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

Death Clinical Trial

Official title:

The Impact of Instituting a Law for Advance Directives on End-of-life Decision Making in Intensive Care Medicine in Germany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294189
• Other study ID #: EOLD
• Status: Completed
• Phase: N/A
• First received: February 10, 2011
• Last updated: February 10, 2011
• Start date: August 2008
• Est. completion date: February 2011

Study information

• Verified date: January 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: February 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients admitted to the ICU

• All patients discharged death from the ICU

Exclusion Criteria:

• All patients discharged alive from the ICU

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Death

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decision makers of end-of-life decisions	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.	08/2008 - 09/2010	No
Secondary	influence of the new German advance directives law on end-of-life decisions	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.	08/2008 - 09/2010	No
Secondary	the process of end-of-life decisions on a German intensive care unit	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.	08/2008 - 09/2010	No