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INTRODUCTION

The medical and financial burden of heart failure hospitalizations has led to a substantive body of research characterizing the timing and etiology of readmissions, identifying methods that predict readmission, and evaluating strategies that reduce readmissions. Findings from epidemiologic surveys indicate that 30% of readmissions occur during the first 2 months after hospital discharge, 50% of readmissions occur within the last 2 months prior to death, and the remaining 20% of readmissions occur between these time periods.^1,2 This pattern of readmissions has been referred to as the “three-phase terrain” of heart failure readmissions.³

The Patient Protection and Affordable Care Act established the federal Hospital Readmissions Reduction Program (HRRP) in 2012. Medicare payments to hospitals that have excess all-cause hospital readmissions following an admission for heart failure, myocardial infarction, or pneumonia are reduced.⁴ Since 2012, additional diagnoses have been added to this list with an increased amount of reimbursement at risk for hospitals with excess readmissions. Since the establishment of the HRRP, hospitals have placed a greater emphasis on efforts to reduce 30- day readmissions for patients with these conditions. It is important to note, however, that efforts to reduce recurrent hospitalizations in heart failure patients had been ongoing for at least 2 decades prior to the introduction of the HRRP. The purpose of this monograph is to review the available evidence concerning strategies to reduce hospital readmissions in heart failure patients with an emphasis on the pharmacist’s responsibilities in the implementation of these strategies.

CHARACTERIZATION OF HEART FAILURE HOSPITALIZATIONS

Over 1 million hospitalizations for HF occur each year in the United States.⁵ In addition, over a half million emergency department visits annually for heart failure. Heart failure accounts for more than 25% of all cardiovascular hospitalizations in the U.S.⁶ It is estimated that 20% of hospitalizations are for new onset heart failure with the remaining 80% representing hospital readmissions in patients with a prior diagnosis of heart failure. Approximately 20% of patients discharged after a heart failure hospitalization are readmitted within the first 30 days after discharge.⁷ The frequency of readmissions is approximately the same in patients with HFrEF compared to patients with HFpEF.⁵ Approximately 17% to 35% of readmissions can be attributed to heart failure exacerbations with 60% or more of readmissions secondary to non- cardiovascular etiologies.⁸ The 5 most common reasons patients with heart failure are readmitted include, in order, heart failure, renal disease, pneumonia, cardiac arrhythmia, and sepsis. This finding highlights the need to focus on the entirety of comorbidities present in heart failure patients.

Strategies designed to reduce readmissions is bolstered by data indicating that a substantial number of readmissions in heart failure patients are avoidable.^9,10 Approximately half of patients believe their readmissions were avoidable and attribute them to medication non- adherence and a lack of knowledge about their disease process.¹¹ A substantial number of individual risk factors have been identified as predictors of heart failure readmissions.^12,13 Table 1 lists the most common avoidable causes of heart failure readmissions. A major obstacle in developing strategies to reduce readmissions in heart failure patients is the inability to identify patients at the highest risk of readmission.¹⁴ Many risk prediction models for heart failure have been studied. These risk prediction models have greater correlation with mortality in patients with heart failure than their ability to predict hospital readmissions. The Centers for Medicare and Medicaid Services (CMS) currently uses the Readmission Risk Score for Heart Failure (Figure 1) to predict readmissions. It is interesting to note that this risk score does not include several variables that may be valuable predictors of readmission including natriuretic peptide levels, NYHA functional class, or the use of guideline directed medical therapy.

Table 1. Avoidable Causes of Heart Failure Hospital Readmissions

Inadequate education and counseling of the patient, family, and/or caregiver Inadequate discharge planning Failure to provide adequate follow-up care Failure to follow non-pharmacologic therapy recommendations Diet, activity, and symptom monitoring Lack of self-care adherence Failure to address the multiple and complex issues that impact patient care Medical (medication adherence, multiple comorbidities) Behavioral (barriers to change, readiness to change, internal motivation) Psychosocial (depression, anxiety, cognitive impairment, social isolation, low health literacy) Environmental (physical or geographic isolation, physical barriers in home) Financial (poverty, lack of health insurance, lack of prescription insurance) Failure of healthcare providers to prescribe guideline directed medical therapy and disease management programs when indicated Pharmacologic Non-pharmacologic Device therapy

STRATEGIES TO REDUCE READMISSIONS IN HEART FAILURE

Once a patient is diagnosed with heart failure, comprehensive pharmacologic and non- pharmacologic therapy should be provided. This would include initiation of guideline-directed medical therapy demonstrated to improve survival and to reduce symptoms and functional class where indicated.^15,16 Most of these drugs used in heart failure require careful titration to achieve optimal hemodynamic and symptom status. At each patient encounter, patients should receive education and counseling about diet, exercise, and medication usage. Patient encounters are typically divided into specific areas of patient care and the nature and intensity of education and counseling should be encountered based on the setting in which patient encounters occur (inpatient, outpatient, and transitions of care). Once a heart failure patient is hospitalized, opportunities to provide more extensive therapeutic interventions can be considered. Referral to a disease management program may be considered, but should be individualized based on the specific patient characteristics. The essential components of a disease management program for heart failure are outlined in Table 2.¹³ The relative utility of the most common types of interventions used in heart failure disease management programs are summarized below.

Table 2. HFSA Recommended Elements of Heart Failure Disease Management Programs13

Comprehensive education and counseling individualized to the patient and patient's environment Promotion of self-care behaviors including potentially self-titration of diuretic dosing (with family member/healthcare provider assistance) Emphasis on behavioral strategies to ensure adequate compliance Adequate follow-up after hospital discharge or clinical instability (preferably within the first 7 days after event) Optimization of oral therapy especially evidenced-based therapy Adequate access to healthcare providers Early attention to signs and symptoms of fluid overload Assistance with financial and social concerns

HFSA = Heart Failure Society of America

In-Home Care Interventions

In-home care visits were one of the earliest interventions to be evaluated in randomized studies of patients discharged following a hospitalization for heart failure.¹⁷ A comprehensive review of the outcome of every study to include home visits as part of a disease management program is beyond the scope of this monograph. Studies that included home visits were inconsistent in terms of both study design and results.^17,18 Several studies included only 1 or 2 in-home visits. Most studies included relatively small numbers of patients. Some studies did not include a comprehensive description of the specific interventions provided during home visits. However, home visits were typically conducted by a nurse or pharmacist who provided education and counseling about diet, physical activity, medication use, and self-care strategies. Several studies demonstrated reductions in hospital readmissions compared to usual care. However, none of the studies incorporating in-home visits demonstrated reductions in mortality. Only 2 studies reported readmission rates at 30 days.^19,20 One study which included 3 months of home visits by an advanced practice nurse demonstrated a significant decrease in all-cause readmissions at 30-days that persisted through the one year follow-up period.²⁰

In the largest published study to incorporate home visits into the disease management intervention, home visits had no favorable impact on outcomes.²¹ The Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH), randomized 1023 patients with NYHA class II/III heart failure to 1 of 3 interventions including a control group (n = 339), a basic support group (n = 340), and an intensive support group (n = 344). All 3 interventions included 4 visits to a cardiologist over an 18-month follow-up period after a heart failure hospital discharge. The basic support intervention included 9 additional visits to a heart failure specialist nurse at an outpatient clinic. The intensive support intervention included 18 additional visits to a heart failure specialist nurse at an outpatient clinic, 2 home visits by the nurse specialist with one occurring in the first month after discharge, and 2 multidisciplinary advice sessions. The usual care group included only the 4 outpatient visits to a cardiologist. The primary endpoint of the composite of heart failure readmission or all-cause mortality occurred in 141 (42%) control patients, 138 (38%) patients in the basic support group, and 132 (38%) patients in the intensive support group. Analysis of the time to the first event determined hazard ratios of 0.96 (95% CI 0.76-1.21; P = 0.73) and 0.93 (95% CI 0.73-1.17; P = 0.53) for the composite outcome comparing basic and intensive support against the control group. All-cause mortality and hospitalizations were not different among the patients randomized to the 3 interventions. The frequency of healthcare contacts initiated by the patient was greater than prescribed in the protocol in all 3 interventions. This was the greatest in the basic support group where the increase in healthcare contacts was 40% while the increase in the control group was 33%. This increase was only 10% in the intensive support group.

The most recently published trial including home visits was a randomized comparison against patients who were seen in a walk-in specialty heart failure clinic. The WHICH (Which Heart Failure Intervention Is Most Cost-Effective & Consumer Friendly in Reducing Hospital Care) study randomized 143 patients to a home-based intervention (HBI) and 137 patients to a specialized heart failure clinic based intervention (CBI) with 12 to 18-month follow- up.²² The primary outcome was the composite of all-cause unplanned hospitalizations or death. There was no significant difference in the primary composite outcome between the HBI (71%) and the CBI (76%) (adjusted hazard ratio 0.97; 95% CI 0.73 to 1.30; P = 0.86) There were also no significant differences in unplanned hospitalizations between the HBI (67%) and the CBI (69%) (P = 0.88) or in all-cause mortality (22% with HBI and 28% with CBI; P = 0.25). Patients in the HBI group did have a significantly shorter median duration of days of hospitalization. The median duration of hospitalization with HBI was 4.0 days (interquartile range of 2.0 to 7.0 days) compared to 6.0 days (interquartile range 3.5 to 13 days) (P = 0.004). Although the HBI was not associated with a significant improvement in the primary outcome compared to the CBI, the shorter hospital stay with HBI was associated with a lower overall healthcare cost (P = 0.03). The costs of the providing the interventions were not significantly differently between HBI ($1813 per patient) and CBI ($1829 per patient).

Outpatient Visit Interventions

No disease management programs using outpatient clinic visits as the primary intervention have reported readmission rates at the 30-day follow-up interval. Outpatient clinic visits utilizing multidisciplinary groups of healthcare providers have demonstrated an ability to significantly reduce all-cause readmissions in heart failure patients at 6 to 12 months of follow- up. As with in-home clinic visits, outpatient specialty heart failure clinics are resource-intensive.  These interventions require patients to travel to clinic locations, which limits their access on a geographic basis.

The results of 2 of the larger trials which included outpatient clinic visits as part of interventions to reduce readmissions were previously discussed. The COACH study found no benefit of adding bi-monthly or monthly outpatient visits compared to usual care.²¹ The WHICH study compared HBI and CBI but did not include a control group.²² In the Heart Failure Adherence and Retention Trial (HART), 902 patients with NYHA class II/III heart failure were randomized to self- management plus an education intervention that included 18 two-hour group meetings offered during the first year after randomization or to an education-alone group who received 18 “Heart Failure Tip Sheets” mailed on the same schedule as the group meetings.²³ Telephone calls were made within 2 to 3 days after each mailing to ensure receipt and comprehension. Patients were followed for a minimum of 2 years (one year of treatment and one year of post- treatment follow-up). The rate of the primary composite outcome of heart failure hospitalization plus all-cause mortality was no different in the self-management plus education group (163 events, 40%) compared to the education alone group (171 events, 41%) after a mean follow-up of 2.56 years (odd ratio 0.95; 95% CI 0.72-1.26). There were also no significant differences in the secondary endpoints of death, heart failure hospitalization, all-cause hospitalization, or quality of life.

Structured Telephone Support Interventions

Disease management interventions relying on outpatient or home visits are resource intensive, costly, and are limited in the numbers of patients that can be impacted. Telemanagement using phone calls or the more complex transmission of patient-related clinical variables (telemonitoring) over telephone or internet connections have the potential to reach unlimited numbers of heart failure patients providing monitoring, education, and self-care management. The format of the telephone calls studied in many these trials used a structured format (e.g., series of scheduled calls with a specific goal, structured questioning, or use of decision-support software).^17,18

Only one small study reported readmission rates at 30 days that compared structured telephone support against usual care.²⁴ Structured telephone support was not associated with a reduction in all-cause hospital admissions. A meta-analysis published in 2007 which pooled the results of 10 studies of structured telephone support concluded that telephone follow-up significantly reduced heart failure readmissions, but did not significantly reduce all-cause mortality or all-cause hospitalization.²⁵ Two of the structured telephone support studies were randomized comparisons against non-invasive telemonitoring disease management programs.^26,27 These studies are discussed in detail in the non-invasive telemonitoring intervention section below.

Non-invasive Telemonitoring Interventions

Non-invasive telemonitoring typically involves remote monitoring of physiologic data (e.g., electrocardiogram, blood pressure, weight, pulse oximetry, respiratory rate, and symptom questionnaires).¹⁸ This data are then conveyed using wireless or internet transmission to a monitoring center. The data can be transmitted on a daily or less-frequent basis. These data are typically reviewed by a nurse specialist or physician to identify patients at risk for clinical deterioration. In response, patients can have medications adjusted (typically diuretic dosages) or be directed to seek medical attention at a clinic or emergency department.

Only one small study reported readmission rates at 30-days comparing non-invasive monitoring against usual care.²⁸ This study was not able to demonstrate a significant reduction in all-cause hospital admissions in patients receiving non-invasive monitoring. A Cochrane database review conducted a meta-analysis including a total of 27 controlled studies including 11 using non- invasive telemonitoring (2710 patients) and 16 using structured telephone support (5613 patients).²⁹ All-cause mortality was significantly reduced by telemonitoring (RR 0.66; 95% CI 0.54-0.81; P < 0.001). Structured telephone support reduced all-cause mortality, but the effect was not statistically significant (RR 0.88; 95% CI 0.76-1.01; P = 0.08). Heart failure hospitalizations were significantly reduced by both telemonitoring (RR 0.79; 95% CI 0.67-0.94; P = 0.008) and structured telephone support (RR 0.77; 95% CI 0.68-0.87; P < 0.0001). Neither structured telephone support nor telemonitoring demonstrated significant reductions in all- cause hospitalizations (structured telephone support: RR 0.95, 95% CI 0.90 to 1.00; non-invasive telemonitoring: RR 0.95, 95% CI 0.89 to 1.01).

Two relatively large randomized controlled studies compared structured telephone support against non-invasive telemonitoring. The Trans-European Network-Home Care Management System (TEN-HMS) study randomized 426 patients to usual care (n = 85), structured telephone support (n = 173) or to non-invasive telemonitoring (n = 168).²⁶ Telemonitoring including twice daily transmission of weight, blood pressure, heart rate, and cardiac rhythm. The primary composite endpoint of all-cause mortality plus all-cause hospitalization as well as the composite of all-cause and heart failure hospitalizations were not significantly different between either of the intervention groups compared to usual care. The differences in these endpoints were also not significantly between telephone support and telemonitoring. However, both intervention groups were associated with significant reductions in all-cause mortality compared to usual care.

The second randomized trial comparing structured telephone support and telemonitoring randomized 160 patients to usual care and 301 patients to 1 of 3 intervention groups.²⁷ Strategy 1 employed structured telephone support alone (n = 104), strategy 2 employed structured telephone support plus weekly transmission of vital signs including changes in weight, blood pressure and symptoms (n = 96), and strategy 3 employed the same intervention used in strategy 2 plus a monthly 24 hour cardiorespiratory recording (n = 101). The cardiorespiratory recording included a 24-hour continuous electrocardiographic recording and assessment of physical activity. All-cause hospitalization, heart failure hospitalization, and mortality were not significantly reduced in either of the intervention groups compared to control patients.

Invasive Telemonitoring Interventions

Four different types of invasive hemodynamic monitoring interventions have been evaluated in patients with heart failure.¹⁷ These include intrathoracic impedance monitoring, pulmonary artery pressure monitoring, right ventricular pressure monitoring, and left atrial pressure monitoring. There are relatively few randomized, controlled trials using invasive hemodynamic monitoring to reduce hospital readmissions in heart failure patients. Only one invasive monitoring intervention has received FDA approval for reductions in readmissions in patients with heart failure. The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) study randomized 550 patients with the pulmonary artery wireless pressure monitor to a treatment group in which clinicians were given access to the pressure results (n = 270) or to a control group in which clinicians did not receive pressure results (n = 280).³⁰ The primary study endpoint was heart failure hospitalizations at 6 months. The rate of heart failure hospitalizations was significantly reduced in the treatment group at 6 months and at the end of the entire follow-up period (15 months). At 6 months, there were 84 heart failure hospitalizations in the treatment group and 120 in the control group (28% RRR; P = 0.0002). At 15 months, there was a 37% reduction in heart failure hospitalizations in the treatment group compared to the control group (P < 0.0001). All-cause hospitalization and mortality were not reported in CHAMPION.

The Heart Failure Society of America (HFSA) and the European Society of Cardiology (ESC) Heart Failure Association recommend enrollment in disease management programs for patients with heart failure who have been recently hospitalized or for high-risk heart failure patients.^31,32 High-risk patients include those with renal dysfunction, diabetes mellitus, chronic obstructive pulmonary disease, NYHA class III or IV symptoms, frequent hospitalizations for any reason, multiple comorbidities, a history of depression, cognitive impairment, inadequate social or home support, poor health literacy, or a history of non-adherence to treatment recommendations. Although comprehensive discharge planning with post-discharge support has been shown to reduce readmission rates in heart failure patients, substantial numbers of patients continue to be readmitted.^33,34 Recent changes in healthcare policy and the HHRP have increased the importance of reducing hospital readmissions in patients discharged with a heart failure diagnosis.

THE ROLE OF THE PHARMACIST IN REDUCING HEART FAILURE READMISSIONS

Pharmacists play a vital role in the education and counseling of the heart failure patient with special emphasis on the appropriate use of drug therapy. The HFSA in conjunction with the American College of Clinical Pharmacy (ACCP) published a position paper that outlined roles for pharmacists in the care of the heart failure patient. Pharmacists can play an essential role in all settings of patient care including hospitalization, the transition from hospital to home, and in the outpatient setting including an active role in the disease management team.³⁵ It is also recommended that pharmacists be included in the multidisciplinary teams of healthcare providers who care for patients receiving heart transplants or mechanical circulatory support devices at institutions providing those interventions. Published data indicates that pharmacist involvement in heart failure care is associated with increased use of guideline-directed medical therapy, reductions in hospitalizations and emergency department visits for heart failure, and a decrease in all-cause hospitalizations. The HFSA/ACCP position paper outlines the specific activities pharmacists should perform in the heart failure patient to reduce the risk of hospital admissions (Table 3).³⁵ These activities include therapeutic drug monitoring, medication reconciliation, prevention of adverse drug reactions and medication errors, evaluation of access to medications and adherence to medications, documentation of processes of care, and dealing with specific drug related problems.

Table 3. HFSA/ACCP Consensus Recommendations – The Role of the Pharmacist in Reducing Hospitalizations in Patients with Heart Failure35

Prevention of adverse events and medication errors Therapeutic drug monitoring Medication reconciliation Medication adherence and access Documentation of processes of care Managing specific drug related problems Untreated conditions – failure to use appropriate therapy Improper drug selection – use of a contraindicated drug Sub-therapeutic dosing Failure to receive drugs – non-adherence Higher than necessary doses Adverse drug reactions Drug use without indication Improper drug storage Dispensing errors Duplication of drug therapy

HFSA=Heart Failure Society of America; ACCP=American College of Clinical Pharmacy

The ACCP Cardiology Practice and Research Network (PRN) has published a best practices document for discharge counseling in the heart failure patient.³⁶ Table 4 summarizes the areas of focus that should be emphasized during counseling sessions with heart failure patients.³⁶ This document reiterates that pharmacists should counsel patients at each contact. Another important recommendation is that an early counseling session should be intensive lasting a minimum of 20 to 30 minutes. The exception to this is in the patient who initially presents with heart failure in the hospital setting. In the patient initially diagnosed with heart failure during a hospitalization, patients receiving more intensive counseling at 1 to 2 weeks post-discharge have greater retention of information. Teaching methods should be varied and based on the patient’s health literacy, cognition, severity of disease, and readiness to learn. Printed educational materials are especially important since the information they provide is durable. Finally, the time where patients are at the greatest risk of readmission is during a transition of care (i.e. early post-hospital discharge). Contact with patients during this time is the most important in terms of preventing avoidable hospital readmissions. The use of discharge/transition of care checklist which requires pharmacists to record patients’ lists of medications and that counseling and education have been completed has been shown to significantly reduce 30-day hospital readmissions that persisted during a 6-month follow-up period.

Table 4. ACCP Cardiology Practice and Research Network Recommendations for Discharge Counseling in Patients with Myocardial Infarction or Heart Failure36

Address existing barriers to optimal therapeutic management Thorough review of medications Guideline directed medical therapy Focus on medications to avoid Ensure vaccinations are up to date Counsel and educate at all patient contacts (inpatient and outpatient) Tailor message to severity of disease Limit information provided in hospital to that considered essential Intensive counseling post-discharge for greater retention Focus on lifestyle modifications Focus on periods of transitions of care (post-discharge is vulnerable period for readmissions) Assess readiness of patient to learn (health literacy and cognition) Vary teaching methods Written materials (6th grade level) Graphs, pictures, figures Internet Telephone Motivational interviewing Engage caregivers (family, friends, hired or volunteer) Engage healthcare providers Emphasize self-care strategies Use teach back method Assess patient resources (financial, social support) Consider referral to a disease management program

ACCP=American College of Clinical Pharmacy

Patients with heart failure should typically be receiving 3 to 6 drugs specifically for heart failure based on current guidelines.^15,16 During hospitalizations for heart failure, almost 50% of patients require the addition of one medication, 24% require the addition of 2 medications, and 14% require the addition of 3 medications to comply with the ACC/AHA/HFSA guidelines.³⁷ These findings are important as patients receiving appropriately dosed guideline-directed medical therapy for heart failure have improved outcomes and fewer hospital readmissions.^39-40 A meta-analysis of medication adherence interventions documented that improved medication adherence in heart failure patients was associated with significant reductions in all- cause mortality and hospitalizations.⁴¹ Patients should be educated about what heart failure is, the type of heart failure they have, its most likely cause, and risk factors for progression. Patients should be educated to recognize signs and symptoms of disease exacerbation and what specific course of action they should follow should an exacerbation occur. Patients need to be educated about all aspects of their use of medications for heart failure and other disease states. Education should also be provided about diet, exercise, and management of risk factors associated with other negative health outcomes (i.e., smoking cessation). Medication adherence strategies should be individualized to fit patients’ lifestyles and facilitate the ease of prescription refills.

SUMMARY

Hospital admissions in heart failure patients are perceived as an indication of either disease progression or poor medical management with substantial economic consequences. Institutions vary considerably regarding their in-patient processes of care, education and counseling at discharge, care transitions, and quality improvement initiatives. Studies evaluating a variety of disease management programs have found mixed results in their ability to consistently reduce hospital readmissions in large groups of heart failure patients. Combinations of disease management strategies individualized to specific patients are most likely to be successful in reducing hospital readmissions. Pharmacist involvement in the care of the heart failure patient has been shown to improve both the process of care and clinical outcomes. Pharmacists’ involvement in the care of the heart failure patient increases the use of guideline directed medical therapy, reductions in hospitalizations and emergency department visits for heart failure, and reductions in all-cause hospitalizations. The HFSA and the ACCP recommend that pharmacists be included in the multidisciplinary healthcare team caring for heart failure patients.

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