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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01914848
First received: November 26, 2012
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention
Palliative Patients
Surrogate Decision Maker
Other: Advance Care Planning ACP
Other: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Multiprofessional Advance Care Planning and Shared Decision-making for End of Life Care MAPS Trial

Resource links provided by NLM:


Further study details as provided by University of Zurich:

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) [ Time Frame: during 2 weeks six months after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • decisional conflict scale ("DCS"), O Connor et al 1995 [ Time Frame: at discharge and during 2 Weeks six months after discharge ] [ Designated as safety issue: No ]
  • Satisfaction with information and care, (see Detering et al 2010) [ Time Frame: at discharge ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression scale ("HADS") [ Time Frame: discharge and during 2 weeks six months after discharge ] [ Designated as safety issue: No ]
  • Having an Advance directive [ Time Frame: at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Any hospital stay [ Time Frame: during 2 weeks three months after discharge and during 2 weeks six months after discharge ] [ Designated as safety issue: No ]
  • Decisions regarding end of life issues already having been made/taken place [ Time Frame: during 2 weeks six months after discharge ] [ Designated as safety issue: No ]
  • open question on important medical decisions being made [ Time Frame: during 2 weeks three months after discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: July 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
A routine care discharge planning with the social service
Other: Control Group
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.

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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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914848

Contacts
Contact: Monika Brunner Sabato monika.brunner@usz.ch
Contact: Tanja Krones, MD tanja.krones@usz.ch

Locations
Switzerland
University Hospital Zurich, Clinical Ethics Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Tanja Krones, MD University Hospital Zurich, Clinical Ethics
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01914848     History of Changes
Other Study ID Numbers: MAPS Trial
Study First Received: November 26, 2012
Last Updated: September 3, 2013
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on October 22, 2014