- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Clinical Ethics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
A routine care discharge planning with the social service
|
A routine care discharge planning with the social service
|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
during 2 weeks six months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
during 2 weeks six months after discharge
|
|
decisional conflict scale ("DCS"), O Connor et al 1995
Time Frame: 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)
Time Frame: at discharge
|
at discharge
|
|
Hospital Anxiety and Depression scale ("HADS")
Time Frame: discharge and during 2 weeks six months after discharge
|
discharge and during 2 weeks six months after discharge
|
|
Having an Advance directive
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: during 2 weeks six months after discharge
|
during 2 weeks six months after discharge
|
|
open question on important medical decisions being made
Time Frame: 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
Time Frame: 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
|
|
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
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at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tanja Krones, MD, University Hospital Zurich, Clinical Ethics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAPS Trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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