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Recruiting NCT04348318

Advance Directive Implementation and Scientific Evaluation Study

Observational Loss of Capability of Judgement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: health related personal data extraction from digital medical records.
Who it may be relevant to
Registry conditions: Loss of Capability of Judgement. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Advance Directive Implementation and Scientific Evaluation (ADVISE) Study

Overview

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

  • 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, sur

Primary outcome measures

  • proportion of patients without predefined health care agents and/or completed advance directives [Time frame: at baseline]
  • number of adequate translations of directives into clinical practice [Time frame: at baseline]
Secondary outcome measures (2)
  • In-hospital outcome (defined as survival and return of neurologic function to premorbid baseline) [Time frame: at baseline]
  • In-hospital outcome (defined as Glasgow Outcome Score) [Time frame: at baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 2 centers
  • Kantonsspital Aarau — Aarau
  • Clinic for Intensive Care Medicine, University Hospital Basel — Basel

Publications

  • Baumann SM, Vock D, Kliem PSC, Amacher SA, Erne Y, Grzonka P, Berger S, Lohri M, Hunziker S, Gebhard CE, Nebiker M, Cioccari L, Sutter R. Prevalence, clinical impact and associated patient-centred outcomes of advance directives in Swiss intensive care units: Results from the retrospective ADVISE Study. Swiss Med Wkly. 2025 Sep 24;155:4625. doi: 10.57187/s.4625. PMID 41085533

Identifiers

NCT: NCT04348318 · 2020-00584; me20Sutter2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗