Severe Sepsis Clinical Trial
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.
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
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