Palliative PatientsMAPSNCT01914848
Multiprofessional Advance Care Planning and Shared Decision Making for End of Life Care
A study testing Advance Care Planning ACP in people with Palliative Patients and Surrogate Decision Maker, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Patients, Surrogate Decision Maker
- What is being tested?
- Advance Care Planning ACP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Clinical Ethics
Zurich, Canton of Zurich, 8091
About this study
Official title: 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).
- Conditions
- Palliative Patients, Surrogate Decision Maker
- Being tested
- Advance Care Planning ACP, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control GroupOther
A routine care discharge planning with the social service
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | A routine care discharge planning with the social service Receives: 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.
-------------------------------------------------------------------------------- Receives: Other: Advance Care Planning ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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,
Measured: during 2 weeks six months after discharge
decisional conflict scale ("DCS"), O Connor et al 1995
Measured: at discharge and during 2 Weeks six months after discharge
Satisfaction with information and care, (see Detering et al 2010)
Measured: at discharge
Hospital Anxiety and Depression scale ("HADS")
Measured: discharge and during 2 weeks six months after discharge
Having an Advance directive
Measured: at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
Having an appointed surrogate decision maker
Measured: at discharge, during 2 weeks three month after discharge and during 2 weeks six month after discharge
Any hospital stay
Measured: 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
Measured: during 2 weeks six months after discharge
open question on important medical decisions being made
Measured: during 2 weeks three months after discharge
Treatment against patients wishes
Measured: 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
Measured: at discharge, during 2 weeks three months after discharge and during 2 weeks six months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja Krones, MD, Principal investigator, University Hospital Zurich, Clinical Ethics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914848
- Sponsor's protocol ID
- MAPS Trial
- Acronym
- MAPS
- Status last verified
- Jun 2016
- First submitted
- 26 Nov 2012
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiprofessional Advance Care Planning and Shared Decision-making for End of Life Care MAPS Trial
- ClinicalTrials.gov ID
- NCT01914848
- Acronym / sponsor ID
- MAPS / MAPS Trial
- Conditions
- Palliative Patients, Surrogate Decision Maker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control GroupA routine care discharge planning with the social service |
| Advance Care Planning ACP | Experimental | Other: Advance Care Planning ACPPatient get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators. -------------------------------------------------------------------------------- |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance Care Planning ACPPatient of the intervention group get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators. | Other | Advance Care Planning ACP |
| Control GroupA routine care discharge planning with the social service | Other | Control Group |
Primary outcome
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
11 secondary outcomes
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
decisional conflict scale ("DCS"), O Connor et al 1995
Time frame: at discharge and during 2 Weeks six months after discharge
Satisfaction with information and care, (see Detering et al 2010)
Time frame: at discharge
Hospital Anxiety and Depression scale ("HADS")
Time frame: 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
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
Any hospital stay
Time frame: 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
open question on important medical decisions being made
Time frame: during 2 weeks three months after discharge
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanja Krones, MD principal investigator
University Hospital Zurich, Clinical Ethics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance Care Planning ACP in people with Palliative Patients and Surrogate Decision Maker, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016; AzTrials last refreshed its copy on 26 Oct 2026.