NCT03392857

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
514

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

112 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
Last Updated

February 15, 2019

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

December 18, 2017

Last Update Submit

February 13, 2019

Conditions

Keywords

Critical care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Variables associated with the perception by caregivers of end-of-life quality

    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)

    Depending of end-of-life duration, usually 6 hours.

Interventions

Quality of the end of life in intensive care units perception will be explore from the side of the caregivers, trough the CAESAR scale.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Caregivers of patients admitted in ICU and dead in ICU.

You may qualify if:

  • Caregivers of intensive care unit whose patient has recently deceased

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (112)

Hôpital Saint-Esprit

Agen, 47923, France

Location

Centre Hospitalier Alès en Cévennes

Alès, 30103, France

Location

CHU Amiens

Amiens, 80080, France

Location

CHU d'Angers

Angers, 49000, France

Location

Hopital Privé d'Antony

Antony, 92166, France

Location

CH d'Argenteuil

Argenteuil, 95100, France

Location

Hopital Mercy

Ars-Laquenexy, 57245, France

Location

Centre Hospitalier René Dauffaut

Avignon, 84000, France

Location

Hopital Nord Franche Comté

Belfort, 90015, France

Location

CHU Besancon

Besançon, 25000, France

Location

CH Germon et Gauthier

Beuvry, 62408, France

Location

Hopital Avicenne

Bobigny, 93000, France

Location

CHU Pellegrin

Bordeaux, 33000, France

Location

Hopital St-Andre

Bordeaux, 33075, France

Location

Hopital Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

Centre Hospitalier fleyriat

Bourg-en-Bresse, 01012, France

Location

HIA Clermont Tonnerre

Brest, 29240, France

Location

CHRU de la Cavale Blanche

Brest, 29609, France

Location

CHU Caen

Caen, 14033, France

Location

Centre Hospitalier Jean Rougie

Cahors, 46000, France

Location

CH Charleville

Charleville-Mézières, 00800, France

Location

Hopital Antoine Beclere

Clamart, 92140, France

Location

HIA Percy

Clamart, 92190, France

Location

Hopital Louis Mourier

Colombes, 92700, France

Location

Centre Hospitalier Compiègne Noyon

Compiègne, 60200, France

Location

Groupe Hospitalier Sud Ile de France

Corbeil-Essonnes, 91100, France

Location

CH Sud Francilien

Corbeil-Essonnes, 91106, France

Location

Clinique des Cèdres

Cornebarrieu, 31700, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

Centre Hospitalier de Dax

Dax, 40100, France

Location

Centre Hospitalier de Dieppe

Dieppe, 76200, France

Location

CHU Dijon Bourgogne

Dijon, 21709, France

Location

Centre Hospitalier de la Dracénie

Draguignan, 83300, France

Location

Centre Hospitalier Victor Jousselin

Dreux, 28102, France

Location

Hopital Simone Veil

Eaubonne, 95600, France

Location

Centre Hospitalier Sud Essonne

Étampes, 95152, France

Location

Centre Hospitalier Communal des Alpes du Sud

Gap, 05007, France

Location

Hopital Raymond Poincare

Garches, 92380, France

Location

Centre Hospitalier Avranche Granville

Granville, 50400, France

Location

CHU Grenoble Alpes

Grenoble, 38700, France

Location

Centre Hospitalier de Gueret

Guéret, 23000, France

Location

Centre Hospitalier de Haguenau

Haguenau, 67500, France

Location

Grand Hopital de l'Est Francilien

Jossigny, 77600, France

Location

Centre Hospitalier des 2 Vallées

Juvisy-sur-Orge, 91260, France

Location

CHU Réunion Saint Pierre

La Réunion, 97400, France

Location

CHD Les Oudairies

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier La Rochelle

La Rochelle, 17000, France

Location

CH de Versailles

Le Chesnay, 78157, France

Location

CHU Kremlin-Bicetre

Le Kremlin-Bicêtre, 94270, France

Location

CH Le Mans

Le Mans, 72037, France

Location

Hopital Roger Salengro

Lille, 59037, France

Location

Centre hospitalier Saint Philibert

Lomme, 59462, France

Location

Centre Hospitalier Bretagne Sud

Lorient, 56322, France

Location

CH St-Joseph St-Luc

Lyon, 69000, France

Location

HIA Desgenettes Lyon

Lyon, 69003, France

Location

Groupe Hospitalier Edouard Herriot

Lyon, 69437, France

Location

Hopital Francois Quesnay

Mantes-la-Jolie, 78200, France

Location

Hopital Européen Marseille

Marseille, 13003, France

Location

CHU Marseille Hopital Nord

Marseille, 13015, France

Location

Hopital de la Timone

Marseille, 13385, France

Location

CH de Meaux

Meaux, 77104, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Centre Hospitalier de Mont de Marsan

Mont-de-Marsan, 40024, France

Location

GHIRM

Montfermeil, 93370, France

Location

CHU Lapeyronie

Montpellier, 34090, France

Location

CHU Nancy

Nancy, 54035, France

Location

CHU Nantes

Nantes, 44000, France

Location

Hopital Laennec

Nantes, 44035, France

Location

American Hospital of Paris

Neuilly-sur-Seine, 92200, France

Location

Hopital l'Archet

Nice, 06202, France

Location

CHU Nimes

Nîmes, 30029, France

Location

CHR d'Orléans Hopital la Source

Orléans, 45067, France

Location

Hopital St Louis

Paris, 75010, France

Location

GH Diaconnesses Croix Saint Simon

Paris, 75012, France

Location

La Pitié Salpetriere

Paris, 75013, France

Location

Cochin

Paris, 75014, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

CHU Necker Enfants Malades

Paris, 75015, France

Location

CHU Robert Debré

Paris, 75015, France

Location

HEGP

Paris, 75015, France

Location

Hopital Tenon

Paris, 75020, France

Location

CH Francois Miterrand

Pau, 64046, France

Location

CH Poissy

Poissy, 78300, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

CH de Pontoise

Pontoise, 95303, France

Location

CH de la Région d'Annecy

Pringy, 74374, France

Location

CH Leon Binet

Provins, 77488, France

Location

Hopital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

CHRU Reims

Reims, 51100, France

Location

CHG Rochefort

Rochefort, 17301, France

Location

CH de St-Brieuc

Saint-Brieuc, 22027, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93200, France

Location

Hopital Delafontaine

Saint-Denis, 93200, France

Location

Clinique de l'Union

Saint-Jean, 31240, France

Location

HIA Béjin

Saint-Mandé, 94160, France

Location

Hopital Saint Clair

Sète, 34200, France

Location

CH de St-Malo

St-Malo, 35403, France

Location

CHU Strasbourg

Strasbourg, 67200, France

Location

CHU Toulouse Rangueil

Toulouse, 31400, France

Location

CHRU Bretonneau

Tours, 37044, France

Location

Hopital Privé du Vert Galan

Tremblay-en-France, 93290, France

Location

Centre Hospitalier de Troyes

Troyes, 01000, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Location

Hopital Jean Bernard

Valenciennes, 59322, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, 56017, France

Location

Centre hospitalier André Mignot

Versailles, 78150, France

Location

Centre Hospitalier de Vichy

Vichy, 03200, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

HIA Robert Pique

Villenave-d'Ornon, 33140, France

Location

Centre Hospitalier Lucie et Raymond Aubrac

Villeneuve-Saint-Georges, 94195, France

Location

Hopital Privé du Val d'Yerres

Yerres, 91330, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Intensive Care Units

Intervention Hierarchy (Ancestors)

Hospital UnitsHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Florence Boissier, MD

    French Intensive Care Society

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 8, 2018

Study Start

March 28, 2018

Primary Completion

October 16, 2018

Study Completion

February 13, 2019

Last Updated

February 15, 2019

Record last verified: 2018-10

Locations