Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions

Not Applicable

Completed

• Conditions: Sepsis; Severe Sepsis; Septic Shock
• Interventions: Other: structured case analysis; Other: strucured screening "every patient, every shift"

• Registration Number: NCT02820675
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-01
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention	strucured screening "every patient, every shift"	all hospitals participating in the icosmos trial will be supported in implenatation of the two main interventions.
intervention	structured case analysis	all hospitals participating in the icosmos trial will be supported in implenatation of the two main interventions.

Primary Outcome Measures

Name	Time	Method
in-hospital mortality	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
sepsis codings	3 years	developement of coding of sepsis, severe sepsis and septic shock in absolte numbers and in relation to the German Average

Trial Locations

Locations (1)

CSCCGermany; 🇩🇪 Jena, Thuringia, Germany