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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Severe Sepsis
Behavioral: SOPs for decision-making and communication

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Time-series Intervention Analysis of End-of-life Decision-making in Patients With Sepsis-related Organ Failure

Resource links provided by NLM:


Further study details as provided by Center for Sepsis Control and Care, Germany:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: "Before"
No Intervention Observation of current practice
"After"
SOPs for decision-making and communication Assessment of practice after implementation of SOPs
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

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247792

Contacts
Contact: Christiane S Hartog, MD 0049 3641 ext 9323171 christiane.hartog@med.uni-jena.de

Locations
Germany
Jena University Hospital Recruiting
Jena, Thuringia, Germany, 07747
Sponsors and Collaborators
Center for Sepsis Control and Care, Germany
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Christiane S Hartog, MD Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
  More Information

Publications:
Responsible Party: Christiane Hartog, PD Dr med. Christiane Hartog, Center for Sepsis Control and Care, Germany
ClinicalTrials.gov Identifier: NCT01247792     History of Changes
Other Study ID Numbers: EIDECS
Study First Received: November 11, 2010
Last Updated: July 29, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Center for Sepsis Control and Care, Germany:
sepsis
organ failure
end-of-life decisions
patient-centered communication

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014