SepsisicosmosNCT02820675
Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions
A study testing structured case analysis and strucured screening "every patient, every shift" in people with Sepsis and Severe Sepsis, run by Center for Sepsis Control and Care, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sepsis, Severe Sepsis, Septic Shock
- What is being tested?
- structured case analysis and strucured screening "every patient, every shift"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hospitals willing to participate
- age over 16
- coding of sepsis, severe sepsis, septic shock
Who cannot join
- no intensive care unit on site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Being tested
- structured case analysis, strucured screening "every patient, every shift"
- Keywords
- quality improvement, routine data, risk adjustment, sepsis, severe sepsis, septic shock, quality of coding
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| intervention | Other | all hospitals participating in the icosmos trial will be supported in implenatation of the two main interventions. Receives: Other: structured case analysis; Other: strucured screening "every patient, every shift" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
sepsis codings
developement of coding of sepsis, severe sepsis and septic shock in absolte numbers and in relation to the German Average
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startAug 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Sepsis Control and Care, Germany
- Sponsor type
- University, hospital or other
- 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, St. Marien-Hospital Düren, Heinrich-Heine University, Duesseldorf, Klinikum St. Georg gGmbH, Rudolf Elle Hospital Eisenberg, Klinikum Emden, BG Klinikum Frankfurt Main, SRH Hospital Gera, Asklepios Clinics, University Hospital Greifswald, Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen, University Hospital in Halle, Hannover Medical School, University Hospital 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
- Responsible party
- Principal investigator, Hendrik Rüddel, Center for Sepsis Control and Care, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820675
- Sponsor's protocol ID
- CSCCGermany
- Acronym
- icosmos
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2016
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Our trial uses publicly accessible routine data and a risk adjustment algorithm being prepared for publication
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.
PubMed 29347952
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions / Deutsches Qualitaetsbuendnis Sepsis (German Quality Network Sepsis)
- ClinicalTrials.gov ID
- NCT02820675
- Acronym / sponsor ID
- icosmos / CSCCGermany
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Keywords
- quality improvement, routine data, risk adjustment, sepsis, severe sepsis, septic shock, quality of coding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Center for Sepsis Control and Care, GermanyUniversity, hospital or other
- 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, St. Marien-Hospital Düren, Heinrich-Heine University, Duesseldorf, Klinikum St. Georg gGmbH, Rudolf Elle Hospital Eisenberg, Klinikum Emden, BG Klinikum Frankfurt Main, SRH Hospital Gera, Asklepios Clinics, University Hospital Greifswald, Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen, University Hospital in Halle, Hannover Medical School, University Hospital 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
- Study start
- Aug 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Other | Other: structured case analysis, Other: strucured screening "every patient, every shift"all hospitals participating in the icosmos trial will be supported in implenatation of the two main interventions. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- hospitals willing to participate
- age over 16
- coding of sepsis, severe sepsis, septic shock
Key exclusion criteria (1 listed)
- no intensive care unit on site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| structured case analysisimplementation 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 | intervention |
| 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 | Other | intervention |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Derived from this study: PubMed 29347952Schwarzkopf 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.
- trial homepage (in German)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Our trial uses publicly accessible routine data and a risk adjustment algorithm being prepared for publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing structured case analysis and strucured screening "every patient, every shift" in people with Sepsis and Severe Sepsis, run by Center for Sepsis Control and Care, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.