End Of Life in the Critically Ill patiEnt (EOLE)

The purpose of this multicentric study is to evaluate the perception of the quality of the end of life in intensive care units seen from the side of the caregivers, trough the CAESAR scale.

Study Overview

• Status: Completed
• Conditions: Terminal Illness; Intensive Care Unit Syndrome
• Intervention / Treatment: Other: Assessment by caregivers of the quality of the end of life in intensive care units

Detailed Description

More than 20% of deaths occur in hospital after a stay in intensive care units; up to half of them happens as result of a treatment limitation. Ensuring end-of-life quality is important, not only because is a moral duty of all caregivers, but also to prevent negative effects in close relatives of dead patients.

In an assessment of quality of in-hospital deaths involving 3793 patients, only 35% of the deaths were judged to be of acceptable quality by the nurses.

Assessment tools have been developed recently on this topic. Most studies have focused on the perception of end-of-life quality by close relatives, particularly through the CAESAR scale in the most recent one.

The main purpose of this multicentric study is to evaluate the perception of the quality of the end-of-life in intensive care units seen from the side of the caregivers, in relation to the new French legislative framework.

• Study Type: Observational
• Enrollment (Actual): 514

Contacts and Locations

Study Locations

• France
  • Agen, France, 47923
    • Hôpital Saint-Esprit
  • Alès, France, 30103
    • Centre Hospitalier Alès en Cévennes
  • Amiens, France, 80080
    • CHU Amiens
  • Angers, France, 49000
    • CHU d'Angers
  • Antony, France, 92166
    • Hopital Prive d'Antony
  • Argenteuil, France, 95100
    • CH d'Argenteuil
  • Ars-Laquenexy, France, 57245
    • Hopital Mercy
  • Avignon, France, 84000
    • Centre Hospitalier René Dauffaut
  • Belfort, France, 90015
    • Hôpital Nord Franche Comté
  • Besançon, France, 25000
    • CHU Besançon
  • Beuvry, France, 62408
    • Ch Germon Et Gauthier
  • Bobigny, France, 93000
    • Hôpital Avicenne
  • Bordeaux, France, 33000
    • CHU Pellegrin
  • Bordeaux, France, 33075
    • Hopital St-Andre
  • Boulogne Billancourt, France, 92100
    • Hôpital Ambroise Paré
  • Bourg-en-Bresse, France, 01012
    • Centre Hospitalier Fleyriat
  • Brest, France, 29240
    • HIA Clermont Tonnerre
  • Brest, France, 29609
    • CHRU de la Cavale Blanche
  • Caen, France, 14033
    • CHU Caen
  • Cahors, France, 46000
    • Centre Hospitalier Jean Rougie
  • Charleville-Mézières, France, 00800
    • CH Charleville
  • Clamart, France, 92140
    • Hopital Antoine Beclere
  • Clamart, France, 92190
    • HIA Percy
  • Colombes, France, 92700
    • Hôpital Louis Mourier
  • Compiègne, France, 60200
    • Centre Hospitalier Compiegne Noyon
  • Corbeil-Essonnes, France, 91106
    • CH Sud Francilien
  • Corbeil-Essonnes, France, 91100
    • Groupe Hospitalier Sud Ile de France
  • Cornebarrieu, France, 31700
    • Clinique des Cèdres
  • Creteil, France, 94010
    • CHU Henri Mondor
  • Dax, France, 40100
    • Centre Hospitalier de Dax
  • Dieppe, France, 76200
    • Centre Hospitalier de Dieppe
  • Dijon, France, 21709
    • Chu Dijon Bourgogne
  • Draguignan, France, 83300
    • Centre Hospitalier de la Dracénie
  • Dreux, France, 28102
    • Centre Hospitalier Victor Jousselin
  • Eaubonne, France, 95600
    • Hôpital Simone Veil
  • Gap, France, 05007
    • Centre Hospitalier Communal des Alpes du Sud
  • Garches, France, 92380
    • Hôpital Raymond Poincaré
  • Granville, France, 50400
    • Centre Hospitalier Avranche Granville
  • Grenoble, France, 38700
    • Chu Grenoble Alpes
  • Guéret, France, 23000
    • Centre Hospitalier de Guéret
  • Haguenau, France, 67500
    • Centre Hospitalier de Haguenau
  • Jossigny, France, 77600
    • Grand Hôpital de l'Est Francilien
  • Juvisy-sur-Orge, France, 91260
    • Centre Hospitalier des 2 Vallées
  • La Rochelle, France, 17000
    • Centre Hospitalier La Rochelle
  • La Réunion, France, 97400
    • CHU Réunion Saint Pierre
  • Le Chesnay, France, 78157
    • CH de Versailles
  • Le Kremlin-Bicêtre, France, 94270
    • CHU Kremlin-Bicêtre
  • Le Mans, France, 72037
    • CH Le Mans
  • Lille, France, 59037
    • Hôpital Roger Salengro
  • Lomme, France, 59462
    • Centre Hospitalier Saint Philibert
  • Lorient, France, 56322
    • Centre Hospitalier Bretagne Sud
  • Lyon, France, 69003
    • HIA Desgenettes Lyon
  • Lyon, France, 69437
    • Groupe Hospitalier Edouard Herriot
  • Lyon, France, 69000
    • CH St-Joseph St-Luc
  • Mantes-la-Jolie, France, 78200
    • Hopital Francois Quesnay
  • Marseille, France, 13385
    • Hôpital de la Timone
  • Marseille, France, 13003
    • Hopital européen Marseille
  • Marseille, France, 13015
    • CHU Marseille Hopital Nord
  • Meaux, France, 77104
    • CH de Meaux
  • Metz, France, 57038
    • Hopital Notre-Dame de Bon Secours
  • Mont-de-Marsan, France, 40024
    • Centre Hospitalier de Mont de Marsan
  • Montfermeil, France, 93370
    • GHIRM
  • Montpellier, France, 34090
    • CHU Lapeyronie
  • Nancy, France, 54035
    • CHU Nancy
  • Nantes, France, 44000
    • CHU Nantes
  • Nantes, France, 44035
    • Hôpital Laënnec
  • Neuilly-sur-Seine, France, 92200
    • American Hospital of Paris
  • Nice, France, 06202
    • Hôpital l'Archet
  • Nîmes, France, 30029
    • CHU Nimes
  • Orléans, France, 45067
    • CHR d'Orléans Hopital la Source
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Paris, France, 75020
    • Hôpital Tenon
  • Paris, France, 75014
    • Cochin
  • Paris, France, 75010
    • Hôpital St Louis
  • Paris, France, 75013
    • La Pitié Salpêtrière
  • Paris, France, 75015
    • HEGP
  • Paris, France, 75012
    • GH Diaconnesses Croix Saint Simon
  • Paris, France, 75015
    • CHU Necker Enfants Malades
  • Paris, France, 75015
    • CHU Robert Debré
  • Pau, France, 64046
    • CH Francois Miterrand
  • Poissy, France, 78300
    • CH Poissy
  • Poitiers, France, 86021
    • CHU Poitiers
  • Pontoise, France, 95303
    • CH de Pontoise
  • Pringy, France, 74374
    • CH de la Region d'Annecy
  • Provins, France, 77488
    • CH Leon Binet
  • Quincy-sous-Sénart, France, 91480
    • Hôpital Privé Claude Galien
  • Reims, France, 51100
    • CHRU Reims
  • Rochefort, France, 17301
    • CHG Rochefort
  • Saint-Denis, France, 93200
    • Centre Cardiologique du Nord
  • Saint-Jean, France, 31240
    • Clinique de l'Union
  • St-Brieuc, France, 22027
    • CH de St-Brieuc
  • St-Denis, France, 93200
    • Hôpital Delafontaine
  • St-Malo, France, 35403
    • CH de St-Malo
  • St-Mande, France, 94160
    • HIA Béjin
  • Strasbourg, France, 67200
    • CHU Strasbourg
  • Sète, France, 34200
    • Hopital Saint Clair
  • Toulouse, France, 31400
    • CHU Toulouse Rangueil
  • Tours, France, 37044
    • CHRU Bretonneau
  • Tremblay-en-France, France, 93290
    • Hopital Privé du Vert Galan
  • Troyes, France, 01000
    • Centre Hospitalier de Troyes
  • Valenciennes, France, 59300
    • Centre Hospitalier de Valenciennes
  • Valenciennes, France, 59322
    • Hopital jean Bernard
  • Vannes, France, 56017
    • Centre Hospitalier Bretagne Atlantique
  • Versailles, France, 78150
    • Centre Hospitalier André Mignot
  • Vichy, France, 03200
    • Centre Hospitalier de Vichy
  • Villejuif, France, 94800
    • Institut Gustave Roussy
  • Villejuif, France, 94805
    • Institut Gustave Roussy
  • Villenave-d'Ornon, France, 33140
    • HIA Robert Pique
  • Villeneuve-Saint-Georges, France, 94195
    • Centre Hospitalier Lucie et Raymond Aubrac
  • Yerres, France, 91330
    • Hopital Privé du Val d'Yerres
  • la Roche sur Yon, France, 85925
    • CHD Les Oudairies
  • Étampes, France, 95152
    • Centre Hospitalier Sud Essonne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Caregivers of patients admitted in ICU and dead in ICU.

Description

Inclusion Criteria:

• Caregivers of intensive care unit whose patient has recently deceased

Exclusion Criteria:

• Refusal of participation by caregivers
• Refusal of participation by family of deceased patient
• Patient in cardiac arrest at the time of ICU admission.
• Age of deceased patient was under 18 years
• Patient in brain death

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
15 items questionnaire CAESAR	The CAESAR scale assesses perceptions of palliative stage of patient's pathology, of patient's comfort, of presence and care of close relatives, with a score for each item ranging from 1 (traumatic experience) to 5 (soothing). The purpose of our study is to assess the perception of end-of-life quality seen from the caregivers' side, using the CAESAR scale.	Depending of end-of-life duration, usually 6 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variables associated with the perception by caregivers of end-of-life quality	Evaluate the variables associated with the perception by caregivers of end-of-life quality: proportion of treatment limitations, frequencies of conflicts between close relatives of dead patients and caregivers, frequencies end-of-life deep sedations, detailed description of current sedation practices, proportion of treatments, monitoring and blood tests maintained after treatment limitation during end-of-life .	time needed for the enrollment of caregivers of 5 to 15 consecutive deceased patients per center (depending on the size of the center): usually 1 month
Analogic visual scale (0 to 10)	Analogic visual scale on end-of-life quality seen from the caregiver's side	Depending of end-of-life duration, usually 6 hours.

Collaborators and Investigators

• Sponsor: French Society for Intensive Care
• Collaborators: CHU Nantes
• Investigators: Study Director: Florence Boissier, MD, French Intensive Care Society

Publications and helpful links

General Publications

• SRLF Trial Group. End of life in the critically ill patient: evaluation of experience of end of life by caregivers (EOLE study). Ann Intensive Care. 2021 Nov 26;11(1):162. doi: 10.1186/s13613-021-00944-z. Erratum In: Ann Intensive Care. 2021 Dec 29;11(1):186.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): October 16, 2018
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Critical care
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: EOLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No