- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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)).
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Aix-en-Provence, Frankrig, 13616
- Réanimation médicale Centre hospitalier Pays d'Aix
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Argenteuil, Frankrig, 95107
- Réanimation Polyvalente Centre Hospitalier Victor Dupouy
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Bordeaux, Frankrig, 33000
- Réanimation médicale Hôpital Saint André
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Brest, Frankrig, 29609
- Réanimation médicale CHU de la Cavale Blanche
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Caen, Frankrig, 14033
- Réanimation Chirurgicale
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Caen, Frankrig, 14033
- Réanimation Médicale Hôpital de Caen
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Chambéry, Frankrig, 73011
- Réanimation Médico-Chirugicale CH Chambéry
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Clermont-Ferrand, Frankrig, 63000
- Réanimation CHU ESTAING
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Dieppe, Frankrig, 76202
- Réanimation polyvalente CH de Dieppe
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Evry, Frankrig, 91014
- Réanimation polyvalente CH Sud Francilien
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Gonesse, Frankrig, 95503
- Réanimation Polyvalente Centre Hospitalier de Gonesse
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La Roche sur Yon, Frankrig, 85925
- Réanimation polyvalente Hôpital Les Oudairies
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Le Chesnay, Frankrig, 78157
- Réanimation polyvalente Centre hospitalier de Versailles
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Lille, Frankrig, 59037
- Réanimation médicale Hôpital Calmette
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Lille, Frankrig, 59037
- Réanimation polyvalente Hôpital Roger Salengro
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Lorient, Frankrig, 56322
- Réanimation polyvalente CH Bretagne Sud
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Lyon, Frankrig, 69317
- Réanimation médicale Hôpital de La Croix Rousse
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Lyon, Frankrig, 69437
- Réanimation Médicale Groupement Hospitalier Edouard Herriot
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Lyon, Frankrig, 69437
- Réanimation polyvalente GH Edouard Herriot
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Marseille, Frankrig, 13009
- Service de réanimation Institut Paoli Calmettes
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Marseille, Frankrig, 13385
- Service d'anesthésie et de réanimation Chu Timone
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Marseille, Frankrig, 13915
- Service d'anesthésie et de réanimation Hôpital Nord
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Marseille, Frankrig, 13915
- Service de réanimation, détresses respiratoires et infections sévères Hôpital Nord
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Melun, Frankrig, 77011
- Réanimation Centre hospitalier Marc Jacquet
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Montpellier, Frankrig, 34295
- Réanimation Anesthésie CHU Saint Eloi
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Montreuil, Frankrig, 93105
- Réanimation Centre Hospitalier Intercommunal André Grégoire
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Nancy, Frankrig, 54035
- Réanimation médicale CHU de Nancy- Hôpital central
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Nantes, Frankrig, 44093
- Anesthésie-Réanimation CHU de Nantes- Hôtel Dieu
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Nîmes, Frankrig, 30029
- réanimation chirurgicale Groupe Hospitalier Universitaire Carémeau
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Orléans, Frankrig, 45067
- Service de réanimation polyvalente CHR - Hôpital de la Source
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Paris, Frankrig, 75010
- Reanimation medicale, Hôpital Saint Louis
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Paris, Frankrig, 75013
- Neuro-réanimation chirurgicale Groupe hospitalier Pitié-Salpêtrière
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Paris, Frankrig, 75014
- Service de réanimation Hôpital Saint Joseph
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Paris, Frankrig, 75475
- Réanimation chirurgicale Hôpital Saint-Louis
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Paris, Frankrig, 75475
- Service de réanimation médicale et toxicologique CHU Lariboisière
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Paris, Frankrig, 75679
- Réanimation médicale Hôpital Cochin
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Pringy, Frankrig, 74374
- Réanimation polyvalente au CH d'Annecy
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Roanne, Frankrig, 42300
- Réanimation médico-chirurgicale CH de Roanne
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Roubaix, Frankrig, 59100
- Service de réanimation médicale Hôpital Victor Provo
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Rouen, Frankrig, 76031
- Service de réanimation médicale CHU CH Nicolle
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Saint Lô, Frankrig, 50009
- Service de réanimation polyvalente CH de Saint Lô
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Saint Michel, Frankrig, 16470
- Réanimation polyvalente Centre hospitalier d'Angoulême
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Toulon, Frankrig, 83056
- Réanimation Hôpital Font-Pré
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Tourcoing, Frankrig, 59208
- Réanimation médicale Hôpital Chatilliez
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Valenciennes, Frankrig, 59322
- Service de réanimation polyvalente CH de Valenciennes
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Vannes, Frankrig, 56017
- Réanimation Polyvalente CH Bretagne Atlantique
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Villejuif, Frankrig, 94805
- Service de réanimation médico-chirurgicale Institut Gustave Roussy
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
ICU staff and relatives
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
CAESAR score
Tidsramme: Within 3 weeks after patient's death
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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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Job strain of the physicians and nurses in charge of the patient
Tidsramme: within 3 weeks following patient's death
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Score on the Job strain, a validated scale assessing stress in work environment
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within 3 weeks following patient's death
|
|
Anxiety and depression
Tidsramme: 3 months after patient's death
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Anxiety and depression of the relative, assessed by the Hospital Anxiety and Depression Scale (HADS)
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3 months after patient's death
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Post Traumatic Stress Disorder
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Nancy Kentish-Barnes, PhD, Reanimation medicale, Hôpital Saint Louis
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AOM10104
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