- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
ZH
-
Zurich, ZH, Schweiz, 8091
- University Hospital Zurich, Clinical Ethics
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control Group
A routine care discharge planning with the social service
|
A routine care discharge planning with the social service
|
|
Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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)
Tidsram: during 2 weeks six months after discharge
|
during 2 weeks six months after discharge
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
end of live decisions on last place of care, antibiotics for pneumonia, feeding tube, intravenous fluids, dialysis, intubation and sedation,
Tidsram: during 2 weeks six months after discharge
|
during 2 weeks six months after discharge
|
|
decisional conflict scale ("DCS"), O Connor et al 1995
Tidsram: 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)
Tidsram: at discharge
|
at discharge
|
|
Hospital Anxiety and Depression scale ("HADS")
Tidsram: discharge and during 2 weeks six months after discharge
|
discharge and during 2 weeks six months after discharge
|
|
Having an Advance directive
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: during 2 weeks six months after discharge
|
during 2 weeks six months after discharge
|
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open question on important medical decisions being made
Tidsram: during 2 weeks three months after discharge
|
during 2 weeks three months after discharge
|
|
Treatment against patients wishes
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Tanja Krones, MD, University Hospital Zurich, Clinical Ethics
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MAPS Trial
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