Abstract

BackgroundChronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes.MethodsThis paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted.ResultsThere was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2–13; p = 0.02).ConclusionThe intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care.Trial registrationISRCTN08601529.

Highlights

  • Chronic heart failure (CHF) is a common and disabling condition

  • Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating General practitioner (GP), prohibit definite conclusions, but the Confidence interval (CI) indicates a non-effectiveness of the intervention in this sample

  • We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care

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Summary

Introduction

Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. Chronic (systolic) heart failure (CHF) is a "common, disabling, deadly, and costly disease" often resulting in hospital admissions with a prevalence rate of approximately 1% in Germany[1,2]. New treatments and care strategies tend to focus on the prevention of hospital admissions and improving prognosis. The adherence of physicians to clinical practice guidelines (CPG)[3] and patients to treatment regimens [4], have been found to be predictors of better patient outcomes[5]. There are barriers[6] that must be overcome in order to ensure adequate communication between physicians and patients[7] and in the delivery of evidence-based care [8,9,10]. Increasing evidence shows that psychological comorbidities determine QoL in patients with CHF[14]

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