled trials of disease management programs from 1995-2005 in order to determine the characteristics that were common to successful programs.154 They found that successful disease management always had multiple components, including an in-hospital phase of care, intensive patient education, self-care supportive strategy, optimization of the medical regimen, and ongoing surveillance and management of clinical deterioration. It was considered fundamental that a cardiac nurse and cardiologist be actively involved and that the delivery of follow-up care was flexible.