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

Primary Purpose

Sepsis, Severe Sepsis, Septic Shock

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
structured case analysis
strucured screening "every patient, every shift"
Sponsored by
Center for Sepsis Control and Care, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sepsis focused on measuring quality improvement, routine data, risk adjustment, sepsis, severe sepsis, septic shock, quality of coding

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CSCCGermany

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

intervention

Arm Description

all hospitals participating in the icosmos trial will be supported in implenatation of the two main interventions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 29, 2016
Last Updated
July 14, 2020
Sponsor
Center for Sepsis Control and Care, Germany
Collaborators
German Federal Ministry of Education and Research, Vivantes Berlin Hospitals, Klinikum Nürnberg, Sana Clinics, University Hospital Augsburg, Zentralklinik Bad Berka, Bundeswehrkrankenhaus Berlin, University Hospital, Bonn, Bremen Hospitals, Herzzentrum Coswig, Klinikum Lippe Detmold, 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, Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02820675
Brief Title
Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions
Acronym
icosmos
Official Title
Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions / Deutsches Qualitaetsbuendnis Sepsis (German Quality Network Sepsis)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Sepsis Control and Care, Germany
Collaborators
German Federal Ministry of Education and Research, Vivantes Berlin Hospitals, Klinikum Nürnberg, Sana Clinics, University Hospital Augsburg, Zentralklinik Bad Berka, Bundeswehrkrankenhaus Berlin, University Hospital, Bonn, Bremen Hospitals, Herzzentrum Coswig, Klinikum Lippe Detmold, 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, Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen, 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Severe Sepsis, Septic Shock
Keywords
quality improvement, routine data, risk adjustment, sepsis, severe sepsis, septic shock, quality of coding

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Other
Arm Description
all hospitals participating in the icosmos trial will be supported in implenatation of the two main interventions.
Intervention Type
Other
Intervention Name(s)
structured case analysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
strucured screening "every patient, every shift"
Intervention Description
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 Measure Information:
Title
in-hospital mortality
Description
in-hospital mortality of all patients coded with sepsis, severe sepsis and septic shock in absolute numbers and in relation to the German average
Time Frame
3 years
Title
sepsis codings
Description
developement of coding of sepsis, severe sepsis and septic shock in absolte numbers and in relation to the German Average
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CSCCGermany
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Our trial uses publicly accessible routine data and a risk adjustment algorithm being prepared for publication
Citations:
PubMed Identifier
29347952
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.
Results Reference
derived
Links:
URL
http://www.icosmos.uniklinikum-jena.de
Description
trial homepage (in German)

Learn more about this trial

Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions

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