Medical Education for Sepsis Source Control and Antibiotics

Conditions

Sepsis, Shock, Septic

Keywords

sepsis, shock, septic, quality assurance, health care, quality control, Survival Rate, Follow-Up Studies, Anti-Infective Agents/*therapeutic use

Brief 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.

Daniel Schwarzkopf, Claudia T. Matthaeus-Kraemer, Daniel Thomas‐Rüddel, Hendrik Rüddel, Bernhard Poidinger et al. (100 authors)

Scientific Reports2022-03-105 citations

10.1038/s41598-022-07915-9

Adverse effects of delayed antimicrobial treatment and surgical source control in adults with sepsis: results of a planned secondary analysis of a cluster-randomized controlled trial.

Rüddel H, Thomas-Rüddel DO, Reinhart K, Bach F, Gerlach H, Lindner M, Marshall JC, Simon P, Weiss M, Bloos F, Schwarzkopf D, MEDUSA study group.

2022-02-2845 citations

10.1186/s13054-022-03901-9

Fever and hypothermia represent two populations of sepsis patients and are associated with outside temperature.

Thomas-Rüddel DO, Hoffmann P, Schwarzkopf D, Scheer C, Bach F, Komann M, Gerlach H, Weiss M, Lindner M, Rüddel H, Simon P, Kuhn SO, Wetzker R, Bauer M, Reinhart K, Bloos F, MEDUSA study group.

2021-10-2143 citations

10.1186/s13054-021-03776-2

Influence of pathogen and focus of infection on procalcitonin values in sepsis patients with bacteremia or candidemia.

Thomas-Rüddel DO, Poidinger B, Kott M, Weiss M, Reinhart K, Bloos F, MEDUSA study group.

2018-05-1386 citations

10.1186/s13054-018-2050-9

The German Quality Network Sepsis: study protocol for the evaluation of a quality collaborative on decreasing sepsis-related mortality in a quasi-experimental difference-in-differences design

Daniel Schwarzkopf, Hendrik Rüddel, Matthias Gründling, Christian Putensen, Konrad Reinhart

Implementation Science2018-01-186 citations

10.1186/s13012-017-0706-5

Interventions

BEHAVIORALChange 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

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)

Design outcomes

Primary

Measure	Time frame
All-cause mortality	28 days

Secondary

Measure	Time frame
Duration until antimicrobial therapy	—
Duration until focus control	—
Frequency of blood cultures	—
Fraction of patients with antimicrobial therapy within 1 hour	—
ICU and hospital mortality	—
ICU and and hospital length of stay	—
Frequency of adequate antimicrobial therapy	—

Countries

Germany

Outcome results

None listed