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European Journal of Heart Failure 2005 7(5):921-926; doi:10.1016/j.ejheart.2005.05.009
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© 2005 European Society of Cardiology

Short- and long-term results of a programme for the prevention of readmissions and mortality in patients with heart failure: Are effects maintained after stopping the programme?

Soledad Ojedaa,*, Manuel Anguitaa, Mónica Delgadoa, Felipe Atienzab, Carmen Rusa, Amador L. Granadosa, Federico Ridoccib, Federico Vallésa and Jose A. Velascob

a Department of Cardiology Hospital Universitario Reina Sofía, Córdoba, Spain
b Department of Cardiology Hospital General Universitario de Valencia, Valencia, Spain

* Corresponding author. La Bodega street, 2 5°-8, 14008 Córdoba, Spain. E-mial address: sojeda{at}supercable.es


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
The objective of the study was to evaluate whether improvements obtained during an intervention programme were maintained after the programme was stopped. 153 patients discharged with a diagnosis of heart failure (HF) were randomized to either usual care or an intervention programme, which included patient education, consultation with the cardiologist and monitoring in the Heart Failure Unit. After an average period of 16±8 months, the intervention programme was stopped. One year later, all the patients were re-examined to assess HF readmissions, all-cause mortality, quality of life, and prescribed medical treatment. During the 16±8-month treatment period, patients in the intervention group had a lower rate of HF readmissions (17% vs. 51%, p<0.01), less all-cause mortality (13% vs. 27%, p=0.03), improvement in quality of life (1.5±0.8 vs. 1.9±1, p=0.03) and optimisation of medical treatment was achieved. One year after stopping the intervention, there was no difference in HF readmissions (28% vs. 25%, p=0.72), all-cause mortality (14% vs. 17%, p=0.64) and quality of life (1.7±0.9 vs. 1.8±1, p=0.24) between the groups. Survival and the probability of not being readmitted due to HF were similar in both groups. There was also a reduction in the use of beta-blockers and spironolactone in the intervention group.

Conclusions: The positive effects of an intervention programme are clearly reduced when it is stopped, due to less strict control of the patients and a decrease in the use of drugs with proven efficacy in HF.

Key Words: Heart failure • Management programme

Received July 8, 2004; Revised October 13, 2004; Accepted May 19, 2005


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
Heart failure (HF) is the common final pathway of many cardiovascular diseases. Clinical trials have demonstrated that the high morbidity and mortality rates in HF can be reduced by using drugs such as beta-blockers and angiotensin-converting enzyme inhibitors [1,2]. However, in spite of the improved prognosis observed in clinical trials, the benefits of pharmacological therapy on survival in the general population have been modest [3,4].

It is also interesting to note that in Spain, HF is the main cause of hospitalization in people aged >65 years [5]. Hospital admissions due to HF have increased by 71% in recent years [5] in this group of patients. This increase is mainly due to high rates of rehospitalization, which range from 29% to 59%, 6 months after hospital discharge.

Lack of adherence to the prescribed medical regimen, inappropriate use of drugs, poor follow-up controls after discharge or delays in seeking care have been identified as the most common precipitating factors for readmission due to HF. It is estimated that up to 50% of HF admissions are preventable [6–8]. The limitations of current HF treatment patterns have stimulated the development of new strategies, such as disease management programmes. These programmes are usually multidisciplinary, and vary in the type and nature of the intervention. Recent randomized studies [9–20], including a well-designed meta-analysis [20], have shown that these programmes can reduce hospitalizations in patients with HF, although results vary between studies and the impact on mortality and quality of life is not conclusive [9–20]. In addition, it is not clear whether the beneficial effects obtained with these intervention programmes can be maintained once the programme is stopped.

We therefore performed a prospective study of a HF intervention programme which reported a clear decrease in all-cause mortality, readmissions due to HF, and an improvement of the perception of the quality of life compared to patients receiving usual care.

The study then aimed to evaluate whether this improvement could be maintained once the intervention programme was stopped.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
All patients were participants in a prospective, randomized and controlled multi-centre study (PRICE) which has been previously reported [21]. All patients discharged with a primary diagnosis of HF [22] from the Cardiology ward of our hospital between November 1998 and December 1999 were considered eligible. Exclusion criteria were the presence of terminal disease or expected survival <6 months because of other serious concurrent disease, possibility of specific etiology treatment (such as coronary artery revascularization or valve procedures), or inclusion on the waiting list for heart transplantation. Of the 196 patients discharged within the study period with a diagnosis of HF, 153 were included. Patients were allocated to either usual care (n=77, control group) or to the intervention group (n=76), using a computer-generated randomization list. The study was approved by the Ethics Committee at the co-ordinating centre and informed consent was obtained from all patients.

2.1. Treatment programmes
Patients in the control group received discharge planning according to the routine practice in our centre. Drug therapy was based on guidelines published at the time of the study design. Follow-up was performed by primary care physicians and cardiologists not participating in the study, according to standard care of HF patients.

The intervention programme consisted of formal education about HF and the treatment for patients and their families, prior to discharge. The education session included an explanation of the symptoms and signs of HF decompensation, self-monitoring of vital signs (blood pressure, weight, diuresis, heart rate), diet and exercise counselling, effects of medications, and measures to be taken in case of worsening. A teaching brochure containing written instructions, vital signs charts and medication schedules was given to each patient in the intervention group. After discharge, regular follow-up visits at the outpatient Heart Failure Clinic were scheduled every 3 months, to assess the patient's knowledge of care, to optimize medical therapy and to reinforce the patient's self-care.

Patients allocated to the intervention group could contact a member of staff from our Heart Failure Clinic by phone with any queries about their clinical condition or any changes that had occurred. The Heart Failure Clinic team was also available for consultation during working hours.

The intervention programme was stopped in December 2000. Results of the programme were analysed, and patients were discharged to usual care provided by their physicians and cardiologists. In December 2001, 1 year later, all patients were again assessed in our outpatient clinic, to identify all major events and changes in medical therapy.

2.2. Outcomes
The primary outcome measure was the decrease in readmissions due to heart failure and in all-cause mortality event-free survival, defined on the basis of time to death or HF readmission. Two types of analysis were performed:

  1. Complete monitoring of patients from the beginning of the intervention programme to the final examination in December 2001 (i.e. the duration of the intervention programme and the 1-year period following its suspension).
  2. Assessment of only the year following the suspension of the programme.

The secondary objectives were changes in pharmacological treatment and changes in quality of life, measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ). The best score on this questionnaire is 0 and the worst is 5.

2.3. Statistical methods
All analyses were conducted according to intention-to-treat principle. Baseline date for intervention and control groups were compared using chi2 test for categorical variables, Student's t-test for normally distributed continuous variables and the Wilcoxon rank test for variables not normally distributed. Survival and survival-free of hospital admission were compared according to the Kaplan–Meier method, using the log rank test for statistical inference. P values <0.05 were considered statistically significant. The analysis was performed using SPSS for Windows (version 10.0).


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
3.1. Clinical and treatment features
Baseline clinical features of the control and intervention groups are shown in Table 1. Age and sex distribution were similar between the groups. Both groups were homogeneous in terms of prevalence of cardiovascular risk factors (systemic hypertension, diabetes mellitus and heart disease). Etiology of heart failure was similar in control and intervention patients; ischemic heart disease was the most common cause in both groups.


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  		Table 1 Baseline characteristics of the study patients

 
There were no differences between groups in the severity of heart failure, left ventricular ejection fraction and discharge therapy. One half of all patients received spironolactone (52% control group and 51% intervention group, p=0,9), and one quarter were treated with beta-blockers (26% of control patients and 30% of intervention patients, p=0.5). The most prescribed beta-blocker in both groups was carvedilol. Angiotensin-converting enzyme inhibitors were administered to about 70% of patients in both groups, enalapril being the most used. The percentage of patients receiving angiotensin II antagonists was also similar.

3.2. Effects of the intervention programme
After a mean follow up of 16±8 months, patients allocated to the intervention programme had a significant reduction in readmissions and overall mortality (Table 2, panel A). Probability of survival was 87% in the intervention group and 65% in the control group (p=0.03). Probability of readmissions due to heart failure was 54% in the control group for only 19% in the intervention group (p<0.01). There were no differences in the probability of readmissions not due to heart failure.


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  		Table 2
 
Although the quality of life significantly improved in both groups, this improvement in mean MLWHFQ score was greater in the intervention group 1.5±0.8 than in the control group 1.9±1 (p=0.03).

Medical therapy at the end of the intervention programme showed important differences between the groups (Table 3). 63% of intervention patients received beta-blockers, compared with only 39% of the control group (p=0.03). Also, the dosage of carvedilol was slightly higher in the intervention group patients (16±9 mg/day versus 12±7 mg/day; p=0.08). Although the percentage of patients receiving angiotensin-converting enzyme inhibitors was similar, the doses were higher in the intervention group (enalapril: 21±8 mg/day versus 16±8 mg/day; p<0.01).


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  		Table 3
 
In the multivariate analysis according to the Cox model, assignment to the intervention group (OR: 0.2, IC: 0.1–0.4; p<0.01) and an acceptable score on the quality of life questionnaire before inclusion in the study (OR: 0.4, IC: 0.2–0.8; p=0.01) were the only variables which remained as predictors of a lower risk of readmissions due to heart failure. For mortality, assignment to the intervention group was associated with a lower risk (OR: 0.4, IC: 0.2–0.9; p=0.04), whereas an advanced age (>65 years) implied a higher risk (OR: 3.4, IC: 1.5–7.5; p<0.01).

3.3. Effects of the intervention programme at long term and after the suspension of the programme
Analysis of combined data from both the intervention programme and the 1-year period after it was stopped showed that the programme was also effective in the long term. After a mean follow-up of 25±10 months, the patients in the intervention group had less readmissions for HF (34% versus 56%; p<0.01) and lower all-cause mortality (25% versus 39%; p=0.06). However, analysis of data from only the 1-year period following suspension of the intervention showed that the percentage of readmissions and deaths were not different between the groups. The HF readmission rate was actually slightly higher in the intervention group, although this was not statistically significant (28% versus 25%; p=0.72). Mortality rates were 14% in the intervention group and 17% in the control group (p=0.64) (Table 2, panel B). Both groups had similar probabilities of readmissions and survival. However, the probability of survival was higher in the intervention group at 3 years (66% versus 56%; p=0.04) (Fig. 1); this difference was due to the effect of the period of the intervention programme, since the effect disappeared when only the 1-year period after suspension of the intervention programme was analysed (86% versus 83%; p=0.64) (Fig. 2). This was also true for readmissions (the probability of no readmissions was higher in the intervention group at 3 years (62% versus 41%; p<0.01), but was similar in both groups when only the 1-year period after suspension of the intervention programme was analysed (71% vs. 74%; p=0.73)). Similarly, a worsening of the perception of the quality of life was found among patients in the intervention group, which was probably related to the increase in hospital readmissions, the final average mark in the Minnesota questionnaire being similar in both groups (1.7±0.9 vs. 1.8±1, p=0.24).


Figure 1
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  		Fig. 1 Kaplan–Meier curves for cumulative survival during 36 months of follow-up (including the application of the intervention and the suspension programme).

 


Figure 2
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  		Fig. 2 Kaplan–Meier curves for cumulative survival during 12 months after stopping the intervention programme.

 
Pharmacological therapy was also affected by stopping the intervention programme (Table 3). Prescription rates for beta-blockers and spironolactone were significantly decreased when compared with the intervention period.


   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
Our findings confirm the beneficial effects found by other heart failure management programmes [9–20] in terms of decreasing readmissions in patients hospitalized for decompensated heart failure. We also found a positive impact of the intervention on survival, which was probably related, at least in part, to the better pharmacological treatment achieved (higher rates of beta-blockers and spironolactone, higher dosages of beta-blockers and angiotensin-converting enzyme inhibitors).

The main objective of our study was to determine whether there was any marked accentuation or attenuation of the beneficial effects of the intervention programme once it had been stopped. In the literature, only one study has assessed the effect of suspension of an intervention programme on the medium-term outcome of patients [23]. In this study, the intervention was home-based, and consisted of just one home visit by a cardiac nurse 7–14 days after discharge. After 18 months, there were fewer readmissions in the intervention group compared with the control group. It is difficult to explain the exact mechanism responsible for this favourable outcome, which was even better than that obtained during the first few months after the home visit. Subsequently, the authors showed that the short- to medium-term benefits of a postdischarge intervention programme on prolonged event-free survival, reduced hospital use, and associated costs, were largely sustained over the long term [24].

Our findings suggest that the effects of the intervention clearly decrease once the programme has been stopped; therefore, there are no differences between the study groups for readmission rates, all-cause mortality and quality of life during this period. However, if we analysed these parameters from the beginning of the study, we found significant differences in favour of the patients in the intervention group, which can be explained by the beneficial effect of the intervention programme during its application.

Different reasons for the observed lack of continued benefit following suspension of the intervention programme can be considered. It is possible that the value of these interventions has a "diminishing return" after a period of time, due to the natural history of HF. It is thus possible that there would have been no additional benefit even if the intervention had been continued. Another possible explanation could be that the intervention itself was unsuccessful in teaching patients about their illness and the necessary self-care, so that when the intervention ended, patients were ill-equipped to continue to manage their illness, and reverted to the same pattern of care and outcomes as in the control group. However, we do not believe that this is the main reason, since during the application of the intervention programme we concluded that patients understood the importance of self-care very well. Also, more patients died in the control group during the intervention period, as a result, although the patient groups were similar at the time of randomization, this may no longer have been true at the end of the intervention period; surviving patients in the control group may have been "healthier" than those in the intervention group.

Despite all these considerations, we think the nature of the intervention used was crucial in order to obtain these favourable results, mainly concerning the decrease in overall mortality. The close monitoring of patients and the contact with the cardiologist in charge facilitated a high level of knowledge about the patient's condition, including early recognition of signs and symptoms of decompensation, and optimisation of prescribed medical treatment. Suspension of the programme led to less strict control of the patients, which meant, among other things, a reduction in the use of drugs such as beta-blockers, spironolactone and angiotensin-converting enzyme inhibitors, which have been shown in many clinical trials to improve prognosis of patients with heart failure.

Limitations: The main limitation of our study is that it is possible that these results cannot be extrapolated to all HF patients, since the study only included patients discharged from the Cardiology Service, who are usually younger and with fewer co-morbidities. Therefore, the extrapolation of these results to a general population of patients with heart failure requires further studies. In order to test the hypothesis that withdrawal of the intervention programme is detrimental, we would need to randomize patients to either continuation or withdrawal of the programme, which was not done in this study.

In conclusion, we consider that an intervention programme like this gives undoubted benefits to HF patients, with a significant reduction in HF morbidity and mortality and an improvement in quality of life; these favourable effects clearly decrease after suspension of the programme. Taking into account these results, it seems that long-term programmes are required in order to maintain these beneficial effects.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 

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