Abstract
BackgroundWhile sepsis-related mortality decreased substantially in other developed countries, mortality of severe sepsis remained as high as 44% in Germany. A recent German cluster randomized trial was not able to improve guideline adherence and decrease sepsis-related mortality within the participating hospitals, partly based on lacking support by hospital management and lacking resources for documentation of prospective data. Thus, more pragmatic approaches are needed to improve quality of sepsis care in Germany. The primary objective of the study is to decrease sepsis-related hospital mortality within a quality collaborative relying on claims data.MethodThe German Quality Network Sepsis (GQNS) is a quality collaborative involving 75 hospitals. This study protocol describes the conduction and evaluation of the start-up period of the GQNS running from March 2016 to August 2018. Democratic structures assure participatory action, a study coordination bureau provides central support and resources, and local interdisciplinary quality improvement teams implement changes within the participating hospitals. Quarterly quality reports focusing on risk-adjusted hospital mortality in cases with sepsis based on claims data are provided. Hospitals committed to publish their individual risk-adjusted mortality compared to the German average. A complex risk-model is used to control for differences in patient-related risk factors. Hospitals are encouraged to implement a bundle of interventions, e.g., interdisciplinary case analyses, external peer-reviews, hospital-wide staff education, and implementation of rapid response teams. The effectiveness of the GQNS is evaluated in a quasi-experimental difference-in-differences design by comparing the change of hospital mortality of cases with sepsis with organ dysfunction from a retrospective baseline period (January 2014 to December 2015) and the intervention period (April 2016 to March 2018) between the participating hospitals and all other German hospitals. Structural and process quality indicators of sepsis care as well as efforts for quality improvement are monitored regularly.DiscussionThe GQNS is a large-scale quality collaborative using a pragmatic approach based on claims data. A complex risk-adjustment model allows valid quality comparisons between hospitals and with the German average. If this study finds the approach to be useful for improving quality of sepsis care, it may also be applied to other diseases.Trial registrationClinicalTrials.gov NCT02820675.
Highlights
While sepsis-related mortality decreased substantially in other developed countries, mortality of severe sepsis remained as high as 44% in Germany
The German Quality Network Sepsis (GQNS) is a large-scale quality collaborative using a pragmatic approach based on claims data
If this study finds the approach to be useful for improving quality of sepsis care, it may be applied to other diseases
Summary
While sepsis-related mortality decreased substantially in other developed countries, mortality of severe sepsis remained as high as 44% in Germany. The primary objective of the study is to decrease sepsis-related hospital mortality within a quality collaborative relying on claims data. Sepsis is one of the major challenges for health care today [1] It is the leading cause of death among infectious diseases [2] and might be the leading cause of preventable deaths in hospitals [3, 4]. By using multifaceted interventions to increase guideline adherence on early adequate diagnosis and therapy of sepsis, several regional, national, and international quality initiatives were able to substantially reduce sepsis mortality in the participating hospitals [17,18,19,20,21,22,23]
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