Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study: a cluster randomised controlled trial

BMC Family Practice

Study Protocol

Berna D. L. Broekhuizen¹  Arno W. Hoes¹  Mark J. Valk¹  Frans H. Rutten¹  Arend Mosterd²  Marcel A. Landman³ 

[1] Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, Stratenum 6.131, 3508 AB, Utrecht, The Netherlands;Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, Stratenum 6.131, 3508 AB, Utrecht, The Netherlands;Department of Cardiology, Meander Medical Center, Amersfoort, The Netherlands;van Hardenbroeklaan 21, 3832 CK, Leusden, The Netherlands;

关键词: Heart failure;    General practice;    Drug treatment;    Training;    Cluster randomised controlled trial;   

DOI  :  10.1186/s12875-015-0347-1

 received in 2015-02-25, accepted in 2015-09-23,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundHeart failure (HF) is mainly detected and managed in primary care, but the care is considered suboptimal. We present the rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study. In this study we assess the effect of a single training of GPs in the pharmacological management of patients with HF.Methods/designA cluster randomised controlled trial. Thirty primary care practices are randomly assigned to care as usual or intervention defined as a single training in the up-titration and management of HF drug therapy according to the heart failure guidelines of the European Society of Cardiology (ESC). Patients with a GP’s diagnosis of HF will be re-evaluated by an expert panel of two cardiologists and a GP with expertise in HF to come to a definite diagnosis of HF according to the ESC heart failure guidelines. Those with definite HF will be analysed in this study. Drug use will be measured after six months, health status after twelve months, and heart-related hospital admissions and all-cause mortality after two years.DiscussionOur cluster randomised trial will show whether a single training of GPs improves the pharmacological management of patients with HF and confers beneficial effects on health status after one year, and cardiac hospital admissions and all-cause mortality after two years of follow-up.Trial registrationClinicalTrials.gov Identifier NCT01662323

【 授权许可】

CC BY   
© Valk et al. 2015