Advance Directive Implementation and Scientific Evaluation Study

Recruiting

• Conditions: Loss of Capability of Judgement

• Registration Number: NCT04348318
• Lead Sponsor: University Hospital, Basel, Switzerland

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Study Start: 2021-08-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2050-12
• Study Completion: 2050-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of adequate translations of directives into clinical practice	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.
proportion of patients without predefined health care agents and/or completed advance directives	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.

Secondary Outcome Measures

Name	Time	Method
In-hospital outcome (defined as survival and return of neurologic function to premorbid baseline)	at 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.
In-hospital outcome (defined as Glasgow Outcome Score)	at baseline	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.

Trial Locations

Locations (2)

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Clinic for Intensive Care Medicine, University Hospital Basel; 🇨🇭 Basel, Switzerland