© 2002 European Society of Cardiology
Detecting early clinical deterioration in chronic heart failure patients post-acute hospitalisation—a critical component of multidisciplinary, home-based intervention?
a Centre for Research into Nursing and Health Care/School of Nursing and Midwifery University of South Australia, Australia
b Cardiology Unit, Department of Medicine The Queen Elizabeth Hospital/University of Adelaide, Australia
* Corresponding author. Cardiology Unit, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville, South Australia, 5011, Australia. Tel.: +618-8222-6725; fax: +618-8222-7201. E-mail address: simonstewart1{at}unisa.edu.au
| Abstract |
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Aims: To firstly describe the prevalence, characteristics and consequences of early clinical deterioration (ECD) in chronic heart failure (CHF) patients discharged from acute hospital care and, secondly, to examine the potential benefits of a multidisciplinary, home-based intervention (HBI) in limiting the common sequelae of such deterioration.
Methods: This phenomenon was studied in 90 CHF patients assigned to the intervention arm of a randomised study of HBI. ECD was defined as death, unplanned re-admission or clinical instability (detected at a home visit) within 14 days of hospital discharge. Multivariate analysis was used to determine the independent correlates of ECD. Using these data, a 1:1 case–control ratio of patients assigned to the usual care arm of the study was selected to match those patients exhibiting non-fatal ECD and subject to HBI. Subsequent morbidity and mortality rates were then compared on the basis of the presence or absence of non-fatal ECD and/or HBI.
Results: Of the 90 patients assigned to HBI, two died suddenly, five required an unplanned re-admission to hospital and 28 were found to be clinically unstable at a planned home visit, within 14 days of discharge from the index admission. The combined prevalence of ECD this cohort was therefore 39% (35 of 90 patients) and was independently correlated with greater age (OR=1.1 per yearly increment; P<0.001) and comorbidity (OR=2.0 per incremental Charlson index of comorbidity score; P<0.001). Patients who exhibited clinical instability at the home visit were significantly more likely to be non-adherent to prescribed treatment (10 of 28 vs. 9 of 55; P<0.05). Compared to the remainder of the cohort also subject to HBI, despite remedial intervention, patients who exhibited non-fatal ECD had reduced event-free survival (11 of 33 vs. 38 of 55; P<0.001), more frequent unplanned re-admission (0.2 vs. 0.1 admissions/patient/month; P<0.01), and more prolonged hospital stay (1.6 vs. 0.5 days/patient/month; P<0.001) in the subsequent 6-month period. However, compared to case–controls, these patients (n=33 in both groups) had fewer days of hospitalisation (1.6 vs. 3.6 days/patient/month; P=0.05) and, most significantly, were more likely to survive to 6 months (6 vs. 13 died; P<0.05).
Conclusion: ECD is a common phenomenon in older CHF patients discharged from acute hospital care and is associated with poorer health outcomes in the longer-term. Post-discharge HBI is an important means for identifying and addressing ECD. Although HBI conveys benefits incremental to usual care, these data also provide a sound basis for increasing its effectiveness by applying earlier home visits in selected high-risk patients.
Key Words: Chronic heart failure Hospitalisation Mortality Home visits Multidisciplinary intervention
Received July 17, 2001; Revised October 22, 2001; Accepted December 20, 2001
| 1. Introduction |
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In a series of recently reported randomised studies performed in Australia, we have shown the benefits of applying a nurse-led, multidisciplinary, home-based intervention (HBI) in patients with a variety of chronic disease states discharged from acute hospital care [1], and particularly those with chronic congestive heart failure (CHF) [2,3]. In the most recent study, it was shown that CHF patients exposed to a heart failure-specific version of HBI had more prolonged event-free survival and survival alone, reduced re-admissions and associated stay by more than 50%, in addition to improved quality of life relative to similar patients exposed to usual care over a period of 6 months [4]. Consistent with a previous report [3], the reduction in recurrent hospital stay was sustained in the longer-term (up to 20 months) [4]. These data confirm the relative benefits of this type of intervention, initially documented by Rich and colleagues over a period of 3 months [5], which are supported by subsequent randomised studies in the UK [6] and US [7,8]. Importantly, a recent international comparison of typically older and representative cohorts of CHF patients enrolled in these studies, has confirmed close similarities in their clinical and demographic characteristics and health outcomes following hospital discharge [9].
When compared to similar programmes either not incorporating post-discharge home visits in favour of post-discharge planning alone [10] and/or visits to a specialist heart failure clinic [11,12], or incorporating home visits for the purpose of providing education alone [13], the evidence to date suggests that home visits involving a multifaceted approach to assessing a CHF patient's health status and providing immediate and longer-term solutions to detected problems, provide the greatest benefits overall [14,15]. However, the exact mechanism(s) of the observed beneficial effect of these post-discharge programmes remains uncertain. It is therefore difficult to identify what component(s) of HBI induce a greater beneficial effect relative to those undertaken as part of a clinic-based approach to the post-discharge management of CHF.
We have previously postulated that HBI provides major long-term benefits by detecting and addressing previously unidentified problems likely to lead to poorer health outcomes if left unresolved [1,16]. In this context, the current study examined the prevalence, correlates and consequences of early clinical deterioration (ECD) in a cohort of CHF patients who received a post-discharge, home visit as part of a randomised study of HBI [4]. It also examined the potential modulating effects of HBI in this regard.
| 2. Methods |
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2.1. Patient cohort
As described in our original report [4], patients were recruited from the north-west region of Adelaide, a metropolitan area with a disproportionate number of elderly and socially disadvantaged persons and higher admission rates per capita for the region [17]. All patients were admitted to The Queen Elizabeth Hospital, a tertiary referral hospital servicing the area. Prior to patient recruitment, the study was approved by the institution's ethics of human research committee and all patients signed a consent form (the study therefore conformed to the principles outlined in the Declaration of Helsinki).
During the study a total of 200 patients with a diagnosis of CHF were subsequently discharged alive and randomised to either usual care (n=100) or HBI (n=100). All patients included in the study had the following profile:
- – Evidence of left ventricular systolic dysfunction (e.g. LVEF<55%).
- – A history of at least one hospital admission for acute heart failure.
- – Persistent symptoms of heart failure at discharge (NYHA Class II–IV).
- – Under the care of a cardiologist and general practitioner.
- – Discharged to home.
- – A history of at least one hospital admission for acute heart failure.
2.2. Home visits
As described in greater detail in the original report [4], all patients randomly assigned to HBI (n=100), whilst receiving the same level of care as patients assigned to usual care (n=100), were due to receive a structured home visit by an experienced cardiac-care nurse with post-graduate qualifications, within a target period of 7–14 days post-acute hospitalisation. A total of 88 patients who survived beyond 7 days post-discharge received a home visit. As part of the home visit, patients were subject to a review of their clinical progress since discharge, a detailed physical examination and a review of their prescribed therapy including compliance. Furthermore, as part of the intervention, all the patients cardiologists and primary care physicians (if not already contacted immediately following the home visit) received a written report of the assessments made at the visit and any remedial actions taken or recommended.
2.3. Early clinical deterioration
The proportion of patients exhibiting ECD was determined in patients assigned to a home visit as part of HBI, excluding the 10 patients who subsequently refused the study intervention (n=90). For the purpose of this study, ECD was defined as clinical instability detected at the home visit in addition to death or readmission within 14 days of hospital discharge.
The correlates of non-fatal, ECD were derived from the patients clinical and demographic characteristics documented prior to study follow-up.
2.4. Health outcomes
We compared event-free survival, number of re-admissions, length of hospital stay and all-cause survival within 6 months (the same endpoints collated during the main study), in surviving patients assigned to HBI who received a home visit on the basis of the presence or absence of ECD. In order to examine the potential modulating effects of HBI on subsequent health outcomes, we compared these same parameters in those HBI exhibiting ECD with a 1:1 case–control cohort ratio of patients selected from the usual care arm of the study.
2.5. Statistical analysis
All comparisons (e.g. those with and without ECD) involved the following:
2 analysis [with calculation of odds ratio (OR) and 95% confidence intervals (CI)] for discrete variables; the Student's t-test for normally distributed continuous variables; and the Mann–Whitney test for non-normally distributed continuous variables. Kaplan–Meier survival curves were constructed for time-dependent variables and analysed with both the log-rank and the Breslow tests, to detect differences in both the number and timing of events. Multiple logistical regression, using entry of variables at a significance level of 0.2 from univariate analysis, and step-wise rejection of variables at the 0.05 level of significance, was used to identify the independent correlates of fatal and non-fatal ECD. The case–control cohort were selected (using a blinded protocol) on a sex-specific basis using the correlates of non-fatal ECD, from the cohort of patients assigned to usual care who survived the first 14 days post-hospital discharge. Comparison of health outcomes using the case–control cohort were performed using paired analyses. All analyses were performed using SPSS for Windows (9.0).
| 3. Results |
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3.1. Early clinical deterioration
Although the majority of patients assigned to HBI were discharged from hospital in a clinically stable state, two patients died suddenly at home within 48 h, and five patients experienced an unplanned re-admission within 14 days of hospital discharge. Moreover, a large proportion of the patients subject to a clinical review and physical examination undertaken by the cardiac nurse during the initial home visit had signs of clinical instability. In general, patient heart rates were lower (77±16 vs. 72±10 beats/min), and both systolic blood pressure (121±19 vs. 131±19 mmHg) and diastolic blood pressure (67±12 vs. 73±11 mmHg) were higher than at the time of hospital discharge. On an individual basis, 16 patients reported a decline in exercise tolerance indicative of NYHA Class IV (n=16), nine patients reported episodes of angina pectoris at rest, and six patients described symptoms indicative of paroxysmal nocturnal dyspnoea. On physical examination, 19 patients had basal crepitations and six patients had gross pitting oedema in the lower limbs.
Patients in whom ECD was determined to be present at the initial home visit were significantly more likely to self-report non-compliance with their prescribed fluid restriction (nine of 15 patients) compared to those patients who appeared to be clinically stable (three of 14 patients: P=0.035, OR=5.5; 95% CI=1.2–41). Similarly, patients who demonstrated such clinical instability were also more likely to self-report difficulty in complying with their medication regimen or were found to have significantly deviated from their regimen during the pharmacological assessment (10 of 28 vs. nine of 55: P=0.047, OR=2.8; 95% CI=1.0–9.5).
In total, 28 of the 88 patients initially visited at home (32%) demonstrated ECD—the majority of which attracted remedial intervention (see below). Coupled with those patients who either died or were re-admitted, the overall prevalence of ECD in this cohort was 39% (35 of 90 patients)—refer to Table 1.
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3.2. Remedial intervention
The cardiac nurse considered it necessary to contact a patient's general practitioner during 24 of the home visits and/or the cardiology unit on 15 occasions, in order to arrange either immediate review of the patient's clinical status and/or therapeutic management, or to simply clarify the patients regimen for a combined total of 33 visits (38%). Moreover, the introduction of a compliance device and/or regular pharmacist review (including home visits in some cases) was arranged for 19 patients (22%). New or incremental home-support services were also arranged for 23 patients (26%).
3.3. Correlates of early clinical deterioration
Univariate analysis of the baseline clinical and demographic characteristics of these patients revealed that nine baseline parameters were significantly associated with both fatal and non-fatal ECD. These included age, left ventricular ejection fraction, serum creatinine and urea levels at hospital discharge, extent of co-morbidity as determined by the Charlson index of comorbidity [18], extent of activities of daily living as determined by the Katz ADL score [19], presence/absence of amiodarone at hospital discharge, presence/absence of chronic airway limitation and presence/absence of diabetes (insulin or non-insulin dependent). Subsequent multivariate analysis revealed that there were two independent correlates of fatal and non-fatal ECD: greater age (P=0.008, OR=1.1/year; 95% CI=1.03, 1.2) and greater comorbidity as determined by the Charlson index (P<0.001, OR=2.0/unit score of 1; 95% CI=1.4, 2.9).
3.4. Subsequent health outcomes—significance of early clinical deterioration
Despite the intervention described above, among surviving patients (n=88), ECD was associated with reduced event-free survival, with 38 of the 55 clinically stable patients vs. 11 of the 33 patients exhibiting ECD being alive and free from hospitalisation in the 6 months following the home visit (P<0.001). ECD was also associated with more frequent unplanned readmission (0.2 vs. 0.1 admissions/patient/month—P<0.01) and more prolonged hospital stay resulting from those re-admissions (0.5 vs. 1.6 days/patient/month—P<0.001) during this period.
3.5. Outcomes in the case–control cohort
Based on the univariate and multivariate analysis of the correlates of ECD, we selected a 1:1 case–control cohort of 33 patients who were subject to usual care as part of the randomised study, and who also survived beyond 14 days following initial discharge. Table 2 compares the baseline characteristics of these two cohorts according to these nine parameters—demonstrating that the two groups were well matched in this regard. The two cohorts were also well-matched in respect to prescribed pharmacotherapy and other baseline characteristics likely to influence health outcomes.
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Compared to case–controls, patients who exhibited non-fatal, ECD in the HBI arm of the study had fewer days of hospitalisation (1.5 vs. 3.6 days/patient/month—P=0.05) and were more likely to survive the 6 months following their index hospitalisation (six vs. 13 patients died during this period—P<0.05).
Fig. 1 shows the comparison in event-free survival in patients subject to HBI based on the presence/absence of ECD, in addition to overall survival in those patients who exhibited this phenomenon compared to the case–control patients subject to usual care.
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| 4. Discussion |
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Despite increasing evidence in favour of applying adjunctive strategies to optimise the post-discharge management of CHF [14,15], the inherent difficulty in identifying the exact mechanism(s) of beneficial effect of multi-faceted interventions of this type remains problematic [20]. We have previously postulated that the major benefits of visiting CHF patients in their home post-acute hospitalisation, would be essentially derived from a better assessment of the patient's clinical status and ability to manage their illness(es) in addition to a more accurate determination of their future needs [1–4]. This study examined the value of a post-discharge HBI in detecting and responding to undetected ECD. These results not only confirm a significant component of post-discharge, clinical instability in typically older CHF patients with significant comorbidity likely to complicate treatment, but the potential to improve health outcomes if appropriate action is taken to address contributing factors and to provide greater levels of subsequent follow-up.
4.1. Prevalence and characteristics of early clinical deterioration
In this cohort, we found that approximately 40% of patients were clinically unstable in the 14 days immediately following an acute hospitalisation. In normal circumstances, the estimated prevalence would be closer to 10% (based on the combined total of sudden deaths and hospitalisations). However, despite routine visits to a general practitioner and cardiologist in the first week following hospital discharge, by closely questioning patients about their post-discharge clinical history and performing a detailed physical examination during a home visit approximately 7–14 days following hospital discharge, the cardiac nurse frequently discovered clinical problems that had not been detected and addressed previously. This finding is consistent with the data suggesting that a detailed and comprehensive assessment of the patient in his/her home is more likely to provide a more realistic picture of clinical status and ability to manage their illness [21]. The majority of signs and symptoms (increasing breathlessness, paroxysmal nocturnal dyspnoea, basal crepitations and peripheral oedema) were indicative of worsening CHF following stabilisation during the hospital admission. Those most likely to exhibit ECD were older and had greater comorbidity. Consistent with a previous study [22], these patients were also more likely to be experiencing problems adhering to their prescribed treatment—the greater number of medications, concurrent physical and mental limitations likely to negatively impact upon the ability to implement effective coping strategies, and an increased risk of adverse effects no doubt contributing to the combined and interrelated problems of poor treatment adherence and clinical instability [22].
4.2. The potential benefits of early intervention
Despite an immediate recognition that these patients were at higher risk for subsequent morbidity (and in some cases mortality) and provision of remedial intervention to: (a) increase treatment adherence; (b) optimise prescribed treatment; and (c) provide greater vigilance and more intense medical and nursing follow-up, HBI did not completely ameliorate the subsequent risk of morbidity and mortality in the medium term. Certainly, it would be unrealistic to expect that in such a cohort of generally older patients with significant comorbidity and advanced HF, the natural progression towards increased clinical instability and death could be completely abolished through this type of intervention. Indeed, it is likely that the detection of clinical instability and heightened levels of vigilance and follow-up, increase morbidity levels through appropriate hospitalisation to treat potentially fatal clinical deterioration. We have previously speculated that this is one of the reasons for the observed survival benefit associated with HBI [1–4]. The comparison between the cohort of HBI patients with non-fatal ECD and case–controls subject to usual care, provides some evidence to support this hypothesis. Compared to case–controls, patients exposed to the HBI spent fewer days in hospital (with equivalent numbers of re-admissions) and were more likely to survive the 6-month period following the index hospitalisation. These data are also broadly consistent with studies that have shown this type of intervention improves treatment compliance [23], and is associated with reduced medication-related admissions [1,22].
4.3. Clinical implications
In demonstrating the relative importance of detecting ECD through HBI, this study provides some evidence as to why this type of strategy has proven to be superior to similar programmes not incorporating post-discharge home visits in favour of post-discharge planning alone [8], visits to a specialist heart failure clinic [10,11], and/or incorporating home visits for the purpose of providing education alone [13], in reducing levels of recurrent hospital-use.
If it is accepted that a post-discharge home visit should be undertaken wherever possible, these data highlight some important issues that require comment. Firstly, when should a post-discharge home visit be undertaken? In designing this intervention, we postulated that by delaying a home visit to allow the patient to regain control of their illness and to properly assess the effectiveness of post-discharge planning and care, any subsequent assessment and intervention would be more valuable in determining immediate problems and planning future care. Alternatively, the risk of early fatal events and readmission to hospital has been implicitly recognised by those programmes that incorporate home visits within 48 h of hospital discharge [6]. However, the risk of evoking a clinical cascade, whereby increased detection of, and an enhanced anticipation of treatment for, relatively benign periods of clinical deterioration reflecting the normal fluctuation in the status of CHF patients, may result in increased health-care utilisation and heighten the risk of in-hospital death (e.g. iatrogenic infection) [24]. It may be more prudent, therefore to stratify the intensity of home-based follow-up of patients according to their risk of poor health outcomes. These data suggest that the effectiveness of this form of HBI could be increased if a more intensive HBI was applied selectively. It is on this basis that home visits could be applied in the immediate post-discharge period in pre-selected high-risk patients (e.g. those aged
75 years and a Charlson comorbidity score of
3) only. The remainder of patients would therefore receive a home visit within 10–14 days, whilst the high-risk patients could receive a second home visit during the same time frame.
4.4. Limitations
Although this study represents a prospectively planned analysis of the original data generated from our randomised study of the effects of HBI in patients with CHF [4], there are limitations that require comment. Firstly, the major portion of this study concentrated on those patients assigned to HBI and who agreed to the post-discharge, home visit. We were unable, for example, to identify the true prevalence of ECD in the usual care arm of this controlled study; although, as described in our original report [4], re-admission and survival rates in the first 14 days post-discharge were almost identical for the two groups, diverging only after the approximate timing of the home visit. Similarly, our analysis of the potential modulating effects of HBI in the context of ECD was necessarily confined to a case–control comparison that provides only limited evidence of any influence in this regard.
| 5. Conclusions |
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These data show that ECD is a common phenomenon in older CHF patients discharged from acute hospital care and is associated with poorer health outcomes in the longer-term. They also show that HBI is an important means for identifying and addressing ECD. In the context of increasing re-admission rates [25], a parallel increase in related health care costs [26], in addition to contemporary mortality rates comparable to, and even worse than, many forms of cancer [27], the individual and overall economic benefits of establishing a national heart failure service based on this type intervention are becoming increasingly apparent [28]. Residual morbidity and mortality rates in patients exposed to HBI, however, remain unacceptably high. These data provide a sound basis for increasing the effectiveness of HBI by altering the strategy of visiting patients at 10–14 days post-discharge and applying earlier home visits to selected high-risk patients.
| Acknowledgments |
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Dr Simon Stewart is supported by a National Heart Foundation of Australia Overseas Postdoctoral Research Fellowship.
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