Strategy to recognize and initiate treatment of chronic heart failure in primary care (STRETCH): a cluster randomized trial

BMC Cardiovascular Disorders

Study Protocol

Alexander Limburg¹  Henk van der Hoeven¹  Evelien ES van Riet²  Frans H Rutten²  Marcel AJ Landman²  Arno W Hoes² 

[1] Diakonessenhuis Zeist, Zeist, The Netherlands;Julius Center for Health Sciences and Primary care, University Medical Center Utrecht, PO Box 85500, 3508 AB, Utrecht, The Netherlands;

关键词: Heart failure;    Diagnosis;    Treatment;    Elderly;    Primary care;    Cluster randomized trial;   

DOI  :  10.1186/1471-2261-14-1

 received in 2013-12-18, accepted in 2013-12-30,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundMost patients with heart failure are diagnosed and managed in primary care, however, underdiagnosis and undertreatment are common. We assessed whether implementation of a diagnostic-therapeutic strategy improves functionality, health-related quality of life, and uptake of heart failure medication in primary care.Methods/DesignA selective screening study followed by a single-blind cluster randomized trial in primary care. The study population consists of patients aged 65 years or over who presented themselves to the general practitioner in the previous 12 months with shortness of breath on exertion. Patients already known with established heart failure, confirmed by echocardiography, are excluded. Diagnostic investigations include history taking, physical examination, electrocardiography, and serum N-terminal pro B-type natriuretic peptide levels. Only participants with an abnormal electrocardiogram or an N-terminal pro B-type natriuretic peptide level exceeding the exclusionary cutpoint for non-acute onset heart failure (> 15 pmol/L (≈ 125 pg/ml)) will undergo open-access echocardiography. The diagnosis of heart failure (with reduced or preserved ejection fraction) is established by an expert panel consisting of two cardiologists and a general practitioner, according to the criteria of the European Society of Cardiology guidelines.Patients with newly established heart failure are allocated to either the 'care as usual’ group or the 'intervention’ group. Randomization is at the level of the general practitioner. In the intervention group general practitioners receive a single half-day training in heart failure management and the use of a structured up-titration scheme. All participants fill out quality of life questionnaires at baseline and after six months of follow-up. A six-minute walking test will be performed in patients with heart failure. Information on medication and hospitalization rates is extracted from the electronic medical files of the general practitioners.DiscussionThis study will provide information on the prevalence of unrecognized heart failure in elderly with shortness of breath on exertion, and the randomized comparison will reveal whether management based on a half-day training of general practitioners in the practical application of an up-titration scheme results in improvements in functionality, health-related quality of life, and uptake of heart failure medication in heart failure patients compared to care as usual.Trial registrationClinicalTrials.gov NCT01202006

【 授权许可】

CC BY   
© van Riet et al.; licensee BioMed Central Ltd. 2014