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

NCT01247792 | Completed

• 1 other identifier: EIDECS
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Sepsis

Keywords

sepsis; organ failure; end-of-life decisions; patient-centered communication

Outcome Measures

Primary Outcomes (2)

• Symptoms of burnout by MBI score in ICU caregivers

  once during observation period (1 year)

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

  once during observation period (1 year)

Secondary Outcomes (7)

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

  once during the observation period (1 year)

• 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

• Prevalence and characteristics of EOL-D

  until death or discharge from the ICU

• Prevalence and characteristics of patients' advance directives

  until death or discharge from the ICU

• characteristics of EOL-D communication with relatives

  ICU stay

Study Arms (2)

"Before"

NO INTERVENTION

No Intervention Observation of current practice

"After"

OTHER

SOPs for decision-making and communication Assessment of practice after implementation of SOPs

Behavioral: SOPs for decision-making and communication

Interventions

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

"After"

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Center for Sepsis Control and Care, Germany: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

Jena University Hospital

Jena, Thuringia, 07747, Germany

Location

Related Publications (4)

• 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. doi: 10.1056/NEJMoa063446.

  PMID: 17267907 BACKGROUND

• 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. doi: 10.1097/MCC.0b013e3282efd28a.

  PMID: 17762223 BACKGROUND

• Schwarzkopf D, Westermann I, Skupin H, Riedemann NC, Reinhart K, Pfeifer R, Fritzenwanger M, Gunther 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 psychometric testing. J Crit Care. 2015 Feb;30(1):187-95. doi: 10.1016/j.jcrc.2014.09.015. Epub 2014 Sep 20.

  PMID: 25311265 RESULT

• 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' psychological response. Palliat Med. 2015 Apr;29(4):336-45. doi: 10.1177/0269216314560007. Epub 2015 Jan 29.

  PMID: 25634628 RESULT

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Christiane S Hartog, MD

  Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr med. Christiane Hartog

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 24, 2010
• Study Start: August 1, 2010
• Primary Completion: September 30, 2014
• Study Completion: September 30, 2014
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

DE (1)