Medical Education for Sepsis Source Control and Antibiotics (MEDUSA)

Center for Sepsis Control and Care, Germany

Status: Completed

Conditions: Shock, Septic; Sepsis

Treatments: Behavioral: Change Management

Study type: Interventional

Funder types: Other

Identifiers

NCT01187134

C1.1

U1111-1118-2850 (Other Identifier)

01EO1002 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4,138 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. For the hospitals (cluster):

   • Involved in the primary care of patients with severe sepsis/septic shock
   • Willing to participate in a guideline implementation process

2. For the patients:

   • New onset of suspicion of severe sepsis or septic shock in the following settings:

     1. Prehospital
     2. Emergency department
     3. Operating theatre
     4. Regular ward
     5. Intensive care unit (ICU)/Intermediate Care Unit (IMC)

Exclusion criteria

1. For the hospitals (cluster):

   • No intensive care unit available
   • no acute care for patients with severe sepsis and septic shock

2. For the patients:

   • Start of sepsis therapy in a non-study site
   • Patients not admitted to the ICU/IMC
   • No commitment to full medical support (i.e. DNR)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,138 participants in 2 patient groups

Intervention group

Active Comparator group

Treatment:

Behavioral: Change Management

Conventional CME

No Intervention group

Description:

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.