Disease management programmes for heart failure

Review question

We investigated the effects of disease management programmes on death from heart failure or from any cause, hospital readmissions for heart failure or for any cause, adverse effects, quality of life and cost-effectiveness, in adults who had been admitted to hospital at least once for heart failure.

Background

Heart failure affects a person’s quality of life, is a frequent cause of hospital admission and has a high risk of death. Traditional drug therapy is the main treatment, but people may benefit from additional support from disease management programmes that aim to provide ongoing support rather than crisis management. Such programmes may be run by specialist nurses, as clinic-based interventions, or by multidisciplinary teams. Community-based support of this kind could help to keep people out of hospital by improving day-to-day symptom management and providing an ‘early warning system’ for changes requiring medical attention.

Selection criteria

We conducted a comprehensive search for all studies investigating heart failure-specific disease management interventions for adults who had been admitted to hospital at least once for heart failure (evidence current to 9 January 2018).

Results and conclusions

We included 47 studies, with a total of 10,869 participants. Twenty-eight studies were case management interventions, seven were clinic-based models, nine were multidisciplinary interventions and three could not be categorised as any of these. The average age of the people in most of the studies was between 67 and 80 years old, although 10 studies had younger participants on average, and one included mostly very elderly people. Most trials were in Europe and North America, but others took place in China, Taiwan, Iran and Japan.

We found limited evidence for an effect on mortality due to heart failure, as few studies reported this outcome. There was some evidence that case management may reduce all-cause mortality, and multidisciplinary interventions probably do, but clinic-based studies appeared to have little or no effect on this. Readmissions due to heart failure and due to any cause were probably reduced by case management interventions. Clinic-based interventions probably make little or no difference to heart failure readmissions and may result in little or no difference in readmissions for any cause. Multidisciplinary interventions may reduce the risk of readmission for heart failure or any cause.

Only two studies mentioned adverse events, both stating that none occurred. Many studies measured quality of life, but it is difficult to draw conclusions for any effect because they tended to report this in different ways and did not report it for all their participants. Data on costs and cost-effectiveness were limited, but indicated a slight benefit of disease management programmes, mostly due to reduced hospital readmission costs.

Quality of the evidence

The quality of evidence was very low for mortality due to heart failure, low to moderate for all-cause mortality, low to moderate for heart failure readmissions, and all-cause readmissions, moderate for adverse events (where available), low to very low for quality of life and low to moderate for costs. The quality of evidence is important as it impacts on how certain we can be in the effect of the intervention on the outcomes we are interested in. For example, if the evidence is of very low quality, we cannot be certain of the intervention's effect.

Authors' conclusions: 

We found limited evidence for the effect of disease management programmes on mortality due to heart failure, with few studies reporting this outcome. Case management may reduce all-cause mortality, and multidisciplinary interventions probably also reduce all-cause mortality, but clinic-based interventions had little or no effect on all-cause mortality. Readmissions due to heart failure or any cause were probably reduced by case-management interventions. Clinic-based interventions probably make little or no difference to heart failure readmissions and may result in little or no difference in readmissions for any cause. Multidisciplinary interventions may reduce the risk of readmission for heart failure or for any cause. There was a lack of evidence for adverse effects, and conclusions on quality of life remain uncertain due to poor-quality data. Variations in study location and time of occurrence hamper attempts to review costs and cost-effectiveness.

The potential to improve quality of life is an important consideration but remains poorly reported. Improved reporting in future trials would strengthen the evidence for this patient-relevant outcome.

Read the full abstract...
Background: 

Despite advances in treatment, the increasing and ageing population makes heart failure an important cause of morbidity and death worldwide. It is associated with high healthcare costs, partly driven by frequent hospital readmissions. Disease management interventions may help to manage people with heart failure in a more proactive, preventative way than drug therapy alone. This is the second update of a review published in 2005 and updated in 2012.

Objectives: 

To compare the effects of different disease management interventions for heart failure (which are not purely educational in focus), with usual care, in terms of death, hospital readmissions, quality of life and cost-related outcomes.

Search strategy: 

We searched CENTRAL, MEDLINE, Embase and CINAHL for this review update on 9 January 2018 and two clinical trials registries on 4 July 2018. We applied no language restrictions.

Selection criteria: 

We included randomised controlled trials (RCTs) with at least six months' follow-up, comparing disease management interventions to usual care for adults who had been admitted to hospital at least once with a diagnosis of heart failure. There were three main types of intervention: case management; clinic-based interventions; multidisciplinary interventions.

Data collection and analysis: 

We used standard methodological procedures expected by Cochrane. Outcomes of interest were mortality due to heart failure, mortality due to any cause, hospital readmission for heart failure, hospital readmission for any cause, adverse effects, quality of life, costs and cost-effectiveness.

Main results: 

We found 22 new RCTs, so now include 47 RCTs (10,869 participants). Twenty-eight were case management interventions, seven were clinic-based models, nine were multidisciplinary interventions, and three could not be categorised as any of these. The included studies were predominantly in an older population, with most studies reporting a mean age of between 67 and 80 years. Seven RCTs were in upper-middle-income countries, the rest were in high-income countries.

Only two multidisciplinary-intervention RCTs reported mortality due to heart failure. Pooled analysis gave a risk ratio (RR) of 0.46 (95% confidence interval (CI) 0.23 to 0.95), but the very low-quality evidence means we are uncertain of the effect on mortality due to heart failure. Based on this limited evidence, the number needed to treat for an additional beneficial outcome (NNTB) is 12 (95% CI 9 to 126).

Twenty-six case management RCTs reported all-cause mortality, with low-quality evidence indicating that these may reduce all-cause mortality (RR 0.78, 95% CI 0.68 to 0.90; NNTB 25, 95% CI 17 to 54). We pooled all seven clinic-based studies, with low-quality evidence suggesting they may make little to no difference to all-cause mortality. Pooled analysis of eight multidisciplinary studies gave moderate-quality evidence that these probably reduce all-cause mortality (RR 0.67, 95% CI 0.54 to 0.83; NNTB 17, 95% CI 12 to 32).

We pooled data on heart failure readmissions from 12 case management studies. Moderate-quality evidence suggests that they probably reduce heart failure readmissions (RR 0.64, 95% CI 0.53 to 0.78; NNTB 8, 95% CI 6 to 13). We were able to pool only two clinic-based studies, and the moderate-quality evidence suggested that there is probably little or no difference in heart failure readmissions between clinic-based interventions and usual care (RR 1.01, 95% CI 0.87 to 1.18). Pooled analysis of five multidisciplinary interventions gave low-quality evidence that these may reduce the risk of heart failure readmissions (RR 0.68, 95% CI 0.50 to 0.92; NNTB 11, 95% CI 7 to 44).

Meta-analysis of 14 RCTs gave moderate-quality evidence that case management probably slightly reduces all-cause readmissions (RR 0.92, 95% CI 0.83 to 1.01); a decrease from 491 to 451 in 1000 people (95% CI 407 to 495). Pooling four clinic-based RCTs gave low-quality and somewhat heterogeneous evidence that these may result in little or no difference in all-cause readmissions (RR 0.90, 95% CI 0.72 to 1.12). Low-quality evidence from five RCTs indicated that multidisciplinary interventions may slightly reduce all-cause readmissions (RR 0.85, 95% CI 0.71 to 1.01); a decrease from 450 to 383 in 1000 people (95% CI 320 to 455).

Neither case management nor clinic-based intervention RCTs reported adverse effects. Two multidisciplinary interventions reported that no adverse events occurred. GRADE assessment of moderate quality suggested that there may be little or no difference in adverse effects between multidisciplinary interventions and usual care.

Quality of life was generally poorly reported, with high attrition. Low-quality evidence means we are uncertain about the effect of case management and multidisciplinary interventions on quality of life. Four clinic-based studies reported quality of life but we could not pool them due to differences in reporting. Low-quality evidence indicates that clinic-based interventions may result in little or no difference in quality of life.

Four case management programmes had cost-effectiveness analyses, and seven reported cost data. Low-quality evidence indicates that these may reduce costs and may be cost-effective. Two clinic-based studies reported cost savings. Low-quality evidence indicates that clinic-based interventions may reduce costs slightly. Low-quality data from one multidisciplinary intervention suggested this may be cost-effective from a societal perspective but less so from a health-services perspective.