NCT02820675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable sepsis

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

3.9 years

First QC Date

June 29, 2016

Last Update Submit

July 14, 2020

Conditions

SepsisSevere SepsisSeptic Shock

Keywords

quality improvementroutine datarisk adjustmentsepsis, severe sepsis, septic shockquality of coding

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

intervention

OTHER

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

Other: structured case analysisOther: strucured screening "every patient, every shift"

Interventions

structured case analysisOTHER

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
strucured screening "every patient, every shift"OTHER

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

intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • hospitals willing to participate
  • age over 16
  • coding of sepsis, severe sepsis, septic shock

You may not qualify if:

  • no intensive care unit on site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSCCGermany

Jena, Thuringia, 07747, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29347952DERIVED

Related Links

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
trial manager, leader of trial management team

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 1, 2016

Study Start

August 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Our trial uses publicly accessible routine data and a risk adjustment algorithm being prepared for publication

Locations

DE(1)