Advance Directive Implementation and Scientific Evaluation Study

Study Overview
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Brief Summary
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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 2019 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

Official Title
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Advance Directive Implementation and Scientific Evaluation (ADVISE) Study

Conditions
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Loss of Capability of Judgement

Intervention / Treatment
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* Other: health related personal data extraction from digital medical records


Participation Criteria
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Eligibility Criteria
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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 2011-2019 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: health 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advance directives, life-sustaining treatment, neurocritical illness