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

ABSTRACT: Most 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.A 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.This 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.ClinicalTrials.gov NCT01202006.

SUBMITTER: van Riet EE

PROVIDER: S-EPMC3898002 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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

van Riet Evelien E S EE Hoes Arno W AW Limburg Alexander A van der Hoeven Henk H Landman Marcel A J MA Rutten Frans H FH

BMC cardiovascular disorders 20140108

<h4>Background</h4>Most 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.<h4>Methods/design</h4>A selective screening study followed by a single-blind cluster randomized trial in primary care. The study population consists of patients aged ...[more]

PMID: 24400643

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Project description:Chronic heart failure, is increasing due to the aging population and improvements in heart disease detection and management. The prevalence is estimated at ~10% of the French general practice patient population over 59 years old. The primary objective of this study is to improve the quality of life for heart failure patients though a complex intervention involving patient and general practitioner (GP) education in primary care.A randomised, cluster controlled trial, stratified over 4 areas of the Auvergne region in France comparing intervention and control groups. The inclusion criteria are: patients older than 50 years with New York Heart Association (NYHA) stage I, II, or III heart failure, with reduced ejection fraction or with preserved ejection fraction. Heart failure should be confirmed by the patient's cardiologist according to the European Society of Cardiology guidelines criteria. The exclusion criteria include: severe cognitive disorders, living in an institution, participating in another clinical trial, having NYHA stage IV heart failure, or a lack of French language skills. The complex intervention consists of training at the GP practice with an interactive 2-day workshop to provide a patient's education programme. GPs are trained to perform case management, lifestyle counselling and motivational interviewing, to educate patients on the main topics including clinical alarm signs, physical activity, diet and cardiovascular risk factors. The patients' education sessions are scheduled at 1, 4, 7, 10, 13 and 19 months following the start of the trial. The primary outcome to be assessed is the impact on the quality of life as determined using two questionnaires: the Minnesota Living with Heart Failure Questionnaire and SF-36. To detect a difference in the mean quality of life at 19 months, we anticipate studying a minimum of 400 patients from 80 GPs.This trial will provide insight into the effectiveness of a complex intervention to educate patients with heart failure including a 2-day GP workshop and patients' education programme in the setting of a GP consultation to improve the quality of life in patients with chronic heart failure. This complex intervention tool could be used during initial and further medical training.ETIC is a cluster-randomised, controlled trial registered on ClinicalTrials.gov [ NCT01065142 , 2010, Feb 8] and the French drug agency [Agence Nationale de Sécurité du Médicament et des produits de santé; registration number: 2009-A01142-55, on March 5th, 2010].

Project description:Classification of chronic heart failure (HF) is on the basis of criteria that may not adequately capture disease heterogeneity. Improved phenotyping may help inform research and therapeutic strategies.This study used cluster analysis to explore clinical phenotypes in chronic HF patients.A cluster analysis was performed on 45 baseline clinical variables from 1,619 participants in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) study, which evaluated exercise training versus usual care in chronic systolic HF. An association between identified clusters and clinical outcomes was assessed using Cox proportional hazards modeling. Differential associations between clinical outcomes and exercise testing were examined using interaction testing.Four clusters were identified (ranging from 248 to 773 patients in each), in which patients varied considerably among measures of age, sex, race, symptoms, comorbidities, HF etiology, socioeconomic status, quality of life, cardiopulmonary exercise testing parameters, and biomarker levels. Differential associations were observed for hospitalization and mortality risks between and within clusters. Compared with cluster 1, risk of all-cause mortality and/or all-cause hospitalization ranged from 0.65 (95% confidence interval [95% CI]: 0.54 to 0.78) for cluster 4 to 1.02 (95% CI: 0.87 to 1.19) for cluster 3. However, for all-cause mortality, cluster 3 had a disproportionately lower risk of 0.61 (95% CI: 0.44 to 0.86). Evidence suggested differential effects of exercise treatment on changes in peak oxygen consumption and clinical outcomes between clusters (p for interaction <0.04).Cluster analysis of clinical variables identified 4 distinct phenotypes of chronic HF. Our findings underscore the high degree of disease heterogeneity that exists within chronic HF patients and the need for improved phenotyping of the syndrome. (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure; NCT00047437).

Project description:BackgroundChronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improving patient outcomes, but lack a robust evidence base, especially for primary care. The aim of the study was to explore the effectiveness of a new model of CHF case management conducted by doctors' assistants (DAs, equivalent to a nursing role) and supported by general practitioners (GPs).MethodsThis patient-randomised controlled trial (phase II) included 31 DAs and employing GPs from 29 small office-based practices in Germany. Patients with CHF received either case management (n = 99) consisting of telephone monitoring and home visits or usual care (n = 100) for 12 months. We obtained clinical data, health care utilisation data, and patient-reported data on generic and disease-specific quality of life (QoL, SF-36 and KCCQ), CHF self-care (EHFScBS) and on quality of care (PACIC-5A). To compare between groups at follow-up, we performed analyses of covariance and logistic regression models.ResultsBaseline measurement showed high guideline adherence to evidence-based pharmacotherapy and good patient self-care: Patients received angiotensin converting enzyme inhibitors (or angiotensin-2 receptor antagonists) in 93.8% and 95%, and betablockers in 72.2% and 84%, and received both in combination in 68% and 80% of cases respectively. EHFScBS scores (SD) were 25.4 (8.4) and 25.0 (7.1). KCCQ overall summary scores (SD) were 65.4 (22.6) and 64.7 (22.7). We found low hospital admission and mortality rates. EHFScBS scores (-3.6 [-5.7;-1.6]) and PACIC and 5A scores (both 0.5, [0.3;0.7/0.8]) improved in favour of CM but QoL scores showed no significant group differences (Physical/Mental SF-36 summary scores/KCCQ-os [95%CI]: -0.3 [-3.0;2.5]/-0.1 [-3.4;3.1]/1.7 [-3.0;6.4]).ConclusionsIn this sample, with little room for improvement regarding evidence-based pharmacotherapy and CHF self-care, case management showed no improved health outcomes or health care utilisation. However, case management significantly improved performance and key intermediate outcomes. Our study provides evidence for the feasibility of the case management model.Trial registration numberISRCTN30822978.

Project description:The prevalence of chronic heart failure (CHF) in patients assisted in primary care is not well known. We investigated the prevalence of CHF, its associated factors, and its therapeutic management. This was a cross-sectional, multicenter study conducted in primary care (PC) in baseline patients of the IBERICAN study (Identification of the Spanish Population at Cardiovascular and Renal Risk). CHF was defined as the presence of this condition in the medical history, classifying patients according to the type of ventricular dysfunction in CHF with preserved ejection fraction (pEF), or CHF with reduced ejection fraction (rEF). Clinical characteristics, relationship between CHF and main cardiovascular risk factors (CVRF), and drug treatments used according to ejection fraction (EF) were analyzed. A total of 8066 patients were included (54.5% women), average age (SD) was 57.9 (14.8) years, of which 3.1% (95% CI: 2.3-3.7) presented CHF, without differences between men and women. CHF with pEF (61.8%; 95% CI: 55.5-67.6) was more frequent in women, and CHF with rEF (38.1%; 95% CI: 33.2-45.5) (p = 0.028) was similar in both genders (65.9%; 95% CI: 57.1-73.4 vs. 57.3%; 95% CI: 47.7-65.8) (p = 0.188). A progressive increase of the prevalence with age (15.2% in ≥80 years) and with the aggregation of CVRF was observed. The most prescribed treatments were beta-blockers (54.7%) followed by angiotensin converting enzyme inhibitors (42.8%) and angiotensin II receptor antagonists (41.3%), without differences between pEF and rEF. The variables that are most associated with the probability of suffering CHF were a personal history of left ventricular hypertrophy (OR: 5.968; p < 0.001), of atrial fibrillation (OR: 3.494; p < 0.001), and of peripheral vascular disease (OR: 2.029; p < 0.001). Three in every 100 patients included in the IBERICAN study presented CHF, of which two thirds had pEF. The condition increased exponentially with age and aggregation of CVRF. We did not find any differences in drug treatment according to the type of ventricular dysfunction. The treatment of HF with rEF has much room for improvement.

Dataset Information

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

Publications

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

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