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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01294189
First received: February 10, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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
Death

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • decision makers of end-of-life decisions [ Time Frame: 08/2008 - 09/2010 ] [ Designated as safety issue: No ]

    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:
  • influence of the new German advance directives law on end-of-life decisions [ Time Frame: 08/2008 - 09/2010 ] [ Designated as safety issue: No ]

    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.


  • the process of end-of-life decisions on a German intensive care unit [ Time Frame: 08/2008 - 09/2010 ] [ Designated as safety issue: No ]

    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.



Enrollment: 224
Study Start Date: August 2008
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All intensive care department patients (MAN101i and MAN103i Charité Berlin) will be enrolled in the study

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294189

Locations
Germany
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 Charité Berlin
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Priv.-Doz. Dr. Jan-Peter Braun, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01294189     History of Changes
Other Study ID Numbers: EOLD
Study First Received: February 10, 2011
Last Updated: February 10, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
end-of-life decisions, critical care, advance directive

ClinicalTrials.gov processed this record on May 21, 2013