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

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. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Yonathan Freund [verfasserIn] Judith Gorlicki [verfasserIn] Marine Cachanado [verfasserIn] Sarah Salhi [verfasserIn] Vanessa Lemaître [verfasserIn] Tabassome Simon [verfasserIn] Alexandre Mebazaa [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Schlagwörter:	Elderly Acute heart failure Emergency department

Übergeordnetes Werk:	In: Trials - BMC, 2006, 20(2019), 1, Seite 8
Übergeordnetes Werk:	volume:20 ; year:2019 ; number:1 ; pages:8

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1186/s13063-019-3188-8

Katalog-ID:	DOAJ064130339

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520			\|a 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.
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allfields	10.1186/s13063-019-3188-8 doi (DE-627)DOAJ064130339 (DE-599)DOAJ7ea9be28fe7f43c892f0dc1dc693bfe7 DE-627 ger DE-627 rakwb eng R5-920 Yonathan Freund verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Elderly Acute heart failure Emergency department Medicine (General) Judith Gorlicki verfasserin aut Marine Cachanado verfasserin aut Sarah Salhi verfasserin aut Vanessa Lemaître verfasserin aut Tabassome Simon verfasserin aut Alexandre Mebazaa verfasserin aut In Trials BMC, 2006 20(2019), 1, Seite 8 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:20 year:2019 number:1 pages:8 https://doi.org/10.1186/s13063-019-3188-8 kostenfrei https://doaj.org/article/7ea9be28fe7f43c892f0dc1dc693bfe7 kostenfrei http://link.springer.com/article/10.1186/s13063-019-3188-8 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 8
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allfields_unstemmed	10.1186/s13063-019-3188-8 doi (DE-627)DOAJ064130339 (DE-599)DOAJ7ea9be28fe7f43c892f0dc1dc693bfe7 DE-627 ger DE-627 rakwb eng R5-920 Yonathan Freund verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Elderly Acute heart failure Emergency department Medicine (General) Judith Gorlicki verfasserin aut Marine Cachanado verfasserin aut Sarah Salhi verfasserin aut Vanessa Lemaître verfasserin aut Tabassome Simon verfasserin aut Alexandre Mebazaa verfasserin aut In Trials BMC, 2006 20(2019), 1, Seite 8 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:20 year:2019 number:1 pages:8 https://doi.org/10.1186/s13063-019-3188-8 kostenfrei https://doaj.org/article/7ea9be28fe7f43c892f0dc1dc693bfe7 kostenfrei http://link.springer.com/article/10.1186/s13063-019-3188-8 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 8
allfieldsGer	10.1186/s13063-019-3188-8 doi (DE-627)DOAJ064130339 (DE-599)DOAJ7ea9be28fe7f43c892f0dc1dc693bfe7 DE-627 ger DE-627 rakwb eng R5-920 Yonathan Freund verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Elderly Acute heart failure Emergency department Medicine (General) Judith Gorlicki verfasserin aut Marine Cachanado verfasserin aut Sarah Salhi verfasserin aut Vanessa Lemaître verfasserin aut Tabassome Simon verfasserin aut Alexandre Mebazaa verfasserin aut In Trials BMC, 2006 20(2019), 1, Seite 8 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:20 year:2019 number:1 pages:8 https://doi.org/10.1186/s13063-019-3188-8 kostenfrei https://doaj.org/article/7ea9be28fe7f43c892f0dc1dc693bfe7 kostenfrei http://link.springer.com/article/10.1186/s13063-019-3188-8 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 8
allfieldsSound	10.1186/s13063-019-3188-8 doi (DE-627)DOAJ064130339 (DE-599)DOAJ7ea9be28fe7f43c892f0dc1dc693bfe7 DE-627 ger DE-627 rakwb eng R5-920 Yonathan Freund verfasserin aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Elderly Acute heart failure Emergency department Medicine (General) Judith Gorlicki verfasserin aut Marine Cachanado verfasserin aut Sarah Salhi verfasserin aut Vanessa Lemaître verfasserin aut Tabassome Simon verfasserin aut Alexandre Mebazaa verfasserin aut In Trials BMC, 2006 20(2019), 1, Seite 8 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:20 year:2019 number:1 pages:8 https://doi.org/10.1186/s13063-019-3188-8 kostenfrei https://doaj.org/article/7ea9be28fe7f43c892f0dc1dc693bfe7 kostenfrei http://link.springer.com/article/10.1186/s13063-019-3188-8 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 8
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topic_title	R5-920 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 Elderly Acute heart failure Emergency department
topic	misc R5-920 misc Elderly misc Acute heart failure misc Emergency department misc Medicine (General)
topic_unstemmed	misc R5-920 misc Elderly misc Acute heart failure misc Emergency department misc Medicine (General)
topic_browse	misc R5-920 misc Elderly misc Acute heart failure misc Emergency department misc Medicine (General)
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title	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
ctrlnum	(DE-627)DOAJ064130339 (DE-599)DOAJ7ea9be28fe7f43c892f0dc1dc693bfe7
title_full	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
author_sort	Yonathan Freund
journal	Trials
journalStr	Trials
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publishDateSort	2019
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author_browse	Yonathan Freund Judith Gorlicki Marine Cachanado Sarah Salhi Vanessa Lemaître Tabassome Simon Alexandre Mebazaa
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class	R5-920
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author-letter	Yonathan Freund
doi_str_mv	10.1186/s13063-019-3188-8
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title_sort	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
callnumber	R5-920
title_auth	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
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.
abstractGer	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.
abstract_unstemmed	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.
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title_short	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
url	https://doi.org/10.1186/s13063-019-3188-8 https://doaj.org/article/7ea9be28fe7f43c892f0dc1dc693bfe7 http://link.springer.com/article/10.1186/s13063-019-3188-8 https://doaj.org/toc/1745-6215
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author2	Judith Gorlicki Marine Cachanado Sarah Salhi Vanessa Lemaître Tabassome Simon Alexandre Mebazaa
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up_date	2024-07-03T21:20:17.002Z
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