Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial

Study Overview
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Brief Summary
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This is a prospective multicentre (N=15), stepped-wedge randomized trial that aims to evaluate the benefit of a protocolised comprehensive care bundle for early management of acute heart failure in the ED.

Detailed Description
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Acute heart failure (AHF) is one of the most common diagnoses for elderly patients in the emergency department (ED), with an admission rate higher than 80% and 1-month mortality around 10%. There is scarce evidence of any clinical added value of a specific treatment to improve outcomes, and European guidelines for the management of AHF are based on moderate levels of evidence, due to the lack of randomized controlled trials. Recent reports suggest that the very early administration of full recommended therapy may decrease mortality. However, several studies highlighted that elderly patients often received suboptimal treatment: For example, less than a third of them received nitrates therapy while it is recommended. Furthermore, a recent preliminary study reported that only 50% of them are assessed for precipitating factors - although it has been reported that precipitating factors are independently associated with mortality. The hypothesis of the Elisabeth Study s 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.

Official Title
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Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial

Conditions
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Acute Heart Failure

Intervention / Treatment
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* Procedure: Early intensive care bundle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 75 years and older admitted to the emergency department with a diagnosis of acute heart failure determined by the emergency physician, based on the presence of: at least one of the following symptoms : acute, or worsening of dyspnea, orthopnea one or more of the followings: pulmonary rales, peripheral edema, a chest radiograph or transthoracic echocardiography showing pulmonary vascular congestion signs, increased natriuretic peptides (BNP or NT-pro-BNP). Patients affiliated to French social security (AME excepted) Written informed consent signed by the patient / the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will been signed by the patient (if need be by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code) Exclusion Criteria: Patients are excluded if they have any of the followings: other obvious cause of acute illness (severe sepsis, ST elevation Myocardial infarction) systolic blood pressure less than 100 mmHg severe mitral or aortic stenosis, or severe aortic regurgitation known chronic kidney injury on dialysis shock from any cause Time from ED entrance to inclusion > 6h Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention period : early and comprehensive care bundle<br> | Procedure: Early intensive care bundle<br>* The care bundle comprises a list of items to follow and tick on a handover checklist within 4 hours of ED management: Treatment of the congestion: (international guidelines and recommendations) Treatment of precipitating factors NIV (non-invasive ventilation) if respiratory distress with hypercapnia and pH < 7.35 in absence of contra indication. Preventive LMWH (low molecular weight heparin) if no pre-existing anticoagulation therapy.<br>|
| No Intervention: acute heart failure standard therapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days alive and out of hospital | Number of days alive and out of hospital | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of AHF management on the 30-day cardiovascular death | cardiovascular death | 30 days | 
| To evaluate the effect of AHF management on the 30-day all causes death | all causes death | 30 days | 
| To evaluate the effect of AHF management on the hospital readmission at 30 days | hospital readmission | 30 days | 
| To evaluate the effect of AHF management on the length of stay in hospital | length of stay in hospital | 30 days | 
| To evaluate the effect of AHF management on changes of more than 2 fold in creatinine level from randomization to day 30 or to discharge whichever comes first | creatinine level | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency department, Elderly, Acute heart failure, Pulmonary edema