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Completed

NCT Number: NCT01247792

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.

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jena University Hospital

Jena, Thuringia, 07747, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOPs for decision-making and communication

Behavioral

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

Primary outcomes

  1. Symptoms of burnout by MBI score in ICU caregivers

    Time frame: once during observation period (1 year)

  2. Symptoms of post-traumatic stress disorder by IES and HADS scores in relatives at 90 days

    Time frame: once during observation period (1 year)

Secondary outcomes

  1. Psychological symptoms by IES, HADS or MBI subscales in caregivers or relatives, respectively

    Time frame: once during the observation period (1 year)

  2. 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

  3. Prevalence and characteristics of EOL-D

    Time frame: until death or discharge from the ICU

  4. Prevalence and characteristics of patients' advance directives

    Time frame: until death or discharge from the ICU

  5. characteristics of EOL-D communication with relatives

    Time frame: ICU stay

  6. Prevalence of request for "Ethik Konsil" (counseling by an external ethical review board)

    Time frame: until death or discharge from the ICU

  7. direct costs of treatment of survivors and non-survivors

    Time frame: until death or discharge from the ICU

Sponsors and collaborators

Lead sponsor

Center for Sepsis Control and Care, Germany

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

A Time-series Intervention Analysis of End-of-life Decision-making in Patients With Sepsis-related Organ Failure

Acronym: EIDECS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2010
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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