Advance Directive Implementation and Scientific Evaluation Study (ADVISE)

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 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

Study Overview

• Status: Recruiting
• Conditions: Loss of Capability of Judgement
• Intervention / Treatment: Other: health related personal data extraction from digital medical records

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Raoul Sutter, PD Dr. med; Phone Number: +41 61 87928; Email: raoul.sutter@usb.ch
• Study Contact Backup: Name: Sira Baumann, Cand. med.; Email: Cand. med. Sira Maria Baumann <sira.baumann@stud.unibas.ch>

Study Locations

• Switzerland
  • Aarau, Switzerland
    • Recruiting
    • Kantonsspital Aarau
    • Contact: Luca Cioccari, PD Dr. med.
    • Principal Investigator: Luca Cioccari, PD Dr. med.
  • Basel, Switzerland, 4031
    • Recruiting
    • Clinic for Intensive Care Medicine, University Hospital Basel
    • Contact: Raoul Sutter, PD Dr. med; Phone Number: +41 61 265 25 25; Email: raoul.sutter@usb.ch
    • Contact: Sira Baumann, Cand. med.; Email: sira.baumann@stud.unibas.ch
    • Sub-Investigator: Sarah Tschudin Sutter, Prof. Dr. med
    • Sub-Investigator: Sira Baumann, Cand. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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 2019.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Raoul Sutter, PD Dr. med, Clinic for Intensive Care Medicine, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: advance directives; life-sustaining treatment; neurocritical illness
• Other Study ID Numbers: 2020-00584; me20Sutter2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No