Multiprofessional Advance Care Planning and Shared Decision Making for End of Life Care

Palliative Patients Clinical Trial

— MAPS  

Official title:

Multiprofessional Advance Care Planning and Shared Decision-making for End of Life Care MAPS Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914848
• Other study ID #: MAPS Trial
• Status: Completed
• Phase: N/A
• First received: November 26, 2012
• Last updated: June 3, 2016
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: June 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Palliative Patients
• Surrogate Decision Maker

Intervention

Other:
• Advance Care Planning ACP
Patient of the intervention group get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators.
• Control Group
A routine care discharge planning with the social service

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Clinical Ethics	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		during 2 weeks six months after discharge	No
Secondary	end of live decisions on last place of care, antibiotics for pneumonia, feeding tube, intravenous fluids, dialysis, intubation and sedation,		during 2 weeks six months after discharge	No
Secondary	decisional conflict scale ("DCS"), O Connor et al 1995		at discharge and during 2 Weeks six months after discharge	No
Secondary	Satisfaction with information and care, (see Detering et al 2010)		at discharge	No
Secondary	Hospital Anxiety and Depression scale ("HADS")		discharge and during 2 weeks six months after discharge	No
Secondary	Having an Advance directive		at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge	No
Secondary	Having an appointed surrogate decision maker		at discharge, during 2 weeks three month after discharge and during 2 weeks six month after discharge	No
Secondary	Any hospital stay		during 2 weeks three months after discharge and during 2 weeks six months after discharge	No
Secondary	Decisions regarding end of life issues already having been made/taken place		during 2 weeks six months after discharge	No
Secondary	open question on important medical decisions being made		during 2 weeks three months after discharge	No
Secondary	Treatment against patients wishes		during 2 weeks three months after discharge and during 2 weeks six months after discharge, or 3 month after death	Yes
Secondary	Distress of Patients or relatives because of content of the consultation		at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge	Yes