Disease Management and Telemedicine in Heart Failure


Heart failure (HF) currently affects more than 5 million Americans, and because of the aging population and the expected growth of the US population, the prevalence of HF is expected to increase to more than 8 million Americans by 2030 ( see also Chapter 18 ). Projections show that the total cost of HF will increase to almost $70 billion per year by 2030. HF is the leading cause of hospitalization in patients older than 65 years of age. Due to the high cost and increasing prevalence of HF hospitalizations, starting in 2012 the Centers for Medicare and Medicaid Services have implemented the Hospital Readmission Reduction Program, which reduces hospitals’ Medicare payments up to 3% for higher-than-expected 30-day readmission rates for HF patients. Many hospitals have responded to this potential financial penalty by initiating HF disease management and care coordination programs or processes that target high-risk HF patients.

Early studies demonstrate that HF disease management, defined as an integrative approach that aims to enhance quality of health care and its cost-effectiveness for patients with chronic conditions, decreases hospital readmission rates, improves quality of life (QOL), and decreases costs. Rich and colleagues published a landmark multicenter randomized controlled trial examining HF disease management in 1995. The intervention consisted of intense education about HF and its treatment by an experienced cardiovascular team, including a geriatric cardiologist, clinic nurse, dietitian, case manager, and home care provider. The study demonstrated that survival for 90 days without readmission (the primary endpoint) occurred in 54% of the control group versus 64% in the treatment group ( P = .09). However, when the analysis was restricted to survivors of the initial hospitalization, a significant difference in survival for 90 days without readmission was noted (risk ratio [RR] = 0.56, P = .02). The study also showed a significant improvement in the QOL and a decrease in the total cost of care in the treatment group versus the control group. Common features of early studies on HF disease management are that they were based at health care systems, traditionally enrolled inpatients, and had small, single-center trial designs. Because most HF patients receive their care in a community setting, it is unclear if trials performed at large health care centers can be replicated in a more “real-world” setting. There are many limitations to single-center trial designs, namely limited external validity (interventions tested in a single clinical environment are not necessarily generalizable to a broader population), implausible effect size, and unequal allocation of resources (often single-center trials are performed by an investigator with highly atypical expertise and commitment). Along those lines, several meta-analyses were performed on disease management programs for HF. Although these studies show favorable results for HF disease management programs, because these meta-analyses are based on small, single-center trials, caution must be used when interpreting these results.

Since then, several large, multicenter, randomized controlled trials have been published related to HF disease management programs. The results of these trials have been mixed, with many being neutral. The reason for the lack of benefit in many of these HF disease management trials is unclear. There was significant heterogeneity among these trials; each targeted a different patient population, provided varying quality of usual care, and used different program designs and interventions. In this chapter, we will explore types of HF disease management program types and discuss how the approach to HF disease management may change in the future.

Defining Disease Management

Disease management is an approach to patient care that coordinates medical resources for patients across the entire health care delivery system. A critical distinction between disease management and other approaches to traditional medical care is a shift in focus from treating patients during discrete episodes of care (i.e., hospital or clinic) to provisions of high-quality care across the continuum of care. The goals of disease management are to (1) improve patients’ knowledge about their disease state; (2) facilitate health behavior change that improves self-care, including adherence to treatment and management of symptoms; and (3) improve clinical outcomes, including lower mortality and hospital readmissions.

HF is a prime target for implementation of disease management programs because of its increasing prevalence, high costs to patients and society, high mortality and hospitalization rates, availability of evidence-based therapies, and need for timely identification of symptom progression and clinical deterioration. HF is often accompanied by a multitude of comorbidities and barriers to care, including advanced age, cognitive deficits, depression, low socioeconomic class, and low health literacy. HF patients also have multiple baseline risk factors such as medication or dietary nonadherence and propensity to ischemia, infection, and arrhythmias that may cause a perturbation of their already tenuous state and trigger deterioration that requires a hospitalization. These factors must be taken into account when conceptualizing an HF disease management program. HF disease management aims at detecting instability before the point of clinical deterioration severe enough to warrant admission to the hospital by (1) implementing strategies that modify patients’ baseline risk; (2) monitoring for worsening signs and symptoms of decompensation; and (3) encouraging patient participation in their own care ( Fig. 47.1 ).

Fig. 47.1, Conceptual model for heart failure disease management (HFDM) and mechanisms by which HFDM interventions reduce hospitalizations.

The Self-Care Paradigm

Self-care is the foundation upon which successful management of HF is built. The self-care process includes both maintenance and management components. Examples of self-care maintenance are adhering to prescribed medications, diets, exercise regimens, and doctor’s appointments. Self-care management involves more complex skills, including monitoring symptoms and making decisions regarding their severity, identifying possible treatment options, and assessing whether the treatment implemented was effective. Since the initial symptoms of a HF exacerbation are often subtle, health care management is often difficult for patients to perform successfully, especially in situations involving cognitive deficits and depression. A major factor that influences patients’ skills at self-care management activities is self-efficacy, or confidence in one’s ability to perform self-care. Most HF disease management programs involve a patient education component designed to provide knowledge so that patients can successfully perform self-care maintenance. In addition, HF disease management programs typically include a monitoring component in the outpatient setting, such as specialized HF clinics, home visits by nurses, structured telephone support (STS), or telemonitoring (TM) to help patients with self-care management.

Heart Failure Disease Management Classification Schemes

Considerable variability exists among disease management programs in the literature. Significantly different populations have been targeted, and the spectrum of interventions studied has been wide. This heterogeneity has made comparison of HF disease management programs difficult. Grady and colleagues developed a classification scheme in an attempt to better categorize HF management programs. They identified the following settings for disease management: inpatient, specialty HF care outside the clinic setting (home visits, telephone calls, or TM), and primary care clinic. In 2006, 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. The taxonomy would include descriptions of eight domains: patient population, recipient, intervention content, delivery personnel, method of communication, intensity and complexity, environment, and outcome measures. The goal of this taxonomy is to establish a common language for evaluation of disease management. The authors hope that it will ultimately facilitate more rapid identification of effective program components.

Heart Failure Disease Management in the Inpatient Setting

Despite the opportunity to closely assess patients, modify therapy under observation, and provide intensive education during hospitalization for an acute exacerbation, the preponderance of evidence suggests that HF management during hospitalization is inadequate. Approximately 20% of unplanned hospital readmissions for HF have been attributed to substandard inpatient care.

In 1996, the Centers for Medicare and Medicaid Services (CMS) first implemented a program to track and improve the quality of HF care in hospitals. CMS subsequently aligned with The Joint Commission to create a national standardized “core” set of four HF performance metrics: measuring left ventricular function, using angiotensin-converting enzyme (ACE) inhibitors in patients with left ventricular systolic dysfunction, providing complete HF discharge instructions, and providing smoking cessation counseling in current or recent smokers. The original HF process measures have been modified only once since then by adding use of angiotensin II receptor blockers as an alternative to ACE inhibitors. From 2002 to 2007, provision of discharge instructions improved from 31% to 78%, left ventricular function measures improved from 82% to 95%, use of ACE inhibitors or angiotensin II receptor blockers for left ventricular systolic dysfunction improved from 74% to 90%, and provision of smoking cessation advice improved from 42% to 96%. Unfortunately, these improvements in performance measures did not correlate with improvements in 30-day or 1-year mortality or rehospitalization. Since 2014, CMS no longer required data collection for discharge instructions and ACE inhibitors/ARB, but The Joint Commission still requires documentation of ACE inhibitors/ARB use.

It is unclear why an improvement in compliance with performance metrics did not correlate with improvement in clinical outcomes, but one hypothesis is that the perceived improvement in core metrics may simply have been better documentation of care that hospitals have been providing all along. Conversely, it may appear that hospitals have improved adherence with core metrics by “checking the appropriate boxes.” The reason for lack of clinically meaningful improvement could also be due to poorly chosen metrics. Of the four CMS-mandated HF performance measures, only prescription of an ACE inhibitor or ARB is supported by direct clinical trial evidence. Data from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF), a registry and performance improvement program for patients hospitalized with HF, β-blockade at the time of hospital discharge, currently not a CMS performance measure, were strongly associated with reduced risk of mortality (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.30–0.79; P = .004) and mortality/rehospitalization during follow-up. This performance measure was added to the AHA/ACC in 2011 Performance Measures ( Table 47.1 ). In addition, rather than discharge instructions, the updated AHA/ACC Performance Measures also evaluates postdischarge appointments after HF hospitalization.

TABLE 47.1
ACC/AHA Heart Failure Performance Measures 2011
From Bonow RO, Ganiats TG, Beam CT, et al. ACCF/AHA/AMA-PCPI 2011 performance measures for adults with heart failure a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association–Physician Consortium for Performance Improvement. J Am Coll Cardiol . 2012 59(20):1812–1832.
Performance Measure Name Measure Description Care Setting Level of Measurement
1. LVEF Assessment Percentage of patients aged ≥18 yr with a diagnosis of HF for whom the quantitative or qualitative results of a recent or prior (any time in the past) LVEF assessment is documented within a 12-mo period Outpatient Individual Provider
2. LVEF assessment Percentage of patients aged ≥18 yr with a principal discharge diagnosis of HF with documentation in the hospital record of the results of an LVEF assessment performed either before arrival or during hospitalization, OR documentation in the hospital record that LVEF assessment is planned after discharge Inpatient Individual practitioner and facility
3. Symptom and activity assessment Percentage of patient visits for those patients aged ≥18 yr with a diagnosis of HF with quantitative results of an evaluation of both current level of activity and clinical symptoms documented Outpatient Individual practitioner
4. Symptom management Percentage of patient visits for those patients aged ≥18 yr with a diagnosis of HF and with quantitative results of an evaluation of both level of activity AND clinical symptoms documented in which patient symptoms have improved or remained consistent with treatment goals since last assessment, OR patient symptoms have demonstrated clinically important deterioration since last assessment with a documented plan of care Outpatient Individual practitioner
5. Patient self-care education Percentage of patients aged ≥18 yr with a diagnosis of HF who were provided with self-care education on ≥3 elements of education during ≥1 visit within a 12-mo period Outpatient Individual practitioner
6. β-Blocker therapy for LVSD (outpatient and inpatient setting) Percentage of patients aged ≥18 yr with a diagnosis of HF with a current or prior LVEF of <40% who were prescribed β-blocker therapy with bisoprolol, carvedilol, or sustained-release metoprolol succinate either within a 12-mo period when seen in the outpatient setting or at hospital discharge Inpatient and outpatient Individual practitioner and facility
7. ACE inhibitor (ACEI), or angiotensin receptor blocker (ARB) for LVS dysfunction (LVSD) Percentage of patients aged ≥18 yr with a diagnosis of HF with a current or prior LVEF of <40% who were prescribed ACE inhibitor or ARB therapy either within a 12-mo period when seen in the outpatient setting or at hospital discharge Inpatient and Outpatient Individual practitioner and facility
8. Counseling about ICD implantation for patients with LVSD receiving combination medical therapy Percentage of patients aged ≥18 yr with a diagnosis of HF with current LVEF ≤35% despite ACE inhibitor/ARB and β-blocker therapy for at least 3 mo who were counseled about ICD implantation as a treatment option for the prophylaxis of sudden death Outpatient Individual practitioner
9. Postdischarge appointment for HF patients Percentage of patients, regardless of age, discharged from an inpatient facility to ambulatory care or home health care with a principal discharge diagnosis of HF for whom a follow-up appointment was scheduled and documented, including location, date, and time for a follow-up office visit or home healthcare visit (as specified) Inpatient Facility
ACE , Angiotensin-converting enzyme; HF , heart failure; ICD , implantable cardioverter-defibrillator; LVEF , left ventricular ejection fraction; LVSD , left ventricular systolic dysfunction.

Although most evidence-based HF therapies are not represented by the CMS outcome metrics, an HF hospitalization is an opportune time to ensure patients are prescribed these potentially life-saving therapies. It is also an excellent time to initiate and/or reinforce patient education on topics such as dietary recommendations, medications, activity and exercise, risk factor modification, and symptom monitoring and recognition. In 2005, the American Heart Association launched the Get With The Guidelines-HF (GWTG-HF) program. This is an in-hospital quality improvement program to ensure that every patient with HF receives the best care. The GWTG-HF module has a patient management tool that provides patient-specific guideline recommendations, allows for real-time data validation, and enables each institution to track its adherence to the guidelines individually and against national benchmarks. The GWTG-HF program facilitates data collection and provides quality improvement tools to hospitals, including clinical decision support and dissemination of best practices, and regularly reports performance back to the participating hospitals. Heidenreich and associates demonstrated that process of care, as defined by CMS performance measures, is higher in the GWTG-HF–participating hospitals than in other US hospitals. In addition, readmission rates, but not mortality, were lower in GWTG-HF hospitals. In 2016, 637 hospitals were participating in GWTG-HF, and more than 86 publications had originated from the data.

The process of disease management and self-care starts during an acute HF hospitalization. The transition of care from one health care venue (inpatient) to the next (outpatient: home, nursing home, etc.) can be difficult in HF patients. Poor communication between inpatient teams and outpatient caregivers can result in medication errors and other mistakes that can result in adverse events for patients. Forster and associates found that 66% of untoward outcomes in discharged patients were due to adverse drug events. Similarly, Gray and colleagues identified adverse drug events in 20% of patients discharged from hospital to home with home health care services. Naylor et al. conducted a randomized controlled trial of a transitional care intervention for elderly patients hospitalized with acute HF. This 3-month comprehensive program included discharge planning and home follow-up led by advanced practice nurses (APN) with daily visits in the hospital, at least eight home visits (the first one within 24 hours of discharge), and daily telephone availability. Specifically, the intervention included the following components: (1) a standardized orientation and training program guided by a multidisciplinary team of HF for APNs; (2) use of care management strategies including identification of patients’ and caregivers’ goals, individualized plans of care developed and implemented by APNs in collaboration with patients’ physicians, educational and behavioral strategies to address patients’ and caregivers’ learning needs, continuity of care, and care coordination across settings; and (3) APN implementation of an evidence-based protocol. This transitional care intervention decreased rehospitalizations or deaths at 1 year (56/118 [47.5%] vs. 74/121 [61.2%], adjusted P = .01).

Heart Failure Disease Management in the Outpatient Setting

HF practice guidelines have a class I recommendation (level of evidence, A) to implement a multidisciplinary heart failure transitional care and disease management (HFDM) program for individuals at high risk for clinical decline or hospitalization. A variety of HFDM programs has been evaluated. These programs can be clinic based, home visit based, telephone/telehealth based, or a combination of the above. Many of these programs exist but are not properly used. Using GWTG-HF data, Gharacholou et al. showed that patients were not receiving regular referrals to specialized HFDM programs and referral occurred in only 19.2% of patients. The median rate of HFDM referral among all hospitals was 3.5% (25th–75th percentiles 0%–16.7%), and higher in hospitals who previously referred patients to HF management programs. In addition, it appeared that patients at higher risk of 90-day mortality were less likely referred to programs. Thus there is a clear need to improve referrals to these programs, as HFDM programs have been shown to reduce hospitalizations, improve QOL, lower costs, and lower symptom burden, compared with patients not followed in HFDM.

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