Medical Education for Sepsis Source Control and Antibiotics (MEDUSA)
|ClinicalTrials.gov Identifier: NCT01187134|
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : August 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Shock, Septic||Behavioral: Change Management||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Medical Education for Sepsis Source Control and Antibiotics|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||July 2013|
|Active Comparator: Intervention group||
Behavioral: Change Management
Hospitals have to create local change teams which are supported and trained by the study center. Local awareness of the staff is increased by PowerPoint presentations, posters, and brochures. The change teams receive monthly information about their quality indicator (duration until antimicrobial therapy). Anonymous comparison to other hospitals is possible (Benchmarking). Hospitals are visited three times a year to discuss progress of quality. In case of failure to improve, the change team is supported with specific tools for change management such as SWOT-analysis or resistance radar.
No Intervention: Conventional CME
Hospitals receive conventional continuing medical education in lecture style twice a year. They receive current publications and recommendations for national and international meetings regarding diagnosis and therapy of sepsis.
- All-cause mortality [ Time Frame: 28 days ]
- Fraction of patients with antimicrobial therapy within 1 hour
- Duration until antimicrobial therapy
- Duration until focus control
- Frequency of blood cultures
- Frequency of adequate antimicrobial therapy
- ICU and hospital mortality
- ICU and and hospital length of stay
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187134
|Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH|
|HELIOS Klinikum Aue|
|Zentralklinik Bad Berka GmbH|
|Bad Berka, Germany|
|Bad Langensalza, Germany|
|HELIOS Kliniken Berlin-Buch|
|HELIOS Klinikum Emil von Behring|
|Vivantes Klinikum Neukölln|
|Ev. Krankenhaus Bielefeld|
|HELIOS St. Josefs-Hospital Bochum-Linden|
|Universitätsklinikum Carl Gustav Carus|
|St. Georg Klinikum Eisenach gGmbH|
|Waldkrankenhaus Rudolf Elle GmbH|
|Helios Klinikum Erfurt|
|Katholisches Krankenhaus St. Johann Nepomuk|
|SRH Waldklinikum Gera|
|Klinik am Eichert|
|Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH|
|HELIOS-Klinikum Krefeld GmbH|
|Klinikum Meiningen GmbH|
|Südharz-Krankenhaus Nordhausen gGmbH|
|Thüringen-Klinik Pößneck gGmbH|
|ASKLEPIOS-ASB Krankenhaus Radeberg GmbH|
|Thüringen-Kliniken "Georgius Agricola" GmbH|
|Klinikum Saarbrücken gGmbH|
|Diakonie-Klinikum Schwäbisch-Hall gGmbH|
|SRH Zentralklinikum Suhl GmbH|
|Sophien- und Hufeland-Klinikum gGmbH|
|HELIOS Klinikum Wuppertal|
|Principal Investigator:||Reinhart Konrad, MD||Jena University Hospital, Germany|
|Principal Investigator:||Frank Bloos, MD, Ph.D.||Jena University Hospital|