NCT01549197

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)).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
475

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

47 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

1.3 years

First QC Date

March 6, 2012

Last Update Submit

November 19, 2012

Conditions

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

  • CAESAR score

    Score on the 32-item CAESAR scale assessing quality of end-of-life process

    Within 3 weeks after patient's death

Secondary Outcomes (6)

  • Job strain of the physicians and nurses in charge of the patient

    within 3 weeks following patient's death

  • Anxiety and depression

    3 months after patient's death

  • Post Traumatic Stress Disorder

    3 months after patient's death

  • Complicated Grief

    6 months after patients' death

  • PTSD

    6 months after patient's death

  • +1 more secondary outcomes

Study Arms (1)

ICU staff and relatives

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • no French-speaking relative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Réanimation médicale Centre hospitalier Pays d'Aix

Aix-en-Provence, 13616, France

Location

Réanimation Polyvalente Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Réanimation médicale Hôpital Saint André

Bordeaux, 33000, France

Location

Réanimation médicale CHU de la Cavale Blanche

Brest, 29609, France

Location

Réanimation Chirurgicale

Caen, 14033, France

Location

Réanimation Médicale Hôpital de Caen

Caen, 14033, France

Location

Réanimation Médico-Chirugicale CH Chambéry

Chambéry, 73011, France

Location

Réanimation CHU ESTAING

Clermont-Ferrand, 63000, France

Location

Réanimation polyvalente CH de Dieppe

Dieppe, 76202, France

Location

Réanimation polyvalente CH Sud Francilien

Évry, 91014, France

Location

Réanimation Polyvalente Centre Hospitalier de Gonesse

Gonesse, 95503, France

Location

Réanimation polyvalente Hôpital Les Oudairies

La Roche-sur-Yon, 85925, France

Location

Réanimation polyvalente Centre hospitalier de Versailles

Le Chesnay, 78157, France

Location

Réanimation médicale Hôpital Calmette

Lille, 59037, France

Location

Réanimation polyvalente Hôpital Roger Salengro

Lille, 59037, France

Location

Réanimation polyvalente CH Bretagne Sud

Lorient, 56322, France

Location

Réanimation médicale Hôpital de La Croix Rousse

Lyon, 69317, France

Location

Réanimation Médicale Groupement Hospitalier Edouard Herriot

Lyon, 69437, France

Location

Réanimation polyvalente GH Edouard Herriot

Lyon, 69437, France

Location

Service de réanimation Institut Paoli Calmettes

Marseille, 13009, France

Location

Service d'anesthésie et de réanimation Chu Timone

Marseille, 13385, France

Location

Service d'anesthésie et de réanimation Hôpital Nord

Marseille, 13915, France

Location

Service de réanimation, détresses respiratoires et infections sévères Hôpital Nord

Marseille, 13915, France

Location

Réanimation Centre hospitalier Marc Jacquet

Melun, 77011, France

Location

Réanimation Anesthésie CHU Saint Eloi

Montpellier, 34295, France

Location

Réanimation Centre Hospitalier Intercommunal André Grégoire

Montreuil, 93105, France

Location

Réanimation médicale CHU de Nancy- Hôpital central

Nancy, 54035, France

Location

Anesthésie-Réanimation CHU de Nantes- Hôtel Dieu

Nantes, 44093, France

Location

réanimation chirurgicale Groupe Hospitalier Universitaire Carémeau

Nîmes, 30029, France

Location

Service de réanimation polyvalente CHR - Hôpital de la Source

Orléans, 45067, France

Location

Reanimation medicale, Hôpital Saint Louis

Paris, 75010, France

Location

Neuro-réanimation chirurgicale Groupe hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Service de réanimation Hôpital Saint Joseph

Paris, 75014, France

Location

Réanimation chirurgicale Hôpital Saint-Louis

Paris, 75475, France

Location

Service de réanimation médicale et toxicologique CHU Lariboisière

Paris, 75475, France

Location

Réanimation médicale Hôpital Cochin

Paris, 75679, France

Location

Réanimation polyvalente au CH d'Annecy

Pringy, 74374, France

Location

Réanimation médico-chirurgicale CH de Roanne

Roanne, 42300, France

Location

Service de réanimation médicale Hôpital Victor Provo

Roubaix, 59100, France

Location

Service de réanimation médicale CHU CH Nicolle

Rouen, 76031, France

Location

Service de réanimation polyvalente CH de Saint Lô

Saint-Lô, 50009, France

Location

Réanimation polyvalente Centre hospitalier d'Angoulême

Saint-Michel, 16470, France

Location

Réanimation Hôpital Font-Pré

Toulon, 83056, France

Location

Réanimation médicale Hôpital Chatilliez

Tourcoing, 59208, France

Location

Service de réanimation polyvalente CH de Valenciennes

Valenciennes, 59322, France

Location

Réanimation Polyvalente CH Bretagne Atlantique

Vannes, 56017, France

Location

Service de réanimation médico-chirurgicale Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Nancy Kentish-Barnes, PhD

    Reanimation Médicale, Hôpital Saint Louis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 9, 2012

Study Start

August 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations