Sepsis Clinical Trial
Official title:
Medical Education for Sepsis Source Control and Antibiotics
Patients with severe sepsis or septic shock suffer from life-threatening infections. Fast and
adequate therapy with antibiotics is crucial for survival. Current guidelines recommend the
application of broad-spectrum antibiotics within 1 hour after diagnosis. However, recent
studies showed that such treatment is delayed for several hours.
In this study, medical staff of participating hospitals is trained to achieve a duration
until antimicrobial therapy of less than 1 hour. Tools of change management are used. The
data are compared to a control group (hospitals without intervention).
It is hypothesized that a multifaceted educational program decreases duration until
antimicrobial therapy and improves survival.
This study is a cluster randomized trial (CRT) where the hospitals are the clusters. 44
hospitals in Germany have confirmed their participation. Hospitals are randomized into two
groups: a control and an interventional group. The control group receives conventional CMEs.
The interventional group receives tools for increasing awareness such as posters and
brochures. Quality measure such as benchmarking and feedback of quality indicators are used.
Depending on the improvement process tools such as SWOT analyses and resistance radar will be
implemented.
The CRT was preceded by a 5 months observational study (Dec. 2010 - April 2011). In about
1000 patients, participating hospitals documented their patients with severe sepsis or septic
shock into a register. These data are used for final sample size calculation of the CRT and
for stratification of the randomization.
The groups switch after completion of the CRT and observation continues. Thus, centers of the
control group now receive the change management while the former intervention group is now
without external support and is assessed for sustainability of the intervention. This study
phase is planned for Nov. 2013 until March 2015. Sample size will be calculated when the CRT
has been finished.
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|---|---|---|---|
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