Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009250

Trial Description

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Title

Quality Improvement in Infection Control and Sepsis Management in Model Regions

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Trial Acronym

ICOSMOS

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URL of the Trial

https://www.uniklinikum-jena.de/icosmos/Willkommen.html

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Brief Summary in Lay Language

Analysis of Reimbursement Data ($21 KHEntgG) as Basis for performance improvements and structured analysis of recognition, treatment and prevention of sepsis

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Brief Summary in Scientific Language

Can risk-adjusted analyses of routine data (i.e. standardized hospitals' reimbursement claims data) be used for improvements in sepsis recognition, diagnosis, therapy and outcome?

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Organizational Data

  •   DRKS00009250
  •   2018/11/13
  •   [---]*
  •   yes
  •   Approved
  •   4536-08/15, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   R57.2 -  Septic shock
  •   R65.1 -  Systemic Inflammatory Response Syndrome of infectious origin with organ failure
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Interventions/Observational Groups

  •   Risk-adjusted analysis of standardized data from hospital reimbursement claims (§21-Datatset according to the German Law of Hospital Reimbursement (Krankenhausentgeltgesetz)) of patients with sepsis, severe sepsis and septic shock of participating hospitals. The quality reports for analyses are created every three months for all participating hospitals allowing individual case analyses, analyses according to departments, and anonymous benchmarking with all other participating hospitals and the German average.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

standardized mortality ratio (i.e. ratio of actual to expected mortality) of patients with sepsis, severe sepsis and septic shock for each participating hospital, analysed every 3 months by §21-dataset

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Secondary Outcome

same as primary end point but in relation to German average

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2015/10/01
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Hospitals with intensive care unit (participants of the trial are hospitals, not patients!)

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Exclusion Criteria

Hospitals without intensive care units

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Addresses

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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    • Klinik für Anästhesiologie und IntensivtherapieUniversitätsklinikum Jena
    • Mr.  Dr. med.  Hendrik  Rüddel 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Klinik für Anästhesiologie und IntensivtherapieUniversitätsklinikum Jena
    • Mr.  Dr. med.  Hendrik  Rüddel 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   2018/07/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.