© 2008 European Society of Cardiology
When, how and where should we "coach" patients with heart failure: The COACH results in perspective
Department of Cardiology University Medical Center Groningen The Netherlands
* Corresponding author. Department of Cardiology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands. Tel.: +31 50 3612355; fax: +31 50 3614391. E-mail address: d.j.van.veldhuisen{at}thorax.umcg.nl (D.J. van Veldhuisen).
Received February 18, 2008; Accepted February 27, 2008
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1. Introduction |
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 Top 1. Introduction 2. Results from COACH3. Interpretation of the...4. Future implicationsReferences |
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Heart failure (HF) is a major medical and epidemiological problem, and over the last 20 years a large number of studies have examined the value and place of several forms of disease management programmes for patients with heart failure [1]. These programmes have varied significantly in terms of how early in the disease process HF patients would need counselling and coaching (when), which forms and "dose" of counselling would be required and necessary (how), and lastly, in which setting such interventions should take place, i.e. in hospital or possibly outside the hospital (where). Despite these differences, many of these studies reported positive effects and as a result, disease management programmes are recommended in international HF guidelines, both in Europe and in the United States [2,3]. However, many of the studies were relatively small, and it also is not unlikely, that studies that found beneficial effects may have published relatively more frequently, than those that did not find such favourable effects, i.e. a publication bias could be present.
Recently the data from The Coordinating study evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) study were published [4]. COACH is the largest study so far, to examine the effect of a multidisciplinary disease management programme for patients with HF. It was hoped that the eagerly awaited results of COACH would provide a better understanding of the dose of the intervention and would help in making better choices in HF heart failure disease management. Interestingly, and somewhat surprisingly, the findings of COACH did not fully confirm results from previous studies. While it was the first trial to be adequately powered to examine the effect on outcome, i.e. on the combined endpoint of time to readmission and all-cause mortality, it did not show a significant reduction on outcome.
Since these findings were somewhat unexpected, and may lead to some potentially erroneous conclusions, we believe it is important to discuss these results and to provide some interpretations that may shed new light on these findings.
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2. Results from COACH |
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Top1. Introduction2. Results from COACH3. Interpretation of the...4. Future implicationsReferences |
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The COACH-study was a multicenter randomised controlled trial which enrolled 1023 patients (mean age 71±11 years; 38% female), who were enrolled after a hospitalisation for HF and followed for 18 months. Patients were recruited from 17 centres in the Netherlands. Patients were assigned to one of three groups: a control group (planned follow-up by cardiologist), and two intervention groups with additional basic, or intensive support by a heart failure nurse [5]. The follow-up care in the control group was provided by cardiologists according to a protocol, meaning that patients were scheduled to see a cardiologist within 2 months of discharge and thereafter every 6 months. The education and support in the 2 intervention arms were provided by trained HF nurses, according to a patient tailored education protocol, using self-care enhancement strategies, supported by educational materials. COACH had 2 primary endpoints: the first was a composite of HF hospitalisation or death from any cause. The second primary endpoint was the number of unfavourable days, i.e. the number of days lost because of death or hospitalisation. There were several secondary endpoints, which included of course all-cause mortality alone.
During the 18 months of the study, 411 patients (40%) were readmitted for HF or died from any cause, with no statistically significant difference between the 3 groups: 42% in the control group, and 41% and 38% in the basic and intensive support groups respectively (Fig. 1). The number of days lost to death or hospitalisation was 39,960 in the control group, it was 15% lower in the intervention groups, however, this difference was not statistically significant. There was a trend towards a lower mortality (15%) in the two intervention groups compared to the control group (p=NS), which was not consistent over time. This was however, accompanied by slightly more (but shorter) hospitalisations for HF in both intervention groups (p=NS). Although the design of the study was such that patients in the control group had a limited number of visits to the cardiologist (see above and ref [5]), these patients nevertheless had 33% more visits to their doctor than was originally planned.
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3. Interpretation of the COACH data |
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Top1. Introduction2. Results from COACH3. Interpretation of the...4. Future implicationsReferences |
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The results from the COACH study do not fully support previous reports and meta-analyses, which suggest that disease management programmes lead to a reduction in hospitalisations and may possibly reduce mortality in patients with HF [6,7]. The results however, do suggest that mortality may possibly be favourably affected, but at the expense of slightly more, short hospitalisations.
3.1. How can these findings be explained?
First, patients in the control group were managed well enough already, thus making it difficult to further improve outcome with an added intervention. Compared to earlier studies, the level of management (coaching) in the control group was relatively high. In most previous studies the care in the control group consisted of conventional follow-up in primary health care without any or very limited follow-up by a cardiologist. In the COACH study, the cardiologists were instructed to schedule four follow-up visits per patient during the 18 month follow-up period, but at the end of the study it turned out that the 339 patients in the control group had had 286 extra, unplanned visits to their cardiologist, presumably these extra visits were often related to an increase in symptoms. Moreover, primary health care, in particular the level of care by general practitioners, is very well developed in the Netherlands, and patients in the control group may also have had support from this side. Compliance with advice and adherence to medication are known to play an important role in HF [8,9], and an important part of the success of disease management programmes is related to improving these two factors. In COACH, compliance and adherence was relatively high, even in the control group. Overall, the higher level of "basic care" in the control group may have been one factor why there was no effect of the interventions on the primary endpoint.
Second, it is possible that the two interventions may not have been effective at achieving their goals, i.e. the intervention was not successful in counselling and educating patients, so that hospital admissions for HF were not prevented. Although this possibility cannot be excluded, we do not believe that it is very likely, since substantial time and effort was spent by an organized group of professionals.
We observed a 15% reduction in all-cause mortality, when we compared the control group with the 2 intervention groups, which was not statistically significant. In the control group 99/339 patients died (29%), as compared to 90/340 patients (27%) in the basic intervention or support group, and 83/344 patients (24%) in the intensive support group, i.e. a 2% and 5% absolute difference, respectively. This favourable trend was offset by more hospitalisations in the intervention groups, and the latter might have been due to a lower threshold of patients to health care providers—in this case the HF nurses—who often intervened by admitting the patient. As stated in the commentary by Cleland et al. [10], it is debatable whether hospitalisation is a good thing or bad thing. Appropriate and timely hospitalisation in a good HF programme is likely to relieve symptoms and result in better diagnosis and management, although increasing admissions might not be the aim of health care policy makers. Indeed, we found that readmissions were shorter in the intervention groups and the challenge for health care providers in future might be to shorten these hospitalisations even further and to organize care more efficiently.
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4. Future implications |
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Top1. Introduction2. Results from COACH3. Interpretation of the...4. Future implicationsReferences |
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It has become increasingly clear that we need to optimize the content of follow-up strategies for patients after discharge following a hospitalisation due to worsening of chronic heart failure [11]. It appears wise to focus on a general integrative concept, which needs to include important components such as optimisation of treatment, counselling, education, improving adherence and adequate reactions to signs and symptoms from both health providers and patients [8].
The next challenge will be to individualize care and treatment for each patient [12]. A dedicated team is needed to provide this service, including motivated cardiologists as well as nurses. The COACH study makes us more aware how complex care for patients with HF is and how important it is to have a tailored approach.
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References |
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Top1. Introduction2. Results from COACH3. Interpretation of the...4. Future implicationsReferences |
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- Phillips C.O., Singa R.M., Rubin H.R., Jaarsma T. Complexity of program and clinical outcomes of heart failure disease management incorporating specialist nurse-led heart failure clinics. A meta-regression analysis. Eur J Heart Fail (2005) 7:333–341.
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[Free Full Text] - Heart Failure Society of America. Executive summary: HFSA 2006. Comprehensive heart failure practice guideline. J Card Fail (2006) 12:10–38.[CrossRef][Web of Science][Medline]
- Jaarsma T., van der Wal M.H.L., Lesman-Leegte I., et al. Effect of moderate or intensive disease management program on outcome in patients with heart failure. The Coordinating study evaluating Outcomes of Advising and Counselling in Heart Failure (COACH). Arch Intern Med (2008) 168:316–324.
[Abstract/Free Full Text] - Jaarsma T., Van Der Wal M.H., Hogenhuis J., et al. Design and methodology of the COACH study: a multicenter randomised Coordinating study evaluating Outcomes of Advising and Counselling in Heart failure. Eur J Heart Fail (2004) 6:227–233.
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[Abstract/Free Full Text] - Van der Wal M.H.L., Jaarsma T., Van Veldhuisen D.J. Non-compliance in patients with heart failure; how can we manage it? Eur J Heart Fail (2005) 7:5–17.
[Abstract/Free Full Text] - Cleland J.G., Coletta A.P., Clark A.L. Clinical trials update from the American College of Cardiology 2007: ALPHA, EVEREST, FUSION II, VALIDD, PARR-2, REMODEL, SPICE, COURAGE, COACH, REMADHE, pro-BNP for the evaluation of dyspnoea and THIS-diet. Eur J Heart Fail (2007) 9:740–745.
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