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European Journal of Heart Failure 2005 7(5):910-920; doi:10.1016/j.ejheart.2004.11.004
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© 2004 European Society of Cardiology

Heart failure programmes in countries with a primary care-based health care system. Are additional trials necessary? Design of the DEAL-HF study

Pieta W.F. Bruggink-André de la Portea,b,*, Dirk J.A. Lokb, Jan van Wijngaardenb, Jan H. Cornelc, Dian Pruijsers-Lamersb, Dirk J. van Veldhuisend and Arno W. Hoesa

a Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, The Netherlands
b Cardiology Department Deventer Hospital, Fesevurstraat 7, 7415 CM Deventer, The Netherlands
c Cardiology Department Medical Center Alkmaar, Alkmaar, The Netherlands
d Cardiology Department Groningen University Hospital, Groningen, The Netherlands

* Corresponding author. Cardiology Department, Deventer Hospital, Fesevurstraat 7, 7415 CM Deventer, The Netherlands. Tel.: +31 570 646712; fax: +31 570 620492. E-mial address: P.Bruggink{at}dz.nl


   Abstract
Top
 Abstract
1. Introduction
 2. Randomised studies of...
 3. Deventer-Alkmaar Heart...
 4. Methods
 5. Summary
 References
 
Background: Several randomised studies of heart failure (HF) management programmes in the United States, Australia and Europe have shown a considerable reduction in hospitalisation rates for HF. In this article, a comprehensive review of these studies will be provided and their applicability to countries, with a primary care-based healthcare system, will be discussed. In addition, the design of the Deventer-Alkmaar HF Project (DEAL-HF), a randomised study of the effect of a nurse and physician-directed intervention over 1 year in The Netherlands, will also be presented.

Aim: To discuss the applicability of the results of available studies on heart failure management programmes to countries with well-structured primary care facilities and to determine whether additional trials should be conducted in these countries.

Methods: We performed a literature search in PubMed. In a review of the available studies, essential methodological aspects, in particular, the population involved, the sample size, follow-up period, setting, type of intervention, and the outcome parameters, are discussed critically. Also, the applicability of these studies to countries with a primary care-based healthcare system and easy access to medical care is evaluated.

Conclusion: Applicability of the results of the available studies on the efficacy of heart failure management programmes to countries with a primary care-based health care system is doubtful. An efficacy trial in a country with a well-established primary care-based healthcare system, such as The Netherlands, is due to report soon (DEAL-HF).

Key Words: Heart failure • HF management programmes • Education

Received May 4, 2004; Revised September 24, 2004; Accepted November 11, 2004


   1. Introduction
Top
 Abstract
 1. Introduction
2. Randomised studies of...
 3. Deventer-Alkmaar Heart...
 4. Methods
 5. Summary
 References
 
In recent years, several randomised studies of heart failure management programmes in the United States [1–6], Australia [7–9] and Europe [10–14] have reported a considerable reduction in readmissions for heart failure and total readmissions. However, many of these studies are characterised by limited sample size, short follow-up period or limited accessibility to the healthcare system in the respective country. Furthermore, the setting and interventions of the heart failure management programmes differ considerably. Evidence of the cost-effectiveness and impact on outcomes of these programmes in countries with a primary care-based healthcare system and easy access to healthcare is not readily available. In this article, we will critically discuss the published randomised trials assessing the effectiveness of heart failure management programmes. Apart from methodological issues, the applicability of the results of these studies to the European situation will be discussed. Finally, we present the rationale and design of the randomised, prospective trial, the Deventer–Alkmaar Heart Failure Clinic Project (DEAL-HF), which aims to evaluate the effect of a heart failure outpatient clinic in a country with an easy access primary care-based healthcare system.


   2. Randomised studies of heart failure management programmes
Top
 Abstract
 1. Introduction
 2. Randomised studies of...
3. Deventer-Alkmaar Heart...
 4. Methods
 5. Summary
 References
 
We performed a literature search in PubMed of randomised trials published in English, assessing the effect of heart failure management programmes.

In 2001, a metaanalysis was published of 11 of such trials [15]. Since this publication, many more relevant publications of randomised controlled trials have been reported. In Table 1, the characteristics of most of these trials are reported [1,3–14,16–23]. All trials are designed as prospective, randomised, controlled trials, thus minimising the possibility of bias. The important methodological aspects of these studies are as follows:

(1) Patient characteristics: Most patients included in the trials were males (55%), and the mean age was 72.8 years. The seriousness of the disease varied from mild to very serious, NYHA I–IV, in the available studies (I–IV: two studies; II–IV: nine studies; III–IV: five studies; IV: one study). Not all studies provided information on the NYHA classification.
(2) Setting: The setting of these heart failure management programmes varied widely and included primary care clinics, outpatient clinics, home visits, telephone monitoring and televideocare. Most studies were performed in countries with a less well-organised primary care system and more difficult access to medical care than in European countries with a well-established primary care-based health care system, such as Denmark, the United Kingdom and The Netherlands.
(3) Intervention: Only few studies provided a precise description of the intervention and the intensity, thus limiting the applicability of the intervention. Some clinics were run by a nurse only, some by a nurse and a physician and some by a nurse and a multidisciplinary team. The number of visits related to the interventions also differed considerably. In addition, most studies tested multiple interventions, making it difficult to discern the optimal, i.e., most effective, combination of interventions.
(4) Sample size: The sample size of the majority of the available studies was limited (mean: 190 patients; range: 60–504 patients).
(5) Follow-up period: The follow-up period of most of the available studies was 6 months or less. One study reported a long-term effect after 4.2 years.
(6) Outcome parameters: The outcome parameters studied varied greatly and included readmission rates, time to readmission, readmission-free survival and the combined endpoint readmission for CHF and/or all-cause mortality.


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  		Table 1 Characteristics of randomised trials of the effect of heart failure management programs

 
The findings of 21 randomised trials of the effect of heart failure management programmes are summarised in Table 2. Five studies showed a statistically significant reduction in the combined endpoint of readmissions and/or mortality, irrespective of the reason [5,7–9,14], and two studies reported a statistically significant reduction in the combined endpoint of readmission rates for heart failure and/or death [11,12].


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  		Table 2 Results of randomised trials of the effect of heart failure management programmes

 
In seven studies, a reduction in the readmission rate, irrespective of cause [1,2,7–9,11,13] was observed, and a reduction of readmissions for heart failure was demonstrated in five studies [1,4,6,11,12]. A statistically significant decrease in the number of days spent in hospital was reported in five studies [1,4,7,8,14].

Stewart et al. [8,9] demonstrated a prolonged event-free survival in two studies involving follow-up periods of 18 months and 4.2 years, respectively. Strömberg et al. [14] was the first to show a significant reduction in mortality rate related to a heart failure management programme.

In four studies [1,4,20,23], an improvement in quality of life was shown, and two studies reported an improvement in self-care scores [14,22]. Significant cost-savings by a heart failure management programme were reported in three studies [4,6,9].

In summary, in 15 of the 21 studies, a positive impact on one of the primary outcome parameters was observed, while in three studies [18,21,22], no effect was shown. In one study [16], the heart failure management programme actually increased the total readmission rates and the number of the days spent in the hospital.

2.1. Applicability of the available studies to countries with a primary care-based healthcare system and easy access to medical care
For several reasons, the applicability of these abovementioned data on heart failure management programmes to a country with a relatively strong primary care system is debatable.

Firstly, in health care systems with a strong primary care basis, such as Denmark, the United Kingdom and The Netherlands, the general practitioner is still the first physician to diagnose and treat most complaints/illnesses and to decide on referral to hospital specialists—the gate-keeping function—in contrast to, for example, the US. More than 50% of patients with heart failure in The Netherlands will be diagnosed and treated by their GP [24]. Thus, some aspects of heart failure management are, at least potentially, taken care of by the general practitioner, e.g., regular supervision and support of patients with severe heart failure and easy access to medical care when heart failure symptoms worsen. This would imply that room for improvement by counseling in a heart failure management programme would be smaller in these European countries as compared to countries with less well-structured primary care facilities. It should be noted, however, that two recent studies showed that the diagnosis and treatment of heart failure by general practitioners in The Netherlands and other European countries are far from optimal. Our group showed a relatively, albeit understandably, low number of additional investigations, such as echocardiography (12% vs. 97% in secondary care), in patients with suspected heart failure in primary care. In addition, lower prescription rates of "evidence-based" medication are seen in "GP patients" in comparison with patients managed by a cardiologist [25]. These data confirm the results of the "IMPROVEMENT of Heart Failure Programme", an international survey conducted in 15 countries [26].

A second aspect concerns the changes that have taken place in the treatment of heart failure over the last decade as a result of the positive outcomes of large studies of ACE inhibitors, beta-blockers and spironolactone. Although there is still underuse and underdosing of these drugs, their benefits will certainly influence the outcomes of current studies of heart failure management. In addition, in recent years, the greater awareness of the importance of heart failure by physicians and improved education of the patient leading to better understanding and compliance by the patient may have reduced the number of hospitalisations and improved survival, making extrapolation of the results of previous studies to the present questionable [27]. Several studies (e.g., in The Netherlands and Scotland) reported a peak in hospitalisation rates for heart failure as the principle diagnosis around 1993, after which a decline was noted in subsequent years [28,29]. This recent change in hospitalisation rates for heart failure could partly be attributed to improvements in the treatment of heart failure and could result in less potential for clinical improvement from heart failure management programmes.

Thirdly, the previously mentioned limitations of some studies, in particular the short follow-up periods, the relatively small sample sizes and the variety in setting and intervention programmes, are reasons why it is not advisable to uncritically implement heart failure management programs in countries with a different healthcare system.

In summary, the value of a heart failure management programme as a positive addition to a healthcare system with a strong primary care remains to be proven. This is the justification for the DEAL-HF study (Deventer–Alkmaar Heart Failure Clinic Project) which commenced in 2000 in The Netherlands. The design of this study is presented below. In contrast to most earlier studies, a trained cardiovascular nurse and an experienced heart failure physician worked closely together in our heart failure management programme. Other important differences from earlier studies include the fact that, in previous studies, patients could only be included if they were hospitalised for heart failure, while in our study, NYHA class III–IV outpatients were also included. Furthermore, the selection criteria in DEAL-HF were not particularly stringent, so that the patient characteristics more accurately reflect those of "real life" heart failure patients. Finally, DEAL-HF includes both patients with symptomatic left ventricular systolic dysfunction and patients with symptomatic heart failure with preserved left ventricular systolic function.


   3. Deventer–Alkmaar Heart Failure Project (DEAL-HF)
Top
 Abstract
 1. Introduction
 2. Randomised studies of...
 3. Deventer-Alkmaar Heart...
4. Methods
 5. Summary
 References
 
The Cardiology Department of the Deventer Hospital in The Netherlands is undertaking a prospective, randomised, parallel group trial to determine the effects of a nurse and physician-directed multidisciplinary intervention in a country with a relatively strong primary care system. The follow-up period is 1 year. Outcome parameters included rates of hospitalisation for worsening heart failure and/or all cause mortality; rates of hospitalisation for worsening heart failure and/or cardiovascular mortality; ventricular function and plasma neurohormone level (NT-proBNP), quality of life, time to first event, compliance to medication and costs of care. The trial is being performed in collaboration with the Julius Center for Health Sciences and Primary Care of the University Medical Center in Utrecht, The Netherlands and the Cardiology Department of the Groningen University Hospital in Groningen, The Netherlands. In March 2002, the Cardiology Department of the medical Center Alkmaar joined the project. Patients were only recruited in Deventer and Alkmaar, which are both regional teaching hospitals.


   4. Methods
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 Abstract
 1. Introduction
 2. Randomised studies of...
 3. Deventer-Alkmaar Heart...
 4. Methods
5. Summary
 References
 
4.1. Patients
Inpatients and outpatients with New York Heart Association Class III or IV heart failure who gave written informed consent were eligible for the study. Diagnosis of heart failure was established by typical clinical signs and symptoms of heart failure in conjunction with radiographic and/or echocardiographic findings of a reduced left ventricular systolic function (LVEF≤45%) or preserved left ventricular systolic function (diastolic dysfunction), according to the guidelines for the diagnosis of heart failure of the European Society of Cardiology. The criteria for exclusion included dementia or psychiatric illness, discharge to or stay in a nursing home, disease other than HF with an expected survival of less than one year, participation in another intervention study, planned hospitalisation or ongoing hospitalisation and kidney function replacement therapy.

4.2. Randomisation
The study was approved by the local ethics committees. Following screening, eligible patients were randomised by computer-generated allocation to either the intervention group or the control group.

4.3. Intervention group
The intervention consists of an intensive follow-up of the patient, with their caregiver, at a heart failure outpatient clinic (nine visits performed at increasing time intervals). An experienced cardiovascular nurse and a trained heart failure physician directed each visit. Visits commence within a week of hospital discharge or referral from the outpatient clinic (Table 3). Comprehensive education [30] and counseling is given to help patients and caregivers to acquire the knowledge, skills and motivation needed to comply with the treatment programme and participate in self-care [31]. Intervention includes the following components:

– verbal and written education and counseling with emphasis on behavioural strategies to increase compliance;
– vigilant follow-up of patient's condition;
– checking and optimisation of medical therapy, assessment of ECG and lab results;
– increased access to health care providers (extra visits whenever needed, telephone calls);
– early attention to signs and symptoms of fluid overload;
– coordination with home healthcare, primary care and cardiologist, if needed;
– one dietician consultation (more if needed);
– self-care (adjustment of diuretics, patient diary).


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  		Table 3 DEAL-HF study design

 
Patient education covers the following areas:
– what is heart failure, and what causes this patient's heart failure;
– differences between expected and serious symptoms and how to monitor them;
– most common symptoms before hospitalisation for CHF: dyspnea, edema, fatigue, cough, chest pain, sudden weight gain, difficult breathing while sleeping, palpitations [32];
– reason for each type of medication, how to take it routinely and how to improve compliance;
– importance of risk factor modification;
– specific sodium, fluid and alcohol restrictions with individualized diet;
– importance of daily self-measurement of patient's weight and of weight gain and loss;
– exercise and rest recommendations;
– how to change his/her behavior;
– how to cope with his/her disease (psychosocial care).

In addition, patients are taught the following skills:

– how to recognize symptoms;
– what signs and symptoms are important;
– how to respond to symptoms in a timely manner;
– when to call their health care provider;
– how to sort food into high- and low-sodium groups [33,34].

Repetition and individualized care are provided.

– The duration of the first two visits at the outpatient clinic is 1 h each. The nurse takes the patient's history, measures weight, pulse and blood pressure and starts the education programme. A patient diary with documentation on all relevant items is provided. An overall assessment is conducted by the physician for 30 min (introduction, physical examination, ECG, electrolytes, anemia and kidney function check and medication check with optimisation if needed). Then the nurse and physician develop a treatment plan. The nurse contacts homecare services if needed, and an appointment for a dietician consultation is made.
– Three days after the first visit, the nurse will make a telephone call to check on the patient.
– At the regular follow-up visits (7x 15–30 min, at increasing time intervals) at the outpatient clinic, education, counseling, check-up and reinforcement pertaining to the abovementioned items are provided by the nurse (Table 3). The nurse also performs a short physical examination and assesses the social circumstances of the patient. Six of the visits are combined nurse–physician visits (6x 15 min for the physician; see Table 3). The patient is first seen by the nurse and then, after a short review, by the physician. The physician assesses the clinical condition, performs a physical examination, monitors the laboratory results and ECG, checks and optimises the (medical) treatment regimen and, together with the nurse, performs the overall assessment. When a change of medication is initiated, the patient visits the heart failure clinic again after 2 weeks. In case of worsening heart failure, leading to additional drug therapy, the patient is seen at the heart failure clinic within 1–3 days. If deemed necessary, serious complications will be discussed with one of the cardiologists during the same visit.
– Patients included in the intervention group can always phone and/or visit the outpatient clinic, with a limited possibility of home visits by the nurse or physician if a patient is unable to visit the hospital.

The duration of the intervention period is 1 year. The flowchart summarises the visit schedule and the assessments at each visit (Table 3).

4.4. Control group
Patients in the control group receive usual care, including (non protocolised) outpatient visits, according to the requirements of each individual cardiologist in the Cardiology Department of the Deventer or Alkmaar hospital and care as usual from their general practitioner and possibly other health care professionals.

4.5. Outcome assessments
At baseline, 3 and 12 months plasma samples for neurohormone tests (NT-proBNP) will be taken, echocardiography will be performed to assess ventricular function (and stored on videotape) and quality of life questionnaires and NYHA classifications (by the physician) will be assessed in both patient groups, to determine if the intervention, by possibly improving fluid balance and cardiac performance, influences these outcome parameters.

The hospital pharmacist will organize 3-monthly overviews of medication (collected by the patient or caregivers) for all patients in order to determine patients' drug compliance. Hospitalisations are tracked by means of patient recall, chart review and hospital databases. A clinical endpoint committee will judge all causes of hospitalisation and death.

4.6. Primary and secondary outcomes
The combined primary endpoints are; occurrence of hospitalisation for worsening heart failure and/or all cause mortality and occurrence of hospitalisation for worsening heart failure and/or cardiovascular mortality; ventricular function (left ventricular ejection fraction), plasma neurohormone level (NT-proBNP), NYHA functional class and quality of life assessment. Secondary endpoints include time to death or hospitalisation, cost-effectiveness analysis and utilization of heart failure medication (diuretics, ACEi/AII antagonists, beta-blockers, spironolactone, digoxin) and adherence to prescribed medication.

4.7. Quality of life
Quality of life will be evaluated using the Rand 36 quality of life questionnaire [35], while disease-specific quality of life will be assessed by the Minnesota Living with Heart Failure questionnaire [36].

4.8. Sample size
Calculation of the sample size (236 patients) is based on the assumption of a reduction of the primary outcome (occurrence of hospitalisation for worsening heart failure and/or all cause mortality) of 50%, with an alpha of 5%, a discriminating power of 80% and an estimated 30% of hospitalisation or mortality in the control group. The total number of patients required in each treatment arm is 118.

4.9. Study organization
The Deventer Hospital and the Alkmaar Medical Centre are participating in this study in collaboration with the University Medical Center Utrecht and the Cardiology Department, Groningen University Hospital, The Netherlands.

The last (240th) patient was recruited in April 2003. Data analyses will start in May 2004.

4.10. Steering committee
Prof. A.W. Hoes, MD, PhD, chairman; Prof. D.J. van Veldhuisen, MD, PhD; P.W.F. Bruggink-André de la Porte, MD, principal investigator; D.J.A. Lok, MD, J. van Wijngaarden, MD, PhD and J.H. Cornel, MD, PhD.

4.11. Endpoint committee
A panel of three independent cardiologists from other hospitals will decide about the cause of hospitalisation and death. The panel will be blinded for the patient's intervention arm.

4.12. After study follow-up measurements
After the study period of 1 year, data on (re) admission, morbidity and mortality of both groups will still be collected by means of 6-monthly telephone calls.


   5. Summary
Top
 Abstract
 1. Introduction
 2. Randomised studies of...
 3. Deventer-Alkmaar Heart...
 4. Methods
 5. Summary
References
 
The results of the DEAL-HF study will contribute to our knowledge of the effect of a heart failure clinic, directed by a trained cardiovascular nurse and a specialised heart failure physician, with an intensive intervention over 1 year, in a country with a relatively strong primary care system.


   References
Top
 Abstract
 1. Introduction
 2. Randomised studies of...
 3. Deventer-Alkmaar Heart...
 4. Methods
 5. Summary
 References
 

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