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NCT Number: NCT02820675

Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Severe Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CSCCGermany

Jena, Thuringia, 07747, Germany

About this study

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

  • An algorithm for structured analysis of
  • low-risk-fatalities as potentially preventable deaths for underlying problems in diagnosis, treatment, etc
  • high-risk-survivors as "best practice"
  • coding errors for improvement of coding quality
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

structured case analysis

Other

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"

Other

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

Primary outcomes

  1. in-hospital mortality

    Time frame: 3 years

    in-hospital mortality of all patients coded with sepsis, severe sepsis and septic shock in absolute numbers and in relation to the German average

  2. sepsis codings

    Time frame: 3 years

    developement of coding of sepsis, severe sepsis and septic shock in absolte numbers and in relation to the German Average

Sponsors and collaborators

Lead sponsor

Center for Sepsis Control and Care, Germany

Other

Collaborators

  • Asklepios Clinics
  • BG Klinikum Frankfurt Main
  • Bremen Hospitals
  • Bundeswehrkrankenhaus Berlin
  • Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen
  • German Federal Ministry of Education and Research
  • Greifswald University Hospital
  • Hannover Medical School
  • Havelland Hospitals
  • Heinrich-Heine University, Duesseldorf
  • Herzzentrum Coswig
  • Klinikum Emden
  • Klinikum Lippe Detmold
  • Klinikum Nürnberg
  • Klinikum St. Georg gGmbH
  • Krankenhaus Dresden Friedrichstadt
  • 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
  • SRH Central Hospital Suhl
  • SRH Hospital Gera
  • Saarbruecken Hospital
  • Sana Clinics
  • Siegen Diakonie Hospital
  • St. Elisabeth Hospital Cologne
  • St. Marien-Hospital Düren
  • Stuttgart Hospital
  • Trauma Center Murnau
  • University Hospital Augsburg
  • University Hospital Schleswig-Holstein
  • University Hospital in Halle
  • University Hospital, Bonn
  • Vivantes Berlin Hospitals
  • Werdau Pleissetal Hospital
  • Zentralklinik Bad Berka

Registry information

Official study title

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

Acronym: icosmos

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2016
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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