Advance Directive Implementation and Scientific Evaluation Study
ConditionLoss of Capability of Judgement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with documented refusal of the general consent.
Patients who have been treated in the intensive care unit for less than 48 hours
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
health related personal data extraction from digital medical records
Other interventionhealth 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
at baseline2
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.
Time frame
at baselineSecondary outcomes
1
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.
Time frame
at baseline2
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.
Time frame
at baselineSponsors and contacts
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Source ClinicalTrials.gov