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

Depression Clinical Trial

— CAESAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549197
• Other study ID #: AOM10104
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: November 19, 2012
• Start date: August 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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)).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Depression
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
France	Réanimation médicale Centre hospitalier Pays d'Aix	Aix-en-Provence
France	Réanimation Polyvalente Centre Hospitalier Victor Dupouy	Argenteuil
France	Réanimation médicale Hôpital Saint André	Bordeaux
France	Réanimation médicale CHU de la Cavale Blanche	Brest
France	Réanimation Chirurgicale	Caen
France	Réanimation Médicale Hôpital de Caen	Caen
France	Réanimation Médico-Chirugicale CH Chambéry	Chambéry
France	Réanimation CHU ESTAING	Clermont-Ferrand
France	Réanimation polyvalente CH de Dieppe	Dieppe
France	Réanimation polyvalente CH Sud Francilien	Evry
France	Réanimation Polyvalente Centre Hospitalier de Gonesse	Gonesse
France	Réanimation polyvalente Hôpital Les Oudairies	La Roche sur Yon
France	Réanimation polyvalente Centre hospitalier de Versailles	Le Chesnay
France	Réanimation médicale Hôpital Calmette	Lille
France	Réanimation polyvalente Hôpital Roger Salengro	Lille
France	Réanimation polyvalente CH Bretagne Sud	Lorient
France	Réanimation Médicale Groupement Hospitalier Edouard Herriot	Lyon
France	Réanimation médicale Hôpital de La Croix Rousse	Lyon
France	Réanimation polyvalente GH Edouard Herriot	Lyon
France	Service d'anesthésie et de réanimation Chu Timone	Marseille
France	Service d'anesthésie et de réanimation Hôpital Nord	Marseille
France	Service de réanimation Institut Paoli Calmettes	Marseille
France	Service de réanimation, détresses respiratoires et infections sévères Hôpital Nord	Marseille
France	Réanimation Centre hospitalier Marc Jacquet	Melun
France	Réanimation Anesthésie CHU Saint Eloi	Montpellier
France	Réanimation Centre Hospitalier Intercommunal André Grégoire	Montreuil
France	Réanimation médicale CHU de Nancy- Hôpital central	Nancy
France	Anesthésie-Réanimation CHU de Nantes- Hôtel Dieu	Nantes
France	réanimation chirurgicale Groupe Hospitalier Universitaire Carémeau	Nîmes
France	Service de réanimation polyvalente CHR - Hôpital de la Source	Orléans
France	Neuro-réanimation chirurgicale Groupe hospitalier Pitié-Salpêtrière	Paris
France	Réanimation chirurgicale Hôpital Saint-Louis	Paris
France	Réanimation médicale Hôpital Cochin	Paris
France	Reanimation medicale, Hôpital Saint Louis	Paris
France	Service de réanimation Hôpital Saint Joseph	Paris
France	Service de réanimation médicale et toxicologique CHU Lariboisière	Paris
France	Réanimation polyvalente au CH d'Annecy	Pringy
France	Réanimation médico-chirurgicale CH de Roanne	Roanne
France	Service de réanimation médicale Hôpital Victor Provo	Roubaix
France	Service de réanimation médicale CHU CH Nicolle	Rouen
France	Service de réanimation polyvalente CH de Saint Lô	Saint Lô
France	Réanimation polyvalente Centre hospitalier d'Angoulême	Saint Michel
France	Réanimation Hôpital Font-Pré	Toulon
France	Réanimation médicale Hôpital Chatilliez	Tourcoing
France	Service de réanimation polyvalente CH de Valenciennes	Valenciennes
France	Réanimation Polyvalente CH Bretagne Atlantique	Vannes
France	Service de réanimation médico-chirurgicale Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAESAR score	Score on the 32-item CAESAR scale assessing quality of end-of-life process	Within 3 weeks after patient's death	No
Secondary	Job strain of the physicians and nurses in charge of the patient	Score on the Job strain, a validated scale assessing stress in work environment	within 3 weeks following patient's death	No
Secondary	Anxiety and depression	Anxiety and depression of the relative, assessed by the Hospital Anxiety and Depression Scale (HADS)	3 months after patient's death	No
Secondary	Post Traumatic Stress Disorder	PTSD of relatives assessed by Inventory of Event Scale revised (IES-R)	3 months after patient's death	No
Secondary	Complicated Grief	Complicated grief assessed by the Inventory of Complicated Grief (ICG) scale	6 months after patients' death	No
Secondary	PTSD	PTSD assessed by IES-R	6 months after patient's death	No
Secondary	PTSD	PTSD assessed by IES-R	12 months after patient's death	No