January 8, 2014Open Access
Strategy to recognize and initiate treatment of chronic heart failure in primary care (STRETCH): a cluster randomized trial
Key Result
A primary care diagnostic-therapeutic strategy for heart failure, including GP training and a structured up-titration scheme, successfully enrolled 585 older adults with shortness of breath on exertion for evaluation in a cluster randomized trial.
Study Design
Type
RCT (n=585)
Blinding
Single-blind
Randomization
Cluster randomized at the level of the general practitioner
Multicenter
Yes
Structured PICO
Does general practitioner training and a structured up-titration scheme improve functional capacity and medication uptake in elderly patients with newly detected heart failure?
P
Population
585 older adults aged 65 years or older presenting with shortness of breath on exertion were enrolled in a cluster randomized trial to evaluate a primary care heart failure management strategy.
I
Intervention
General practitioner management guided by a half-day training in heart failure management and the practical application of a structured up-titration scheme for HF-REF and HF-PEF.
C
Comparator
Care as usual by general practitioners without specific training or a structured up-titration scheme.
O
Outcome
Difference in mean distance walked during the six-minute walking test (6MWT) between the two groups after six months follow-up.surrogate
This study protocol describes a cluster randomized trial to evaluate whether general practitioner training and a structured up-titration scheme can improve functional capacity and medication uptake in elderly patients with newly diagnosed heart failure.
Limitations
- GPs in the care as usual group cannot be blinded to the existence of an intervention arm
- Potential risk of contamination between patient groups, though mitigated by cluster randomization
Abstract
BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01202006.