Clinical trial NCT03392857: End Of Life in the Critically Ill patiEnt
Official title: End Of Life in the Critically Ill patiEnt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Terminal Illness
Intensive Care Unit Syndrome
Keywords: Critical care
Lead sponsor: French Society for Intensive Care
Sponsor class: OTHER
Collaborators: name: Nantes University Hospital
First posted: 2018-01-08
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Caregivers of patients admitted in ICU and dead in ICU.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 15 items questionnaire CAESAR
timeFrame: Depending of end-of-life duration, usually 6 hours.
Secondary outcomes:
measure: Variables associated with the perception by caregivers of end-of-life quality
timeFrame: 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
measure: Analogic visual scale (0 to 10)
timeFrame: Depending of end-of-life duration, usually 6 hours.
Other outcomes:
Locations:
city: Agen
country: France
facility: Hôpital Saint-Esprit
city: Alès
country: France
facility: Centre Hospitalier Alès en Cévennes
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Antony
country: France
facility: Hopital Privé d'Antony
city: Argenteuil
country: France
facility: CH d'Argenteuil
city: Ars-Laquenexy
country: France
facility: Hopital Mercy
city: Avignon
country: France
facility: Centre Hospitalier René Dauffaut
city: Belfort
country: France
facility: Hopital Nord Franche Comté
city: Besançon
country: France
facility: CHU Besancon
city: Beuvry
country: France
facility: CH Germon et Gauthier
city: Bobigny
country: France
facility: Hopital Avicenne
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Bordeaux
country: France
facility: Hopital St-Andre
city: Boulogne Billancourt
country: France
facility: Hopital Ambroise Pare
city: Bourg-en-Bresse
country: France
facility: Centre Hospitalier fleyriat
city: Brest
country: France
facility: HIA Clermont Tonnerre
city: Brest
country: France
facility: CHRU de la Cavale Blanche
city: Caen
country: France
facility: CHU Caen
city: Cahors
country: France
facility: Centre Hospitalier Jean Rougie
city: Charleville-Mézières
country: France
facility: CH Charleville
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Clamart
country: France
facility: HIA Percy
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Compiègne
country: France
facility: Centre Hospitalier Compiègne Noyon
city: Corbeil-Essonnes
country: France
facility: Groupe Hospitalier Sud Ile de France
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Creteil
country: France
facility: CHU Henri Mondor
city: Dax
country: France
facility: Centre Hospitalier de Dax
city: Dieppe
country: France
facility: Centre Hospitalier de Dieppe
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Draguignan
country: France
facility: Centre Hospitalier de la Dracénie
city: Dreux
country: France
facility: Centre Hospitalier Victor Jousselin
city: Eaubonne
country: France
facility: Hopital Simone Veil
city: Gap
country: France
facility: Centre Hospitalier Communal des Alpes du Sud
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Granville
country: France
facility: Centre Hospitalier Avranche Granville
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Guéret
country: France
facility: Centre Hospitalier de Gueret
city: Haguenau
country: France
facility: Centre Hospitalier de Haguenau
city: Jossigny
country: France
facility: Grand Hopital de l'Est Francilien
city: Juvisy-sur-Orge
country: France
facility: Centre Hospitalier des 2 Vallées
city: la Roche sur Yon
country: France
facility: CHD Les Oudairies
city: La Rochelle
country: France
facility: Centre Hospitalier La Rochelle
city: La Réunion
country: France
facility: CHU Réunion Saint Pierre
city: Le Chesnay
country: France
facility: CH de Versailles
city: Le Kremlin-Bicêtre
country: France
facility: CHU Kremlin-Bicetre
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: Hopital Roger Salengro
city: Lomme
country: France
facility: Centre hospitalier Saint Philibert
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Lyon
country: France
facility: CH St-Joseph St-Luc
city: Lyon
country: France
facility: HIA Desgenettes Lyon
city: Lyon
country: France
facility: Groupe Hospitalier Edouard Herriot
city: Mantes-la-Jolie
country: France
facility: Hopital Francois Quesnay
city: Marseille
country: France
facility: Hopital Européen Marseille
city: Marseille
country: France
facility: CHU Marseille Hopital Nord
city: Marseille
country: France
facility: Hopital de la Timone
city: Meaux
country: France
facility: CH de Meaux
city: Metz
country: France
facility: Hopital Notre-Dame de Bon Secours
city: Mont-de-Marsan
country: France
facility: Centre Hospitalier de Mont de Marsan
city: Montfermeil
country: France
facility: GHIRM
city: Montpellier
country: France
facility: CHU Lapeyronie
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Nantes
country: France
facility: Hopital Laennec
city: Neuilly-sur-Seine
country: France
facility: American Hospital of Paris
city: Nice
country: France
facility: Hopital l'Archet
city: Nîmes
country: France
facility: CHU Nimes
city: Orléans
country: France
facility: CHR d'Orléans Hopital la Source
city: Paris
country: France
facility: Hopital St Louis
city: Paris
country: France
facility: GH Diaconnesses Croix Saint Simon
city: Paris
country: France
facility: La Pitié Salpetriere
city: Paris
country: France
facility: Cochin
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: CHU Necker Enfants Malades
city: Paris
country: France
facility: CHU Robert Debré
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Hopital Tenon
city: Pau
country: France
facility: CH Francois Miterrand
city: Poissy
country: France
facility: CH Poissy
city: Poitiers
country: France
facility: CHU Poitiers
city: Pontoise
country: France
facility: CH de Pontoise
city: Pringy
country: France
facility: CH de la Région d'Annecy
city: Provins
country: France
facility: CH Leon Binet
city: Quincy-sous-Sénart
country: France
facility: Hopital Privé Claude Galien
city: Reims
country: France
facility: CHRU Reims
city: Rochefort
country: France
facility: CHG Rochefort
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Saint-Jean
country: France
facility: Clinique de l'Union
city: St-Brieuc
country: France
facility: CH de St-Brieuc
city: St-Denis
country: France
facility: Hopital Delafontaine
city: St-Malo
country: France
facility: CH de St-Malo
city: St-Mande
country: France
facility: HIA Béjin
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Sète
country: France
facility: Hopital Saint Clair
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Tours
country: France
facility: CHRU Bretonneau
city: Tremblay-en-France
country: France
facility: Hopital Privé du Vert Galan
city: Troyes
country: France
facility: Centre Hospitalier de Troyes
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
city: Valenciennes
country: France
facility: Hopital Jean Bernard
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
city: Versailles
country: France
facility: Centre hospitalier André Mignot
city: Vichy
country: France
facility: Centre Hospitalier de Vichy
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villenave-d'Ornon
country: France
facility: HIA Robert Pique
city: Villeneuve-Saint-Georges
country: France
facility: Centre Hospitalier Lucie et Raymond Aubrac
city: Yerres
country: France
facility: Hopital Privé du Val d'Yerres
city: Étampes
country: France
facility: Centre Hospitalier Sud Essonne
Study officials:
affiliation: French Intensive Care Society
name: Florence Boissier, MD
role: STUDY_DIRECTOR
References:
citation: 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.