AIMS: 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 anangiotensin-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). CONCLUSION: 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.
RCT Entities:
AIMS: 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). CONCLUSION: 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: Dalia M Dawoud; Alexander Haines; David Wonderling; Joanna Ashe; Jennifer Hill; Mihir Varia; Philip Dyer; Julian Bion Journal: Pharmacoeconomics Date: 2019-10 Impact factor: 4.981
Authors: Adam D DeVore; Phillip J Schulte; Robert J Mentz; N Chantelle Hardy; Jacob P Kelly; Eric J Velazquez; Juan F Maya; Adrian Kielhorn; Harshali K Patel; Shelby D Reed; Adrian F Hernandez Journal: Am J Cardiol Date: 2015-12-30 Impact factor: 2.778
Authors: Nathalie Conrad; Andrew Judge; Dexter Canoy; Jenny Tran; Johanna O'Donnell; Milad Nazarzadeh; Gholamreza Salimi-Khorshidi; F D Richard Hobbs; John G Cleland; John J V McMurray; Kazem Rahimi Journal: PLoS Med Date: 2019-05-21 Impact factor: 11.069
Authors: Kannan O Ahmed; Imad Taj Eldin; Mirghani Yousif; Ahmed A Albarraq; Bashir A Yousef; Nasrein Ahmed; Anas Babiker Journal: Integr Pharm Res Pract Date: 2021-11-11