- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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).
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
ZH
-
Zurich, ZH, Sveits, 8091
- University Hospital Zurich, Clinical Ethics
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Control Group
A routine care discharge planning with the social service
|
A routine care discharge planning with the social service
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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)
Tidsramme: during 2 weeks six months after discharge
|
during 2 weeks six months after discharge
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
end of live decisions on last place of care, antibiotics for pneumonia, feeding tube, intravenous fluids, dialysis, intubation and sedation,
Tidsramme: during 2 weeks six months after discharge
|
during 2 weeks six months after discharge
|
decisional conflict scale ("DCS"), O Connor et al 1995
Tidsramme: 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)
Tidsramme: at discharge
|
at discharge
|
Hospital Anxiety and Depression scale ("HADS")
Tidsramme: discharge and during 2 weeks six months after discharge
|
discharge and during 2 weeks six months after discharge
|
Having an Advance directive
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: during 2 weeks six months after discharge
|
during 2 weeks six months after discharge
|
open question on important medical decisions being made
Tidsramme: during 2 weeks three months after discharge
|
during 2 weeks three months after discharge
|
Treatment against patients wishes
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Tanja Krones, MD, University Hospital Zurich, Clinical Ethics
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MAPS Trial
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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