Article Text
Abstract
Unplanned admissions for heart failure are common and some are considered preventable.
Objective Undertake a systematic literature review and meta-analysis to evaluate the effectiveness of specialist clinics in reducing unplanned hospital admissions in people with heart failure.
Data sources 18 databases were searched from inception to June 2010. Relevant websites and reference lists of included studies were checked for additional publications.
Study selection Randomised controlled trials in Organisation for Economic Co-operation and Development countries that evaluated the effectiveness of specialist clinic interventions for heart failure compared with usual care, where unplanned heart failure admissions or readmissions were an outcome.
Data extraction Data were extracted by one reviewer and checked by a second reviewer.
Results 10 of 17 randomised controlled trials met the inclusion criteria. Specialist clinics showed a reduction in unplanned admissions at 12 months (pooled risk ratio (RR) for five studies 0.51 (95% CI 0.33 to 0.76); absolute risk reduction 16 per 100 (95% CI 12 to 20)). Studies with initial frequent (weekly/fortnightly) appointments reducing in frequency over the study duration demonstrated a 58% RR reduction in unplanned admissions (pooled RR for three studies 0.42 (95% CI 0.27 to 0.65); absolute risk reduction 14 per 100 (95% CI 7 to 20)). Clinics conducted on a monthly or 3 monthly basis throughout or tailored to the individual patients did not show an effect.
Conclusions Specialist clinics for patients with heart failure can reduce the risk of unplanned admissions; these were most effective when there was a high intensity of clinic appointments close to the time of discharge which then reduced over the follow-up period.
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Background
Heart failure is a complex condition and patients are frequently admitted to hospital often due to poor compliance with medication, fluid restriction or insufficient medical therapy.1–3 In England, there were 53 413 such admissions in 2009/10.4 Current UK clinical guidelines recommend that heart failure care is delivered in the community by a multidisciplinary team.5 Specialist clinics for heart failure were developed to meet this recommendation and provide advanced diagnostic or treatment services.5 Specialist clinics aim to use disease protocols focusing on optimal management of the condition, education of patient and carers about the signs and symptoms of worsening disease, and medication compliance.6
One benefit of specialist clinics is thought to be a reduction in emergency or unplanned admissions, in addition to reduced length of hospital stay, improved quality of life and better value for money. The total overall cost of admissions for heart failure in England is around £119 million per annum, mean length of stay is 11 days and risk of readmission is high.4 ,7 The aim of this systematic review was to examine the effectiveness of specialist clinics in reducing unplanned hospital admissions for heart failure.
Methods
A wide range of electronic databases were searched (online supplementary table 1) to identify all studies of interventions used to reduce unplanned hospital admissions. This review considers the evidence for effectiveness of specialist clinics for heart failure in reducing heart failure specific unplanned admissions. Specialist clinics were defined as units providing access to multidisciplinary teams including specialist heart failure nurses, physicians or cardiologists delivering advanced diagnostic or treatment services.
Inclusion and exclusion criteria
Inclusion criteria were: randomised controlled trials (RCTs) of specialist clinics conducted in primary or secondary care for people with heart failure in which one of the outcomes was the number of unplanned hospital admissions or readmissions for heart failure; published in English or with an English abstract; and carried out in an Organisation for Economic Co-operation and Development country. This last criterion was chosen so that the results could be broadly applicable to the UK and other similar health systems.8 Unplanned, emergency or unscheduled hospital admissions were defined as ‘Admission or readmission with an overnight stay that was not previously planned or scheduled or ‘elective’’.
RCTs were excluded if unplanned admissions could not be separated from planned or elective admissions using data provided in the paper or by the authors.
Searches
The search strategy (online supplementary web appendix 1) was designed in OVID Medline using a combination of text words and Medical Subject Headings. Using a set of key papers known to the group, the strategy was further refined to ensure a good balance of sensitivity and specificity. For the rest of the databases, search terms were adapted according to the search capabilities of each particular database. Searches were from inception to June 2010.
A methodological filter from the Cochrane Effective Practice and Organisation of Care Group was applied, to retrieve study designs considered eligible for the review.9
The following websites were searched using the key term of ‘hospital admissions’:
Agency for Healthcare Research and Quality (http://www.ahrq.gov/), Centre for Reviews and Dissemination (http://www.york.ac.uk/inst/crd/), EPPI-Centre (http://eppi.ioe.ac.uk/EPPIWeb/home.aspx) and the King's Fund (http://www.kingsfund.org.uk/).
In addition, reference lists of all included studies and previous systematic reviews were checked for additional relevant publications.
Data collection and analysis
Selection of studies
Two reviewers independently screened each reference title and abstract (if available) for relevance to this review. Where there was disagreement, a third reviewer made the final decision. We obtained the full article for citations included at this stage. One of two reviewers then assessed full articles based on the agreed inclusion/exclusion criteria. Non-English articles were translated in full to English at this stage. Exclusions were checked by a third reviewer. Data were extracted by one reviewer into Cochrane Review Manager ( Copenhagen, Denmark) software V.5.1 and checked by a second reviewer.
Assessment of risk of bias in included studies
The risk of bias was assessed in each study using the Cochrane risk of bias tool. This is a domain based evaluation in which critical assessments are made separately for seven domains: sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessors, incomplete outcome data, selective reporting and other sources of bias. Each domain is rated as high, low or of unclear risk of bias.10
Data synthesis
Outcome data in the included studies were reported in different formats: total number of unplanned admissions or readmissions and number of patients experiencing (single or multiple) admission or readmission. We attempted to contact authors if data were incomplete or were not in a usable form.
The outcome of number of patients with an admission or readmission was treated as dichotomous and using Review Manager V.5.1, individual risk ratios (RRs) were calculated. Total numbers of admissions were treated as count data and rate ratios calculated.11 The total number of admissions were also dichotomised using the Poisson distribution12 to estimate the probability of one or more unplanned admissions, allowing calculation of RRs. Both risk and rate ratios are presented with their 95% CI.
If there were at least three studies in which admissions or readmissions were measured, a meta-analysis was performed with a fixed or random effects model depending on the level of between study heterogeneity estimated using the I2 statistic.11
Results
Study selection
The search identified 17 papers reporting RCTs of specialist heart failure clinics, six of which were excluded for reasons listed in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagram (figure 1). The 11 included papers that reported 10 RCTs from eight countries across Europe,8 New Zealand1 and America,1 and reported between 1998 and 2008.
Study characteristics
The specialist clinics evaluated were mainly located in hospital outpatients departments with only one study using a day hospital.13 Three clinics were specialist nurse-led14–16 with the remainder using a multidisciplinary team always consisting of specialist nurses and cardiologists with some studies using additional specialists such as a general practitioner (GP),17–19 physician,20 dietician,13 ,20 physiotherapists,13 ,21 psychologist13 ,21 or social workers13 (online supplementary table 2). The studies all focused on heart failure of varying degrees, described as heart failure, chronic heart failure or New York Heart Association classification II–IV. The mean ages of included subjects ranged from 56 to 80.3 years.13 ,15
All of the studies contained an education component focusing on the signs and symptoms of worsening heart failure, self monitoring, weight management, diet restrictions, and exercise and medication compliance. The majority of the education sessions were conducted on a one to one basis with the specialist nurse or cardiologist conducting the session; however, two studies18 ,21 used group education sessions. The remaining components of the interventions were clinical monitoring as well as optimisation of treatment and referrals for diagnostic testing.
The duration of follow-up within the studies varied: 3 months (n=1), 6 months (n=3), 12 months (n=5) and 18 months (n=1). The level of contact with patients also varied between specialist clinics and broadly can be grouped into the following categories: (1) intensive follow-up where appointments were scheduled every 4–6 weeks, (2) decreasing intensity where appointments were scheduled every 1–2 weeks for the first 2 months and then reduced to once every 3 months, (3) regular follow-up where appointments were scheduled once every 3–4 months and (4) tailored follow-up where appointments were scheduled depending on patient need without any further detail provided.
Risk of bias
Overall, the included studies had a moderate risk of bias (figure 2). There was a lack of detail provided by some studies affecting assessment of bias especially around the method of allocation concealment.13 ,20–22 It was not possible to blind participants in this type of intervention and this question was therefore rated as high risk in all cases, although some studies did blind the assessors.14 ,19 ,20 ,22 ,23 All of the studies used intention to treat analysis and no reporting or attrition biases were detected in any of the studies. Other sources of bias were found in four studies, two of which did not include all eligible patients which is suggestive of a selection bias, 17 ,20 and in two studies there was possible contamination of the usual care group.19 ,23
Study results
The studies were assessed according to their duration of follow-up and across follow-up periods for (a) the intensity of the follow-up appointments and (b) if the intervention began prior to hospital discharge.
3 Month follow-up
There was one study which followed people for 3 months.22 ,24 The intervention used both a cardiologist and a specialist nurse and began with education before hospital discharge, with clinic attendance at 2 and 6 weeks postdischarge and weekly telephone monitoring throughout the 3 month follow-up period. There were no unplanned readmissions for either group within 30 days of discharge. After 3 months, there was a significant reduction in the number of unplanned admissions (RR 0.10, 95% CI 0.01 to 0.78; rate ratio 0.08, 95% CI 0.01 to 0.65).
6 Month follow-up
There were three studies with a follow-up period of 6 months. Kasper et al 19 used a GP, specialist nurse and a cardiologist with monthly clinic visits, occasional home visits and regular telephone contact for the full 6 month follow-up period. There was possible contamination of the usual care group as physicians in the usual care group received expert recommendations at the time of discharge from hospital. Ekman et al 15 used a specialist nurse-led intervention with clinic visits beginning 1 week postdischarge and subsequent visits tailored to the patients needs with regular telephone contact. Wierzchowiec et al 21 used a cardiologist and specialist nurse along with a physiotherapist and a psychologist with clinic visits beginning 2 weeks postdischarge with follow-ups at 1, 3 and 6 months There was a non-significant reduction in the number of patients with an admission (figure 3) (pooled RR 0.83, 95% CI 0.65 to 1.07).
12 Month follow-up
Five studies had a follow-up period of 12 months.13 ,14 ,17 ,18 ,20 Atienza et al 17 used a GP, specialist nurse and cardiologist, the intervention began with patient education before discharge with alternating clinic and GP appointments every 3 months with continuous telemonitoring. This study did not include all potentially eligible patients. Blue et al 14 assessed a specialist nurse-led home based intervention which was attached to a specialist clinic with telemonitoring. Capomolla et al 13 used a large multidisciplinary team consisting of cardiologist, specialist nurse, physiotherapist, dietician, psychologist and a social assistant in a day hospital setting. The intervention included planned appointments and open access to the day hospital with telemonitoring; however, the frequency of contacts was not provided. Bruggink-Andre de la Porte et al 20 used a heart failure physician, specialist nurse and a dietician and had an intensive follow-up with clinic visits at 1, 3, 5 and 7 weeks and 3, 6, 9 and 12 months postdischarge. Again, this study did not include all potentially eligible patients. Doughty et al 18 included a GP, cardiologist and specialist nurse with the first clinical review occurring 2 weeks postdischarge with one visit every 6 weeks alternating between GP and specialist clinic. The initial education session was on an individual basis with group education thereafter. Overall, these studies showed a 49% reduction (figure 3) in the risk and a 65% reduction in the rate of unplanned hospital admissions (pooled RR 0.51, 95% CI 0.41 to 0.63; pooled rate ratio 0.35, 95% CI 0.17 to 0.75). The event rate was 31 per 100 in the control group and 15 per 100 in the intervention group and therefore the intervention reduced the event rate (absolute risk reduction) to16 per 100 (95% CI 12 to 20).
Capomolla et al 13 used a day hospital which was a different setting to the other studies included. They also included the youngest group of patients mean (SD) age 56 (8) years compared with 70 (10) years in Bruggink-Andre de la Porte et al,20 72.5 (7.6) years in Doughty et al,18 75.6 (7.5) years in Blue et al 14 and median (range) 69 (61–74) years in Atienza et al. 17 A sensitivity analysis was conducted to explore the effects of removing this study from the meta-analyses. There was a small increase in the pooled RR to 0.56 (95% CI 0.45 to 0.71) and in the pooled rate ratio to 0.52 (95% CI 0.37 to 0.74); however, a significant reduction in unplanned admissions still remained.
18 Month follow-up
The remaining study had a follow-up period of 18 months23 and looked at the effects of a basic and more intensive intervention against usual care. The basic and intensive interventions differed in the number of clinic visits and care providers with the basic intervention being specialist nurse-led with four clinic visits with the cardiologist and nine with the nurse. The intensive intervention had more clinic visits with the nurse (n=18), with an additional home nurse visitation (n=2) and multidisciplinary advice sessions (n=2). The intervention continued for the whole of the 18 month follow-up period. Both the number of patients with an admission and the total number of admissions were provided. There was no evidence of an effect of either the basic (RR 1.01, 95% CI 0.82 to 1.24) or intensive interventions (RR 1.10, 95% CI 0.90 to 1.34) versus the control or for the two intervention groups combined against the control (RR 1.04, 95% CI 0.83 to 1.30). There was possible contamination of the usual care group in this study as the usual care for patients with heart failure in The Netherlands is cardiologist care and while investigators discouraged increased visits, at times of worsening signs and symptoms contacts were intensified in this group.
Intensity of follow-up visits
Studies were also assessed depending on the schedule of follow-up visits (figure 4). Three studies had intensive follow-up schedules over periods of 6,19 1218 and 18 months.23 Three studies had decreasing intensity of follow-up visits over a period of 322 and 12 months.14 ,20 Two studies described their follow-up schedule as tailored over a period of 615 and 12 months.13 Finally, three studies had regular follow-up visits over a period of 6,21 1217 and 18 months.23 Those studies with a decreasing intensity of follow-up showed a significant 58% reduction in unplanned hospital admissions (pooled RR 0.42, 95% CI 0.27 to 0.65).14 ,20 ,24 The event rate was 24 per 100 control and 10 per 100 intervention and therefore the intervention reduced the event rate (absolute risk reduction) to 14 per 100 (95% CI 7 to 20). No significant reduction in unplanned admissions was seen for those studies with intensive, tailored or regular follow-up of patients throughout the follow-up periods.
Inpatient interventions
There were three RCTs which began before the patient was discharged from hospital.17 ,22 ,23 Two studies showed a significant reduction in unplanned admissions.17 ,22 The remaining study was subject to possible contamination of the control group therefore biasing the effect of the intervention towards the null. The pooled RR for the three studies was 0.47 (95% CI 0.17 to 1.29); removing the study with contamination bias led to a significant reduction in unplanned admissions (RR 0.26, 95% CI 0.07 to 0.92). However, both the remaining studies had small sample sizes (online supplementary web appendix 2).
Other outcomes
All studies examined the effects of their intervention on either all cause or heart failure specific mortality. Two studies demonstrated significantly lower death rates,13 ,17 while the remaining eight studies found non-significant lower rates18 ,20 or no difference between the intervention and control groups. 14 ,15 ,19 ,21–23 Four studies examined the effects of the intervention on outcomes other than unplanned hospital admissions.17 ,18 ,25 ,26 These demonstrated benefits on longer time to first readmission or death, a reduction in all cause admissions and improved survival17 and quality of life. 18 ,25 However, there was one further study which failed to show any improvement in quality of life or survival rates.26
Discussion
Statement of principle findings
This systematic review provides evidence from 10 RCTs from eight countries (mainly Europe and UK—8 studies) reported between 1998 and 2008 that specialist clinics for patients with heart failure with clinic appointments and monitoring over a 12 month period reduce the number of unplanned hospital admissions. Across the studies, those which provided more intensive monitoring of patients within the first 2 months with one visit every 3 months thereafter had a significant reduction in the number of unplanned admissions. There was also some evidence which indicated there may be a potential benefit from beginning this type of intervention before hospital discharge although this was limited by the number of studies and sample size.
Strengths and weakness of the study
The strengths of this systematic review were the comprehensive search strategy employed without limitations and the robust reviewing by two reviewers initially with disagreements screened by a third reviewer. Only RCTs were included and the quality of these studies was assessed. The limitations of this review were the narrow focus of the research question and therefore studies of specialist clinics focusing on other important outcomes such as quality of life, self-care behaviour and mortality which did not include unplanned admissions were excluded, as were the effects these clinics may have beyond that of the follow-up period. Another limitation of this systematic review and that of other reviews is the quality of the studies it includes with an overall moderate risk of bias.
It is widely accepted that only a proportion of research projects will be published in sources identifiable to reviewers.26 While this review contains negative studies, there may be more negative unpublished studies. However, the identification of both positive and negative trials by the search strategy employed makes it unlikely that further supportive or unsupportive high quality trials would remain unpublished or be in the public domain and therefore a funnel plot was not performed.
Strengths and weaknesses in relation to other studies
There have been four previous systematic reviews of multidisciplinary interventions for heart failure.29–30 They combined different aspects of multidisciplinary care such as case management, outpatient clinics and inpatient or discharge related interventions and they did not take into account the follow-up periods of the studies. Only one of the previous reviews reported on hospital admissions for worsening heart failure and performed a meta-analysis.28 They found a 24% reduction in heart failure hospitalisation rates from multidisciplinary clinics from seven studies (RR 0.76, 95% CI 0.58 to 0.99).27 An additional six studies are included within our review, four of which were published after the previous review. The remaining three reviews reported on all admissions and not just unplanned admissions and did not identify enough studies to conduct a meta-analysis28–30; however, they concluded that no benefit was shown in the reduction of hospital admissions by specialist clinics.
Meaning of the study
A recent audit of heart failure admissions in England and Wales highlighted overall death and/or readmission rates to hospital with heart failure in a 12 month period were 51%.31 Death rates after discharge were significantly lower in those referred for cardiology or specialist nursing clinic follow-up. This systematic review provides evidence that admissions are also reduced by specialist clinic intervention.
It is important to understand whether interventions have an effect in the initial high risk period after discharge and also an enduring effect over time. The reduced rates of admission at 12 months suggest that potential cost savings from reducing unplanned admissions for heart failure are large. There were 53 413 such admissions in England in 2009/10.4 Around 18% (9850) of heart failure admissions within a 12 month period are readmissions.32 The average cost of a non-elective inpatient admission for heart failure was £2231 in 2010.32 Based on these estimates and the reported pooled RR for reduction in unplanned readmissions at 12 months (pooled RR for five studies 0.50, 95% CI 0.33 to 0.76), potential savings in readmission costs for the NHS in England could be in the order of £11 million (£10 987 675) with a range from £7 251 866 to £16 701 266 based on the CIs we have reported. These figures do not take account the cost of delivering any new services required and may be an overestimate as some readmitted patients will have received specialist care. However, the number of eligible patients has been underestimated as some recorded first admissions for 1 year will be readmissions of patients from a previous financial year.
The finding that those interventions that started intensively but then reduced over time seemed to be effective when those which were intensive throughout did not show an effect seems surprising. However, the decreasing intensity studies commenced with appointments every 2 weeks whereas in those with intensive follow-up the first appointment was at 4–6 weeks and so it is possible patients benefit from more support initially following discharge from hospital. In addition, in two of the three intensive follow-up studies we identified possible contamination of the usual care group which may have reduced the demonstrated effect of the intervention.19 ,23
Specialist clinics for heart failure are a tool for delivering care according to clinical guidelines and providing advanced diagnostic or treatment services. Previous evidence suggests there are three crucial elements required for multidisciplinary disease management programmes for heart failure: (1) trained specialist nurses should have a key role, (2) education of patients and caregivers about heart failure and (3) ready access to clinicians trained in heart failure.27 ,33 These three elements have been incorporated into the specialist clinics assessed here which, if conducted over a period of 12 months or if begun with intensive clinic appointments for the first 2 months reducing in frequency thereafter, would appear to reduce the number of subsequent unplanned admissions for people with heart failure. There may also be a benefit from beginning this type of intervention prior to hospital discharge; however, there is only a limited evidence base for this.
Acknowledgments
We would like to thank both our advisory group and patient advisory group for their advice and input to the systematic review.
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Files in this Data Supplement:
- Data supplement 1 - Online appendix 1
- Data supplement 2 - Online appendix 2
- Data supplement 3 - Online table 1
- Data supplement 4 - Online table 2
Footnotes
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Contributors S Purdy, S Paranjothy, D Huws and G Elwyn were responsible for the original conception and design of the study. M Mann, A Huntley and R Thomas undertook searching, screening and analysis. R Thomas and S Paranjothy led on interpretation of data and drafted the article. All authors were responsible for revising it critically for important intellectual content and final approval of the version to be published. S Purdy is the guarantor for the paper.
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Disclaimer This research was funded by the National Institute for Health Research, Research for Patient Benefit programme (grant PB-PG-1208-18013). This report presents independent research commissioned by the National Institute of Health Research (NIHR). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
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Competing interests None.
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Provenance and peer review Commissioned; internally peer reviewed.