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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock; Severe Sepsis
• Intervention / Treatment: Other: structured case analysis; Other: strucured screening "every patient, every shift"

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • CSCCGermany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 years
sepsis codings	developement of coding of sepsis, severe sepsis and septic shock in absolte numbers and in relation to the German Average	3 years

Collaborators and Investigators

• Sponsor: Center for Sepsis Control and Care, Germany
• Collaborators: Hannover Medical School; German Federal Ministry of Education and Research; University Hospital, Bonn; Klinikum St. Georg gGmbH; Klinikum Nürnberg; Klinikum Emden; Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen; University Hospital Augsburg; Zentralklinik Bad Berka; Herzzentrum Coswig; Vivantes Berlin Hospitals; Sana Clinics; Bundeswehrkrankenhaus Berlin; Bremen Hospitals; Klinikum Lippe Detmold; Krankenhaus Dresden Friedrichstadt; Krankenhaus Düren; University Hospital Düsseldorf; Rudolf Elle Hospital Eisenberg; BG Klinikum Frankfurt Main; SRH Hospital Gera; Asklepios Clinics; Greifswald University Hospital; University Hospital in Halle; 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• trial homepage (in German)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: quality improvement; routine data; risk adjustment; sepsis, severe sepsis, septic shock; quality of coding
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Toxemia; Shock, Septic
• Other Study ID Numbers: CSCCGermany

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Our trial uses publicly accessible routine data and a risk adjustment algorithm being prepared for publication