- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01914848
Multiprofessional Advance Care Planning and Shared Decision Making for End of Life Care (MAPS)
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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
ZH
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Zurich, ZH, Svizzera, 8091
- University Hospital Zurich, Clinical Ethics
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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)
Lasso di tempo: during 2 weeks six months after discharge
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during 2 weeks six months after discharge
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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end of live decisions on last place of care, antibiotics for pneumonia, feeding tube, intravenous fluids, dialysis, intubation and sedation,
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: at discharge
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at discharge
|
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Hospital Anxiety and Depression scale ("HADS")
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Having an appointed surrogate decision maker
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Tanja Krones, MD, University Hospital Zurich, Clinical Ethics
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MAPS Trial
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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