Abstract
BackgroundChronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improving patient outcomes, but lack a robust evidence base, especially for primary care. The aim of the study was to explore the effectiveness of a new model of CHF case management conducted by doctors' assistants (DAs, equivalent to a nursing role) and supported by general practitioners (GPs).MethodsThis patient-randomised controlled trial (phase II) included 31 DAs and employing GPs from 29 small office-based practices in Germany. Patients with CHF received either case management (n = 99) consisting of telephone monitoring and home visits or usual care (n = 100) for 12 months. We obtained clinical data, health care utilisation data, and patient-reported data on generic and disease-specific quality of life (QoL, SF-36 and KCCQ), CHF self-care (EHFScBS) and on quality of care (PACIC-5A). To compare between groups at follow-up, we performed analyses of covariance and logistic regression models.ResultsBaseline measurement showed high guideline adherence to evidence-based pharmacotherapy and good patient self-care: Patients received angiotensin converting enzyme inhibitors (or angiotensin-2 receptor antagonists) in 93.8% and 95%, and betablockers in 72.2% and 84%, and received both in combination in 68% and 80% of cases respectively. EHFScBS scores (SD) were 25.4 (8.4) and 25.0 (7.1). KCCQ overall summary scores (SD) were 65.4 (22.6) and 64.7 (22.7). We found low hospital admission and mortality rates. EHFScBS scores (-3.6 [-5.7;-1.6]) and PACIC and 5A scores (both 0.5, [0.3;0.7/0.8]) improved in favour of CM but QoL scores showed no significant group differences (Physical/Mental SF-36 summary scores/KCCQ-os [95%CI]: -0.3 [-3.0;2.5]/-0.1 [-3.4;3.1]/1.7 [-3.0;6.4]).ConclusionsIn this sample, with little room for improvement regarding evidence-based pharmacotherapy and CHF self-care, case management showed no improved health outcomes or health care utilisation. However, case management significantly improved performance and key intermediate outcomes. Our study provides evidence for the feasibility of the case management model.Trial registration numberISRCTN30822978
Highlights
Chronic heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease
The trial was an independent project within subproject 10 "Quality of Life" within the German "Competence Network Heart Failure", a nationwide research network that bundles the scientific expertise in a large-scale research network, sponsored by the Federal Ministry of Education and Research http://www.knhi.de[22]
In a phase II trial [14,15], we explored whether a comprehensive case management intervention would improve patients' health-related quality of life (QoL), heart failure self-care, and patient-reported quality of care
Summary
Chronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improving patient outcomes, but lack a robust evidence base, especially for primary care. The aim of the study was to explore the effectiveness of a new model of CHF case management conducted by doctors' assistants (DAs, equivalent to a nursing role) and supported by general practitioners (GPs). Chronic (systolic) heart failure (CHF) is a "common, disabling, deadly, and costly disease" [1] characterised by hospital admissions due to clinical deterioration. General practices are the primary caregivers and first point of contact for the majority of heart failure patients and represent a practical target for delivering case management interventions aimed at improved outcomes
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