Multiprofessional Advance Care Planning and Shared Decision Making for End of Life Care (MAPS)
3 de junio de 2016 actualizado por: University of Zurich
Multiprofessional Advance Care Planning and Shared Decision-making for End of Life Care MAPS Trial
Multiprofessional Advance Care Planning and shared decision making for end of live care for terminal patients and their relatives.
The aim of this study is to develop, implement and test a complex intervention for improving patients' preparation for and participation in end of life decisions. In cooperation with local, national and international partners, the investigators will focus on strategies to enhance advance care planning and shared decision making on end of life issues, and documentation and transferability of end of life decisions across health care settings in coordinated approach involving patients, their families and care givers (in and out of hospital).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
115
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
ZH
-
Zurich, ZH, Suiza, 8091
- University Hospital Zurich, Clinical Ethics
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion criteria: -patients in which the treating physician on the ward would not be surprised if the patient died during the next year (surprise question of Weissman et al 2011)
- male and female patients above 18 years of age
- signed informed consent after being informed
- patients able to appoint a surrogate decision maker (SM) and/or responsible physician to be contacted after discharge
Exclusion criteria: -patients not capable of speaking german
- patients having no responsible physician to be contacted after discharge and no relative/future surrogate decision maker (SM)
- inhouse patients being discharged within the next 2 days or ambulatory patients not regularly coming to the wards (at least every two month)
- patients assessed by their physician to be in obvious denial of their situation (illness/prognosis)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Control Group
A routine care discharge planning with the social service
|
A routine care discharge planning with the social service
|
|
Experimental: Advance Care Planning ACP
Patient get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators. -------------------------------------------------------------------------------- |
Patient of the intervention group get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
end of life wish on resuscitation known (if alive) or fulfilled(if dead) after 6 month by responsible physician and/or surrogate decision maker (SM)
Periodo de tiempo: during 2 weeks six months after discharge
|
during 2 weeks six months after discharge
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
end of live decisions on last place of care, antibiotics for pneumonia, feeding tube, intravenous fluids, dialysis, intubation and sedation,
Periodo de tiempo: during 2 weeks six months after discharge
|
during 2 weeks six months after discharge
|
|
decisional conflict scale ("DCS"), O Connor et al 1995
Periodo de tiempo: at discharge and during 2 Weeks six months after discharge
|
at discharge and during 2 Weeks six months after discharge
|
|
Satisfaction with information and care, (see Detering et al 2010)
Periodo de tiempo: at discharge
|
at discharge
|
|
Hospital Anxiety and Depression scale ("HADS")
Periodo de tiempo: discharge and during 2 weeks six months after discharge
|
discharge and during 2 weeks six months after discharge
|
|
Having an Advance directive
Periodo de tiempo: at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
|
at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
|
|
Having an appointed surrogate decision maker
Periodo de tiempo: at discharge, during 2 weeks three month after discharge and during 2 weeks six month after discharge
|
at discharge, during 2 weeks three month after discharge and during 2 weeks six month after discharge
|
|
Any hospital stay
Periodo de tiempo: during 2 weeks three months after discharge and during 2 weeks six months after discharge
|
during 2 weeks three months after discharge and during 2 weeks six months after discharge
|
|
Decisions regarding end of life issues already having been made/taken place
Periodo de tiempo: during 2 weeks six months after discharge
|
during 2 weeks six months after discharge
|
|
open question on important medical decisions being made
Periodo de tiempo: during 2 weeks three months after discharge
|
during 2 weeks three months after discharge
|
|
Treatment against patients wishes
Periodo de tiempo: during 2 weeks three months after discharge and during 2 weeks six months after discharge, or 3 month after death
|
during 2 weeks three months after discharge and during 2 weeks six months after discharge, or 3 month after death
|
|
Distress of Patients or relatives because of content of the consultation
Periodo de tiempo: at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
|
at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Tanja Krones, MD, University Hospital Zurich, Clinical Ethics
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2013
Finalización primaria (Actual)
1 de abril de 2015
Finalización del estudio (Actual)
1 de agosto de 2015
Fechas de registro del estudio
Enviado por primera vez
26 de noviembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
30 de julio de 2013
Publicado por primera vez (Estimar)
2 de agosto de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de junio de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2016
Última verificación
1 de junio de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MAPS Trial
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. .