Clinical trial NCT01549197: Quality of Dying in the Intensive Care Unit: Validation of the CAESAR Scale
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Depression
Posttraumatic Stress Disorder
Keywords: PTSD
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians and nurses in charged of ICU deceased patients Bereaved relatives of ICU patients

Brief summary: 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)).

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 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

Primary outcomes:
measure: CAESAR score
timeFrame: Within 3 weeks after patient's death
Secondary outcomes:
measure: Job strain of the physicians and nurses in charge of the patient
timeFrame: within 3 weeks following patient's death
measure: Anxiety and depression
timeFrame: 3 months after patient's death
measure: Post Traumatic Stress Disorder
timeFrame: 3 months after patient's death
measure: Complicated Grief
timeFrame: 6 months after patients' death
measure: PTSD
timeFrame: 6 months after patient's death
measure: PTSD
timeFrame: 12 months after patient's death
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Réanimation médicale Centre hospitalier Pays d'Aix
city: Argenteuil
country: France
facility: Réanimation Polyvalente Centre Hospitalier Victor Dupouy
city: Bordeaux
country: France
facility: Réanimation médicale Hôpital Saint André
city: Brest
country: France
facility: Réanimation médicale CHU de la Cavale Blanche
city: Caen
country: France
facility: Réanimation Chirurgicale
city: Caen
country: France
facility: Réanimation Médicale Hôpital de Caen
city: Chambéry
country: France
facility: Réanimation Médico-Chirugicale CH Chambéry
city: Clermont-Ferrand
country: France
facility: Réanimation CHU ESTAING
city: Dieppe
country: France
facility: Réanimation polyvalente CH de Dieppe
city: Evry
country: France
facility: Réanimation polyvalente CH Sud Francilien
city: Gonesse
country: France
facility: Réanimation Polyvalente Centre Hospitalier de Gonesse
city: La Roche sur Yon
country: France
facility: Réanimation polyvalente Hôpital Les Oudairies
city: Le Chesnay
country: France
facility: Réanimation polyvalente Centre hospitalier de Versailles
city: Lille
country: France
facility: Réanimation médicale Hôpital Calmette
city: Lille
country: France
facility: Réanimation polyvalente Hôpital Roger Salengro
city: Lorient
country: France
facility: Réanimation polyvalente CH Bretagne Sud
city: Lyon
country: France
facility: Réanimation médicale Hôpital de La Croix Rousse
city: Lyon
country: France
facility: Réanimation Médicale Groupement Hospitalier Edouard Herriot
city: Lyon
country: France
facility: Réanimation polyvalente GH Edouard Herriot
city: Marseille
country: France
facility: Service de réanimation Institut Paoli Calmettes
city: Marseille
country: France
facility: Service d'anesthésie et de réanimation Chu Timone
city: Marseille
country: France
facility: Service d'anesthésie et de réanimation Hôpital Nord
city: Marseille
country: France
facility: Service de réanimation, détresses respiratoires et infections sévères Hôpital Nord
city: Melun
country: France
facility: Réanimation Centre hospitalier Marc Jacquet
city: Montpellier
country: France
facility: Réanimation Anesthésie CHU Saint Eloi
city: Montreuil
country: France
facility: Réanimation Centre Hospitalier Intercommunal André Grégoire
city: Nancy
country: France
facility: Réanimation médicale CHU de Nancy- Hôpital central
city: Nantes
country: France
facility: Anesthésie-Réanimation CHU de Nantes- Hôtel Dieu
city: Nîmes
country: France
facility: réanimation chirurgicale Groupe Hospitalier Universitaire Carémeau
city: Orléans
country: France
facility: Service de réanimation polyvalente CHR - Hôpital de la Source
city: Paris
country: France
facility: Reanimation medicale, Hôpital Saint Louis
city: Paris
country: France
facility: Neuro-réanimation chirurgicale Groupe hospitalier Pitié-Salpêtrière
city: Paris
country: France
facility: Service de réanimation Hôpital Saint Joseph
city: Paris
country: France
facility: Réanimation chirurgicale Hôpital Saint-Louis
city: Paris
country: France
facility: Service de réanimation médicale et toxicologique CHU Lariboisière
city: Paris
country: France
facility: Réanimation médicale Hôpital Cochin
city: Pringy
country: France
facility: Réanimation polyvalente au CH d'Annecy
city: Roanne
country: France
facility: Réanimation médico-chirurgicale CH de Roanne
city: Roubaix
country: France
facility: Service de réanimation médicale Hôpital Victor Provo
city: Rouen
country: France
facility: Service de réanimation médicale CHU CH Nicolle
city: Saint Lô
country: France
facility: Service de réanimation polyvalente CH de Saint Lô
city: Saint Michel
country: France
facility: Réanimation polyvalente Centre hospitalier d'Angoulême
city: Toulon
country: France
facility: Réanimation Hôpital Font-Pré
city: Tourcoing
country: France
facility: Réanimation médicale Hôpital Chatilliez
city: Valenciennes
country: France
facility: Service de réanimation polyvalente CH de Valenciennes
city: Vannes
country: France
facility: Réanimation Polyvalente CH Bretagne Atlantique
city: Villejuif
country: France
facility: Service de réanimation médico-chirurgicale Institut Gustave Roussy
Study officials:
affiliation: Reanimation Médicale, Hôpital Saint Louis
name: Nancy Kentish-Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References: