© 2005 European Society of Cardiology
Complexity of program and clinical outcomes of heart failure disease management incorporating specialist nurse-led heart failure clinics. A meta-regression analysis
a Brigham and Women's Hospital, Harvard Medical School Boston, MA, United States
b Johns Hopkins University School of Medicine, Quality of Care Research and General Internal Medicine Baltimore, MD, United States
c Johns Hopkins University Bloomberg School of Public Health Baltimore, MD, United States
d University Hospital of Groningen Groningen, The Netherlands
* Corresponding author. Section of Hospital Medicine, E13, Department of General Internal Medicine, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195, USA. Tel.: +1 216 444 0933; fax: +1 216 445 5632. E-mail address: chr_phi{at}yahoo.com
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Abstract |
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 Top Abstract 1. Background2. Methods3. Results4. DiscussionAppendix A. Characteristics of...References |
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Objectives: To determine whether a hierarchy of effectiveness exists with respect to complexity of published protocols of heart failure (HF) disease management (DM) incorporating specialist nurse-led HF clinics.
Data sources and study selection: We searched MEDLINE (1966–November 2004), the Cochrane Library, article bibliographies, and contacted experts. Inclusion criteria were random allocation of at least 100 patients, specialist HF nurses, HF clinics, and readmission as an outcome measure.
Data extraction: Paired reviewers conducted quality assessment, deconstructed and categorized protocols by complexity, and extracted results for readmission, mortality, the combined endpoint of mortality and hospitalization, HF readmission, and hospital days utilized.
Data synthesis: Six trials were selected (N=949, mean age 73 years [range 62–79], men 58%, LVEF 34% [27–41], and average follow-up of 8.5 months [3–12]). Compared with usual care, the overall relative risk [95% confidence interval] for readmission with this strategy was 0.91 [0.72, 1.16], mortality was 0.80 [0.57, 1.06], and the combined endpoint of mortality and hospitalization was 0.88 [0.74, 1.04]. We observed better outcomes for programs with versus programs without hospital discharge planning and immediate post-discharge follow-up; readmission 0.30 [0.04, 2.60] vs. 1.00 [0.86, 1.17], mortality 0.96 [0.63, 1.47] vs. 0.75 [0.55, 1.03], the combined endpoint of mortality and hospitalization 0.61 [0.18, 2.02] vs. 0.91 [0.80, 1.03], HF readmission 0.09 [0.10, 0.65] vs. 0.65 [0.43, 1.00], and hospitalized days utilized per patient –0.26 [–0.49,–0.02] vs. 0.09 [–1.17, 1.34].
Conclusions: HF DM with specialist nurse-led HF clinics is a promising strategy or effective alternative whose benefit may be optimized by programs with a homogeneous structure and components that are delivered with consistency.
Key Words: Heart failure • Specialist heart failure nurse • Heart failure clinics • Meta-regression analysis
Received May 18, 2004; Revised January 10, 2005; Accepted January 18, 2005
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1. Background |
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TopAbstract1. Background2. Methods3. Results4. DiscussionAppendix A. Characteristics of...References |
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For many industrialized countries, the prevalence of heart failure (HF) approaches 1–4% of the population and medical expenditures have been estimated at 1–5% of health care spending in some settings [1–7]. Mortality at 30 days and 1 year after the initial diagnosis of HF increases with advanced age and co-morbidity, and current estimates are 7% and 18% for younger patients to 18% and 60% for older patients with higher co-morbidity [5,6,8–17]. Reducing morbidity and mortality, resource utilization, and the burden of disease to families and/or caregivers of patients with HF is an important public health challenge [16–20].
Studies of HF disease management (DM) have reported consistent reductions in the burden of hospital utilization, particularly readmission rate [21–25]. These study protocols have employed a variety of interventions, some with or without components for hospital discharge planning and widely differing strategies for post-discharge care. We have recently reported substantive reductions in readmission rate and costs associated with comprehensive discharge planning plus post-discharge support for older patients with this syndrome [23].
Specialist nurse-led HF clinics have been proposed as an effective addition to established programs or an efficient alternative for HF DM. Gonseth et al. have recently reviewed all published controlled trials and observational studies of this strategy and found inconsistent results, particularly with respect to the effects on readmission rate [25]. It is not known whether differences in complexity of these programs and/or the type of personnel involved in the delivery of these interventions influence the overall efficacy of these interventions. To determine the association between complexity of intervention and clinical outcomes, and to investigate whether a hierarchy of effectiveness exists, we reviewed and deconstructed published protocols from randomized trials of HF DM with specialist nurse-led HF clinics. We conducted meta-regression analysis to study the relationship between differences in complexity of intervention and readmission rate, mortality, the combined endpoint of mortality and hospitalization, HF readmission, the number of hospital days utilized per patient during follow-up, quality of life (QOL), and cost of care.
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2. Methods |
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TopAbstract1. Background2. Methods3. Results4. DiscussionAppendix A. Characteristics of...References |
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2.1. Search strategy
With the assistance of a professional librarian, we performed a systematic search of MEDLINE (1966–November 2004). We also searched EMBASE (1980–November 2004), the Cochrane Library (Controlled Trials Registry, Database of Systematic Reviews, and the Effective Practice and Organization of Care Study Registry), all years, article bibliographies, and contacted experts. We used both medical subject heading (MeSH) and text terms for our search including: congestive heart failure, chronic heart failure, multidisciplinary care, disease management, disease management programs, patient education, social work, case management, comprehensive discharge planning, discharge planning, hospital discharge, patient discharge, patient care planning, after care, and readmission.
2.2. Inclusion criteria
We selected English language studies with random allocation of at least 100 patients, clearly defined protocols, the addition of specialist heart failure nurses, heart failure clinics, and readmission as a primary outcome.
2.3. Quality assessment
Two authors (COP and RMS) performed assessments of eligibility and methodologic quality without the use of masking [26] and calculated the Jadad score (min 0, max 5) for each study by assigning one point to reported data for the following components of the study design: randomization, randomization generation, allocation concealment, double blinding, and loss to follow-up [27].
2.4. Data extraction
We used qualitative methods to deconstruct and analyze study protocols for recurrent themes, categorized studies based on complexity of intervention and number of components, and extracted patient outcomes (readmission, mortality, the combined endpoint of mortality and hospitalization, HF readmission, the number of hospital days utilized per patient during follow-up, QOL scores, and medical costs).
2.5. Data synthesis
We used STATA software (Version No. 8, College Station, TX) to pool data for the listed outcomes. Due to the high event rates, we chose relative risk (relative risk [RR]; 95% confidence intervals [CI]) as the principal measure of association. Utilizing assumptions of intention-to-treat, we pooled data from all studies using both fixed (Mantel–Haensel) and random-effects statistical models that used weighting based on inverse variance calculated according to DerSemonian and Laird [28]. Hospital days utilized per patient during follow-up were analyzed as a continuous variable (mean±S.D.). We imputed missing variance for some studies by pooling the average number of days per patient reported per study in strata defined by complexity of protocols and used the new S.D. for the analysis.
We checked for publication bias [29] and quantitative heterogeneity using chi-square test, and conducted sensitivity analysis and trial level subgroup analyses to assess consistency of intervention effects by selected patient demographics (mean age and left ventricular ejection fraction (LVEF%) <35% and 
35%) and angiotensin-converting enzyme inhibitor (ACEI) use. We used meta-regression to assess the relationship between complexity of interventions and clinical outcomes.
Where appropriate, we used descriptive statistics to summarize data for some endpoints (QOL and medical costs) and compared differences in means using t-tests. Using each study as the unit of analysis, we standardized the change in QOL scores to percentage improvement (or decline) compared with baseline scores for each group within a study using the following formula: final–baseline/baseline (QOL) scorex100%. We performed both weighted and unweighted analyses to compute the average change in QOL (mean±S.E.M.) between intervention and control groups and compared the difference. For weighted analysis, we multiplied percentage improvement from baseline to follow-up in each study group by the number of observations in that group, summed the numbers across studies then divided by the total number of observations. We report unweighted values when results are similar. All costs are reported in United States dollars after adjusting for inflation using year 2004 Consumer Price Index.
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3. Results |
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TopAbstract1. Background2. Methods3. Results4. DiscussionAppendix A. Characteristics of...References |
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Of the 3741 potentially relevant reports initially identified, we excluded 2909 for reasons listed in Fig. 1. We retrieved 832 reports for in-depth screening and selected 107 studies for detailed evaluation, of which seven reports for six studies were eligible for analysis [30–36]. Study characteristics and components for HF disease management with specialist heart failure nurse-led clinics are summarized in Appendix A. Usual care was not specifically or consistently defined. The median Jadad score was 3.5 (IQR 3–4).
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The pooled patient population was 949, of which 58% were male and the mean age was 72 years [range 62–79] (Table 1). The Patients with New York Heart Association (NYHA) Class II–IV were evenly represented. Important demographic characteristics and co-morbidities are summarized in Table 1. The use of proven therapies at baseline was sub-optimal (59.1% [range 21.2%–90.2%] for ACEI and 34.2% [range 10.2%– 57.6%] for beta-blockers). There was some improvement in ACEI usage at follow-up in studies reporting this data [30,34,36]. Reported use of these agents at baseline did not differ significantly between intervention or usual care patients (p=0.90).
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3.1. Complexity of study protocols
Table 2 summarizes components of the deconstructed study protocols. Two programs were categorized as the most complex, containing an additional component for hospital discharge planning, immediate post-discharge follow-up, and no delay in continuity of the intervention after hospital discharge [30,32,33]. Programs without hospital discharge planning or with fewer components were categorized as less complex [31,34–36].
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3.2. Hospital utilization
The overall relative risk [95% confidence interval] for readmission with the intervention versus usual care was 0.91 [0.72, 1.16] (Table 3). Point estimates for the effect of more complex programs containing discharge planning and immediate post-discharge follow-up compared with programs with fewer components and without hospital discharge planning was 0.30 [0.04, 2.60] vs. 1.00 [0.86, 1.17] for readmission, 0.09 [0.10, 0.65] vs. 0.65 [0.43, 1.00] for HF readmission, and –0.26 [–0.49, –0.02] vs. 0.09 [–1.17, 1.34] for the number of hospital days utilized during follow-up. There was only minimal evidence for quantitative heterogeneity in study results for readmission rate and this was completely accounted for by wide variations in sample size between trials reporting this endpoint [30,32,33]. There was no evidence for publication bias on a Begg's funnel plot for studies reporting these outcomes. Sensitivity analysis using different statistical models and analyses for subgroups defined by mean age or LVEF (<35%,
35%) did not significantly alter the point estimates.
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3.3. All cause mortality
The overall result for mortality with all studies was 0.80 [0.57, 1.13]. We found mixed results for the effects on mortality according to program complexity, 0.96 [0.63, 1.47] for complex programs vs. 0.75 [0.55, 1.03] for less complex protocols (Table 4), and the combined endpoint of mortality and hospitalization was 0.61 [0.18, 2.02] vs. 0.91 [0.80, 1.03] (Table 5). The pooled result for mortality from studies in which ACE inhibitors use was >75% at baseline and follow-up was 0.59 [0.40, 0.86] [32–36]. In contrast, mortality for studies in which this agent was underutilized was 1.07 [0.76, 1.51] [30,31].
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3.4. Quality of life
QOL was reported for five studies. The instruments used were the Nottingham Health Profile (NHP) [30], the Minnesota Living With Heart Failure Questionnaire (MLWHFQ) [33–35], and the Heart Failure Self Care behavior Scale (HFSBS) [36]. Complete data were not reported for all programs categorized as complex versus less complex. Therefore we report the overall results for all studies, which demonstrate that QOL scores improved for both groups relative to baseline scores and there was a trend towards greater percentage improvement in quality of life scores for intervention patients compared with controls (30.6±20.7% vs. 19.3±12.6%, p=0.13, n=3) [30,33–35].
3.5. Medical costs
Only the most complex programs containing components for hospital discharge planning reported complete data for cost of care (initial hospital care, intervention costs, outpatient care including cost of medications, and charges for readmissions) [30,32,33]. Results from three studies suggest that the initial additional cost associated with administering the intervention, including salaries for specialist heart failure nurses, was US$74.5 per patient per month (range US$18.80–154.13). The potential saving was US$277.88 per patient per month (range US$108.25– 555.67) for medical care relative to usual care but this difference was not statistically significant (p=0.34).
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4. Discussion |
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TopAbstract1. Background2. Methods3. Results4. DiscussionAppendix A. Characteristics of...References |
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Complex programs that included hospital discharge planning and no delay in post-discharge clinic follow-up were the most successful, with the results showing a trend towards 70% relative reduction in risk for first readmission, two fewer hospital days utilized per patient per readmission (p=0.02), and a 70% reduction in risk of HF readmission relative to usual care (p=0.01). Less complex programs did not impact readmission or hospital days utilized during follow-up relative to usual care. However there was a 35% reduction in risk for HF readmission (p<0.05), a finding that was half the effect of more complex programs. In subsets of studies, we found a modest improvement in QOL for all study patients compared with baseline scores (19–31%, p=0.13) and an average reduction in costs of US$277.88 per patient per month when the major aspects of medical care were considered (p=0.34).
The magnitude of benefit seen in the present meta-analysis is consistent with results of previous studies of multidisciplinary heart failure care. However, the association between complexity of intervention and clinical outcomes and the effects of this specific strategy for HF DM over the range of outcomes we reviewed in this meta-analysis has not been previously reported. Given the observed variations in program complexity and the hierarchy of effectiveness we have observed, there is room for substantive improvements in order to optimize the benefit of this strategy. Community-based follow-up in specialist nurse-led HF clinics is an appealing strategy given the shortage of specialist physicians, which is likely to worsen as the population ages. Because nurses are better trained in discharge planning and identifying resources for post-discharge care of patients with chronic diseases, additional training in HF disease management and routine integration into HF clinics may optimize continuity of care.
There is continuing uncertainty about the identity of patient characteristics for which this strategy is most likely to beneficial, the optimal interval for ambulatory follow-up after hospital discharge, and/or the minimal intensity of these HF clinics that would be most cost-effective. Although the pooled study population we reviewed was representative of most patients with chronic HF due to left ventricular systolic dysfunction, only a limited number of patients met eligibility criteria and were enrolled in the studies we reviewed (20.8% [range 5.4–45.8%]). In one study, 29% of patients randomized to the intervention did not attend the clinic because of fatigue [31]. Whereas this strategy did not reduce first readmission rate for very sick patients (NYHA III–IV, RR 0.99 [0.85, 1.17]), patients with better symptom control were more likely to derive benefit (NYHA II–III, RR 0.68 [0.32, 1.43]). However, this effect was inconclusive on account of the small sample size. This difference in effects may be partially explained by a delay, 2 weeks on average, in the time to first clinic follow-up reported for most studies. We agree with the suggestion by Doughty et al. that earlier clinical follow-up may have been preferred [34]. Unfortunately the optimal timing of post-discharge follow-up after hospitalization for acute decompensated HF is not known. For many patients, this time period may be unsettling because of sub-optimal discharge planning, inadequate social support systems, or intolerance of newly prescribed therapy. The evidence suggests that HF disease management with components for hospital discharge planning and post-discharge follow-up in specialist nurse-led HF clinics may be most beneficial for stable patients with good symptom control.
Specialist HF nurses and HF clinics may be critical to the success of HF DM, which employs clinic follow-up as a distinct strategy for post-discharge care. Oddone et al. reported results for a subgroup of HF patients (n=443) who were enrolled in a larger study to evaluate the effects of frequent clinical follow-up and found higher readmission rates for intervention patients compared with usual care [37]. This study protocol was not specifically tailored to patients with HF and did not employ the use of specialist nurses or HF clinics and this may have contributed to the observed lack of benefit. In order to optimize the success of this strategy, the available data suggest that the components of these programs may need to be standardized and delivered with consistency. To date there are no studies comparing the relative effectiveness of different programs or effects of specific program components on clinical outcomes. The resolution to these issues may be initiated with data gathered in a large multi-center randomized study of 1050 patients in the Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH) in which advising and counseling in two different intensities will be compared to usual follow-up without a heart failure nurse [38].
We also found that ACEIs were underutilized at baseline with only slight improvement in usage at follow-up. Five studies reported that less than 50% of patients were at target doses [29,30,33–35]. In the study by McDonald et al. over 50% of enrollees received target doses of ACEIs [31,32]. This study also reported significant reductions in the primary outcomes we evaluated and the overall results favored intervention patients. Studies with higher use of ACEIs (>75%) showed a 49% relative reduction in risk of death versus usual care (p=0.006) [32–36]. In contrast, mortality in studies with <75% ACEI usage was not reduced. We found that optimizing the use of these agents resulted in substantive reductions in mortality and this finding supports previous assertions by some investigators that the benefit of multidisciplinary heart failure care could be optimized by better ACEI usage without preferential use of these agents among intervention patients [39]. Our findings suggest that other important targets for optimizing HF care include clinical stability prior to hospital discharge, optimal usage and titration to target dose of ACEIs and beta-blockers, and early clinical follow-up.
This review is subject to several limitations. First, our limitation to English language studies may have introduced bias with the selection process. However, we believe that this type of bias was unlikely to have significantly altered our results [40]. We found minimal evidence for quantitative heterogeneity in study results. We also found no significant evidence for publication bias in most of the outcomes evaluated. Second, the pooled data were study means rather than results for individual patients, and we urge caution with interpretation and general application of the overall results to individual patients or to interventions not specifically described in the study protocols. Third, these results reflect data from a limited number of studies that were not powered to detect changes in the range of outcomes we have evaluated. Therefore, the possibility of a Type II error cannot be ruled out. However, we believe that observations from this group of randomized clinical trials are valid because of reproducibility of results, consistency of study effects reported by different investigators and for patients from different health care systems and clinical backgrounds, and the suggestion of a dose–response relationship with more complex DM programs.
The available evidence suggests that specialist nurse-led HF clinics are efficient additions to, or promising alternatives for, HF DM and a very appealing strategy for carefully selected patients. Nurses are better trained to optimize hospital discharge planning and post-discharge care of patients and the addition of specialty training in HF may meet increased demands for HF DM in order to optimize care of aging populations with this syndrome. Future studies should identify patient characteristics for which this strategy is most likely to be beneficial, other intervention components that are most effective, and the minimal intensity of these HF clinics that would be most cost-effective.
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Appendix A. Characteristics of randomized clinical trials of CHF disease management with specialist heart failure nurse-led clinics |
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Acknowledgements |
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Dr. Rubin's contribution to this study was supported, in part, by NHLBI K24 HL073347.
Funding for Dr. Phillips for a larger study from which this substudy originated was through a National Research Service Award-HRSA fellowship training grant 2-T32-PE10025.
This study was presented in poster form as part of a larger study at the 26th Annual Meeting of the Society of General Internal Medicine, Vancouver, BC.
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References |
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J. G.F. Cleland, A. P. Coletta, and A. L. Clark 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, June 1, 2007; 9(6-7): 740 - 745. [Abstract] [Full Text] [PDF]
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K. McDonald, C. Conlon, and M. Ledwidge Disease management programs for heart failure: Not just for the 'sick' heart failure population Eur J Heart Fail, February 1, 2007; 9(2): 113 - 117. [Abstract] [Full Text] [PDF]
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