title: The Heart failure and Optimal Outcomes from Pharmacy Study (HOOPS): rationale, design, and baseline characteristics.
abstract: OBJECTIVE
  The effect on mortality and morbidity of pharmacist-led intervention to optimize pharmacological therapy in patients with systolic heart failure (HF) has not been tested in a large-scale, long-term, clinical trial.
  
  
  METHODS
  We describe the rationale and design of a UK, primary care-based, prospective cluster-randomized controlled trial of a pharmacist-led intervention in HF and report baseline characteristics of the patients randomized. Eighty-seven practices (1092 patients) were assigned to the intervention arm and 87 practices (1077 patients) to usual care. The average age of patients at baseline was 71 years, 70% were male, 86% were treated with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and 62% with a beta-blocker. Data for the primary outcome of death from any cause or hospitalization for HF will be available up to 31 December 2010, giving a mean follow-up of 5 years. More than 750 patients would have experienced the primary outcome during this period. The first secondary outcome is death from any cause or hospitalization for a cardiovascular reason. Deaths and hospitalizations are being identified using the Scottish National Health Service electronic patient record-linkage system (hence the delay between the end of follow-up and database lock).
  
  
  CONCLUSIONS
  This trial is powered to provide a robust evaluation of the effect of pharmacist-led treatment optimization in patients with systolic HF in primary care.
authors.affiliation: NHS Greater Glasgow and Clyde, Glasgow, Scotland, UK. Richard.Lowrie@ggc.scot.nhs.uk
authors.forename: Richard
authors.initials: R
authors.lastname: Lowrie
authors.forename: Frances S
authors.initials: FS
authors.lastname: Mair
authors.forename: Nicola
authors.initials: N
authors.lastname: Greenlaw
authors.forename: Paul
authors.initials: P
authors.lastname: Forsyth
authors.forename: Alex
authors.initials: A
authors.lastname: McConnachie
authors.forename: Janice
authors.initials: J
authors.lastname: Richardson
authors.forename: Nina
authors.initials: N
authors.lastname: Khan
authors.forename: Deborah
authors.initials: D
authors.lastname: Morrison
authors.forename: Claudia-Martina
authors.initials: CM
authors.lastname: Messow
authors.forename: Brian
authors.initials: B
authors.lastname: Rae
authors.forename: John J V
authors.initials: JJ
authors.lastname: McMurray
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000368:Aged; D057911:Angiotensin Receptor Antagonists / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D010595:Pharmacists; D012107:Research Design
chemical_list: D000319:Adrenergic beta-Antagonists; D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors