- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01549197
Quality of Dying in the Intensive Care Unit: Validation of the CAESAR Scale (CAESAR)
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
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)).
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Aix-en-Provence, Frankrike, 13616
- Réanimation médicale Centre hospitalier Pays d'Aix
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Argenteuil, Frankrike, 95107
- Réanimation Polyvalente Centre Hospitalier Victor Dupouy
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Bordeaux, Frankrike, 33000
- Réanimation médicale Hôpital Saint André
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Brest, Frankrike, 29609
- Réanimation médicale CHU de la Cavale Blanche
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Caen, Frankrike, 14033
- Réanimation Chirurgicale
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Caen, Frankrike, 14033
- Réanimation Médicale Hôpital de Caen
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Chambéry, Frankrike, 73011
- Réanimation Médico-Chirugicale CH Chambéry
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Clermont-Ferrand, Frankrike, 63000
- Réanimation CHU ESTAING
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Dieppe, Frankrike, 76202
- Réanimation polyvalente CH de Dieppe
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Evry, Frankrike, 91014
- Réanimation polyvalente CH Sud Francilien
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Gonesse, Frankrike, 95503
- Réanimation Polyvalente Centre Hospitalier de Gonesse
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La Roche sur Yon, Frankrike, 85925
- Réanimation polyvalente Hôpital Les Oudairies
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Le Chesnay, Frankrike, 78157
- Réanimation polyvalente Centre hospitalier de Versailles
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Lille, Frankrike, 59037
- Réanimation médicale Hôpital Calmette
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Lille, Frankrike, 59037
- Réanimation polyvalente Hôpital Roger Salengro
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Lorient, Frankrike, 56322
- Réanimation polyvalente CH Bretagne Sud
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Lyon, Frankrike, 69317
- Réanimation médicale Hôpital de La Croix Rousse
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Lyon, Frankrike, 69437
- Réanimation Médicale Groupement Hospitalier Edouard Herriot
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Lyon, Frankrike, 69437
- Réanimation polyvalente GH Edouard Herriot
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Marseille, Frankrike, 13009
- Service de réanimation Institut Paoli Calmettes
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Marseille, Frankrike, 13385
- Service d'anesthésie et de réanimation Chu Timone
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Marseille, Frankrike, 13915
- Service d'anesthésie et de réanimation Hôpital Nord
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Marseille, Frankrike, 13915
- Service de réanimation, détresses respiratoires et infections sévères Hôpital Nord
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Melun, Frankrike, 77011
- Réanimation Centre hospitalier Marc Jacquet
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Montpellier, Frankrike, 34295
- Réanimation Anesthésie CHU Saint Eloi
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Montreuil, Frankrike, 93105
- Réanimation Centre Hospitalier Intercommunal André Grégoire
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Nancy, Frankrike, 54035
- Réanimation médicale CHU de Nancy- Hôpital central
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Nantes, Frankrike, 44093
- Anesthésie-Réanimation CHU de Nantes- Hôtel Dieu
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Nîmes, Frankrike, 30029
- réanimation chirurgicale Groupe Hospitalier Universitaire Carémeau
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Orléans, Frankrike, 45067
- Service de réanimation polyvalente CHR - Hôpital de la Source
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Paris, Frankrike, 75010
- Reanimation medicale, Hôpital Saint Louis
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Paris, Frankrike, 75013
- Neuro-réanimation chirurgicale Groupe hospitalier Pitié-Salpêtrière
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Paris, Frankrike, 75014
- Service de réanimation Hôpital Saint Joseph
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Paris, Frankrike, 75475
- Réanimation chirurgicale Hôpital Saint-Louis
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Paris, Frankrike, 75475
- Service de réanimation médicale et toxicologique CHU Lariboisière
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Paris, Frankrike, 75679
- Réanimation médicale Hôpital Cochin
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Pringy, Frankrike, 74374
- Réanimation polyvalente au CH d'Annecy
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Roanne, Frankrike, 42300
- Réanimation médico-chirurgicale CH de Roanne
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Roubaix, Frankrike, 59100
- Service de réanimation médicale Hôpital Victor Provo
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Rouen, Frankrike, 76031
- Service de réanimation médicale CHU CH Nicolle
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Saint Lô, Frankrike, 50009
- Service de réanimation polyvalente CH de Saint Lô
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Saint Michel, Frankrike, 16470
- Réanimation polyvalente Centre hospitalier d'Angoulême
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Toulon, Frankrike, 83056
- Réanimation Hôpital Font-Pré
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Tourcoing, Frankrike, 59208
- Réanimation médicale Hôpital Chatilliez
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Valenciennes, Frankrike, 59322
- Service de réanimation polyvalente CH de Valenciennes
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Vannes, Frankrike, 56017
- Réanimation Polyvalente CH Bretagne Atlantique
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Villejuif, Frankrike, 94805
- Service de réanimation médico-chirurgicale Institut Gustave Roussy
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
ICU staff and relatives
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
CAESAR score
Tidsram: Within 3 weeks after patient's death
|
Score on the 32-item CAESAR scale assessing quality of end-of-life process
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Within 3 weeks after patient's death
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Job strain of the physicians and nurses in charge of the patient
Tidsram: within 3 weeks following patient's death
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Score on the Job strain, a validated scale assessing stress in work environment
|
within 3 weeks following patient's death
|
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Anxiety and depression
Tidsram: 3 months after patient's death
|
Anxiety and depression of the relative, assessed by the Hospital Anxiety and Depression Scale (HADS)
|
3 months after patient's death
|
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Post Traumatic Stress Disorder
Tidsram: 3 months after patient's death
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PTSD of relatives assessed by Inventory of Event Scale revised (IES-R)
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3 months after patient's death
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Complicated Grief
Tidsram: 6 months after patients' death
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Complicated grief assessed by the Inventory of Complicated Grief (ICG) scale
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6 months after patients' death
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PTSD
Tidsram: 6 months after patient's death
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PTSD assessed by IES-R
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6 months after patient's death
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PTSD
Tidsram: 12 months after patient's death
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PTSD assessed by IES-R
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12 months after patient's death
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Nancy Kentish-Barnes, PhD, Reanimation medicale, Hôpital Saint Louis
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AOM10104
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