Loss of Capability of JudgementADVISENCT04348318
Advance Directive Implementation and Scientific Evaluation Study
An observational study of Loss of Capability of Judgement, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
This study is to better understand the use of advance directives, their implementation in the intensive care unit, and their effects on outcome. Data from the digital medical records of all consecutive adult patients admitted to the intensive care unit at the University Hospital Basel from 2011 to 2023 are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loss of Capability of Judgement
- What is being tested?
- health related personal data extraction from digital medical records
- How many people
- 2,000 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 3 Aug 2021to Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will include all consecutive adult patients (i.e., ≥18 years of age) treated in the intensive care unit at the University Hospital Basel from 2011 to 2023.
Who may be able to join
- adult patients treated for more than 48 hours in the intensive care unit (post-operative or internal medicine) of the University Hospital Basel in the years 2011-2023
Who cannot join
- Patients with documented refusal of the general consent.
- Patients who have been treated in the intensive care unit for less than 48 hours
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sira Baumann, Cand. med. contact
Switzerland2 sites, 2 recruiting
- Recruiting
Kantonsspital Aarau
Aarau
Luca Cioccari, PD Dr. med.
Luca Cioccari, PD Dr. med.
- Recruiting
Clinic for Intensive Care Medicine, University Hospital Basel
Basel, 4031
Raoul Sutter, PD Dr. med, +41 61 265 25 25, raoul.sutter@usb.ch
Sira Baumann, Cand. med., sira.baumann@stud.unibas.ch
About this study
Official title: Advance Directive Implementation and Scientific Evaluation (ADVISE) Study
This study is to better understand the use of advance directives, their implementation in the intensive care unit, and their effects on outcome. Data from the digital medical records of all consecutive adult patients admitted to the intensive care unit at the University Hospital Basel from 2011 to 2023 are retrospectively extracted. Descriptive analyses will be applied to report the proportion of patients with an advance directive. In-hospital outcome (defined as survival, Glasgow Outcome Score, and return of neurologic function to premorbid baseline) will be compared between patients with and without advanced directives
- Conditions
- Loss of Capability of Judgement
- Being tested
- health related personal data extraction from digital medical records
- Keywords
- advance directives, life-sustaining treatment, neurocritical illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health related personal data extraction from digital medical recordsOther
health related personal data extraction from digital medical records (i.e. patient characteristics; start, end and duration of hospitalization and ICU stay; admitted from another hospital, nursing home or comes with emergency medical Service; formal data of written advance directives; data of unwritten advance directive; information on the contents of the advance directives (regarding life-worthy conditions, health care agents, resuscitation, pain management, artificial nutrition, hydration, surgeries, renal replacement, mechanical circulation, mechanical ventilation, pacemaker, administration of blood products, treatment of infections, organ donation, autopsy); patient history; clinical data; therapeutic features; outcome at discharge; knowledge regarding relatives and their level of information about the advance directives; discussion of euthanasia and self-determination of dying.
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients without predefined health care agents and/or completed advance directives
Descriptive analyses will be applied to report the proportion of patients with an advance directive. The core components of the advance directives will be analyzed regarding their translation into clinical practice. Patient and disease related characteristics will be compared between patients with and without advance directives applying the Chi-square and Fisher's exact test (where appropriate) for comparisons of proportions and the Mann-Whitney-U-test for the comparisons of continuous variables.
Measured: at baseline
number of adequate translations of directives into clinical practice
Descriptive analyses will be applied to report the proportion of patients with an advance directive. The core components of the advance directives will be analyzed regarding their translation into clinical practice. Patient and disease related characteristics will be compared between patients with and without advance directives applying the Chi-square and Fisher's exact test (where appropriate) for comparisons of proportions and the Mann-Whitney-U-test for the comparisons of continuous variables.
Measured: at baseline
Secondary outcomes (2)
In-hospital outcome (defined as survival and return of neurologic function to premorbid baseline)
In-hospital outcome (defined as survival and return of neurologic function to premorbid baseline) will be compared between patients with and without advanced directives applying the Chi-square and Fisher's exact test (where appropriate) for comparisons of proportions and the Mann-Whitney-U-test for the comparisons of continuous variables.
Measured: at baseline
In-hospital outcome (defined as Glasgow Outcome Score)
scale of patients with brain injuries that groups victims by the objective degree of recovery.The scale consists of five ordinal outcome categories: good recovery (able to live independently, able to return to work or school), moderate disability (able to live independently, unable to return to work or school), severe disability (able to follow commands, unable to live independently), persistent vegetative state (unable to interact with the environment, unresponsive), and death.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start3 Aug 2021
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Loss of Capability of JudgementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Sutter, PD Dr. med, Principal investigator, Clinic for Intensive Care Medicine, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348318
- Sponsor's protocol ID
- 2020-00584; me20Sutter2
- Acronym
- ADVISE
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2020
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baumann SM, Vock D, Kliem PSC, Amacher SA, Erne Y, Grzonka P, Berger S, Lohri M, Hunziker S, Gebhard CE, Nebiker M, Cioccari L, Sutter R. Prevalence, clinical impact and associated patient-centred outcomes of advance directives in Swiss intensive care units: Results from the retrospective ADVISE Study. Swiss Med Wkly. 2025 Sep 24;155:4625. doi: 10.57187/s.4625.
PubMed 41085533
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advance Directive Implementation and Scientific Evaluation (ADVISE) Study
- ClinicalTrials.gov ID
- NCT04348318
- Acronym / sponsor ID
- ADVISE / 2020-00584; me20Sutter2
- Conditions
- Loss of Capability of Judgement
- Keywords
- advance directives, life-sustaining treatment, neurocritical illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 16 Apr 2020 (actual)
- 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.
This study is to better understand the use of advance directives, their implementation in the intensive care unit, and their effects on outcome. Data from the digital medical records of all consecutive adult patients admitted to the intensive care unit at the University Hospital Basel from 2011 to 2023 are retrospectively extracted. Descriptive analyses will be applied to report the proportion of patients with an advance directive. In-hospital outcome (defined as survival, Glasgow Outcome Score, and return of neurologic function to premorbid baseline) will be compared between patients with and without advanced directives
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all consecutive adult patients (i.e., ≥18 years of age) treated in the intensive care unit at the University Hospital Basel from 2011 to 2023.
Key inclusion criteria (1 listed)
- adult patients treated for more than 48 hours in the intensive care unit (post-operative or internal medicine) of the University Hospital Basel in the years 2011-2023
Key exclusion criteria (2 listed)
- Patients with documented refusal of the general consent.
- Patients who have been treated in the intensive care unit for less than 48 hours
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 |
|---|---|---|
| health related personal data extraction from digital medical recordshealth related personal data extraction from digital medical records (i.e. patient characteristics; start, end and duration of hospitalization and ICU stay; admitted from another hospital, nursing home or comes with emergency medical Service; formal data of written advance directives; data of unwritten advance directive; information on the contents of the advance directives (regarding life-worthy conditions, health care agents, resuscitation, pain management, artificial nutrition, hydration, surgeries, renal replacement, mechanical circulation, mechanical ventilation, pacemaker, administration of blood products, treatment of infections, organ donation, autopsy); patient history; clinical data; therapeutic features; outcome at discharge; knowledge regarding relatives and their level of information about the advance directives; discussion of euthanasia and self-determination of dying. | Other | – |
Primary outcome
proportion of patients without predefined health care agents and/or completed advance directives
Time frame: at baseline
Descriptive analyses will be applied to report the proportion of patients with an advance directive. The core components of the advance directives will be analyzed regarding their translation into clinical practice. Patient and disease related characteristics will be compared between patients with and without advance directives applying the Chi-square and Fisher's exact test (where appropriate) for comparisons of proportions and the Mann-Whitney-U-test for the comparisons of continuous variables.
number of adequate translations of directives into clinical practice
Time frame: at baseline
Descriptive analyses will be applied to report the proportion of patients with an advance directive. The core components of the advance directives will be analyzed regarding their translation into clinical practice. Patient and disease related characteristics will be compared between patients with and without advance directives applying the Chi-square and Fisher's exact test (where appropriate) for comparisons of proportions and the Mann-Whitney-U-test for the comparisons of continuous variables.
2 secondary outcomes
In-hospital outcome (defined as survival and return of neurologic function to premorbid baseline)
Time frame: at baseline
In-hospital outcome (defined as Glasgow Outcome Score)
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Derived from this study: PubMed 41085533Baumann SM, Vock D, Kliem PSC, Amacher SA, Erne Y, Grzonka P, Berger S, Lohri M, Hunziker S, Gebhard CE, Nebiker M, Cioccari L, Sutter R. Prevalence, clinical impact and associated patient-centred outcomes of advance directives in Swiss intensive care units: Results from the retrospective ADVISE Study. Swiss Med Wkly. 2025 Sep 24;155:4625. doi: 10.57187/s.4625.
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.
Sira Baumann, Cand. med. contact
Raoul Sutter, PD Dr. med principal investigator
Clinic for Intensive Care Medicine, University Hospital Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Loss of Capability of Judgement, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raoul Sutter, PD Dr. med (+41 61 87928, raoul.sutter@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients without predefined health care agents and/or completed advance directives (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348318, which also lists 1 linked publication.
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 17 Jun 2026.