Multiprofessional Advance Care Planning and Shared Decision Making for End of Life Care (MAPS)
3 juin 2016 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
115
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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ZH
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Zurich, ZH, Suisse, 8091
- University Hospital Zurich, Clinical Ethics
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Control Group
A routine care discharge planning with the social service
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A routine care discharge planning with the social service
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Expérimental: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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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)
Délai: during 2 weeks six months after discharge
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during 2 weeks six months after discharge
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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end of live decisions on last place of care, antibiotics for pneumonia, feeding tube, intravenous fluids, dialysis, intubation and sedation,
Délai: during 2 weeks six months after discharge
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during 2 weeks six months after discharge
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decisional conflict scale ("DCS"), O Connor et al 1995
Délai: at discharge and during 2 Weeks six months after discharge
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at discharge and during 2 Weeks six months after discharge
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Satisfaction with information and care, (see Detering et al 2010)
Délai: at discharge
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at discharge
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Hospital Anxiety and Depression scale ("HADS")
Délai: discharge and during 2 weeks six months after discharge
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discharge and during 2 weeks six months after discharge
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Having an Advance directive
Délai: at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
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at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
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Having an appointed surrogate decision maker
Délai: at discharge, during 2 weeks three month after discharge and during 2 weeks six month after discharge
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at discharge, during 2 weeks three month after discharge and during 2 weeks six month after discharge
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Any hospital stay
Délai: during 2 weeks three months after discharge and during 2 weeks six months after discharge
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during 2 weeks three months after discharge and during 2 weeks six months after discharge
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Decisions regarding end of life issues already having been made/taken place
Délai: during 2 weeks six months after discharge
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during 2 weeks six months after discharge
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open question on important medical decisions being made
Délai: during 2 weeks three months after discharge
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during 2 weeks three months after discharge
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Treatment against patients wishes
Délai: during 2 weeks three months after discharge and during 2 weeks six months after discharge, or 3 month after death
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during 2 weeks three months after discharge and during 2 weeks six months after discharge, or 3 month after death
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Distress of Patients or relatives because of content of the consultation
Délai: at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
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at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Tanja Krones, MD, University Hospital Zurich, Clinical Ethics
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2013
Achèvement primaire (Réel)
1 avril 2015
Achèvement de l'étude (Réel)
1 août 2015
Dates d'inscription aux études
Première soumission
26 novembre 2012
Première soumission répondant aux critères de contrôle qualité
30 juillet 2013
Première publication (Estimation)
2 août 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
6 juin 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juin 2016
Dernière vérification
1 juin 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MAPS Trial
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .