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

Completed

• Conditions: Anxiety; Depression; Posttraumatic Stress Disorder

• Registration Number: NCT01549197
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-09
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-19
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CAESAR score	Within 3 weeks after patient's death	Score on the 32-item CAESAR scale assessing quality of end-of-life process

Secondary Outcome Measures

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

Trial Locations

Locations (47)

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

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