NCT01914848

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

November 26, 2012

Last Update Submit

June 3, 2016

Conditions

Palliative PatientsSurrogate Decision Maker

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • 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

  • decisional conflict scale ("DCS"), O Connor et al 1995

    at discharge and during 2 Weeks six months after discharge

  • Satisfaction with information and care, (see Detering et al 2010)

    at discharge

  • Hospital Anxiety and Depression scale ("HADS")

    discharge and during 2 weeks six months after discharge

  • Having an Advance directive

    at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge

  • +6 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

A routine care discharge planning with the social service

Other: Control Group

Advance Care Planning ACP

EXPERIMENTAL

Patient get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators. \--------------------------------------------------------------------------------

Other: Advance Care Planning ACP

Interventions

Advance Care Planning ACPOTHER

Patient of the intervention group get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators.

Advance Care Planning ACP
Control GroupOTHER

A routine care discharge planning with the social service

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Clinical Ethics

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Advance Care PlanningControl Groups

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services AdministrationEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Tanja Krones, MD

    University Hospital Zurich, Clinical Ethics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2012

First Posted

August 2, 2013

Study Start

July 1, 2013

Primary Completion

April 1, 2015

Study Completion

August 1, 2015

Last Updated

June 6, 2016

Record last verified: 2016-06

Locations

CH(1)