- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02329418
Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit (LATA)
Impact of a Written Document on Post Traumatic Stress Disorder (PTSD) Diagnosed in Family Members After Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit
Relatives of patients in situation of withholding and withdrawing life-sustaining therapies often show post traumatic stress disorder (PTSD) (60%)[1]. This number is even greater when family members are active in this decision (81%) or when communication is not optimal between medical team and family members.
There are several ways to assist families of patients in intensive care units [2], amongst them the use of a written document to explain the environment, therapies and possible outcomes.
Here the investigators want to test the impact of a written document in the context of end-of-life conference in intensive care units. Specifically, this research addresses wether such written support could decrease 3-months post-traumatic stress disorder, anxiety and depression exhibited by the closest family member or the patient representative.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Grenoble, Francia, 38043
- Anesthesiology and Critical Care Depratment, Grenoble University Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
The study will enroll patient representant (family member or close friends designed by the family or pre-admission legal representant).
Inclusion Criteria:
- Medical team anticipates a decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
- verbal consent to participate
- Able to communicate in French
Exclusion Criteria:
- representant of a patient < 18 years old
- representant of a patient whose stay in ICU lasted less than 48 hours
- representant of a patient without social security
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Written document
Accompanying relatives with a written document when discussing withholding and withdrawing life-sustaining therapies .
All other procedures are standard.
|
Otro: Explaining withholding and withdrawing life-sustaining therapies along with a written document
The document describes the law and the role of family members and medical team in the decision.
|
Comparador activo: Standard
Discussing withholding and withdrawing life-sustaining therapies following standard procedure without written document
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Rate of PTSD
Periodo de tiempo: 3 months
|
PTSD is assessed with Impact Event Scale (IES) on the family representative
|
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Rate of depression
Periodo de tiempo: 3 months
|
Depression is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
|
3 months
|
Rate of anxiety
Periodo de tiempo: 3 months
|
Anxiety is assessed with Hospital Anxiety and Depression scale (HADS) on the family representative
|
3 months
|
Mean level of HADS (anxiety and depression subscales)
Periodo de tiempo: 3 months
|
3 months
|
|
Mean level of IES
Periodo de tiempo: 3 months
|
3 months
|
|
Length of the processus from decision to withhold and withdraw life-sustaining therapies to intensive care unit (ICU) discharge
Periodo de tiempo: An average of 6 days
|
An average of 6 days
|
|
Respectfulness of the law regarding withholding and withdrawing life-sustaining therapies
Periodo de tiempo: An average of 6 days
|
An average of 6 days
|
|
Rate of decision to withhold and withdraw life-sustaining therapies in different intensive care units from the hospital
Periodo de tiempo: ICU discharge (an average of 3 weeks)
|
ICU discharge (an average of 3 weeks)
|
|
Medical Doctor satisfaction with the processus
Periodo de tiempo: ICU discharge (an average of 3 weeks)
|
ICU discharge (an average of 3 weeks)
|
|
Description of the processus
Periodo de tiempo: ICU discharge (an average of 3 weeks)
|
ICU discharge (an average of 3 weeks)
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
- Schmidt M, Azoulay E. Having a loved one in the ICU: the forgotten family. Curr Opin Crit Care. 2012 Oct;18(5):540-7. doi: 10.1097/MCC.0b013e328357f141.
- Robin S, Labarriere C, Sechaud G, Dessertaine G, Bosson JL, Payen JF. Information Pamphlet Given to Relatives During the End-of-Life Decision in the ICU: An Assessor-Blinded, Randomized Controlled Trial. Chest. 2021 Jun;159(6):2301-2308. doi: 10.1016/j.chest.2021.01.072. Epub 2021 Feb 5.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2014-A00758-39
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .