Terminal IllnessEOLENCT03392857
End Of Life in the Critically Ill patiEnt
An observational study of Terminal Illness and Intensive Care Unit Syndrome, run by French Society for Intensive Care at 112 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Illness, Intensive Care Unit Syndrome
- What is being tested?
- Assessment by caregivers of the quality of the end of life in intensive care units
- How many people
- 514 participants
- Where
- 112 sitesFrance
- Study dates
- 28 Mar 2018to 13 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Caregivers of patients admitted in ICU and dead in ICU.
Who may be able to join
- Caregivers of intensive care unit whose patient has recently deceased
Who cannot join
- 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
Trial locations and contacts
112 sites in 1 country.
112 sites in 1 country
France112 sites
Hôpital Saint-Esprit
Agen, 47923
Centre Hospitalier Alès en Cévennes
Alès, 30103
CHU Amiens
Amiens, 80080
CHU d'Angers
Angers, 49000
Hopital Privé d'Antony
Antony, 92166
CH d'Argenteuil
Argenteuil, 95100
Hopital Mercy
Ars-Laquenexy, 57245
Centre Hospitalier René Dauffaut
Avignon, 84000
Hopital Nord Franche Comté
Belfort, 90015
CHU Besancon
Besançon, 25000
CH Germon et Gauthier
Beuvry, 62408
Hopital Avicenne
Bobigny, 93000
CHU Pellegrin
Bordeaux, 33000
Hopital St-Andre
Bordeaux, 33075
Hopital Ambroise Pare
Boulogne-Billancourt, 92100
Centre Hospitalier fleyriat
Bourg-en-Bresse, 01012
HIA Clermont Tonnerre
Brest, 29240
CHRU de la Cavale Blanche
Brest, 29609
CHU Caen
Caen, 14033
Centre Hospitalier Jean Rougie
Cahors, 46000
CH Charleville
Charleville-Mézières, 00800
Hopital Antoine Beclere
Clamart, 92140
HIA Percy
Clamart, 92190
Hopital Louis Mourier
Colombes, 92700
Centre Hospitalier Compiègne Noyon
Compiègne, 60200
Groupe Hospitalier Sud Ile de France
Corbeil-Essonnes, 91100
CH Sud Francilien
Corbeil-Essonnes, 91106
Clinique des Cèdres
Cornebarrieu, 31700
CHU Henri Mondor
Créteil, 94010
Centre Hospitalier de Dax
Dax, 40100
Centre Hospitalier de Dieppe
Dieppe, 76200
CHU Dijon Bourgogne
Dijon, 21709
Centre Hospitalier de la Dracénie
Draguignan, 83300
Centre Hospitalier Victor Jousselin
Dreux, 28102
Hopital Simone Veil
Eaubonne, 95600
Centre Hospitalier Sud Essonne
Étampes, 95152
Centre Hospitalier Communal des Alpes du Sud
Gap, 05007
Hopital Raymond Poincare
Garches, 92380
Centre Hospitalier Avranche Granville
Granville, 50400
CHU Grenoble Alpes
Grenoble, 38700
Centre Hospitalier de Gueret
Guéret, 23000
Centre Hospitalier de Haguenau
Haguenau, 67500
Grand Hopital de l'Est Francilien
Jossigny, 77600
Centre Hospitalier des 2 Vallées
Juvisy-sur-Orge, 91260
CHU Réunion Saint Pierre
La Réunion, 97400
CHD Les Oudairies
La Roche-sur-Yon, 85925
Centre Hospitalier La Rochelle
La Rochelle, 17000
CH de Versailles
Le Chesnay, 78157
CHU Kremlin-Bicetre
Le Kremlin-Bicêtre, 94270
CH Le Mans
Le Mans, 72037
Hopital Roger Salengro
Lille, 59037
Centre hospitalier Saint Philibert
Lomme, 59462
Centre Hospitalier Bretagne Sud
Lorient, 56322
CH St-Joseph St-Luc
Lyon, 69000
HIA Desgenettes Lyon
Lyon, 69003
Groupe Hospitalier Edouard Herriot
Lyon, 69437
Hopital Francois Quesnay
Mantes-la-Jolie, 78200
Hopital Européen Marseille
Marseille, 13003
CHU Marseille Hopital Nord
Marseille, 13015
Hopital de la Timone
Marseille, 13385
CH de Meaux
Meaux, 77104
Hopital Notre-Dame de Bon Secours
Metz, 57038
Centre Hospitalier de Mont de Marsan
Mont-de-Marsan, 40024
GHIRM
Montfermeil, 93370
CHU Lapeyronie
Montpellier, 34090
CHU Nancy
Nancy, 54035
CHU Nantes
Nantes, 44000
Hopital Laennec
Nantes, 44035
American Hospital of Paris
Neuilly-sur-Seine, 92200
Hopital l'Archet
Nice, 06202
CHU Nimes
Nîmes, 30029
CHR d'Orléans Hopital la Source
Orléans, 45067
Hopital St Louis
Paris, 75010
GH Diaconnesses Croix Saint Simon
Paris, 75012
La Pitié Salpetriere
Paris, 75013
Cochin
Paris, 75014
Institut Mutualiste Montsouris
Paris, 75014
CHU Necker Enfants Malades
Paris, 75015
CHU Robert Debré
Paris, 75015
HEGP
Paris, 75015
Hopital Tenon
Paris, 75020
CH Francois Miterrand
Pau, 64046
CH Poissy
Poissy, 78300
CHU Poitiers
Poitiers, 86021
CH de Pontoise
Pontoise, 95303
CH de la Région d'Annecy
Pringy, 74374
CH Leon Binet
Provins, 77488
Hopital Privé Claude Galien
Quincy-sous-Sénart, 91480
CHRU Reims
Reims, 51100
CHG Rochefort
Rochefort, 17301
CH de St-Brieuc
Saint-Brieuc, 22027
Centre Cardiologique du Nord
Saint-Denis, 93200
Hopital Delafontaine
Saint-Denis, 93200
Clinique de l'Union
Saint-Jean, 31240
HIA Béjin
Saint-Mandé, 94160
Hopital Saint Clair
Sète, 34200
CH de St-Malo
St-Malo, 35403
CHU Strasbourg
Strasbourg, 67200
CHU Toulouse Rangueil
Toulouse, 31400
CHRU Bretonneau
Tours, 37044
Hopital Privé du Vert Galan
Tremblay-en-France, 93290
Centre Hospitalier de Troyes
Troyes, 01000
Centre Hospitalier de Valenciennes
Valenciennes, 59300
Hopital Jean Bernard
Valenciennes, 59322
Centre Hospitalier Bretagne Atlantique
Vannes, 56017
Centre hospitalier André Mignot
Versailles, 78150
Centre Hospitalier de Vichy
Vichy, 03200
Institut Gustave Roussy
Villejuif, 94800
Institut Gustave Roussy
Villejuif, 94805
HIA Robert Pique
Villenave-d'Ornon, 33140
Centre Hospitalier Lucie et Raymond Aubrac
Villeneuve-Saint-Georges, 94195
Hopital Privé du Val d'Yerres
Yerres, 91330
About this study
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.
Read the 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.
- Conditions
- Terminal Illness, Intensive Care Unit Syndrome
- Being tested
- Assessment by caregivers of the quality of the end of life in intensive care units
- Keywords
- Critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment by caregivers of the quality of the end of life in intensive care unitsOther
Quality of the end of life in intensive care units perception will be explore from the side of the caregivers, trough the CAESAR scale.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Depending of end-of-life duration, usually 6 hours.
Secondary outcomes (2)
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 .
Measured: 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
Measured: Depending of end-of-life duration, usually 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start28 Mar 2018
- Primary completion16 Oct 2018
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Terminal IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Society for Intensive Care
- Sponsor type
- University, hospital or other
- Collaborators
- Nantes University Hospital
- Responsible party
- Sponsor
- Investigators
- Florence Boissier, MD, Study director, French Intensive Care Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392857
- Sponsor's protocol ID
- EOLE
- Acronym
- EOLE
- Status last verified
- Oct 2018
- First submitted
- 18 Dec 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34825996
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End Of Life in the Critically Ill patiEnt
- ClinicalTrials.gov ID
- NCT03392857
- Acronym / sponsor ID
- EOLE / EOLE
- Conditions
- Terminal Illness, Intensive Care Unit Syndrome
- Keywords
- Critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- French Society for Intensive CareUniversity, hospital or other
- Collaborators
- Nantes University Hospital
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Caregivers of patients admitted in ICU and dead in ICU.
Key inclusion criteria (1 listed)
- Caregivers of intensive care unit whose patient has recently deceased
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment by caregivers of the quality of the end of life in intensive care unitsQuality of the end of life in intensive care units perception will be explore from the side of the caregivers, trough the CAESAR scale. | Other | – |
Primary outcome
15 items questionnaire CAESAR
Time frame: Depending of end-of-life duration, usually 6 hours.
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.
2 secondary outcomes
Variables associated with the perception by caregivers of end-of-life quality
Time frame: 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)
Time frame: Depending of end-of-life duration, usually 6 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 34825996SRLF 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Boissier, MD study director
French Intensive Care Society
112 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Terminal Illness and Intensive Care Unit Syndrome, run by French Society for Intensive Care at 112 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
15 items questionnaire CAESAR (time frame: Depending of end-of-life duration, usually 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03392857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.