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Advance Directive Implementation and Scientific Evaluation Study

Advance Directive Implementation and Scientific Evaluation (ADVISE) Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04348318
Acronym
ADVISE
Enrollment
2000
Registered
2020-04-16
Start date
2021-08-03
Completion date
2050-12-01
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loss of Capability of Judgement

Keywords

advance directives, life-sustaining treatment, neurocritical illness

Brief 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 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

Interventions

OTHERhealth related personal data extraction from digital medical records

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.

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients with documented refusal of the general consent. * Patients who have been treated in the intensive care unit for less than 48 hours

Design outcomes

Primary

MeasureTime frameDescription
proportion of patients without predefined health care agents and/or completed advance directivesat baselineDescriptive 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 practiceat baselineDescriptive 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.

Secondary

MeasureTime frameDescription
In-hospital outcome (defined as survival and return of neurologic function to premorbid baseline)at baselineIn-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.
In-hospital outcome (defined as Glasgow Outcome Score)at baselinescale 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.

Countries

Switzerland

Contacts

CONTACTRaoul Sutter, PD Dr. med
raoul.sutter@usb.ch+41 61 87928
CONTACTSira Baumann, Cand. med.
Cand. med. Sira Maria Baumann <sira.baumann@stud.unibas.ch>
PRINCIPAL_INVESTIGATORRaoul Sutter, PD Dr. med

Clinic for Intensive Care Medicine, University Hospital Basel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026