NCT01187134

Medical Education for Sepsis Source Control and Antibiotics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,138 (actual)
• Sponsor: Center for Sepsis Control and Care, Germany · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Sepsis
• Shock, Septic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2010-08-23
• Last updated: 2017-08-09

Locations

42 sites across 1 country: Germany