A multicomponent complex intervention for supportive follow-up of persons with chronic heart failure: a randomized controlled pilot study (the UTILE project).

BACKGROUND: Heart failure (HF) is a progressive disease associated with a high burden of symptoms, high morbidity and mortality, and low quality of life (QoL). This study aimed to evaluate the feasibility and potential outcomes of a novel multicomponent complex intervention, to inform a future full-scale randomized controlled trial (RCT) in Switzerland. METHODS: We conducted a pilot RCT at a secondary care hospital for people with HF hospitalized due to decompensated HF or with a history of HF decompensation over the past 6 months. We randomized 1:1; usual care for the control (CG) and intervention group (IG) who received the intervention as well as usual care. Feasibility measures included patient recruitment rate, study nurse time, study attrition, the number and duration of consultations, intervention acceptability and intervention fidelity. Patient-reported outcomes included HF-specific self-care and HF-related health status (KCCQ-12) at 3 months follow-up. Clinical outcomes were all-cause mortality, hospitalization and days spent in hospital. RESULTS: We recruited 60 persons with HF (age mean = 75.7 years, ± 8.9) over a 62-week period, requiring 1011 h of study nurse time. Recruitment rate was 46.15%; study attrition rate was 31.7%. Follow-up included 2.14 (mean, ± 0.97) visits per patient lasting a total of 166.96 min (mean, ± 72.55), and 3.1 (mean, ± 1.7) additional telephone contacts. Intervention acceptability was high. Mean intervention fidelity was 0.71. We found a 20-point difference in mean self-care management change from baseline to 3 months in favour of the IG (Cohens' d = 0.59). Small effect sizes for KCCQ-12 variables; less IG participants worsened in health status compared to CG participants. Five deaths occurred (IG = 3, CG = 2). There were 13 (IG) and 18 (CG) all-cause hospital admissions; participants spent 8.90 (median, IQR = 9.70, IG) and 15.38 (median, IQR = 18.41, CG) days in hospital. A subsequent full-scale effectiveness trial would require 304 (for a mono-centric trial) and 751 participants (for a ten-centre trial) for HF-related QoL (effect size = 0.3; power = 0.80, alpha = 0.05). CONCLUSION: We found the intervention, research methods and outcomes were feasible and acceptable. We propose increasing intervention fidelity strategies for a full-scale trial. TRIAL REGISTRATION: ISRCTN10151805 , retrospectively registered 04/10/2019.

What Are Effective Program Characteristics of Self-Management Interventions in Patients With Heart Failure? An Individual Patient Data Meta-analysis.

BACKGROUND: To identify those characteristics of self-management interventions in patients with heart failure (HF) that are effective in influencing health-related quality of life, mortality, and hospitalizations. METHODS AND RESULTS: Randomized trials on self-management interventions conducted between January 1985 and June 2013 were identified and individual patient data were requested for meta-analysis. Generalized mixed effects models and Cox proportional hazard models including frailty terms were used to assess the relation between characteristics of interventions and health-related outcomes. Twenty randomized trials (5624 patients) were included. Longer intervention duration reduced mortality risk (hazard ratio 0.99, 95% confidence interval [CI] 0.97-0.999 per month increase in duration), risk of HF-related hospitalization (hazard ratio 0.98, 95% CI 0.96-0.99), and HF-related hospitalization at 6 months (risk ratio 0.96, 95% CI 0.92-0.995). Although results were not consistent across outcomes, interventions comprising standardized training of interventionists, peer contact, log keeping, or goal-setting skills appeared less effective than interventions without these characteristics. CONCLUSION: No specific program characteristics were consistently associated with better effects of self-management interventions, but longer duration seemed to improve the effect of self-management interventions on several outcomes. Future research using factorial trial designs and process evaluations is needed to understand the working mechanism of specific program characteristics of self-management interventions in HF patients.

Do Self-Management Interventions Work in Patients With Heart Failure? An Individual Patient Data Meta-Analysis.

BACKGROUND: Self-management interventions are widely implemented in the care for patients with heart failure (HF). However, trials show inconsistent results, and whether specific patient groups respond differently is unknown. This individual patient data meta-analysis assessed the effectiveness of self-management interventions in patients with HF and whether subgroups of patients respond differently. METHODS AND RESULTS: A systematic literature search identified randomized trials of self-management interventions. Data from 20 studies, representing 5624 patients, were included and analyzed with the use of mixed-effects models and Cox proportional-hazard models, including interaction terms. Self-management interventions reduced the risk of time to the combined end point of HF-related hospitalization or all-cause death (hazard ratio, 0.80; 95% confidence interval [CI], 0.71-0.89), time to HF-related hospitalization (hazard ratio, 0.80; 95% CI, 0.69-0.92), and improved 12-month HF-related quality of life (standardized mean difference, 0.15; 95% CI, 0.00-0.30). Subgroup analysis revealed a protective effect of self-management on the number of HF-related hospital days in patients <65 years of age (mean, 0.70 versus 5.35 days; interaction P=0.03). Patients without depression did not show an effect of self-management on survival (hazard ratio for all-cause mortality, 0.86; 95% CI, 0.69-1.06), whereas in patients with moderate/severe depression, self-management reduced survival (hazard ratio, 1.39; 95% CI, 1.06-1.83, interaction P=0.01). CONCLUSIONS: This study shows that self-management interventions had a beneficial effect on time to HF-related hospitalization or all-cause death and HF-related hospitalization alone and elicited a small increase in HF-related quality of life. The findings do not endorse limiting self-management interventions to subgroups of patients with HF, but increased mortality in depressed patients warrants caution in applying self-management strategies in these patients.

End-of-life preferences of elderly patients with chronic heart failure.

AIMS: Elderly heart failure (HF) patients are assumed to prefer improved quality of life over longevity, but sufficient data are lacking. Therefore, we assessed the willingness to trade survival time for quality-of-life (QoL) and the preferences for resuscitation. METHODS AND RESULTS: At baseline and after 12 and 18 months, 622 HF patients aged ≥60 years (77 ± 8 years, 74% NYHA-class ≥III) participating in the Trial of Intensified vs. standard Medical therapy in Elderly patients with Congestive Heart Failure had prospective evaluation of end-of-life preferences by answering trade-off questions (willingness to accept a shorter life span in return for living without symptoms) and preferences for resuscitation if necessary. The time trade-off question was answered by 555 patients (89%), 74% of whom were not willing to trade survival time for improved QoL. This proportion increased over time (Month 12: 85%, Month 18: 87%, P < 0.001). In multivariable analysis, willingness to trade survival time increased with age, female sex, a reduced Duke Activity Status Index, Geriatric Depression Score, and history of gout, exercise intolerance, constipation and oedema, but even combining these variables did not result in reliable prediction. Of 603 (97%) patients expressing their resuscitation preference, 51% wished resuscitation, 39% did not, and 10% were undecided, with little changes over time. In 430 patients resuscitation orders were known; they differed from patients' preferences 32% of the time. End-of-life preferences were not correlated to 18-month outcome. CONCLUSION: Elderly HF patients are willing to address their end-of-life preferences. The majority prefers longevity over QoL and half wished resuscitation if necessary. Prediction of individual preferences was inaccurate.

Self-reported cardiovascular risk factors in immigrants and Swiss nationals.

OBJECTIVE: The purpose of this study was to investigate whether the prevalence of self-reported cardiovascular risk factors differs between immigrants and Swiss nationals. DESIGN AND SAMPLE: This study is a secondary data analysis of the Swiss Health Survey 2002, a cross-sectional survey. In total, 19,249 individuals living in Switzerland were included. MEASURES: The prevalence of hypertension, high cholesterol level, smoking, diabetes, overweight, low fruit and vegetable intake, and physical inactivity were calculated for major immigrant groups and Swiss nationals. Demographic data were used to control for age and socioeconomic status. RESULTS: Major immigrant groups were people from Italy, Germany, former Yugoslavia, Spain, Portugal, France, and Turkey. Compared with Swiss women, women from former Yugoslavia were more likely to have hypertension, and women from Germany were more likely to have high cholesterol levels. Women from Italy, former Yugoslavia, Spain, Portugal, and Turkey were more likely to show physical inactivity and (except Turkish women) to be overweight. Men from these countries (except Spanish men) were more likely to be overweight than Swiss men. CONCLUSIONS: Differences exist in the prevalence of modifiable cardiovascular risk factors between Swiss nationals and many of the immigrant groups. Age and socioeconomic status could only partly explain the differences.

Swiss Interdisciplinary Management Programme for Heart Failure (SWIM-HF): a randomised controlled trial study of an outpatient inter-professional management programme for heart failure patients in Switzerland.

PRINCIPLES: International guidelines for heart failure (HF) care recommend the implementation of inter-professional disease management programmes. To date, no such programme has been tested in Switzerland. The aim of this randomised controlled trial (RCT) was to test the effect on hospitalisation, mortality and quality of life of an adult ambulatory disease management programme for patients with HF in Switzerland. METHODS: Consecutive patients admitted to internal medicine in a Swiss university hospital were screened for decompensated HF. A total of 42 eligible patients were randomised to an intervention (n = 22) or usual care group (n = 20). Medical treatment was optimised and lifestyle recommendations were given to all patients. Intervention patients additionally received a home visit by a HF-nurse, followed by 17 telephone calls of decreasing frequency over 12 months, focusing on self-care. Calls from the HF nurse to primary care physicians communicated health concerns and identified goals of care. Data were collected at baseline, 3, 6, 9 and 12 months. Mixed regression analysis (quality of life) was used. Outcome assessment was conducted by researchers blinded to group assignment. RESULTS: After 12 months, 22 (52%) patients had an all-cause re-admission or died. Only 3 patients were hospitalised with HF decompensation. No significant effect of the intervention was found on HF related to quality of life. CONCLUSIONS: An inter-professional disease management programme is possible in the Swiss healthcare setting but effects on outcomes need to be confirmed in larger studies.

Which interventions are used by health care professionals to enhance medication adherence in cardiovascular patients? A survey of current clinical practice.

BACKGROUND: Complex medication regimens are often required to manage cardiovascular diseases. As non-adherence, which can have severe negative outcomes, is common among cardiovascular patients, various interventions to improve adherence should be implemented in daily practice. AIM: To assess which strategies cardiovascular nurses and allied health professionals utilize to (1) assess patients' adherence to medication regimen, and (2) enhance medication adherence via educational/cognitive, counseling/behavioral, and psychological/affective interventions. METHOD: A 45-item questionnaire to assess adherence assessment and interventional strategies utilized by health care professionals in daily clinical practice was distributed to a convenience sample of attendants of the 10th Annual Spring Meeting of the European Society of Cardiology Council on Cardiovascular Nursing and Allied Professions conference in Geneva (Switzerland) in March 2010. Respondents not in direct clinical practice were excluded. Descriptive statistics were used to describe practice patterns regarding adherence management. RESULTS: Of 276 distributed questionnaires, 171 (62%) were returned, of which 34 (20%) were excluded as respondents performed no direct patient care. Questioning patients about non-adherence during follow-up was the most frequently reported assessment strategy (56%). Educational/cognitive adherence enhancing interventions were used most frequently, followed by counseling/behavioral interventions. Psychological/affective interventions were less frequently used. The most frequent intervention used was providing reading materials (66%) followed by training patients regarding medication taking during inpatient recovery (48%). Slightly over two-thirds (69%) reported using a combination of interventions to improve patient's adherence. CONCLUSION: Educational interventions are used most in clinical practice, although evidence shows they are less effective than behavioral interventions at enhancing medication adherence.

Palliative care in heart failure: a position statement from the palliative care workshop of the Heart Failure Association of the European Society of Cardiology.

Heart failure is a serious condition and equivalent to malignant disease in terms of symptom burden and mortality. At this moment only a comparatively small number of heart failure patients receive specialist palliative care. Heart failure patients may have generic palliative care needs, such as refractory multifaceted symptoms, communication and decision making issues and the requirement for family support. The Advanced Heart Failure Study Group of the Heart Failure Association of the European Society of Cardiology organized a workshop to address the issue of palliative care in heart failure to increase awareness of the need for palliative care. Additional objectives included improving the accessibility and quality of palliative care for heart failure patients and promoting the development of heart failure-orientated palliative care services across Europe. This document represents a synthesis of the presentations and discussion during the workshop and describes recommendations in the area of delivery of quality care to patients and families, education, treatment coordination, research and policy.

Negotiating compliance in heart failure: remaining issues and questions.

Living with heart failure (HF) means living with a chronic illness characterized by periods of acute decompensation alternating with periods of relative stability. Improved medical care for patients with cardiovascular diseases, coupled with the aging of the populations in the developed world, has resulted in a steadily increasing prevalence of HF. Rehospitalization rates are high for this patient population. In 20-64% of the cases, poor compliance by patients with the prescribed HF treatment is a contributing factor to hospitalization. This article uses a review of the literature on HF non-compliance, including the prevalence, barriers, consequences, and the long-term outcomes of non-compliance with HF therapy, to illustrate remaining issues and questions. Original studies published in English or German between 1966 and June 2004 identified by combining patient compliance, non-compliance, adherence, self-care, rehospitalization, patient education, and management programs, with heart failure in the search strategy are included. Creative approaches to achieving a true partnership between providers and patients are needed if clinical outcomes are to improve.

Complexity in caring for an ageing heart failure population: concomitant chronic conditions and age related impairments.

The complexity of caring for the ageing heart failure (HF) population is further complicated by concomitant chronic conditions (i.e., polypharmacy, depression), age related impairments (i.e., hearing, visual and cognitive impairments, impairments in activities of daily living (ADL/IADL), and other issues (e.g., health illiteracy, lack of social support). This paper provides an overview of these risk factors, outlines how they individually and in interplay endanger favourable outcome by putting patients at risk for poor self-management. Moreover, suggestions are made on how these issues could be addressed and integrated in heart failure management by applying gerontological care principles in caring for the ageing heart failure population.

Differences in psychosocial and behavioral profiles between heart failure patients admitted to cardiology and geriatric wards.

BACKGROUND: Heart failure represents a growing epidemic, primarily in the elderly. Development and implementation of management programs designed for use in daily clinical practice remains a major challenge. AIMS: This study aimed at profiling a hospitalized heart failure population in view of medical, behavioral, educational, psychosocial and health resources utilization parameters stratified by admission to cardiology and geriatric wards. METHODS AND RESULTS: Using a descriptive comparative design, 109 European heart failure patients admitted to cardiology (42%) and geriatric wards (58%) were included. Significant differences (all P<0.0001) were identified between the two groups. Patients admitted to cardiology had a mean age of 68.5, 33% were women, and the mean ejection fraction was 38%. Patients admitted to geriatrics had a mean age of 85, 68% were women, and the mean ejection fraction was 56%. Sixty-six percent were admitted for cardiac reasons. Medical, educational, behavioral, psychosocial and health resources utilization data were retrieved from medical files as well as by patient and family interviews. Results showed significant differences between groups. Patients admitted to geriatric wards received significantly less ACE inhibition and beta-blockers. Moreover, these patients were significantly less knowledgeable, showed poorer self-management, poorer hearing, more cognitive impairment, a higher degree of depressive symptomatology, more problems with ADL and IADL, and used significantly more home health care services compared to patients admitted to cardiology wards. CONCLUSION: The characteristics of the heart failure population at large are quite different from those of populations included in large-scale therapeutic trials. Findings from this study provide options for tailored management strategies for both profiled subgroups.