© 2005 European Society of Cardiology
Heart failure care in a hospital unit: a comparison of standard 3-month and extended 6-month programs
St Vincent's University Hospital HF Unit Elm Park, Dublin 4, Ireland
* Corresponding author. Tel.: +353 1 2304629; fax: +353 1 2304639. E-mail address: kenneth.mcdonald{at}ucd.ie
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Abstract |
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 TopNotes Abstract 1. Background2. Methods3. Criteria for admission4. Results5. Discussion6. ConclusionsReferences |
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Background: We have previously shown that a structured in-hospital and outpatient heart failure (HF) program reduces clinical events over a 3-month period following hospital discharge.
Aims: This prospective randomized controlled study examines the additional benefits of extending the standard 3-month HF program to 6 months on death and readmission over a 2-year follow-up period.
Methods: Of 161 patients admitted with NYHA class IV HF who completed the standard 3-month HF program, 130 consenting patients (mean age 69.9±12.2 years, 65% male) were randomized to the extended 6-month HF program (EP; n=62) or standard care (SP; n=68). The primary endpoint was death and/or unplanned rehospitalization for HF at 2 years postrandomization.
Results: In the 2-year follow-up period, there were eight people with unplanned hospitalizations for HF and 16 deaths in the EP group (event rate 38.7%) compared to seven people with unplanned HF readmissions and 14 deaths in the SP group (event rate 30.9%, p=0.348 versus EP). Kaplan–Meier survival analysis demonstrated no difference in outcome between standard and extended program (p=0.315). There were no differences between the groups in terms of unscheduled clinic visits or non-HF-related readmissions in the 2-year follow-up period.
Conclusions: There is no measured clinical advantage in terms of death and/or HF readmission in extending a structured hospital-based disease management program for HF beyond 3 months postdischarge. However, it appears that patients continue to need access to the service to help abort clinical deteriorations, and this may have implication for the optimal organisation of such programs.
Key Words: Management programs • Hospitalisation
Received May 10, 2004; Revised September 23, 2004; Accepted October 20, 2004
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1. Background |
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TopNotesAbstract1. Background2. Methods3. Criteria for admission4. Results5. Discussion6. ConclusionsReferences |
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Hospital admission for heart failure (HF) is a common and problematic outcome of the morbidity associated with this syndrome [1–3]. Furthermore, it accounts for approximately 70% of the costs of management of this growing cardiovascular problem, which consumes 2–4% of the health care budget [4,5]. Advances in the pharmacological management of HF have resulted in a reduction in hospitalization in HF trial populations. However, hospital admission remains a serious problem because these therapies are not widely applied in the community, patients are often not followed up in a structured way, and patient/carer education is frequently inadequate [6–8].
Structured HF care plans have evolved to address these problems [9–15]. With few exceptions, these plans have focused on patients admitted to hospital with left ventricular failure in an attempt to reduce readmission rates as high as 46% in the 3 months following index admission [9–15]. Various structures have been used, including outpatient clinics with physician and specialist nurse involvement [9,10,13], community specialist nurses attending patients in their homes [11,12], and combined hospital, outpatient and community programs [9,14]. While most of these approaches have demonstrated a reduction in readmission or repeated admission, there remain many unanswered questions, particularly, where and for how long we should focus our efforts and limited resources in this growing illness.
We have demonstrated a significant reduction in 1-month and 3-month hospital readmission with a hospital-based HF program [14,15]. This is now the standard of care for HF management in our institution. However, it is not known if such a structured program should be continued indefinitely. At some point, patients must be considered to have derived the major benefit from a hospital-based program, and care should revert to the primary care team. As readmission rates are highest in the first 3 months following discharge, this may be the period that should receive most attention. Furthermore, while the program has been shown to be highly cost-effective in the first 3 months postdischarge [16], it may not represent efficient use of resources to manage these patients with scheduled follow-up of every program patient beyond 3 months. Finally, since some recent studies have demonstrated significant clinical benefit in long-term follow-up of patients following a single home visit from a specialist nurse or pharmacist [17], it is possible that continued structured follow-up of patients for a further 3-month period could also provide long-term clinical benefit.
Therefore, to investigate the clinical benefit of extending a structured care program beyond 3 months, we conducted a prospective randomized open study of the relative efficacy of a 3-month versus 6-month hospital-based HF program.
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2. Methods |
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TopNotesAbstract1. Background2. Methods3. Criteria for admission4. Results5. Discussion6. ConclusionsReferences |
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2.1. Design, sample and randomization
This is a prospective randomized open study. The preplanned follow-up assessment was at 3 months. However, due to a low number of primary endpoints, it was decided to extend the follow-up to a full 2 years postrandomization which is reported here. The investigation conforms to the principles outlined in the Declaration of Helsinki and was approved by the St Vincent's University Hospital Ethics Committee. We assumed a priori that a 25% decrease in death and/or hospital readmission would be achieved over the 3-month period and that, by taking a two-sided-alpha of 0.05% and 85% power, we required a sample size of n=56 per arm (i.e., total n=112). We aimed to recruit at least 60 patients per arm. Patients were selected from those admitted to the Hospital with a diagnosis of HF, which was confirmed or refuted by a cardiologist based on the presence of the following four criteria: history and examination compatible with HF, chest X-ray appearance of congestion, echocardiography-evidenced left ventricular systolic and/or diastolic dysfunction and response to initial therapy. Patients presenting with HF in the setting of myocardial infarction or unstable angina or where failure was not thought to be the primary problem were excluded. Also not considered were those with illnesses that could compromise survival over the duration of the study or with cognitive impairment. Once stable and when informed written consent was obtained, patients were entered into a disease management program which commenced during the index hospital admission and which extended to 3 months postdischarge. This program, described in detail elsewhere [14,15], provides patients with systematic medical follow-up along with specialist nurse-led education and specialist dietician consults on three or more occasions during the index admission. All patients received optimal guideline-driven medical therapy for heart failure. The education program focused on daily weight monitoring, disease and medication understanding and salt restriction. Similar advice was given to the patient's caregiver where applicable. Specific stability criteria had to be fulfilled before patient discharge. In outpatient follow-up, telephone contact was made by the HF nurse specialist with the patient at 3 days following discharge and weekly thereafter until 12 weeks. At 2, 6 and 12 weeks patients attended the clinic to check clinical status and further revise key education issues.
Following completion of the program described above, patients were asked for consent to be randomized to a further 3 months extended HF program as an outpatient or to be discharged to standard community care.
2.2. Standard care (SP) group
Patients randomized to the SP group after participation in the initial 3-month HF program were referred back to their primary physician with a letter stating participation in the study and that routine management of their condition could carry on as they see fit, including review by the hospital cardiology or HF services, if required. Both the patient and their physician were asked to inform the study centre if admission to any hospital occurred before the 3-month follow-up period. All patients were reviewed at 3 months postrandomization at the HF clinic for formal clinical assessment, which included history and physical examination by a physician. Patients were also followed up for 2 years postrandomization for evaluation of endpoints.
2.3. Extended HF program (EP) group
Patients randomized to a further 3 months HF program received weekly telephone calls from one of three experienced specialist HF nurses who, in most cases, was the specialist nurse who had managed the patient during the first 3 months following discharge. The purpose of these unscripted telephone calls was to determine clinical stability of the patient, address any questions or concerns they had and revise key education points as deemed necessary by the nurse. The key education points revised concerned daily weight monitoring, disease and medication understanding, compliance with prescribed therapy and dietary salt restriction. An in-house educational book about HF was supplied and used in the clinic and phone education sessions with patients and carers. This book served to standardize the education points provided to patients by nurses and covered the disease, its causes, associated symptoms and investigations, and pharmacological and nonpharmacological treatments.
Patients were asked to attend the HF clinic at 6 and 12 weeks postrandomization for formal clinical assessment by clinic medical and nursing staff. This included history and physical examination by a physician, review of HF medications and key education issues by the nurse and nutrition review by the dietician.
2.4. Unscheduled clinic visits
In the event of clinical deterioration and/or weight gain of at least 2 kg over 48 h with no change in clinical status, EP patients were asked to contact the HF service. SP patients were asked to refer initially to a family doctor, although contact with the service was allowed.
Clinical deterioration resulted in full clinical review. In the event of weight gain alone without clinical deterioration, advice was given to the patient to increase diuretic therapy by 40 mg of frusemide or its equivalent. The patient was also asked to attend the HF clinic for assessment of urea and electrolytes. Failure of this approach to bring body weight back to baseline resulted in full clinical review.
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3. Criteria for admission |
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TopNotesAbstract1. Background2. Methods3. Criteria for admission4. Results5. Discussion6. ConclusionsReferences |
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SP group: The decision to admit a patient was usually the responsibility of the physicians in charge of care and was not influenced by the persons involved in this study. However, in the case of a patient reviewed by the HF service following referral by the family doctor, the decision to readmit was made according to specific predefined criteria—namely: NYHA class IV, potassium <2.8 meq/l or >6.0 meq/l, failure of the tiered medical response (augmentation of oral diuretic, clinical review and use of intravenous diuretic on one occasion) to manage clinical deterioration and/or weight gain. The use of these predefined criteria attempts to avoid bias in decisions to readmit for HF in the setting of an open study.
EP group: The decision to readmit a patient for HF-related causes was made according to specific predefined criteria described above: NYHA class IV, potassium <2.8 meq/l or >6.0 meq/l, failure of the tiered medical response to manage clinical deterioration and/or weight gain.
3.1. Endpoints and data analysis
The primary endpoint in this study is the number of patients who had HF-related emergency admissions and/or deaths at 3 months and 2 years postrandomization. We also evaluated the total number of HF readmissions, the numbers of emergency admissions for non-HF causes and the numbers of unscheduled clinic visits at 3 months and 2 years postrandomization. HF emergency admissions were defined as requiring at least 1 night in-hospital stay and were confirmed or refuted by a cardiologist based on the presence of the following four criteria: history and examination compatible with HF, chest X-ray appearance of congestion, echocardiography evidenced left ventricular systolic and/or diastolic dysfunction and response to initial therapy.
Data are presented as the mean value±the standard deviation (S.D.) for continuous variables and absolute or relative frequencies for discrete variables. Statistical models employed include t-test for continuous variables (two-sided, 
=0.05), and Chi-squared analysis was used for discrete variables. The Kaplan–Meier method of survival analysis was used to generate and adjust survival curves for standard and extended groups. Patients lost to follow-up or known to be still alive were censored. The Mantel–Haenszel log–rank test was used to test the equality of the survivor functions. All analyses were carried out using SPSS Vs. 11 statistical software [Statistical Package for the Social Sciences (SPSS), Chicago, IL, 2001].
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4. Results |
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TopNotesAbstract1. Background2. Methods3. Criteria for admission4. Results5. Discussion6. ConclusionsReferences |
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Of 161 patients who completed the prerandomization standard 3-month HF program, 31 refused consent to participate in the present study for a range of reasons, including inconvenience, distance from the centre, unwillingness to be referred back to the family doctor for HF care and no specified reason. Remaining patients (n=130) were included and randomized in the study, with 62 in the EP group and 68 in the SP group (Fig. 1). The demographic characteristics of this population are detailed in Table 1.
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There were no significant differences in the primary endpoint between the SP and EP groups at 3 months and 2 years postrandomization (Fig. 2). At 3 months, there were seven primary endpoints in the EP group (six deaths, one HF-related admission rate 11.3%) and seven primary endpoints in the SP group (five deaths, two HF-related admissions, rate 10.3%, p=0.851 vs. SP). After a follow-up period of 2 years, there were 24 primary endpoints in the EP group (16 deaths, 8 HF-related admissions, rate 38.7%) and 21 primary endpoints in the SP group (14 deaths, 7 HF-related admissions, rate 30.9%, p=0.348 vs. EP). The total number of heart-failure-related in-hospital bed days for patients in the SP and EP groups was 120 and 110, respectively. The total number of in-hospital bed days (all cause admission) for patients in the SP and EP groups was 377 and 358, respectively.
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Kaplan–Meier survival curves for both SP and EP groups using the primary endpoint are presented in Fig. 3 and demonstrate no significant difference in survival over the follow-up period of 2 years (p=0.315).
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Similar numbers of patients were referred to the HF service during the intervention period (12 and 11 patients in the SP and EP group, respectively) for clinical deterioration, with 5 and 4, respectively, requiring outpatient intravenous diuretic to regain clinical stability (no difference between SP and EP groups). The total numbers of patients and events recorded, including unscheduled HF clinic visits and non-HF-related hospitalizations, during the 2-year follow-up period are presented in Table 2. The greater proportion of patients in the EP group with non-HF-related hospitalizations did not reach statistical significance (p=0.127). There were four and seven patients in the SP and EP groups, respectively, who were admitted to a hospital for HF during review in the HF clinic for clinical deterioration.
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HF medication usage was similar in both groups at discharge. Of the 100 patients alive at the end of the 2-year follow-up period, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy was in use in 91% and beta-blockers in 71% of the population with confirmed systolic dysfunction. Moreover, clinical trial doses of these agents were used in conjunction in 93% of patients on ACE inhibitors and 67% of patients on beta-blockers, and there were no differences between EP and SP groups in this regard.
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5. Discussion |
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TopNotesAbstract1. Background2. Methods3. Criteria for admission4. Results5. Discussion6. ConclusionsReferences |
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This randomized controlled study shows that there is no measurable clinical benefit in terms of death and/or readmission for HF in maintaining a structured outpatient follow-up of HF patients in our hospital-based program beyond 3 months following discharge. However, patients referred back to the care of the GP appear to need continuing access to the service in the event of clinical deterioration and/or weight gain.
The benefits of structured care of HF programs have been widely reported, with most studies demonstrating a reduction in rehospitalization [9–16] and more recently in prognosis [17,18]. The majority of programs have appropriately focused on patients admitted to hospital for HF as this group of patients is most at risk for subsequent readmission.
However, the important issue of optimal duration of follow-up in disease management programs for HF has yet to be addressed in the available literature. The duration of care postdischarge in hospital-based programs reported to date ranges from 3 months to 1 year, and yet none has reported in a prospective randomized manner on how long the specialist care phase should last. Some home visit programs appear to require a single visit, and at least one has shown resulting clinical benefit in morbidity and mortality in long-term follow-up [17]. Therefore, it was important to determine whether extension of our hospital-based HF program, comprising weekly telemonitoring or clinical assessment of all patients, could add value in terms of longer-term morbidity and mortality. Indeed, while most studies have shown benefit, [19] given the lack of benefit seen in at least one outpatient care of heart failure programs [20], it was important for us to justify any proposed extension of our program.
For hospital-based programs, the inpatient phase is likely a critical component of HF programs not least because the available data have shown that the rate of increase of readmission is highest in the early months following discharge. The in-hospital phase in our program is intensive, focusing on transfer of care to the specialty HF service, guideline-driven medical therapy, more than 3 h of one-on-one education and specific predefined stability criteria to define suitability for discharge [14,15]. Because of this and the continuation of the HF program following discharge, we have shown that 1-month readmission for HF can be eliminated [14], and highly significant reductions in 3-month death and/or readmission rates can be achieved [15].
However, the structured outpatient phase of our program is also intensive and time-consuming, with 3 scheduled clinic visits and 10 separate clinic-initiated telephone consultations with the patient in the 3-month postdischarge period. While the notion is attractive, extended structured follow-up with a specialty service might not add clinical benefit and moreover could prove deleterious if it were to become a substitute for the important role of the family doctor in ongoing patient care.
The results of this study demonstrate that an extended 6-month structured program does not reduce the clinical endpoints of death and/or hospital readmission compared to a 3-month program when follow-up is extended to 2 years. This important observation allows rationalization of the program to focus resources on the critical 3-month postdischarge period. The omission of scheduled clinic visits and 10 scheduled telephone consultations as a result of the shorter program saves nurse and clinic time and strongly suggests that longer structured outpatient follow-up does not add value.
While the data support the implementation of a shorter 3-month structured program, it is clear that patients continue to need ongoing access to the service for clinical deteriorations that inevitably develop. Indeed, there were no differences in the rates of unscheduled clinic visits between EP and SP groups in the follow-up periods. This could have impacted on outcomes, and, whereas the primary responsibility for care of the patient should revert to the family doctor after 3 months, it is possible that the similar event rate observed in the EP and SP groups is due to the similar use of the HF service by patients when acute decompensation threatened. HF education may have been sufficient during the initial 3-month program to empower patients to decide when and how to most effectively use the service. Furthermore, it must also be borne in mind that the resource implications of providing this unscheduled patient-initiated access to the service for suspected clinical deterioration are considerably reduced compared to regular scheduled review of all program patients.
We did not find evidence of an excess of non-HF-related hospitalizations in the EP group during long-term follow-up. Whereas specialty HF services have been shown to manage HF-related issues more effectively, they are not a substitute for the role of the family doctor in cocoordinating patient care across a range of specialties. A potential downside of the program provided to the EP group could be a reluctance of patients to attend the family doctor regularly or even an overreliance on the HF service for general medical care. While differences between the groups in non-HF-related hospitalizations did not reach statistical significance, we did not evaluate other markers of general medical care and cannot conclude that the EP program is as effective as the SC program with respect to care of non-HF issues.
The overall 2-year readmission rate for HF-related causes at 17% of patients appears to be low for such a high-risk population. This may reflect the intensity of follow-up during the initial postdischarge period, the availability of the service for clinic visits arising from suspected clinical deterioration, the successful application of trial-proven medical therapy and the time spent educating patients and their families about self-management of HF. However, it must be borne in mind that the study population is selected and may be biased to healthier HF patients since 8 patients out of 169 enrolled into the initial 3-month program died and 31 refused consent to participate in the present study.
The low event rates in this selected HF population may also reflect the high accordance of medical therapy in both groups with HF guidelines [21] This is a result of the intensive nature of our in-hospital and early outpatient phases prerandomization and may also explain the equivalence of HF medical therapy usage in both groups. Furthermore, this observation is in contrast to the widely acknowledged differences between cardiologists and family doctors in the usage and dosing of guideline medical therapy for HF [22] and suggests that, once patients are stabilized on appropriate doses of guideline medical therapy for HF by specialist physicians, family doctors are satisfied to monitor and maintain such therapy.
There are certain limitations to this work. As part of an intensive care of HF program because of deaths prior to randomization and because a sizeable number of patients refused consent to participate, the patient population may be somewhat selected. It may therefore be difficult to generalize these results to less intensive programs or different populations. Although we predefined readmission criteria as an open study, bias could have been introduced within the HF service with respect to HF-related admissions. We have only looked at certain markers of clinical benefit (death, readmission and unscheduled clinic visits) and cannot conclude that the extended program did not provide other forms of clinical benefit (such as improved quality of life, patient perception of health and psychosocial well-being). The study may well be underpowered to detect an actual difference between the SP and EP groups, although the data may suggest that any difference would be small and not clinically relevant. The unscheduled clinic visit data reflect HF care only, and we do not have information on simultaneous utilization of the family doctor. While the study shows that a hospital-based HF clinic should concentrate efforts during the in-hospital phase and in the first 3 months following discharge, it does not address what is the best format for an outpatient HF clinic. Whether a hospital-based, a community-based or a "shared care" approach is used, the initial 3 months following discharge will likely remain the most critical period. Finally, the work does not allow us to comment on whether a shorter postdischarge follow-up period might be sufficient to provide long-term clinical benefit.
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6. Conclusions |
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TopNotesAbstract1. Background2. Methods3. Criteria for admission4. Results5. Discussion6. ConclusionsReferences |
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There is no measured clinical advantage in terms of death and/or HF readmission in extending our structured hospital-based disease management program for HF beyond 3 months postdischarge. There is no difference in non-HF-related hospitalizations between EP and SP groups. However, because of similar levels of follow-up unscheduled clinic visits to the service in both groups, it appears that patients continue to need access to the service to help abort clinical deteriorations. These results may have organisational and resource implications for hospital-based disease management programs in HF.
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Acknowledgements |
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This study was supported by unrestricted grants from the Irish Heart Foundation and Servier Laboratories, Ireland.
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TopNotesAbstract1. Background2. Methods3. Criteria for admission4. Results5. Discussion6. ConclusionsReferences |
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1 Council on HF, Irish Heart Foundation.
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TopNotesAbstract1. Background2. Methods3. Criteria for admission4. Results5. Discussion6. ConclusionsReferences |
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