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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01549197
First received: March 6, 2012
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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)).


Condition
Anxiety
Depression
Posttraumatic Stress Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • CAESAR score [ Time Frame: Within 3 weeks after patient's death ] [ Designated as safety issue: No ]
    Score on the 32-item CAESAR scale assessing quality of end-of-life process


Secondary Outcome Measures:
  • Job strain of the physicians and nurses in charge of the patient [ Time Frame: within 3 weeks following patient's death ] [ Designated as safety issue: No ]
    Score on the Job strain, a validated scale assessing stress in work environment

  • Anxiety and depression [ Time Frame: 3 months after patient's death ] [ Designated as safety issue: No ]
    Anxiety and depression of the relative, assessed by the Hospital Anxiety and Depression Scale (HADS)

  • Post Traumatic Stress Disorder [ Time Frame: 3 months after patient's death ] [ Designated as safety issue: No ]
    PTSD of relatives assessed by Inventory of Event Scale revised (IES-R)

  • Complicated Grief [ Time Frame: 6 months after patients' death ] [ Designated as safety issue: No ]
    Complicated grief assessed by the Inventory of Complicated Grief (ICG) scale

  • PTSD [ Time Frame: 6 months after patient's death ] [ Designated as safety issue: No ]
    PTSD assessed by IES-R

  • PTSD [ Time Frame: 12 months after patient's death ] [ Designated as safety issue: No ]
    PTSD assessed by IES-R


Enrollment: 475
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICU staff and relatives

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549197

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01549197     History of Changes
Other Study ID Numbers: AOM10104
Study First Received: March 6, 2012
Last Updated: November 19, 2012
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by Assistance Publique - Hôpitaux de Paris:
PTSD

Additional relevant MeSH terms:
Depression
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Behavioral Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on October 22, 2014