Defining Disease Management, 674
The Self-Care Paradigm, 675
Heart Failure Disease Management Classification Schemes, 675
Heart Failure Disease Management in the Inpatient Setting, 675
Heart Failure Disease Management in the Outpatient Setting, 676
Cardiac Rehabilitation for Heart Failure, 676
Clinic-Based Follow-Up, 678
Home Nursing Visits, 678
Telephone Interventions and Telemonitoring, 679
Cardiac Telerehabilitation, 681
Invasive Telemonitoring, 681
Wearables and mHealth in Heart Failure, 684
Why Have We not Seen Clear Benefit With Heart Failure Disease Management Programs? 684
Are We Targeting the Correct Patient Population?, 684
Do We Have the Correct Health Care Providers on the Team?, 684
Are We Measuring the Right Parameters?, 685
Future Direction of Heart Failure Disease Management Programs, 685
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 ).
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.
|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|
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.
Cardiac Rehabilitation for Heart Failure
One of the proven outpatient disease management programs is cardiac rehabilitation (CR). These programs comprise exercise counseling and training, risk factor and dietary education, and stress reduction. The efficacy and safety of exercise training among HF patients was testing the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) trial. This was a multicenter randomized controlled trial of 2331 medically stable outpatients with HFrEF of 35% or less, and NYHA class II to IV symptoms despite optimal medical therapy for at least 6 weeks, which evaluated 36 supervised exercise training sessions in addition to usual care versus usual care alone. There were nonsignificant improvements in the primary endpoints of all-cause mortality and hospitalization (HR, 0.93; 95% CI, 0.84–1.02; P = .13) with exercise training. After adjustment for highly prognostic predictors of the primary endpoint, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization (HR, 0.89; 95% CI, 0.81–0.99; P = .03).
Endurance-type exercise training is known to favorably affect peak VO 2 , central hemodynamic function, autonomic function, peripheral vascular and muscle function, and exercise capacity in HF. To summarize the studies on CR in HF, a Cochrane review was conducted in 2010 and updated in 2017 to include a total of 33 randomized controlled trials with 4740 patients with HF, predominantly HFrEF with NYHA class II to III symptoms. There was no difference seen in pooled mortality in exercise-based CR versus no exercise controls in trials with up to 1-year follow-up (25 trials, 1871 participants, RR 0.93; 95% CI 0.69–1.27, fixed-effect analysis). However, there was trend toward a reduction in mortality with exercise in trials with more than 1 year of follow-up (6 trials, 2845 participants: RR 0.88; 95% CI 0.75–1.02, fixed-effect analysis). In addition, compared with control, exercise training reduced the rate of overall (15 trials, 1328 participants: RR 0.75; 95% CI 0.62–0.92, fixed-effect analysis) and HF specific hospitalization (12 trials, 1036 participants: RR 0.61; 95% CI 0.46–0.80, fixed-effect analysis). Exercise also resulted in a clinically important improvement superior in the Minnesota Living with HF questionnaire (13 trials, 1270 participants: mean difference: −5.8 points; 95% CI −9.2 to −2.4, random-effects analysis). The 2013 ACCF/AHA guidelines for the management of HF provide a class I recommendation for the safety and efficacy of exercise training or regular physical exercise in patients with HF who are able to participate to improve functional status. CR is assigned a class IIa recommendation in clinically stable patients with HF to improve functional capacity, exercise duration, health-related quality of life (QOL), and mortality.
On the basis of the accumulating evidence in favor of CR in HF, on February 18, 2014, the CMS expanded coverage for CR to include patients with stable, chronic HF with LVEF <35% and NYHA II-IV symptoms for 6 weeks despite being on optimal medical therapy and who have not had recent (<6 weeks) or planned (<6 months) major cardiovascular hospitalizations or procedures.
Nevertheless, there are still several challenges to the use of CR in HF patients. The mean age of the HF-ACTION trial patients was 59 years. The incidence of HF increases with age, with incidence of 20 per 1000 in individuals 65 to 69 years of age to more than 80 per 1000 individuals in those older than 85 years of age. The effect of CR in elderly patients is not known. Furthermore, the efficacy and safety of CR in the immediate post HF hospitalization period is not known. There is also a dearth of information on CR in HFpEF patients. Referral to CR overall, and specifically in HF patients, has been low; an estimate using the Get with the Guidelines HF registry reports a 10.4% referral rate between 2005 and 2014, although this has been increasing. Furthermore, CR has a dose response relationship with mortality; therefore adherence to therapy is important, and this has been a challenge with CR overall.
The data on outpatient follow-up for HF patients after hospital discharge have been mixed. In a recent meta-analysis by McAlister and colleagues, the investigators determined that strategies incorporating follow-up by a specialized multidisciplinary team reduced mortality (RR 0.75, 95% CI 0.59–0.96), HF hospitalizations (RR 0.74, 95% CI 0.63–0.87), and all-cause hospitalizations (RR 0.81, 95% CI 0.71–0.92). Programs that focused on enhancing patient self-care activities reduced HF hospitalizations (RR 0.66, 95% CI 0.52–0.83) and all-cause hospitalizations (RR 0.73, 95% CI 0.57–0.93) but had no effect on mortality (RR 1.14, 95% CI 0.67–1.94). Strategies that employed telephone contact and advised patients to contact their primary care physician in the event of deterioration reduced HF hospitalizations (RR 0.75, 95% CI 0.57–0.99) but not mortality (RR 0.91, 95% CI 0.67–1.29) or all-cause hospitalizations (RR 0.98, 95% CI 0.80–1.20). In 15 of 18 trials that evaluated cost, multidisciplinary strategies were cost saving.
Phillips and et al. conducted a meta-analysis to determine the efficacy of interventions consisting of comprehensive discharge planning plus postdischarge support for older inpatients with HF. Eighteen studies with a total of 3304 patients were evaluated. During a pooled mean observation period of 8 months (range, 3–12 months), fewer intervention patients were readmitted compared with controls (555/1590 vs. 741/1714, number needed to treat = 12; RR 0.75; 95% CI 0.64–0.88). There was no statically significant difference in mortality between the control versus the intervention groups.
Using GWTG-HF data, Hernandez et al. examined whether close outpatient follow-up after HF admission affected 30-day readmissions. Data from 225 hospitals, which included 30,136 patients, showed that there was substantial variation in rates of early outpatient follow-up. Those who were admitted to hospitals with the lowest quartile of early follow-up had higher readmission rates (30-day readmission rate, 23.3%) compared with those in higher quartiles: the rates of 30-day readmission were 20.5% among patients in the second quartile (risk-adjusted HR, 0.85; 95% CI, 0.78–0.93), 20.5% among patients in the third quartile (risk-adjusted HR, 0.87; 95% CI, 0.78–0.96), and 20.9% among patients in the fourth quartile (risk-adjusted HR, 0.91; 95% CI, 0.83–1.00). HF patients with decreased mobility may find it difficult to frequently commute to the doctor’s office, especially if they live in rural areas. Given these limitations, alternative HF disease management approaches have been studied, including visiting home nurses, telephone monitoring, and TM.
Home Nursing Visits
There are HF programs that deliver care primarily in patients’ homes. Patients do not routinely go to a clinic or other outpatient setting to receive care; rather, the health care provider calls on the telephone or comes to the home. There are many advantages to implementing a home-based HF disease management program. The home is the most important context of care for individuals with chronic HF. Patients often struggle to manage a complex regimen of medications, follow an unfamiliar diet, monitor weight and vital signs, and work to coordinate care among various providers who, in some cases, fail to communicate effectively. Intuitively, it would seem that a home-based HF disease management approach would improve outcomes and reduce costs. It is unclear if a home-based approach is superior to other types of HF disease management programs.
In 2012, Stewart and associates published the Which Heart Failure Intervention Is Most Cost-Effective and Consumer-Friendly in Reducing Hospital Care? (WHICH) trial, comparing a home-based intervention (HBI) with a clinic-based intervention (CBI). This was a prospective, multicenter, randomized controlled trial that enrolled 280 patients with HF being discharged from the hospital. The primary endpoint was all-cause, unplanned hospitalization or death during a 12- to 18-month follow-up. The primary endpoint occurred in 102 of 143 (71%) HBI versus 104 of 137 (76%) CBI patients (adjusted HR 0.97; 95% CI 0.73–1.30; P = .81). Ninety-six (67.1%) HBI versus 95 (69.3%) CBI patients had an unplanned hospitalization ( P = .89), and 31 (21.7%) versus 38 (27.7%) died ( P = .25). Stewart and colleagues were able to follow 274 of these patients for more than 3 years, and found similar long-term results; that is, home-based interventions were not associated with prolonged event free survival compared with clinic-based interventions.
Despite the merits of a home-based HF disease management program, it may not be feasible to conduct on a large scale due to limited nursing personnel and costs. Therefore, alternative methods of HF disease management have been explored, such as telephone-based interventions and TM.
Telephone Interventions and Telemonitoring
Another method of delivering care involves telephone and TM. STS consists of a health care provider, most often a nurse, calling patients after hospital discharge to confirm adherence to treatment, enhance patient education, and manage symptoms. TM is a digital, broadband, satellite, wireless, or Bluetooth transmission of physiologic data (e.g., electrocardiogram [ECG], blood pressure, weight, pulse oximetry, and respiratory rate). Both models of care have the potential to provide access to specialist care for a much larger number of patients across a much greater geography and might reduce the cost of care. However, as in HF disease management trials of multidisciplinary clinics and home nursing visits, the results of trials in STS and TM are mixed.
The Alere Trial (HF Home Care Trial), published in 2008, was a multicenter randomized controlled trial examining a computer-based home disease management program among older minority and female Medicare beneficiaries with HF receiving care in a community-based primary care setting. The study randomized 315 patients to examine the effect of the Alere DayLink Monitoring System in a resource-limited, diverse population. The HFMS system was compared with standard HF care, including enhanced patient education, education to clinicians, and follow-up. The primary endpoint of treatment failure, defined as the composite of cardiovascular death or rehospitalization within 6 months of enrollment, was compared between groups. No statistically significant difference was found between groups.
The Home or Hospital in Heart Failure (HHH) study was a multinational, randomized controlled clinical trial, conducted in the United Kingdom, Poland, and Italy. Across these 11 centers, 461 HF patients were enrolled and randomized to either the usual outpatient care or HTM administered as three randomized strategies: (1) monthly telephone contact, (2) strategy 1 plus weekly transmission of vital signs, and (3) strategy 2 plus monthly 24-hour recording of cardiorespiratory activity. Over a 12-month follow-up, there was no significant effect of HTM in reducing bed-days occupancy for HF or cardiac death plus HF hospitalization. In 2012, the Interdisciplinary Network for Heart Failure (INH) study developed and evaluated in a randomized, controlled trial a nurse-coordinated disease management program (HeartNetCare-HF, HNC) ; 715 patients hospitalized for systolic HF were randomly assigned to HNC or usual care (UC). Besides telephone-based monitoring and education, HNC addressed individual problems raised by patients, pursued networking of health care providers, and provided training for caregivers. Endpoints were time to death or rehospitalization. Within 180 days, 130 HNC and 137 UC patients reached the primary endpoint (HR 1.02; 95% CI 0.81–1.30; P = .89), because more HNC patients were readmitted. Overall, 32 HNC and 52 UC patients died. Uncensored HR was 0.62 (0.40–0.96; P = .03). HNC patients improved more regarding NYHA class ( P = .05), physical functioning ( P = .03), and physical health component ( P = .03).
In 2010, Chaudhry and colleagues published the Tele-HF study, a multicenter, randomized controlled trial to determine whether TM would reduce the combined endpoint of readmission or death from any cause among patients recently hospitalized for HF; 1653 patients were randomized to TM versus usual care. The intervention consisted of an interactive voice response system that collected data but did not provide education. Adherence with the system was poor, suggesting that patients did not engage with the service, perhaps because of the nature of the technology. There was no significant difference between the two groups with respect to readmission for any cause or death.
In 2011, Koehler and associates published Impact of Remote Telemedical Management (RTM) on Mortality and Hospitalization in Ambulatory Patients with Chronic Heart Failure: the Telemedical Interventional Monitoring in Heart Failure Study (TIM-HF). This was a multicenter, randomized controlled trial designed to determine whether physician-led RTM compared with UC would result in reduced mortality in ambulatory patients with chronic HF; 710 stable HF patients (NYHA class II and III) were randomly assigned to RTM or UC. RTM used portable devices for ECG, blood pressure, and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers. The primary endpoint was death from any cause. The first secondary endpoint was a composite of cardiovascular death and hospitalization for HF. Compared with UC, RTM had no significant effect on all-cause mortality (HR 0.97; 95% CI 0.67–1.41; P = .87) or on cardiovascular death or HF hospitalization (HR 0.89; 95% CI 0.67–1.19; P = .44). The lack of significant clinical improvement in TIM-HF may be related to the target population. Stable patients who are exceptionally well managed may not obtain as much benefit from TM as a group of patients who may not have exposure to such high-quality care at baseline. The Weight Monitoring in Patients with Severe Heart Failure (WISH) Trial was published in 2012. This was a multicenter, randomized controlled trial designed to determine if daily electronic transmission of body weight to a HF clinic would reduce cardiac hospitalization in patients recently hospitalized with HF. A total of 344 patients were randomized to the intervention group versus the control group. No significant differences were found for the primary endpoint, cardiac rehospitalization (HR 0.90; 95% CI 0.65–1.26; P = .54), or for the secondary endpoints, which included all-cause hospitalization (HR 0.83; 95% CI 0.61–1.13; P = .24), death from any cause (HR 0.57; 95% CI 0.19–1.73; P = .32), or the composite endpoint of cardiac hospitalization and death from any cause (HR 0.90; 95% CI 0.65–1.26; P = .54).
Bekelman et al. conducted a randomized controlled trial comparing a collaborative patient-centered disease management program of HF patients at four Veterans Affairs centers. Each intervention team consisted of a local primary care provider, cardiologist, psychiatrist, and nurse coordinator (registered nurse). The team assessed each intervention patient through a review of the VA electronic health record and baseline depression scores. In addition, the intervention patients received daily TM which collected biometric data and self-reported symptoms. After 1 year, there was significant improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scores in both groups. There were fewer deaths at 1 year in the intervention arm (8 of 187 [4.3%]) than in the usual care arm (19 of 197 [9.6%]) ( P = .04). There was no significant difference in 1-year hospitalization rates between the intervention arm and the usual care arm (29.4% vs. 29.9%, P = .87).
A Cochrane Review evaluating the effectiveness of STS and TM as a primary component of a chronic HF disease management program was published in 2011. They included randomized controlled trials comparing TM or STS to UC in patients with HF. The primary outcomes analyzed were mortality and hospitalizations. Twenty-five peer-reviewed studies were included (11 evaluated TM and 16 evaluated STS, with 2 studies testing both TM and STS). Tele-HF, TIM-HF, and WISH were not included, because they were reported after the meta-analysis was completed. TM reduced all-cause mortality (RR 0.66; 95% CI 0.54–0.81; P < .0001). STS showed a similar but nonsignificant trend (RR 0.77; 95% CI 0.76–1.01; P = .08) ( Fig. 47.2 ). Both TM (RR 0.79; 95% CI 0.76–0.940; P = .008) and STM (RR 0.77; 95% CI 0.68–0.87; P < .0001) reduced HF-related hospitalizations. The quality of the methods used in the studies was variable, and many of the studies were small.