Multiprofessional Advance Care Planning and Shared Decision Making for End of Life Care (MAPS)
Primary Purpose
Palliative Patients, Surrogate Decision Maker
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Advance Care Planning ACP
Control Group
Sponsored by
About this trial
This is an interventional supportive care trial for Palliative Patients
Eligibility Criteria
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)
Sites / Locations
- University Hospital Zurich, Clinical Ethics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Advance Care Planning ACP
Arm Description
A routine care discharge planning with the social service
Patient get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators. --------------------------------------------------------------------------------
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
end of live decisions on last place of care, antibiotics for pneumonia, feeding tube, intravenous fluids, dialysis, intubation and sedation,
decisional conflict scale ("DCS"), O Connor et al 1995
Satisfaction with information and care, (see Detering et al 2010)
Hospital Anxiety and Depression scale ("HADS")
Having an Advance directive
Having an appointed surrogate decision maker
Any hospital stay
Decisions regarding end of life issues already having been made/taken place
open question on important medical decisions being made
Treatment against patients wishes
Distress of Patients or relatives because of content of the consultation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01914848
Brief Title
Multiprofessional Advance Care Planning and Shared Decision Making for End of Life Care
Acronym
MAPS
Official Title
Multiprofessional Advance Care Planning and Shared Decision-making for End of Life Care MAPS Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palliative Patients, Surrogate Decision Maker
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
A routine care discharge planning with the social service
Arm Title
Advance Care Planning ACP
Arm Type
Experimental
Arm Description
Patient get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators.
--------------------------------------------------------------------------------
Intervention Type
Other
Intervention Name(s)
Advance Care Planning ACP
Intervention Description
Patient of the intervention group get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
A routine care discharge planning with the social service
Primary Outcome Measure Information:
Title
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)
Time Frame
during 2 weeks six months after discharge
Secondary Outcome Measure Information:
Title
end of live decisions on last place of care, antibiotics for pneumonia, feeding tube, intravenous fluids, dialysis, intubation and sedation,
Time Frame
during 2 weeks six months after discharge
Title
decisional conflict scale ("DCS"), O Connor et al 1995
Time Frame
at discharge and during 2 Weeks six months after discharge
Title
Satisfaction with information and care, (see Detering et al 2010)
Time Frame
at discharge
Title
Hospital Anxiety and Depression scale ("HADS")
Time Frame
discharge and during 2 weeks six months after discharge
Title
Having an Advance directive
Time Frame
at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
Title
Having an appointed surrogate decision maker
Time Frame
at discharge, during 2 weeks three month after discharge and during 2 weeks six month after discharge
Title
Any hospital stay
Time Frame
during 2 weeks three months after discharge and during 2 weeks six months after discharge
Title
Decisions regarding end of life issues already having been made/taken place
Time Frame
during 2 weeks six months after discharge
Title
open question on important medical decisions being made
Time Frame
during 2 weeks three months after discharge
Title
Treatment against patients wishes
Time Frame
during 2 weeks three months after discharge and during 2 weeks six months after discharge, or 3 month after death
Title
Distress of Patients or relatives because of content of the consultation
Time Frame
at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja Krones, MD
Organizational Affiliation
University Hospital Zurich, Clinical Ethics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Clinical Ethics
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
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Multiprofessional Advance Care Planning and Shared Decision Making for End of Life Care
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