Early and comprehensive care bundle in the elderly for acute heart failure in the emergency department: study protocol of the ELISABETH stepped-wedge cluster randomized trial

Yonathan Freund, Judith Gorlicki, Marine Cachanado, Sarah Salhi, Vanessa Lemaître, Tabassome Simon, Alexandre Mebazaa, Yonathan Freund, Judith Gorlicki, Marine Cachanado, Sarah Salhi, Vanessa Lemaître, Tabassome Simon, Alexandre Mebazaa

Abstract

Background: Acute heart failure (AHF) is one of the most common diagnoses for elderly patients in the emergency department (ED), with an admission rate above 80% and 1-month mortality around 10%. The European guidelines for the management of AHF are based on moderate levels of evidence, due to the lack of randomized controlled trials and the scarce evidence of any clinical added value of a specific treatment to improve outcomes. Recent reports suggest that the very early administration of full recommended therapy may decrease mortality. However, several studies have highlighted that elderly patients often received suboptimal treatment. Our hypothesis is that an early care bundle that comprises early and comprehensive management of symptoms, along with prompt detection and treatment of precipitating factors should improve AHF outcome in elderly patients.

Methods/design: ELISABETH is a stepped-wedge, cluster randomized controlled, clinical trial in 15 emergency departments in France recruiting all patients aged 75 years and older with a diagnosis of AHF. The tested intervention is a care bundle with a checklist that mandates detection and early treatment of AHF precipitating factors, early and intensive treatment of congestion with intravenously administered nitrate boluses, and application of other recommended treatment (low-dose diuretics, non-invasive ventilation when indicated, and preventive low-molecular-weight heparin). Each center is randomized to the order in which they will switch from a "control period" to an "intervention period." All centers begin the trials with the control period for 2 weeks, then after each 2-week step a new center will enter the intervention period. At the end of the trial, all clusters will receive the intervention regimen. The primary outcome is the number of days alive and out of the hospital at 30 days.

Discussion: If our hypothesis is confirmed, this trial will strengthen the level of evidence of AHF guidelines and stress the importance of the associated early and comprehensive treatment of precipitating factors. This trial could be the first to report a reduction in short-term morbidity and mortality in elderly AHF patients.

Trial registration: ClinicalTrials.gov, ID: NCT03683212. Prospectively registered on 25 September 2018.

Keywords: Acute heart failure; Elderly; Emergency department.

Conflict of interest statement

Ethics approval and consent to participate

Informed consent will be obtained from all study participants whenever possible. If the patient is unable to consent, informed consent from a relative will be obtained. If there is no relative, an emergency consent could be obtained. In all cases, the patient’s consent will be obtained as soon as their condition allows it. An Institutional Review Board authorized the study (Comité de Protection des Personnes SOOM 2, ID-RCB: 2018-AO1139–46, 6 September 2018) for all participating centers, as this trial will be conducted in France only.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Handover sheet with checklist for acute heart failure (AHF) management

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