Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions

Sepsis Clinical Trial

— icosmos  

Official title:

Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions / Deutsches Qualitaetsbuendnis Sepsis (German Quality Network Sepsis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820675
• Other study ID #: CSCCGermany
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 2019

Study information

• Verified date: July 2020
• Source: Center for Sepsis Control and Care, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The German Quality Network Sepsis is an association trying to improve quality of care for patients with sepsis, severe sepsis and septic shock or being in risc thereof.

The icosmos trial investigates the impact on the use of routine data, a risk adjustment algorithm and feedback to all hospitals as well as a structured implementation for regular screening for deteriorating patients, and education on in-hospital mortality.

Description:

All German hospitals provide a set of routine data to federal adminsitration for reimbursement. This dataset includes all ICD-10-Codes (German adaption) as well as all procedure codes.

This dataset is pseudonomized and risk adjusted for every individual case and afterwards feedbacked to each participating hospital including all accumulated data from all other hospitals as well as the German Average for sepsis mortalities provided by the German Federal Institute of Statistcs for benchmarkings.

Based on this data, the icosmos trial will provide support to all participating hospitals for two major strategies to be implemented

1. An algorithm for structured analysis of

1. low-risk-fatalities as potentially preventable deaths for underlying problems in diagnosis, treatment, etc

2. high-risk-survivors as "best practice"

3. coding errors for improvement of coding quality

2. a structured sreening program of every patient on every ward in every shift for deterioration and support algorithms including consiliary support and outreach teams as well as structured education

The icosmos trial will investigate the effects as well on quality of coding and sepsis incidence as well as on sepsis-related sepsis in-hospital mortality for participating hospitals in comparison to the German Average.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria for hospitals:

• hospitals willing to participate

Inclusion Criteria for patients / patients' data

• age over 16

• coding of sepsis, severe sepsis, septic shock

Exclusion Criteria for hospitals:

• no intensive care unit on site

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock, Septic
• Toxemia

Intervention

Other:
• structured case analysis
implementation of a structured analysis of cases coded as sepsis, severe sepsis, or septic shock after risk adjustment for low-risk-fatalities, high-risk-survivors, and coding errors for preventable deaths, best practice, quality improvement and improvement in coding precision.
• strucured screening "every patient, every shift"
implementation of a strutured screening and rescue algorithm on regular wards, emergency departements, and intermediate and intensive care units by checking every patient in every shifts for clinical signs of deterioration and apllying a rescue algorithm including consiliary help and/or the help of outreach teams

Locations

Country	Name	City	State
Germany	CSCCGermany	Jena	Thuringia

Sponsors (42)

Lead Sponsor

Collaborator

Center for Sepsis Control and Care, Germany

Asklepios Clinics, BG Klinikum Frankfurt Main, Bremen Hospitals, Bundeswehrkrankenhaus Berlin, Detmold Lippe Hospitals, Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen, German Federal Ministry of Education and Research, Greifswald University Hospital, Hannover Medical School, Havelland Hospitals, Herzzentrum Coswig, Klinikum Augsburg, Klinikum Emden, Klinikum Nürnberg, Klinikum St. Georg gGmbH, Krankenhaus Dresden Friedrichstadt, Krankenhaus Düren, Leipzig University Hospital, Magdeburg University Hospital, Mannheim University Hospital, MediClin Mueritz Hospital Waren, Munich University Hospital Rechts der Isar, Nordhausen South Harz Hospital, Oldenburg Hospital, Rostock Southern City Hospital, Rudolf Elle Hospital Eisenberg, Saarbruecken Hospital, Sana Clinics, Siegen Diakonie Hospital, SRH Central Hospital Suhl, SRH Hospital Gera, St. Elisabeth Hospital Cologne, Stuttgart Hospital, Trauma Center Murnau, University Hospital Düsseldorf, University Hospital in Halle, University Hospital, Bonn, University Hospitals of Schleswig-Holstein, Vivantes Berlin Hospitals, Werdau Pleissetal Hospital, Zentralklinik Bad Berka

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-hospital mortality	in-hospital mortality of all patients coded with sepsis, severe sepsis and septic shock in absolute numbers and in relation to the German average	3 years
Primary	sepsis codings	developement of coding of sepsis, severe sepsis and septic shock in absolte numbers and in relation to the German Average	3 years

External Links

•   trial homepage (in German)