© 2005 European Society of Cardiology
Success of a multidisciplinary heart failure clinic for initiation and up-titration of key therapeutic agents
a Department of Cardiology St. Bartholomews and the London NHS Trust London, United Kingdom
b Department of Cardiology Newham HealthCare NHS Trust London, United Kingdom
* Corresponding author. Department Cardiology, London Chest Hospital, Bonner Rd, London E2 9JX, United Kingdom. Tel.: +44 20 8983 2413; fax: +44 20 8983 2298. E-mail address: timmis{at}lch.demon.co.uk
| Abstract |
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Background: Heart failure has a poor prognosis, yet drugs known to improve outcomes are either not prescribed, or prescribed at sub-therapeutic doses. The National Service Framework (NSF) for coronary heart disease recommended specialist heart failure clinics to address this problem but their efficacy has not been evaluated.
Objectives: To determine the effectiveness of a protocol-driven heart failure clinic staffed by nurse and pharmacist specialists for improving symptoms and optimising treatment with key therapeutic agents, without adversely affecting renal function.
Results: Of the 234 patients with at least one follow-up visit, 127 (57%) were receiving none or only one key therapeutic agent when first seen, this was reduced to 25 patients (11%) at most recent follow-up. The improvement in prescription rates was accompanied by significant up-titration of dose, the proportion of patients on "medium" or "high" doses rising from 43 (18%) to 134 (57%) for beta-blockers, and from 129 (55%) to 201 (86%) for ACE-inhibitors/angiotensin receptor blockers. Clinical improvement was reflected in reductions in patients with NYHA functional classes III and IV (93 (40%) to 53 (23%)), and in patients with moderate or severe symptoms. Significant reductions in alcohol consumption and cigarette smoking were recorded. Up-titration of treatment was associated with reductions in heart rate and systolic blood pressure; increases in serum potassium and creatinine concentrations were small.
Conclusion: In a heart failure clinic staffed by nurse and pharmacist specialists, it is possible to achieve target doses of key therapeutic agents and improve symptoms without adversely affecting electrolytes or renal function.
Key Words: Heart failure Heart failure clinics National Service Framework Nurse care management Drug treatment
Received June 4, 2004; Revised August 5, 2004; Accepted September 20, 2004
| 1. Introduction |
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Heart failure accounts for about 5% of all medical admissions, has high readmission rates, is increasing in prevalence, and has a prognosis rivalling that of major cancers. Randomised trials have shown that in all classes of heart failure, treatment with ACE-inhibitors and beta-blockers improves symptoms and outcomes, and these treatments are currently recommended for first line management [1]. Spironolactone exhibits similar benefits in moderate to severe (NYHA classes III and IV) heart failure [2], and most recently a role for angiotensin receptor blockers has been confirmed, particularly in patients intolerant of ACE-inhibitors [3].
Despite the evidence, however, these drugs are often not prescribed or, if prescribed, target doses are rarely achieved. The EuroHeart Failure Survey reported UK treatment rates for ACE-inhibitors and beta-blockers of less than 55% and 25%, respectively [4]. The National Service Framework (NSF) for coronary heart disease, in response to this under provision of care has now recommended the establishment of specialised heart failure clinics [5], but although service models have been proposed [6] there have been no UK reports of the efficacy of these clinics. A single Swedish report showing improved outcomes at 12 months, albeit with no significant effect on prescription of ACE-inhibitors or beta-blockers [7] has been published. Indeed, this has been the pattern of other reports of specialist intervention, by nurses or physicians, which have commented on improved clinical outcomes [8,9], with only a variable effect on prescription of ACE-inhibitors and no effect on prescription of beta-blockers [10,11]. Whether this reflects concerns about potential unwanted effects of treatment on blood pressure and renal function is unclear, but at present the value of heart failure clinics for optimising treatment regimes remains largely unproven.
In this study, we report the effectiveness of a protocol-driven heart failure clinic staffed by nurse and pharmacist specialists. Effectiveness has been measured by prescription and up-titration of key therapeutic agents, symptomatic responses, lifestyle changes and effects on serum creatinine and electrolyte levels.
| 2. Methods |
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2.1. Heart failure clinic
Clinics were established at Newham Healthcare Trust and St Bartholomew's and The London Trust (BLT) staffed by nurse specialists and a pharmacist specialist, who led in seeing the patients under the supervision of a consultant cardiologist. Management guidelines were developed, with protocols for initiation and up-titration of all key therapeutic agents. Protocols for biochemical monitoring were also included. The requirement was for patients without contra-indications to receive therapeutic doses of ACE-inhibitors (or angiotensin receptor blockers if these were not tolerated, a policy now vindicated by the CHARM investigators [3]) and then to be started on beta-blockers. Patients whose initial presentation (almost invariably before first attendance at the clinic) was with NYHA class III–IV symptoms also received spironolactone. Management protocols were implemented by the nurse and pharmacist specialists who supervised treatment and drew up prescriptions. To ensure evidence based, competent practice all non-medical staff (nurses and pharmacists) underwent a formal documented assessment before participating in the nurse led heart failure clinic. Their level of competence was determined using a predefined set of competencies. The nurse/pharmacist had to achieve competent status before being allowed to use the Patient Group Directives, which allows prescription of specified medications. Study material was provided and the nurse/pharmacist was observed in the clinical setting for a number of sessions. A minimum of two out of the three assessors assessed each nurse/pharmacist. Assessors included the consultant cardiologist, consultant nurse and the senior cardiac pharmacist. A record of achievement was retained within the heart failure department and a copy was sent to the individual's manager to be kept in their personal file. In one of the clinics, the nurse and pharmacist specialists have now been authorised to sign prescriptions under Patient Group Directions legislation [12], but in the second clinic prescribing continues to be performed by the lead physician. Although the clinics were nurse/pharmacist-led, a consultant cardiologist (less commonly a specialist registrar) was always available within the clinic to provide supervision and advice as necessary.
2.2. Data collection
Patients referred internally or from primary care were weighed and underwent an electrocardiogram, chest radiograph and cardiac ultrasound examination prior to or at the first consultation, at which time blood samples were drawn for serum urea, creatinine and electrolyte measurements, and blood count. All clinical data were entered onto an electronic database at the time of, or shortly after, each clinic attendance. We recorded demographic factors, New York Heart Association functional class, and symptoms (peripheral oedema, dyspnoea and fatigue) on a four-point scale (none, mild, moderate, severe). Also recorded were heart rate and blood pressure, and initiation and up-titration of key therapeutic agents. Patients were directly questioned regarding cigarettes smoked per day and units of alcohol consumed per month, at each of their clinic visits. Built into the database was an internal audit mechanism, which generated a cumulative record for individual patients setting out blood pressure, renal function and current and previous prescriptions of key therapeutic agents. This identified at a glance the up-titration status and the future strategy necessary to meet protocol requirements. It also provided a simple means of communicating progress to primary care (Fig. 1).
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2.3. Data analysis
Data for the first 2.5 years were analysed by paired t-testing for continuous variables and chi square testing for nominal variables. For comparative purposes, the daily dose of individual therapeutic agents were converted to a titration score (Table 1), doses falling between titration scores being assigned the higher value.
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| 3. Results |
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3.1. Patient characteristics
Since starting the clinics, 265 patients have been seen of whom 234 (89%) have had at least one follow-up visit over a median (inter-quartile range) of 112 (58–189) days (Table 2).
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3.2. Treatment (Tables 3 and 4)
Prescription analysis for ACE-inhibitors, beta-blockers and spironolactone showed that 143 patients (62%) were receiving none or only one of these agents when first seen, this was reduced to 50 patients (22%) at most recent follow-up (Table 3). With inclusion of angiotensin receptor blockers, the data were 127 (57%) falling to 25 (11%) patients. Reasons for non-prescription of these drugs are shown in Table 4, which indicates that among eligible patients only 19 (8%) were not challenged with a beta-blocker, and 4 (2%) with an ACE-inhibitor or angiotensin receptor blocker. The improvement in prescription rates was accompanied by a significant increase in dosage from the first to the most recent follow-up visit (Fig. 2), the proportion of patients on "medium" or "high" dose titrations rising from 43 (18%) to 134 (57%) for beta-blockers, and from 107 (46%) to 153 (66%) for ACE-inhibition (129 (55%) to 201 (86%), with inclusion of angiotensin receptor blockers).
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3.3. Clinical haemodynamic and biochemical changes (Table 3)
Clinical improvement was reflected in significant reductions in patients with NYHA functional classes III and IV from 93 (40%) to 53 (23%), and in patients with moderate or severe symptoms (dyspnoea, 66 (30%) to 23 (10%); fatigue, 55 (25%) to 42 (19%); peripheral oedema, 15 (7%) to 10 (4%)). There were also lifestyle benefits with reductions in alcohol consumption and the number of patients smoking. Comparison of the first and most recent follow-up visit showed reductions in heart rate and blood pressure. Increases in serum potassium and creatinine concentrations, though statistically significant were small.
| 4. Discussion |
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This study has shown that a heart failure clinic staffed by nurse and pharmacist specialists can successfully enhance clinical status, modify lifestyle and initiate and optimise those key therapeutic agents that have been associated with improved long-term prognosis. Importantly, the data show that these therapeutic agents, especially beta-blockers, can be safely up-titrated with only minor deterioration in renal function.
The recommendation in the NSF for specialist heart failure clinics has been widely implemented throughout the UK, yet evidence of clinical effectiveness is sparse. A Swedish group has shown that a nurse-monitored structured care programme can improve prescription of ACE inhibitors in elderly patients with moderate to severe chronic heart failure, although treatment rates remained lower than those seen in large intervention trials [13]. Further it has been shown that the prescribing and up-titration of beta blockers in patients with heart failure is achieved more successfully by nurse led intervention [14], and we believe that the success of our clinic was largely attributable to the use of nurse and pharmacist specialists for implementation of approved management protocols and prescription of agreed therapeutic agents. This increased their stake in the management process and their commitment to the clinic. Heart failure lends itself well to protocol-driven prescribing because the number of key therapeutic agents is small, and up-titration schedules can be made explicit in management protocols. Of course, contra-indications ensured that not all patients could be treated with ACE-inhibitors and beta-blockers but some of the shortfall was also the result of our conservative data analysis which applied to the last recorded clinic visit and included, therefore, some patients only recently recruited (18 patients had had a single follow-up visit) in whom initiation and up-titration of treatment was in its early stages.
Also important to the success of the clinic was careful electronic data collection that underpinned the audit process driving the prescription and up-titration of key therapeutic agents. This could only have been achieved within a specialist clinic with a manageable dataset. It simplified the job of our nurse and pharmacist specialists by prompting them to ask the relevant questions contained in the dataset and by providing them with a list of standardised answers in drop-down menus that facilitated the data analysis presented in this paper. It also provided a cumulative record of key clinical therapeutic and biochemical variables for individual patients to guide treatment according to protocol requirements. This same record, which was generated automatically, doubled as a clinic letter for the patients' primary care physician.
| 5. Limitations of this study |
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Although this study is limited by the fact that it is descriptive in nature, we have endeavoured to include as large a number of patients as possible in this analysis, improving the validity of our findings. The demographic and risk factors of the patient population that attend the combined clinics are fairly typical. However, we had a relatively young population and a preponderance of males, this can perhaps be explained by the fact that we follow-up a large number of South Asian patients (ethnic minorities comprised 38% of the study population), in whom coronary artery disease occurs pre-dominantly in males, and at a relatively young age. The high proportion of patients from ethnic minorities is presumably explained by the inner London location of both of these clinics. Cigarette and alcohol consumption may have been under-reported by our patients, thus overestimating the effects of health education in the clinic. We are considering employing more objective assessments of these parameters to be carried out at clinical follow-up.
The nurse and pharmacist led prescribing in our clinic was based on Patient Group Directions Legislation, agreed within the NHS trust. A limitation of the study is that it would not be possible to extend this prescribing method to primary care, where supplementary— prescribing by non-medical staff would perhaps be a more appropriate approach.
| 6. Conclusion |
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In conclusion, we have shown that in accordance with National Service Framework recommendations, this heart failure clinic staffed by experienced cardiac nurses and a cardiac pharmacist has successfully increased the proportion of patients receiving therapeutic doses of ACE-inhibitors or angiotensin blockers and beta-blockers. This was associated with symptomatic improvement but no significant deterioration in renal function. We attribute the success of this clinic to a protocol-driven treatment policy, prescribing privileges for the nurse and pharmacist specialists, careful consultant supervision, and electronic data-basing which permitted continuous internal audit of treatment strategies.
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