Clinical trial NCT02820675: Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions
Official title: Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions / Deutsches Qualitaetsbuendnis Sepsis (German Quality Network Sepsis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Severe Sepsis
Septic Shock
Keywords: quality improvement
routine data
risk adjustment
sepsis, severe sepsis, septic shock
quality of coding
Lead sponsor: Center for Sepsis Control and Care, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Vivantes Berlin Hospitals
name: Klinikum Nürnberg
name: Sana Clinics
name: University Hospital Augsburg
name: Zentralklinik Bad Berka
name: Bundeswehrkrankenhaus Berlin
name: University Hospital, Bonn
name: Bremen Hospitals
name: Herzzentrum Coswig
name: Klinikum Lippe Detmold
name: Krankenhaus Dresden Friedrichstadt
name: Krankenhaus Düren
name: Heinrich-Heine University, Duesseldorf
name: Klinikum St. Georg gGmbH
name: Rudolf Elle Hospital Eisenberg
name: Klinikum Emden
name: BG Klinikum Frankfurt Main
name: SRH Hospital Gera
name: Asklepios Clinics
name: Greifswald University Hospital
name: Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
name: University Hospital in Halle
name: Hannover Medical School
name: University Hospitals of Schleswig-Holstein
name: St. Elisabeth Hospital Cologne
name: Leipzig University Hospital
name: Magdeburg University Hospital
name: Mannheim University Hospital
name: Munich University Hospital Rechts der Isar
name: Trauma Center Murnau
name: Havelland Hospitals
name: Nordhausen South Harz Hospital
name: Oldenburg Hospital
name: Rostock Southern City Hospital
name: Saarbruecken Hospital
name: Siegen Diakonie Hospital
name: Stuttgart Hospital
name: SRH Central Hospital Suhl
name: MediClin Mueritz Hospital Waren
name: Werdau Pleissetal Hospital
First posted: 2016-07-01
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: in-hospital mortality
timeFrame: 3 years
measure: sepsis codings
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: CSCCGermany
state: Thuringia
Study officials:
References:
citation: Schwarzkopf D, Ruddel H, Grundling M, Putensen C, Reinhart K. 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. Implement Sci. 2018 Jan 18;13(1):15. doi: 10.1186/s13012-017-0706-5.