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Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions (icosmos)

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ClinicalTrials.gov Identifier: NCT02820675
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Vivantes Berlin Hospitals
Klinikum Nürnberg
Sana Clinics
Klinikum Augsburg
Zentralklinik Bad Berka
Bundeswehrkrankenhaus Berlin
University Hospital, Bonn
Bremen Hospitals
Herzzentrum Coswig
Detmold Lippe Hospitals
Krankenhaus Dresden Friedrichstadt
Krankenhaus Düren
University Hospital Düsseldorf
Klinikum St. Georg gGmbH
Rudolf Elle Hospital Eisenberg
Klinikum Emden
BG Klinikum Frankfurt Main
SRH Hospital Gera
Asklepios Clinics
Greifswald University Hospital
German Red Cross
University Hospital in Halle
Hannover Medical School
University Hospitals of Schleswig-Holstein
St. Elisabeth Hospital Cologne
Leipzig University Hospital
Magdeburg University Hospital
Mannheim University Hospital
Munich University Hospital Rechts der Isar
Trauma Center Murnau
Havelland Hospitals
Nordhausen South Harz Hospital
Oldenburg Hospital
Rostock Southern City Hospital
Saarbruecken Hospital
Siegen Diakonie Hospital
Stuttgart Hospital
SRH Central Hospital Suhl
MediClin Mueritz Hospital Waren
Werdau Pleissetal Hospital
Information provided by (Responsible Party):
Hendrik Rüddel, Center for Sepsis Control and Care, Germany

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.


Condition or disease Intervention/treatment Phase
Sepsis Severe Sepsis Septic Shock Other: structured case analysis Other: strucured screening "every patient, every shift" Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions / Deutsches Qualitaetsbuendnis Sepsis (German Quality Network Sepsis)
Actual Study Start Date : August 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
intervention
all hospitals participating in the icosmos trial will be supported in implenatation of the two main interventions.
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.

Other: 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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820675


Contacts
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Contact: Hendrik Rueddel, MD +4936419323252 hendrik.rueddel@med.uni-jena.de
Contact: Konrad Reinhart, Prof. +4936419323192 konrad.reinhart@med.uni-jena.de

Locations
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Germany
CSCCGermany Recruiting
Jena, Thuringia, Germany, 07747
Contact: Hendrik Rüddel, MD    +4936419323252    hendrik.rueddel@med.uni-jena.de   
Contact: Konrad Reinhart, Prof    +4936419323192    konrad.reinhart@med.uni-jena.de   
Sponsors and Collaborators
Center for Sepsis Control and Care, Germany
German Federal Ministry of Education and Research
Vivantes Berlin Hospitals
Klinikum Nürnberg
Sana Clinics
Klinikum Augsburg
Zentralklinik Bad Berka
Bundeswehrkrankenhaus Berlin
University Hospital, Bonn
Bremen Hospitals
Herzzentrum Coswig
Detmold Lippe Hospitals
Krankenhaus Dresden Friedrichstadt
Krankenhaus Düren
University Hospital Düsseldorf
Klinikum St. Georg gGmbH
Rudolf Elle Hospital Eisenberg
Klinikum Emden
BG Klinikum Frankfurt Main
SRH Hospital Gera
Asklepios Clinics
Greifswald University Hospital
German Red Cross
University Hospital in Halle
Hannover Medical School
University Hospitals of Schleswig-Holstein
St. Elisabeth Hospital Cologne
Leipzig University Hospital
Magdeburg University Hospital
Mannheim University Hospital
Munich University Hospital Rechts der Isar
Trauma Center Murnau
Havelland Hospitals
Nordhausen South Harz Hospital
Oldenburg Hospital
Rostock Southern City Hospital
Saarbruecken Hospital
Siegen Diakonie Hospital
Stuttgart Hospital
SRH Central Hospital Suhl
MediClin Mueritz Hospital Waren
Werdau Pleissetal Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hendrik Rüddel, trial manager, leader of trial management team, Center for Sepsis Control and Care, Germany
ClinicalTrials.gov Identifier: NCT02820675     History of Changes
Other Study ID Numbers: CSCCGermany
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Our trial uses publicly accessible routine data and a risk adjustment algorithm being prepared for publication
Keywords provided by Hendrik Rüddel, Center for Sepsis Control and Care, Germany:
quality improvement
routine data
risk adjustment
sepsis, severe sepsis, septic shock
quality of coding
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock