Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions (icosmos)
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| ClinicalTrials.gov Identifier: NCT02820675 |
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Recruitment Status :
Recruiting
First Posted : July 1, 2016
Last Update Posted : August 9, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sepsis Severe Sepsis Septic Shock | Other: structured case analysis Other: strucured screening "every patient, every shift" | Not Applicable |
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
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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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 70 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions / Deutsches Qualitaetsbuendnis Sepsis (German Quality Network Sepsis) |
| Actual Study Start Date : | August 2015 |
| Estimated Primary Completion Date : | July 2019 |
| Estimated Study Completion Date : | July 2019 |
| Arm | Intervention/treatment |
|---|---|
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intervention
all hospitals participating in the icosmos trial will be supported in implenatation of the two main interventions.
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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 |
- 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
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820675
| Contact: Hendrik Rueddel, MD | +4936419323252 | hendrik.rueddel@med.uni-jena.de | |
| Contact: Konrad Reinhart, Prof. | +4936419323192 | konrad.reinhart@med.uni-jena.de |
| Germany | |
| CSCCGermany | Recruiting |
| Jena, Thuringia, Germany, 07747 | |
| Contact: Hendrik Rüddel, MD +4936419323252 hendrik.rueddel@med.uni-jena.de | |
| Contact: Konrad Reinhart, Prof +4936419323192 konrad.reinhart@med.uni-jena.de | |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hendrik Rüddel, trial manager, leader of trial management team, Center for Sepsis Control and Care, Germany |
| ClinicalTrials.gov Identifier: | NCT02820675 History of Changes |
| Other Study ID Numbers: |
CSCCGermany |
| First Posted: | July 1, 2016 Key Record Dates |
| Last Update Posted: | August 9, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Our trial uses publicly accessible routine data and a risk adjustment algorithm being prepared for publication |
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quality improvement routine data risk adjustment sepsis, severe sepsis, septic shock quality of coding |
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Sepsis Toxemia Shock, Septic Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Shock |