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

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

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.

Study Overview

• Status: Completed
• Conditions: Death

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 Type: Observational
• Enrollment (Actual): 224

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Graw JA, Spies CD, Wernecke KD, Braun JP. Managing end-of-life decision making in intensive care medicine--a perspective from Charite Hospital, Germany. PLoS One. 2012;7(10):e46446. doi: 10.1371/journal.pone.0046446. Epub 2012 Oct 1.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Estimate): February 11, 2011
• Last Update Submitted That Met QC Criteria: February 10, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: end-of-life decisions, critical care, advance directive
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: EOLD