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Advance Directives and End-of-life Decision Making in Intensive Care Medicine in Germany

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT01294189
Collaborator
(none)
224
Enrollment
1
Location
30
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Description of the decision making process as well as the practices of end of life care in an ICU of a German university hospital during the period when changes of German legislation occurred.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Most patients on the intensive care unit (ICU) die after an end-of-life decision (EOLD) has been made (Sprung et al. 2003). On September 1st 2009 the "advance-directives-law" was inured in Germany considering a written advance directive of an adult binding for physicians and the patient´s surrogate decision makers if it fits into the medical context (BGBL 2009). There is a lack of data describing the process and the factors associated with end-of-life-decisions in ICUs in Germany in detail.

    The purpose of this observational study is to describe the decision making process as well as the practices of end of life care in an ICU of a German university hospital during a period when changes of German legislation occurred.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    224 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    The Impact of Instituting a Law for Advance Directives on End-of-life Decision Making in Intensive Care Medicine in Germany
    Study Start Date :
    Aug 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2010
    Actual Study Completion Date :
    Feb 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    ICU-patients that died on the ICU

    ICU-patients (post-operative and non operative patients) will be enrolled in the study. All patients are followed until their death on the ICU.

    Outcome Measures

    Primary Outcome Measures

    1. decision makers of end-of-life decisions [08/2008 - 09/2010]

      The primary objective of this study performed according to an observational post-ad-hoc design is to identify and analyse the decision makers of end-of-life decisions on an intensive care unit in Germany. Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. Usually in clinical routine end-of-life decisions are documented for decision makers in the patients´ records. The incidences of the different decision makers including members of different clinical specialities and also members with different levels of ICU experience are compared.

    Secondary Outcome Measures

    1. influence of the new German advance directives law on end-of-life decisions [08/2008 - 09/2010]

      The second objective is to investigate what kind of influence the new German law for advance directives had on end-of-life decision making on the ICU. Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. Usually in clinical routine end-of-life decisions are documented for decision makers and procedures in the patients´ records. The incidences of therapeutic procedures in end of life care comparing patients with advance directives at different time points and those patients without advance directives are reviewed for differences.

    2. the process of end-of-life decisions on a German intensive care unit [08/2008 - 09/2010]

      Another objective of this study performed according to an observational post-ad-hoc design is to identify and analyse the process of end-of-life decisions on an intensive care unit in Germany. Approximately 200 patients will be followed up until their death on the ICU. The process of withholding and withdrawing of therapeutic approaches is documented in the patient´s records. The incidences of different therapeutic procedures like ventilation, organ replacement technology, surgery, blood transfusions, antiinfective therapy and nutrition in patients with an EOLD are compared.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients admitted to the ICU

    • All patients discharged death from the ICU

    Exclusion Criteria:
    • All patients discharged alive from the ICU

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte Berlin Germany 10117

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Director: Jan-Peter Braun, MD, Charite University, Berlin, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01294189
    Other Study ID Numbers:
    • EOLD
    First Posted:
    Feb 11, 2011
    Last Update Posted:
    Feb 11, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    end-of-life decisions, critical care, advance directive
    Additional relevant MeSH terms:
    Death

    Study Results

    No Results Posted as of Feb 11, 2011