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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Death

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted to the ICU All patients discharged death from the ICU Exclusion Criteria: All patients discharged alive from the ICU
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU-patients that died on the ICU<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end-of-life decisions, critical care, advance directive