End-of-life Decision-making in Patients With Sepsis-related Organ Failure (EIDECS)

This study is currently recruiting participants.
Verified July 2013 by Center for Sepsis Control and Care, Germany
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Christiane Hartog, Center for Sepsis Control and Care, Germany
ClinicalTrials.gov Identifier:
NCT01247792
First received: November 11, 2010
Last updated: July 29, 2013
Last verified: July 2013

November 11, 2010
July 29, 2013
December 2010
June 2014   (final data collection date for primary outcome measure)
  • Symptoms of burnout by MBI score in ICU caregivers [ Time Frame: once during observation period (1 year) ] [ Designated as safety issue: No ]
  • Symptoms of post-traumatic stress disorder by IES and HADS scores in relatives at 90 days [ Time Frame: once during observation period (1 year) ] [ Designated as safety issue: No ]
  • Symptoms of burnout by MBI score in ICU caregivers [ Time Frame: once during observation period ] [ Designated as safety issue: No ]
  • Symptoms of post-traumatic stress disorder by IES and HADS scores in relatives after approximately 60 - 90 days [ Time Frame: once during observation period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01247792 on ClinicalTrials.gov Archive Site
  • Psychological symptoms by IES, HADS or MBI subscales in caregivers or relatives, respectively [ Time Frame: once during the observation period (1 year) ] [ Designated as safety issue: No ]
  • Characteristics of patients with and without end-of-life decisions (EOL-D) including time periods (time until EOL-D, time between EOL-D until death or discharge) and 28-day and 90-day mortality rates [ Time Frame: until death or discharge from the ICU ] [ Designated as safety issue: No ]
  • Prevalence and characteristics of EOL-D [ Time Frame: until death or discharge from the ICU ] [ Designated as safety issue: No ]
  • Prevalence and characteristics of patients' advance directives [ Time Frame: until death or discharge from the ICU ] [ Designated as safety issue: No ]
  • characteristics of EOL-D communication with relatives [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
  • Prevalence of request for "Ethik Konsil" (counseling by an external ethical review board) [ Time Frame: until death or discharge from the ICU ] [ Designated as safety issue: No ]
  • direct costs of treatment of survivors and non-survivors [ Time Frame: until death or discharge from the ICU ] [ Designated as safety issue: No ]
  • Psychological symptoms by IES, HADS or MBI subcales in caregivers or relatives, respectively [ Time Frame: once during the observation period ] [ Designated as safety issue: No ]
  • Characteristics of patients with and without end-of-life decisions (EOL-D) including time periods (time until EOL-D, time between EOL-D until death or discharge) and 28-day and 90-day mortality rates [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
  • Prevalence and characteristics of EOL-D [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
  • Prevalence and characteristics of patients' advance directives [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
  • characteristics of EOL-D communication with relatives [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
  • Prevalence of request for "Ethik Konsil" (counseling by an external ethical review board) [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
  • direct costs of treatment of survivors and non-survivors [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
End-of-life Decision-making in Patients With Sepsis-related Organ Failure
A Time-series Intervention Analysis of End-of-life Decision-making in Patients With Sepsis-related Organ Failure

The care of patients with sepsis-related organ failure on the intensive care unit (ICU) often includes end-of-life decision (EOL-D) and communication of such decisions to relatives. This increases the psychological burden for caregiver and relatives.

The investigators intend to assess the prevalence and impact of EOL-D on ICU care-givers and relatives ("before") and to use this data to develop and implement standard operating procedures (SOPs) for improved decision-making and communication of these decisions ("after").

The hypothesis is that an improved communication strategy will reduce symptoms of burnout in caregivers and symptoms of anxiety and depression in relatives.

BACKGROUND About half of patients with sepsis related organ failure die on the ICU, frequently after end-of-life decisions (EOL-D), i.e. the decision to withdraw or withhold life-supporting therapies or forgo cardiopulmonary resuscitation. Lack of SOPs about how to communicate and share EOL-decisionmaking among staff and to communicate EOL-D to relatives may increase burnout and anxiety in staff as well as relatives. Also, there is uncertainty about the role of patients' advance directives in EOL-Decision-making.

HYPOTHESES 1. SOPs for interdisciplinary EOL-decisions will alleviate staff burnout; 2. A structured strategy to communicate EOL-decisions to relatives will lead to reduced anxiety and depression in relatives 3 months after the event.

AIMS 1. to develop SOPs for EOL-decision-making which improve timeliness of EOL-D and involvement of interdisciplinary care-givers. 2. to develop a strategy how to communicate these EOL-D to relatives including a structured procedure for participants, set-up, times and content. These aims may be adapted according to the findings of the observation period.

CONDUCT The study is designed as an interrupted time series analysis ("before/after study") located on the mixed, neurological and medical ICUs of the Jena University Hospital. It is composed of 3 observation periods separated by phases of data analysis and implementation of changes in behavioral practice. After the first phase of observation and data analysis, SOPs including an improved communication strategy with relatives will be developed on the basis of the collected data. SOPs will be developed and implemented on participating ICUs. In the following second observation period data will be collected to assess changed procedures and primary endpoints. A third round of data analysis, interpretation and observation will enable to further adapt SOPs and achieve sustainability ("post-implementation phase").

ESTIMATED ENROLLMENT Enrollment of 180 staff members (physicians and nursing staff) and 90 relatives during each study phase

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Severe Sepsis
Behavioral: SOPs for decision-making and communication
Development and implementation of SOPs for timely and interdisciplinary EOL-decisionmaking and a communication strategy with relatives which addresses participants, set-up, time-points, and content
  • No Intervention: "Before"
    No Intervention Observation of current practice
  • "After"
    SOPs for decision-making and communication Assessment of practice after implementation of SOPs
    Intervention: Behavioral: SOPs for decision-making and communication

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2014
June 2014   (final data collection date for primary outcome measure)

Staff:

Inclusion Criteria:

  • all physicians and nursing staff who treat patients with sepsis-related organ failure on participating ICUs who consent to participate

Exclusion Criteria:

  • Decline to participate

Relatives:

  • Relatives of patients with sepsis-related organ failure and EOL-D who consent to participate

Exclusion Criteria:

  • Decline to participate
Both
Not Provided
No
Contact: Christiane S Hartog, MD 0049 3641 ext 9323171 christiane.hartog@med.uni-jena.de
Germany
 
NCT01247792
EIDECS
No
Christiane Hartog, Center for Sepsis Control and Care, Germany
Center for Sepsis Control and Care, Germany
German Federal Ministry of Education and Research
Principal Investigator: Christiane S Hartog, MD Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
Center for Sepsis Control and Care, Germany
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP