Medical Education for Sepsis Source Control and Antibiotics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Medical Education for Sepsis Source Control and Antibiotics

Conditions
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Sepsis, Shock, Septic

Intervention / Treatment
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* Behavioral: Change Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the hospitals (cluster): Involved in the primary care of patients with severe sepsis/septic shock Willing to participate in a guideline implementation process For the patients: New onset of suspicion of severe sepsis or septic shock in the following settings: Prehospital Emergency department Operating theatre Regular ward Intensive care unit (ICU)/Intermediate Care Unit (IMC) Exclusion Criteria: For the hospitals (cluster): No intensive care unit available no acute care for patients with severe sepsis and septic shock 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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br> | Behavioral: Change Management<br>* 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.<br>|
| No Intervention: Conventional CME<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, shock, septic, quality assurance, health care, quality control, Survival Rate, Follow-Up Studies, Anti-Infective Agents/*therapeutic use