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

Severe Sepsis Clinical Trial

— EIDECS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247792
• Other study ID #: EIDECS
• Status: Completed
• Phase: N/A
• First received: November 11, 2010
• Last updated: August 8, 2017
• Start date: August 2010
• Est. completion date: September 30, 2014

Study information

• Verified date: August 2017
• Source: Center for Sepsis Control and Care, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: September 30, 2014
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Germany	Jena University Hospital	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
Center for Sepsis Control and Care, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Embriaco N, Papazian L, Kentish-Barnes N, Pochard F, Azoulay E. Burnout syndrome among critical care healthcare workers. Curr Opin Crit Care. 2007 Oct;13(5):482-8. Review. — View Citation

Hartog CS, Schwarzkopf D, Riedemann NC, Pfeifer R, Guenther A, Egerland K, Sprung CL, Hoyer H, Gensichen J, Reinhart K. End-of-life care in the intensive care unit: a patient-based questionnaire of intensive care unit staff perception and relatives' psych — View Citation

Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203. — View Citation

Schwarzkopf D, Westermann I, Skupin H, Riedemann NC, Reinhart K, Pfeifer R, Fritzenwanger M, Günther A, Witte OW, Hartog CS. A novel questionnaire to measure staff perception of end-of-life decision making in the intensive care unit--development and psych — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of burnout by MBI score in ICU caregivers		once during observation period (1 year)
Primary	Symptoms of post-traumatic stress disorder by IES and HADS scores in relatives at 90 days		once during observation period (1 year)
Secondary	Psychological symptoms by IES, HADS or MBI subscales in caregivers or relatives, respectively		once during the observation period (1 year)
Secondary	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		until death or discharge from the ICU
Secondary	Prevalence and characteristics of EOL-D		until death or discharge from the ICU
Secondary	Prevalence and characteristics of patients' advance directives		until death or discharge from the ICU
Secondary	characteristics of EOL-D communication with relatives		ICU stay
Secondary	Prevalence of request for "Ethik Konsil" (counseling by an external ethical review board)		until death or discharge from the ICU
Secondary	direct costs of treatment of survivors and non-survivors		until death or discharge from the ICU