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

Daniel Schwarzkopf, Hendrik Rüddel, Matthias Gründling, Christian Putensen, Konrad Reinhart, Daniel Schwarzkopf, Hendrik Rüddel, Matthias Gründling, Christian Putensen, Konrad Reinhart

Abstract

Background: While 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.

Method: The 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.

Discussion: The 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 registration: ClinicalTrials.gov NCT02820675.

Keywords: Administrative claims; Hospitals; Interdisciplinary health team; Mortality; Quality improvement; Risk adjustment; Sepsis.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the internal review board of the Jena University Hospital. Since a secondary analysis of claims data is done, the need for informed consent of patients was waved. The study was additionally approved by the data protection supervisor of the Free State of Thuringia, Germany.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study timeline. Study timeline and milestones are presented for the 48 hospitals initially enrolled in the German Quality Network Sepsis. A final analysis comparing these 48 intervention hospitals to all other German hospitals will be done with a delay of 1.5 years when the German national claims data will be made available by the Federal Bureau of Statistics
Fig. 2
Fig. 2
Flows of information in the German Quality Network Sepsis. The study coordinating bureau develops the risk-model based on analyzing the German population claims data hosted by the Felderal Bureau of Statistics. It further provides the specifications for calculating quality indicators to 3M Health Information Systems. Based on quarterly transmissions of claims data by the participating hospitals, 3M produces quality reports and delivers them to the hospitals. Hospitals committed to publish their sepsis-related risk-adjusted hospital mortality in comparison to the German average after 2 years of participation
Fig. 3
Fig. 3
Schematic example of graphical reporting of quality indicators. Presented are SMRs (standardized mortality ratios) with 90% confidence intervals (CI) for cases with sepsis with organ dysfunction (including septic shock) in 2016. Internal quality reporting uses 90% CIs to increase sensitivity for finding true deviations from average quality. Publications of quality indicators by participating hospitals will use 95% CIs. GQNS: German Quality Network Sepsis

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