Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Chronic (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 ed...

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Main Authors: Schellberg Dieter, Müller-Tasch Thomas, Campbell Stephen, Peters-Klimm Frank, Gelbrich Goetz, Herzog Wolfgang, Szecsenyi Joachim
Format: Article
Language:English
Published: BMC 2009-08-01
Series:Trials
Online Access:http://www.trialsjournal.com/content/10/1/68
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author Schellberg Dieter
Müller-Tasch Thomas
Campbell Stephen
Peters-Klimm Frank
Gelbrich Goetz
Herzog Wolfgang
Szecsenyi Joachim
author_facet Schellberg Dieter
Müller-Tasch Thomas
Campbell Stephen
Peters-Klimm Frank
Gelbrich Goetz
Herzog Wolfgang
Szecsenyi Joachim
author_sort Schellberg Dieter
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>Chronic (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.</p> <p>Methods</p> <p>This 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.</p> <p>Results</p> <p>There 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).</p> <p>Conclusion</p> <p>The 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.</p> <p>Trial registration</p> <p>ISRCTN08601529.</p>
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spelling doaj.art-8f501755ddbc4f61aa67561b0c7777c02022-12-21T19:08:38ZengBMCTrials1745-62152009-08-011016810.1186/1745-6215-10-68Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trialSchellberg DieterMüller-Tasch ThomasCampbell StephenPeters-Klimm FrankGelbrich GoetzHerzog WolfgangSzecsenyi Joachim<p>Abstract</p> <p>Background</p> <p>Chronic (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.</p> <p>Methods</p> <p>This 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.</p> <p>Results</p> <p>There 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).</p> <p>Conclusion</p> <p>The 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.</p> <p>Trial registration</p> <p>ISRCTN08601529.</p>http://www.trialsjournal.com/content/10/1/68
spellingShingle Schellberg Dieter
Müller-Tasch Thomas
Campbell Stephen
Peters-Klimm Frank
Gelbrich Goetz
Herzog Wolfgang
Szecsenyi Joachim
Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial
Trials
title Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial
title_full Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial
title_fullStr Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial
title_full_unstemmed Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial
title_short Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial
title_sort primary care based multifaceted interdisciplinary medical educational intervention for patients with systolic heart failure lessons learned from a cluster randomised controlled trial
url http://www.trialsjournal.com/content/10/1/68
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