Severe SepsisEIDECSNCT01247792
End-of-life Decision-making in Patients With Sepsis-related Organ Failure
A study testing SOPs for decision-making and communication in people with Severe Sepsis, run by Center for Sepsis Control and Care, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- SOPs for decision-making and communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to 30 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all physicians and nursing staff who treat patients with sepsis-related organ failure on participating ICUs who consent to participate
Who cannot join
- Decline to participate
- Relatives:
- Relatives of patients with sepsis-related organ failure and EOL-D who consent to participate
- Decline to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Severe Sepsis
- Being tested
- SOPs for decision-making and communication
- Keywords
- sepsis, organ failure, end-of-life decisions, patient-centered communication
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOPs for decision-making and communicationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| "Before" | No intervention | No Intervention Observation of current practice |
| "After" | Other | SOPs for decision-making and communication Assessment of practice after implementation of SOPs Receives: Behavioral: SOPs for decision-making and communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of burnout by MBI score in ICU caregivers
Measured: once during observation period (1 year)
Symptoms of post-traumatic stress disorder by IES and HADS scores in relatives at 90 days
Measured: once during observation period (1 year)
Secondary outcomes (7)
Psychological symptoms by IES, HADS or MBI subscales in caregivers or relatives, respectively
Measured: 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
Measured: until death or discharge from the ICU
Prevalence and characteristics of EOL-D
Measured: until death or discharge from the ICU
Prevalence and characteristics of patients' advance directives
Measured: until death or discharge from the ICU
characteristics of EOL-D communication with relatives
Measured: ICU stay
Prevalence of request for "Ethik Konsil" (counseling by an external ethical review board)
Measured: until death or discharge from the ICU
direct costs of treatment of survivors and non-survivors
Measured: until death or discharge from the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startAug 2010
- Primary completion30 Sep 2014
- Study completion30 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Sepsis Control and Care, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Christiane Hartog, Center for Sepsis Control and Care, Germany
- Investigators
- Christiane S Hartog, MD, Principal investigator, Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247792
- Sponsor's protocol ID
- EIDECS
- Acronym
- EIDECS
- Status last verified
- Aug 2017
- First submitted
- 11 Nov 2010
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17267907Embriaco 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.
PubMed 17762223Schwarzkopf 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.
PubMed 25311265Hartog 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.
PubMed 25634628
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Time-series Intervention Analysis of End-of-life Decision-making in Patients With Sepsis-related Organ Failure
- ClinicalTrials.gov ID
- NCT01247792
- Acronym / sponsor ID
- EIDECS / EIDECS
- Conditions
- Severe Sepsis
- Keywords
- sepsis, organ failure, end-of-life decisions, patient-centered communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Center for Sepsis Control and Care, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Aug 2010
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Before" | No intervention | –No Intervention Observation of current practice |
| "After" | Other | Behavioral: SOPs for decision-making and communicationSOPs for decision-making and communication Assessment of practice after implementation of SOPs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all physicians and nursing staff who treat patients with sepsis-related organ failure on participating ICUs who consent to participate
Key exclusion criteria (4 listed)
- Decline to participate
- Relatives of patients with sepsis-related organ failure and EOL-D who consent to participate
- Decline to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOPs for decision-making and communicationDevelopment 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 | Behavioural | "After" |
Primary outcome
Symptoms of burnout by MBI score in ICU caregivers
Time frame: once during observation period (1 year)
Symptoms of post-traumatic stress disorder by IES and HADS scores in relatives at 90 days
Time frame: once during observation period (1 year)
7 secondary outcomes
Psychological symptoms by IES, HADS or MBI subscales in caregivers or relatives, respectively
Time frame: 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
Time frame: until death or discharge from the ICU
Prevalence and characteristics of EOL-D
Time frame: until death or discharge from the ICU
Prevalence and characteristics of patients' advance directives
Time frame: until death or discharge from the ICU
characteristics of EOL-D communication with relatives
Time frame: ICU stay
Prevalence of request for "Ethik Konsil" (counseling by an external ethical review board)
Time frame: until death or discharge from the ICU
direct costs of treatment of survivors and non-survivors
Time frame: until death or discharge from the ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Background: PubMed 17267907Lautrette 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.
- Background: PubMed 17762223Embriaco 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.
- Results publication: PubMed 25311265Schwarzkopf 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.
- Results publication: PubMed 25634628Hartog 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane S Hartog, MD principal investigator
Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOPs for decision-making and communication in people with Severe Sepsis, run by Center for Sepsis Control and Care, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of burnout by MBI score in ICU caregivers (time frame: once during observation period (1 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01247792, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.