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J Am Coll Cardiol, 2002; 40:1259-1266 © 2002 by the American College of Cardiology Foundation |
* Fondazione "Salvatore Maugeri," IRCCS, Dipartimento di Cardiologia, Istituto Scientifico di Montescano, Montescano, Pavia, Italy
Manuscript received December 28, 2001; revised manuscript received May 13, 2002, accepted June 27, 2002.
* Reprint requests and correspondence: Dr. Soccorso Capomolla, Department of Cardiology, Montescano Medical Center, Via per Montescano, 27040 Montescano, Pavia, Italy.
scapomolla{at}fsm.it
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Abstract |
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BACKGROUND: Previous studies showed that about 50% of readmissions for CHF can be prevented by a multidisciplinary approach However, the performance, effectiveness, and cost/utility ratio of a process of HF outpatient management related to evidence-based medicine have not been considered.
METHODS: A total of 234 prospective patients discharged by a HF Unit were randomized to two management strategies: 122 patients to usual community care and 112 patients to a HF management program delivered by the DH. Management (rate of readmissions, therapeutic interventions), functional parameters (New York Heart Association [NYHA] functional class, left ventricular diameters, and ejection fraction, deceleration time of early diastolic mitral flow, peak oxygen uptake, and mitral regurgitation) and hard outcomes (cardiac death and urgent cardiac transplantation) were evaluated. The cost/utility ratios of the two strategies were compared.
RESULTS: After 12 ± 3 months of follow-up, the individual rate access in DH was 5.5 ± 3.8 days. The DH subjects were readmitted to the hospital less frequently than were the usual-care group patients (13 vs. 78, p < 0.00001). Patients allocated to usual-care management showed heterogeneous changes in NYHA functional class (13% improved and 16% worsened p = NS); In contrast, the DH group showed significant changes in NYHA functional class (23% improved and 11% worsened, p < 0.009). Hard cardiac events in the one-year follow-up occurred in 25/234 (10.6%) patients; cardiac death occurred in 21/122 (17.2%) of the community group and in 3/112 (2.7%) in the DH group (p < 0.0007). One DH patient underwent urgent transplantation. Comparison of the two managerial models by Cox regression analysis showed that DH management significantly protected against the appearance of hard events (relative risk [RR] 0.17; confidence interval [CI] 0.06 to 0.66). The cost/utility ratio of the two management strategies was similar (usual care $2,409 vs. DH $2,244). The incremental analysis revealed a cost savings of $1,068 for each quality-adjusted life year gained. The cost/utility ratio for the integration of DH management of CHF was $19,462 (CI $13,904 to $34,048).
CONCLUSIONS: A heart failure outpatient management program delivered by a DH can reduce mortality and morbidity of CHF patients. This management strategy is cost-effective and has an equitable value from a societal point of view.
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In the early 1990s, a Heart Failure Unit (HFU) was opened in the Medical Center of Montescano. In 1998, a day-hospital (DH), dedicated and open to the community, was established within the HFU, increasing the HF management options available. In this study we describe our comprehensive HF outpatient management program and evaluate cost-effectiveness of this different approach relative to the usual program of care after discharge from an HFU.
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Methods |
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Patients. Patients with CHF referred to the HFU of Montescano Medical Center and the Heart Transplantation Program of the Cardiac Surgery Division of Policlinico S. Matteo, Pavia, between January 1999 and January 2000 were considered. The diagnosis of CHF was supported by clinical history, physical signs and symptoms, and by echocardiographic findings (left ventricular ejection fraction [LVEF] <40%). At referral, patients underwent an initial cardiac prognostic stratification that included a clinical examination, functional status evaluation (NYHA functional class), cardiopulmonary exercise test (peak oxygen uptake [VO2]), echo-Doppler examination (LVEF, mitral regurgitation, left end-diastolic and end-systolic diameters, and deceleration time of early diastolic filling wave), and right hemodynamic measurements (pulmonary wedge pressure, cardiac index). After this first step the patients were prescribed individual tailored therapy following heart practice guidelines and evidence-based medicine (EBM) (16–18). At discharge the patients were randomized either to receive usual care or to enter the HF management program performed in the DH of the HFU.
Management strategies.
Usual care
Patients were referred to their primary care physician and cardiologist. During follow-up the process of care was driven by the patient’s needs into a heterogeneous range of emergency room management, hospital admission, and outpatient access. After 12 months all patients were reevaluated at the HFU by repeating the baseline tests and investigations.
Day-hospital
Staff
The staff of the HF management program consists of one cardiologist, four trained nurses with consolidated experience, and two physiotherapists. There is also part-time participation of a dietician, a psychologist, and a social assistant. The objectives of the multidisciplinary staff are prevention and functional recovery of consequences of acute hemodynamic instabilization. The team members also have the task of creating, analyzing, and correcting the organization that supports the process of treatment identified in an individual care plan (19). There are three different organizational levels (physician, nurse, physiotherapist), each of which coordinates with the others to achieve the treatment objectives. The team management used current HF guidelines and EBM criteria.
Process of care
The process of care is discussed in collaboration among the different health care professionals. A plan of care is structured for each patient (20) and defines: 1) appropriateness of the access; 2) type of access (new patient, patient activated in a program of cardiac transplantation, control or open access); 3) objective of the process (prognostic stratification, therapeutic optimization, analysis of the primary pathology, check of clinical stability, review of cardiovascular risk factors, review of factors of risk for hemodynamic instabilization); 4) use of tools (cardiac echo-Doppler, cardiopulmonary exercise test, Holter monitoring, right heart catheterization, psychological support, nutritional intervention, counseling); 5) markers of outcomes, and finally 6) follow-up counseling.
Tailored interventions
According to the characteristics of the patient and the phase of the illness, particular areas of intervention are:
Patient follow-up
Access to the DH is modulated according to the demands of the care process. If organ function deteriorates during follow-up, or if signs/symptoms of HF develop, the patient re-enters the DH through an open-access program allowing extemporaneous performance of a new care process (intravenous [IV] therapy, laboratory examinations, instrumental controls, therapeutic changes). If the decompensation requires full-time observation, the patient is transferred to the HFU.
Outcome measurements
Three types of outcomes were identified: readmission in hospital and pharmacologic tailored therapy were evaluated as management outcomes; NYHA functional class, left ventricular diameters and ejection fraction, deceleration time of early diastolic filling wave, mitral regurgitation, peak VO2, and quality of life, appraised by the time–trade-off method, were considered as functional outcomes. Finally, death from a cardiac cause was analyzed as a hard outcome. These outcomes were evaluated after a mean follow-up of 12 months.
Economic analyses.
Costs
The cost/utility analysis was performed in a societal perspective (21). The initial and final admissions were not included in the costs of managing the two groups. Cost of readmissions and the management costs of the DH during the follow-up were calculated using the Medicare diagnosis-related group (DRG) reimbursement. We assessed the costs of daily medical therapy by using the average dose of therapy at exit from the two management processes to calculate the number of tablets taken during the follow-up and multiplying this number by the cost per tablet reported in the annual formulary (22). These costs were actualized by assuming an annual rate of increase of 5% (23) and are expressed in U.S. dollars.
Life expectancy
For the evaluation of life expectancy, the two management strategies were considered outcome predictors, adjusting for age, gender, etiology, NYHA functional class, LVEF, peak VO2, baseline heart rate, and mean arterial pressure. The association between predictor variables and outcome was assessed by fitting follow-up data with a Cox proportional hazards regression model. All patients who died from noncardiac causes and those who underwent elective cardiac transplantation were considered as censored observations. The end point of the study was cardiac mortality or urgent heart transplantation. Event-free distribution functions were estimated by the Kaplan-Meier method. Life expectancy was calculated as the area under each curve. The increase in life expectancy was evaluated as the difference between the areas under the two curves (24).
Sensitivity analysis
The sensitivity analyses were performed by recalculation of the cost/utility ratio using an analysis of the extremes; we varied survival (confidence limits) and costs in both prospectives (higher and lower); utility was also recalculated to reflect the current state of health in the new scenario.
Statistical analysis. Between-group comparisons of baseline clinical and functional parameters were performed by one-way analysis of variance for continuous variables and by the chi-square test for categorical variables.
For the purpose of the prognostic evaluation, the two management strategies were considered as predictors of outcome, adjusting for age, gender, etiology, NYHA functional class, LVEF, peak VO2, baseline heart rate, and the mean arterial pressure. The combined end point was cardiac mortality and urgent heart transplantation. Event-free distribution functions were estimated by using the Kaplan-Meier method. Associations between predictor variables and outcome were assessed by fitting follow-up data with a Cox proportional hazards regression model. All patients who died from noncardiac causes and those who underwent elective cardiac transplantation were considered as censored observations. Prognostic information was expressed as relative risk (RR) with 95% confidence interval (CI). Descriptive statistics are presented as mean ± SD. A probability value of <0.05 was considered as statistically significant. Statistical analyses were performed with the SAS/STAT statistical package, release 6.12 (SAS Institute, Cary, North Carolina).
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Results |
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Hard outcomes. Hard cardiac events in the one year follow-up occurred in 25/234 (10.6%) patients; cardiac death occurred in 21/122 (17.2%) of the community group and in 3/112 (2.7%) in the DH group (p < 0.0007). One DH patient underwent urgent transplantation. Comparison of the two managerial models using Cox regression analysis showed that DH management significantly protected against the appearance of hard events (RR, 0.17; CI 0.06 to 0.66).
Pharmacoeconomic analyses.
Pharmacologic costs
At discharge from the initial hospitalization, there was no difference between the two patient groups in terms of dosage and rate of use of drugs. At one year, the annual cost per patient to maintain care was greater in the DH group than in the community group ($741 vs. $490 p < 0.000001) (Table 4).
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Life expectancy
Actuarial survival at one year was 96% in the DH patients and 78% in the community patients (log rank p < 0.0002) (Fig. 1). The incremental life expectancy was 0.083 years per patient. The cumulative incremental life expectancy in the DH group was 9.8 years.
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Quality-adjusted life years (QALY)
Day-hospital management produced a higher QALY than that achieved in the community group (79.4 vs. 70.5, p < 0.01).
Cost/utility analysis
The DH model showed a better cost/utility ratio than that of community management ($2,244 vs. $2,409). Furthermore, the incremental analysis revealed a cost-saving of $1,068 for each QALY gained.
Considering an increase of 0.080 QALY per patient, an annual cost of $1,483 per patient and a 5% annual increase of costs ($1,557), the cost/utility ratio for the integration of DH management of CHF was $19,462 (Table 4).
Sensitivity analysis. As calculated from the one-year survival curves, the 95% CIs of the 0.083-year year difference in life expectancy between the two groups were 0.041 and 0.125 years. The 95% CIs for overall costs were $1,396 and $1,738. These ranges would determine a cost/utility ratio from $13,904 to $34,048 per QALY product.
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Discussion |
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There are essentially two points of strength of our study: 1) the formalization of the process of care and 2) the use of an EBM methodology. To define the care process, the clinicians developed the "health care intervention," identifying the following phases: appropriateness of access to the program; the typology of the patient population; definition of the goals; necessary tools for the organization of the process; modality of the therapeutic intervention; identification and measurement of markers of outcome; evaluation of cardiovascular risk, and definition of follow-up. The EBM methodology offers valid and strong support to the decision of the process of care. In particular, EBM provided the informational and clinical elements to identify the best use of the single procedures activated in the different health care plans.
Furthermore, EBM allowed us to identify the best algorithm to define individual cardiovascular risk, therapeutic treatment, and consequent follow-up. This procedure allows 1) reduction of the use of ineffective and inefficient procedures for the type of clinical case being managed; 2) avoidance of repetition of procedures caused by occasional evaluations of the clinical syndrome; and 3) simulation analysis of consequences of behavior that would subtract resources. Such simulations have allowed us to overcome possible reticence of the health staff in modifying their empirical health care practices.
In this perspective the management of CHF patients changes profoundly: health care is not management of an acute event and/or clinical symptoms—a characteristic of the usual care with interventions in emergency room, and often, of the primary care physicians, cardiologists, and/or surgeons—but a continuous modulation of cardiovascular risk with interventions to prevent hemodynamic imbalance and to optimize therapy to improve quality of life and prognostic outcome.
This link among process of the care, control of management, and application of EBM has allowed two primary objectives to be reached: 1) better performance effectiveness and 2) reduced absorption of resources and their better allocation.
Performance effectiveness. A positive effect of the management program of CHF outpatients might be continuous optimization of therapy such as more titration of long- and short-acting ACE inhibitors. Although 97% of the patients were taking ACE inhibitors, in the DH-managed patients the mean dose of the ACE inhibitors was about 25% higher than usual care patients.
Similar considerations can be made about beta-blocker treatment: at the end of the management, 71% of the DH subjects were receiving beta-blockers versus 40% of community-treated patients. Likewise, the average dose of beta-blockers was 58% higher in the DH subjects at the end of management, and essentially unchanged in the patients receiving usual care. Moreover, in about 45% of the patients cardiovascular risk reevaluation led to therapeutic variations. Although we have not yet analyzed the data on compliance and effectiveness of the health education sessions and controlled physical training, 76% of patients were offered a way of self-management of their illness.
Open access was another important component of the program management. This modality of access is reserved for patients who exhibited markers and symptoms of hemodynamic imbalance during follow-up, despite therapeutic modifications performed at home. Open access to the DH allows extemporaneous execution of new care processes (IV therapy, laboratory examinations, instrumental controls, and therapeutic adjustments) by the HF care team. This implies that hospital admission—the largest part of usual-care management costs—is managed and integrated in a program of continuous definition of cardiovascular risk by echo-Doppler hemodynamic monitoring, cardiopulmonary exercise testing, measurement of biohumoral parameters, and therapeutic effectiveness evaluated by the same care team.
Conversely, in usual care, hospital admission is often a reactive solution to failure of a care process managed by different providers and at different times during the initial course of hemodynamic imbalance. In our experience the open-access service reduced potential hospital admissions by 79%. These combined interventions on therapeutic strategy and managerial organization justify the impact of this new care process on the outcomes in comparison to usual care. Rehospitalization was reduced by 72%. The impact of our managed program in DH on rehospitalization due to CHF was similar to that in other studies.
In a 90-day follow-up of elderly patients, Rich et al. (9) showed a 56% reduction of readmission for HF. In the multifit approach, total hospitalization rates for HF declined by 74% over 12 months (12). Hanumanthu et al. (10) showed that a HF program can reduce hospitalizations for decompensated HF by 63%. Fonarow et al. (8) examined the impact of a HF program on reducing hospitalization. They showed that rehospitalizations fell from 92% in the previous six months to 26% during the study period. A recent study by Hershberger et al. (25) in an outpatient setting demonstrated that a heart failure program can reduce the risk of rehospitalization by 52%. However, some studies show that intensive management by primary-care physicians increases hospital readmission and cost management (26). Using the HFU as a benchmark, we have transferred the experience gained in the HFU into the external setting of the DH with its lower organizational costs while retaining the know-how. This has allowed the creation of a qualified provider able to strengthen and increase the effects initiated by a HF program delivered by the HFU (27,28). This HF program has already had an important impact on mortality, which has been low in patients referred to the HFU, but the effect has been enhanced in the subgroup followed up in the DH program, in whom the annual mortality rate has been reduced by 79% in comparison to that in the group referred to the HFU and subsequently followed up with usual care.
The explanation of this result can, to a large extent, be attributed to the better optimized therapy. This study is the first to report effective titration of beta-blockers in 71% of the population. The BRING-UP study (29) underlined how driven titration of therapy could increase the number of beneficiaries of the treatment.
Resource allocation. Heart failure is the pathology making most demands on health care and absorbing the greatest amount of economic resources. In consideration of this socioeconomic burden, the application of new managerial models should satisfy two important conditions: 1) improve the quality of the performance and 2) not increase the costs. Our model satisfies these two conditions. The effectiveness of the performance is clearly improved. The variation of resources from usual care—used for the management,of discontinuous and diversified treatments of an acute event—to the HF management program in a DH has a better cost/utility ratio with a cost-saving per QALY incremental product of $1,068. When the model is considered as integration to the usual care, the incremental analysis identifies it as favorable. This service has an equitable value from a societal point of view. In fact, the cost patient/year places it between that of pacemaker implantation ($1,516), annual management of chronic pain ($2,996), and geriatric orthopedic rehabilitation ($5,555). If we compare the incremental cost/utility ratio, it is cost-effective and placed between that of ACE-inhibitor treatment in CHF ($7,777), an intravascular ultrasound-guided procedure ($6,439), a two-vessel coronary artery bypass graft surgery ($17,500), and home hemodialysis ($23,794) (30). We have treated the two management strategies as complementary models. Nevertheless, in a new definition of the scenario, the DH could be considered as a provider in the community, supplying the usual care and reducing the total resources absorbed by this pathology.
Study limitations. Various limitations of our study must be acknowledged. Elderly patients and those affected by diastolic HF are poorly represented in our study population. The assessment of the costs could be underestimated because we did not evaluate costs for minor health care services nor indirect costs. Direct and indirect nonhealth care costs were not evaluated. Nevertheless, these factors should be equally distributed between the two study groups and thus should not invalidate the final compared results. The analysis of QALY are referred to the first year of follow-up. But the titration of better therapy could improve survival curves beyond one year, increasing their divergence and the final result. The relationship between the different components of the care process, their absorption of the resources, and relative contributions to the outcomes have not been evaluated. In summary, this randomized prospective study showed that, compared to usual care, a HF management program delivered by a DH improves the cost/utility ratio of managing CHF.
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