title: Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN08601529.
authors.affiliation: Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany. frank.peters@med.uni-heidelberg.de
authors.forename: Frank
authors.initials: F
authors.lastname: Peters-Klimm
authors.forename: Stephen
authors.initials: S
authors.lastname: Campbell
authors.forename: Thomas
authors.initials: T
authors.lastname: Müller-Tasch
authors.forename: Dieter
authors.initials: D
authors.lastname: Schellberg
authors.forename: Goetz
authors.initials: G
authors.lastname: Gelbrich
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Herzog
authors.forename: Joachim
authors.initials: J
authors.lastname: Szecsenyi
mesh_terms: D000328:Adult; D004502:Education, Medical, Continuing; D005500:Follow-Up Studies; D054143:Heart Failure, Systolic / Q000401:mortality / Q000628:therapy*; D006801:Humans; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D010821:Physicians, Family; D011320:Primary Health Care
chemical_list: D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain
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