Quality of Dying in the Intensive Care Unit: Validation of the CAESAR Scale (CAESAR)

November 19, 2012 updated by: Assistance Publique - Hôpitaux de Paris

End-of-life in French Intensive Care Units: Perception of the Quality of Dying and Experience of Physicians, Nurses and Relatives. Validation of the CAESAR Scale

The purpose of the study is to evaluate the quality of the dying process in french ICUs (assessed by the CAESAR scale) and to compare physicians', nurses' and relatives perceptions and experiences, with a one-year follow-up of bereaved relatives.

Our hypothesis is that perception of the quality of dying may impact on relatives' experience of bereavement (anxiety, depression, complicated grief, posttraumatic stress disorder (PTSD)).

Study Overview

Status

Completed

Conditions

Detailed Description

Seventy percent of all deaths occur in the hospital environment, and amongst them 20% occur in intensive care units (ICU). In France, no studies have evaluated the quality of the end-of-life process from both the professional and the lay perspective.

The CAESAR scale has been developed from literature reviews and qualitative interviews with relatives, physicians and nurse to assess quality of dying in ICU. Our hypothesis is that perception of the quality of dying may impact on relatives' experience of bereavement (anxiety, depression, complicated grief, PTSD).

Study Type

Observational

Enrollment (Actual)

475

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France, 13616
        • Réanimation médicale Centre hospitalier Pays d'Aix
      • Argenteuil, France, 95107
        • Réanimation Polyvalente Centre Hospitalier Victor Dupouy
      • Bordeaux, France, 33000
        • Réanimation médicale Hôpital Saint André
      • Brest, France, 29609
        • Réanimation médicale CHU de la Cavale Blanche
      • Caen, France, 14033
        • Réanimation Chirurgicale
      • Caen, France, 14033
        • Réanimation Médicale Hôpital de Caen
      • Chambéry, France, 73011
        • Réanimation Médico-Chirugicale CH Chambéry
      • Clermont-Ferrand, France, 63000
        • Réanimation CHU ESTAING
      • Dieppe, France, 76202
        • Réanimation polyvalente CH de Dieppe
      • Evry, France, 91014
        • Réanimation polyvalente CH Sud Francilien
      • Gonesse, France, 95503
        • Réanimation Polyvalente Centre Hospitalier de Gonesse
      • La Roche sur Yon, France, 85925
        • Réanimation polyvalente Hôpital Les Oudairies
      • Le Chesnay, France, 78157
        • Réanimation polyvalente Centre hospitalier de Versailles
      • Lille, France, 59037
        • Réanimation médicale Hôpital Calmette
      • Lille, France, 59037
        • Réanimation polyvalente Hôpital Roger Salengro
      • Lorient, France, 56322
        • Réanimation polyvalente CH Bretagne Sud
      • Lyon, France, 69317
        • Réanimation médicale Hôpital de La Croix Rousse
      • Lyon, France, 69437
        • Réanimation Médicale Groupement Hospitalier Edouard Herriot
      • Lyon, France, 69437
        • Réanimation polyvalente GH Edouard Herriot
      • Marseille, France, 13009
        • Service de réanimation Institut Paoli Calmettes
      • Marseille, France, 13385
        • Service d'anesthésie et de réanimation Chu Timone
      • Marseille, France, 13915
        • Service d'anesthésie et de réanimation Hôpital Nord
      • Marseille, France, 13915
        • Service de réanimation, détresses respiratoires et infections sévères Hôpital Nord
      • Melun, France, 77011
        • Réanimation Centre hospitalier Marc Jacquet
      • Montpellier, France, 34295
        • Réanimation Anesthésie CHU Saint Eloi
      • Montreuil, France, 93105
        • Réanimation Centre Hospitalier Intercommunal André Grégoire
      • Nancy, France, 54035
        • Réanimation médicale CHU de Nancy- Hôpital central
      • Nantes, France, 44093
        • Anesthésie-Réanimation CHU de Nantes- Hôtel Dieu
      • Nîmes, France, 30029
        • réanimation chirurgicale Groupe Hospitalier Universitaire Carémeau
      • Orléans, France, 45067
        • Service de réanimation polyvalente CHR - Hôpital de la Source
      • Paris, France, 75010
        • Reanimation medicale, Hôpital Saint Louis
      • Paris, France, 75013
        • Neuro-réanimation chirurgicale Groupe hospitalier Pitié-Salpêtrière
      • Paris, France, 75014
        • Service de réanimation Hôpital Saint Joseph
      • Paris, France, 75475
        • Réanimation chirurgicale Hôpital Saint-Louis
      • Paris, France, 75475
        • Service de réanimation médicale et toxicologique CHU Lariboisière
      • Paris, France, 75679
        • Réanimation médicale Hôpital Cochin
      • Pringy, France, 74374
        • Réanimation polyvalente au CH d'Annecy
      • Roanne, France, 42300
        • Réanimation médico-chirurgicale CH de Roanne
      • Roubaix, France, 59100
        • Service de réanimation médicale Hôpital Victor Provo
      • Rouen, France, 76031
        • Service de réanimation médicale CHU CH Nicolle
      • Saint Lô, France, 50009
        • Service de réanimation polyvalente CH de Saint Lô
      • Saint Michel, France, 16470
        • Réanimation polyvalente Centre hospitalier d'Angoulême
      • Toulon, France, 83056
        • Réanimation Hôpital Font-Pré
      • Tourcoing, France, 59208
        • Réanimation médicale Hôpital Chatilliez
      • Valenciennes, France, 59322
        • Service de réanimation polyvalente CH de Valenciennes
      • Vannes, France, 56017
        • Réanimation Polyvalente CH Bretagne Atlantique
      • Villejuif, France, 94805
        • Service de réanimation médico-chirurgicale Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Physicians and nurses in charged of ICU deceased patients Bereaved relatives of ICU patients

Description

Inclusion Criteria:

  • Adult patients Deceased in the ICU after at least 48 hours of ICU stay
  • At least one visit of a relative in the ICU

Exclusion Criteria:

  • no French-speaking relative

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ICU staff and relatives

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAESAR score
Time Frame: Within 3 weeks after patient's death
Score on the 32-item CAESAR scale assessing quality of end-of-life process
Within 3 weeks after patient's death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Job strain of the physicians and nurses in charge of the patient
Time Frame: within 3 weeks following patient's death
Score on the Job strain, a validated scale assessing stress in work environment
within 3 weeks following patient's death
Anxiety and depression
Time Frame: 3 months after patient's death
Anxiety and depression of the relative, assessed by the Hospital Anxiety and Depression Scale (HADS)
3 months after patient's death
Post Traumatic Stress Disorder
Time Frame: 3 months after patient's death
PTSD of relatives assessed by Inventory of Event Scale revised (IES-R)
3 months after patient's death
Complicated Grief
Time Frame: 6 months after patients' death
Complicated grief assessed by the Inventory of Complicated Grief (ICG) scale
6 months after patients' death
PTSD
Time Frame: 6 months after patient's death
PTSD assessed by IES-R
6 months after patient's death
PTSD
Time Frame: 12 months after patient's death
PTSD assessed by IES-R
12 months after patient's death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Nancy Kentish-Barnes, PhD, Reanimation medicale, Hôpital Saint Louis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 19, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM10104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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