Improving Treatment Adherence in Heart Failure
A systematic review and meta-analysis of pharmacological and lifestyle interventions
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Background: Despite improved treatment options, heart failure remains the third most common cause of death in Germany and the most common reason for hospitalization. The treatment recommendations contained in the relevant guidelines have been incompletely applied in practice. The goal of this systematic review is to study the efficacy of adherence-promoting interventions for patients with heart failure with respect to the taking of medications, the implementation of recommended lifestyle changes, and the improvement in clinical endpoints.
Methods: We performed a meta-analysis of pertinent publications retrieved by a systematic literature search.
Results: 55 randomized controlled trials were identified, in which a wide variety of interventions were carried out on heterogeneous patient groups with varying definitions of adherence. These trials included a total of 15 016 patients with heart failure who were cared for as either inpatients or outpatients. The efficacy of interventions to promote adherence to drug treatment was studied in 24 trials; these trials documented improved adherence in 10% of the patients overall (95% confidence interval [CI]: [5; 15]). The efficacy of interventions to promote adherence to lifestyle recommendations was studied in 42 trials; improved adherence was found in 31 trials. Improved adherence to at least one recommendation yielded a long-term absolute reduction in mortality of 2% (95% CI: [0; 4]) and a 10% reduction in the likelihood of hospitalization within 12 months of the start of the intervention (95% CI: [3; 17]).
Conclusion: Many effective interventions are available that can lead to sustained improvement in patient adherence and in clinical endpoints. Long-term success depends on patients’ assuming responsibility for their own health and can be achieved with the aid of coordinated measures such as patient education and regular follow-up contacts.
In spite of improved treatment options, heart failure is the third most common cause of death in Germany and constitutes the most common cause for inpatient admission to hospital (1). This disease burden has remained unchanged at this high level for patients and the healthcare system in spite of falling cardiovascular death rates (2–5) and the successful development of medication treatments. The efficacy of these therapies has been shown in large multicenter studies across all stages and grades of severity of the disorder. This holds true for the introduction of angiotensin converting enzyme (ACE) inhibitors, beta receptor blockers, antiotensin-1 antagonists, and aldosterone antagonists (6–10).
The prognosis for patients can additionally be improved effectively by disorder-specific lifestyle modifications and optimized self-care. These measures include, among others:
- Monitoring for fluid retention by means of regular control of body weight and checking for leg edema (11, 12)
- Independent adjustment of the medication according to agreed schemes
- Putting dietary recommendations into practice (13).
These therapeutic recommendations have found their way into the current guidelines regarding healthcare provision for patients with heart failure (14–16), but they are realized in patients’ everyday lives to an unsatisfactory degree. In this setting, the term adherence describes the extent to which a patient’s behavior with regard to medication intake or lifestyle changes is consistent with therapeutic recommendations (17). In contrast to the term compliance, which was used in the past, adherence implies a therapeutic alliance between doctor and patient, with joint decision making and support for self-care.
In recent years it has been shown repeatedly that in evidence-based and prognosis-relevant treatment measures, a clear interaction exists between adherence and the subsequent prognosis. In a recent cohort study, non-adherent patients accounted for 22.1% of all hospital admissions for clinically manifest heart failure, and they had a markedly shorter time interval until readmission to hospital (hazard ratio [HR] 0.45; 95% confidence interval [CI]: [0.25; 0.52]) (18). It is well known that low adherence to antihypertensive treatment notably increases the risk for clinically manifest heart failure (19).
On the background of the great prognostic importance of limited adherence in chronic heart failure, this systematic review aims to answer the following questions:
- Is it possible to support patients with heart failure and to improve their adherence to medication therapy and lifestyle modifications in a sustained fashion?
- Is improved adherence on the patients’ part associated with improved clinical outcomes, such as lower mortality, fewer inpatient stays in hospital, and improved quality of life?
This systematic review aims to summarize all randomized intervention studies of the improvement of adherence in patients with heart failure. The Box shows the inclusion criteria.
The study was conducted on the basis of the registered (reg No CRD42014009477) and published study protocol (20). The results were reported in accordance with the PRISMA guidelines (21). We searched the databases Medline (Ovid), EMBASE, CENTRAL, PsycInfo, and CINAHL in July 2014 for all suitable studies that had been published since 2000 in English or German. In addition, we manually searched the reference lists of the included studies and systematic reviews.
Study selection and data extraction
The authors SU, FS, or SM checked—independently from one another—titles, summaries/abstracts, and potentially relevant full-text versions on the basis of the inclusion criteria. Information on patients’ adherence was described by using frequency data or scores on medication intake (eTable 1) and implementation of lifestyle modifications (eTable 2). In order to ensure that patients stuck to the interventions, a follow-up period of at least 3 months was a prerequisite for inclusion. Disagreements on the inclusion of studies were discussed with RP. Subsequently, the information set out in the study protocol was extracted by FS and SM and checked by MU. In addition to process parameters on adherence, we also collected data on patient-relevant result parameters, such as quality of life, mortality, and frequency and duration of hospital inpatient stays. The methodological quality of the studies was assessed on the basis of the recommendations of the Cochrane Collaboration (22).
We calculated the effect size by comparing the frequencies of adherent behavior in the intervention and control groups. Furthermore, we calculated risk differences (RD) and numbers needed to treat (NNT). For metrically captured adherence we determined standardized mean differences (SMD). Positive differences describe improved adherence in the intervention group. The SMD allows for comparability of adherence, which was quantified by using several scores (23) and also shows the extent of the standard deviations by which each score was improved by applying the strategies. The treatment effects in the individual studies were summarized by using the random effects model, and the risk of publication bias was investigated by using a funnel plot.
The systematic search identified 5340 potentially relevant articles. After checking titles and abstracts and reading 211 full text articles, we included 55 studies in our review. Altogether 24 studies reported on adherence to medication therapy and 42 studies on lifestyle modifications; 11 studies reported on both subjects (Figure 1).
Description of included studies
The 55 studies that were included in this review had been conducted in 17 countries on four continents and investigated the efficacy of adherence-improving measures in a total of 15 016 patients with heart failure. All studies had used a randomized design; as a rule, randomization took place at the level of the patients and in two studies at the level of doctors’ practices.
Patients were recruited after an acute event in hospital in 39 studies; in 16 studies, they were recruited in a stable condition in the outpatient setting. 62% of study participants were men; three studies included men only. The mean age ranged between 51 years and 78 years. Patients were affected by different limitations in terms of physical resilience and comorbidities such as diabetes, hypertension, fat metabolism disorders, chronic renal failure, or depression. Individual studies excluded patients with severe psychological or cognitive impairments (15 studies), and others excluded patients with renal failure (11 studies).
In most studies, several types of intervention were combined so as to improve adherence by various means—and thus a patient’s prognosis.
Training/education sessions for patients—All studies described training measures for patients on the following topics: disease course and how to deal with the disorder, necessary therapeutic steps, early detection of deteriorating symptoms, and necessary lifestyle modifications. The training sessions were provided on the basis of individual treatment plans by nursing staff or pharmacists and were complemented by lectures, discussion services, brochures, newsletters, computer programs, or other learning materials—interactive ones, in some cases.
Patient reminder systems (22 studies)—These were based on regular telephone calls or home visits by specialized nursing staff, doctors’ assistants, or pharmacists. Details of disease symptoms and adherence were recorded and discussed.
Support for self-care (32 studies)—This included all measures that enabled patients to better deal with their disorder, such as: independent use of measuring instruments, keeping a heart failure diary, schemes for diuretic adjustment, pill organizers, medication lists, or an advisory hotline.
Doctor-oriented interventions (11 studies)—In these, optimized or simplified therapeutic plans and suggestions for how to support patients were developed by pharmacists, nursing staff, or practice assistants; these were made available to treating physicians.
Organizational change (21 studies)—These concerned a restructuring of the tasks involved in caring for the patient during an inpatient stay and after discharge, between primary care physicians, cardiologists, psychologists, pharmacists, and nursing staff. Clinical investigations were undertaken—often by nursing staff—for the purpose of symptom monitoring and advice given on lifestyle modifications and diuretic adjustment.
Telemonitoring systems (13 studies)—These enabled measuring weight, blood pressure, heart rate, and automated prompting for adherence, symptoms, and awareness of medication therapy and lifestyle modifications, as well as direct control by nursing staff/specialized teams.
The greatest restriction to study quality was unblinded self-reported adherence with a potentially high risk of bias in the direction of “desired behavior” (36 studies). Problems in generating randomization or blinded allocation could not be excluded in 23 and 39 studies, respectively. Further limitations resulted from the high rates of dropouts and from per-protocol analyses, which may bias effect sizes (19 studies), deviations between planned and reported endpoints (9 studies), and relevant differences between the intervention groups at the start of the study (14 studies). Publication bias cannot be excluded because negative treatment effects on adherence were rarely reported (eFigure 1, eFigure 2).
Efficacy of the interventions
Adherence to medication treatment—This was tested in 24 studies (eTable 1). Combining the treatment effects from 18 studies shows improved adherence in 10% (95% CI [5; 15]) (Figure 2) of patients by means of the intervention under study (number needed to treat [NNT] 10; 95% CI [7; 20]). It was not possible to calculate risk differences for six studies (e2, e10, e20, e22, e25, e26). None of these studies found improved adherence to medication intake.
Adherence to lifestyle recommendations—This was investigated in a total of 42 studies and improved in 31 studies (eTable 2). The pooled effects of 22 studies in which adherence was calculated by using different summative scores (24, 25), showed improved adherence in the intervention groups in 12 studies (Table). Improved adherence regarding individual recommendations was reported in 15 out of 18 further studies, with some studies reporting summative scores as well as adherence to individual recommendations. Five studies reported adherence by using different scores for which it was not possible to calculate any differences (e25, e28, e39, e44, e49). In four of these studies, adherence improved successfully.
Association between adherence and clinical parameters—44 studies had collected data on the efficacy of the interventions on clinical parameters (mortality, admission to hospital or quality of life). Improved adherence to medication therapy or lifestyle recommendations resulted in 6 and 11 studies, respectively, in significant improvements of at least one clinical endpoint (eTable 3, eTable 4). Improved adherence to at least one of the studied recommendations resulted in the long term in an absolute reduction in mortality of 2 percentage points (95% CI [0; 4]) (17 studies including 6321 patients; eFigure 3) and a 10 percent reduction in the proportion of patients requiring inpatient stays (95% CI [3; 17]) (11 studies including 3368 patients; eFigure 4) within 12 months after the start of the intervention. Only one study investigated and confirmed an association between improved adherence to lifestyle interventions (keeping a heart failure diary) and lower mortality (e55). eTable 5 summarizes all studies that did not find any improvement in clinical endpoints.
Adherence to medication treatment as well as adherence to accompanying lifestyle recommendations can be improved by means of appropriate interventions. The effect sizes we found were lower than assumed, not least because of the pronounced heterogeneity of the included studies. Sustained effects can be expected especially for multimodal approaches that are provided with interactive feedback options for longer time periods.
Improved adherence to medication treatment
Approaches that entailed, among others, maintaining contact with patients for a lengthy period of time in order to practice adherent behaviors and check these were particularly effective (eTable 3). Notably, such sustained effects were usually achieved independently of medical doctors—for example, by specially trained nursing staff, doctors’ assistants (26–30), or pharmacists (29).
Moderately positive, but long-term, effects on quality of life, adherence to medication therapy, and self-care were shown as a result of complex bundles of measures (simplified dosing regimen, education for patients, brochures, keeping a heart failure diary with discussion of the documented entries) (29). Similarly, bundled interventions (telephone monitoring, smoking cessation courses, home visits in instability, advisory hotline) (27) had a positive effect on adherence to medication treatments and on mortality. The large GESICA study (which included 1518 patients) (28) showed that combined interventions had a sustained moderate success (telephone monitoring, information brochure, patient education provided by nursing staff, and recommendations on adjusting medications and emergency admissions).
By contrast, no sustained effects were seen for approaches whose main focus was on educational/training measures in hospital and included only very few contacts with patients for the extended observation period (for example, e3, e16, e49).
Our results therefore confirm the results of other review articles on the adherence to medication treatment: the long-term use of complex patient centered interventions is required for the intervention to be successful. However, this does not reach all patients, with the result that altogether the effects on adherence and clinically important endpoints are rather small (31, 32).
Improved adherence to lifestyle modifications
We estimated the efficacy of interventions to improve adherence to lifestyle modifications in studies with very heterogeneous endpoints; summarizing the results is therefore difficult. What seems promising, however, is multidisciplinary cooperation with a combination of inpatient and outpatient care (eTable 4). This should include primarily patient education/training with individual treatment planning in hospital and subsequent regular outpatient contact, with repeated training sessions, medical histories, and examinations provided by non-doctor medical professionals (33–35). The efficacy of such measures can be supported by further interventions, such as:
- Care provided in a special clinic run by nursing staff (35)
- Structured telephone contact
- Medication adjustment by nursing staff after discussion with cardiologists
- Psychosocial care
- Help provided in a patient’s domestic environment
- Creating a therapeutic bond that is based on trust.
Some studies (e33, e36) showed improved self-care at first follow-up, but they did now show any sustained improvements in results beyond the duration of the intervention. The therapeutic bond with a trusted professional—whether by telephone contact or home visit, or in the setting of a training/educational measure—obviously has a crucial role in improving adherence. A merely technically based solution without human interaction seems neither immediately effective nor able to provide a sustained effect (e23). In another study (e42) patients in the intervention groups were trained up as mentors, who were available to a particular assigned patient personally or by telephone whenever required. Although the implementation was linked to a person, self-care did not notably improve. The possible reason may be in the lack of competence that is perceived in a patient mentor—by contrast to medical personnel, encounters with whom a priori inspire a greater amount of confidence.
The efficacy of the collaboration of acute hospitals and rehabilitation facilities, and the formation of multidisciplinary networks in tertiary prevention of cardiovascular disorders was also emphasized by Labrunée et al (36).
Effect on clinical outcomes
The present review found that improved adherence was associated with additional positive effects on clinically relevant outcomes, which range from improved quality of life to reduced hospital stays to lower mortality. Further review articles have shown the lack of efficacy of patient training alone on clinical outcomes (37) and have shown the need for further patient centered measures in a patient’s domestic environment, such as structured telephone contacts and telemonitoring (38), or multidisciplinary care (39).
One of the limitations of this study is the fact that on the one hand, certain groups—such as patients with depression or dementia syndromes—in whom the risk for lower adherence is particularly great, were excluded from many studies. On the other hand, the studies are probably representative for the group of patients requiring treatment with regard to age and disease severity.
This review includes exclusively strategies for the implementation of measures recommended these days, as the literature search was restricted to the time period starting after the year 2000. A bias to the observed treatment effects by selective publication of positive effects of the intervention on adherence cannot be excluded, especially in studies with primary clinical endpoints. The extensive heterogeneity of the described studies and the lack of objectivity in capturing adherence with the resulting heterogeneous treatment effects should be seen as a critical issue, so that the main result of this review is not the pooled treatment effects but the presentation and discussion of effective interventions.
In the practical implementation of adherence-promoting packages of measures, specialized nursing staff in hospitals, and specially trained doctors’ assistants working in doctors’ private practices are likely to have a crucial part in establishing such measures in a patient-centered way in future. Active participation of patients in the context of shared decision making (40) should form the basis for deciding on individual measures aiming to improve adherence. To this end, patients should be enabled—on the basis of comprehensible, evidence-based information tailored to them—to develop realistic expectations of their own disease course, and to be active and adopt individual responsibility in terms of dealing with their disease and treatment measures.
The authors thank Professor Dr. med. Andreas Klement for his commitment to supervising the entire project.
Conflict of interest statement
The authors declare that no conflict of interest exists.
Manuscript received on 11 December 2015, revised version accepted on
24 March 2016.
Translated from the original German by Birte Twisselmann, PhD.
PD Dr. med. Roland Prondzinsky
Carl-von-Basedow-Klinikum, Saalekreis GmbH
Weiße Mauer 52, 06217 Merseburg
For eReferences please refer to:
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Institute of Health and Nursing Sciences, Martin-Luther-University Halle-Wittenberg, Halle (Saale):
Prof. Dr. phil. Gabriele Meyer
Institute for Medical Epidemiology, Biostatistics and Informatics, Section for General Practice, Martin-Luther-University Halle-Wittenberg, Halle (Saale): Susanne Mittmann, M. A.; Franziska-Antonia Samos, M. A.
Asklepios Parkklinik Bad Salzungen: Malte Unverzagt, B.Sc.
Carl-von-Basedow-Klinikum Saalekreis GmbH: PD Dr. med. Prondzinsky
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