Investigation of the validity and improvement of the utility of claims data for quality improvement of treatment of sepsis in hospitals

Investigation of the validity and improvement of the utility of claims data for quality improvement of treatment of sepsis in hospitals - OPTIMISE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017775

Enrollment

10000

Registered

2019-10-14

Start date

2021-01-07

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis according to old sepsis-definitions (sepsis-1) Sepsis according to new sepsis-definitions ("sepsis-3") A02.1 A20.0 A20.7 A21.7 A22.7 A24.1 A26.7 A28.2 A32.7 A39.1 A39.2 A39.3 A39.4 A40 A41 A42.7 A48.3 A49.9 A54.8 B00.7 B37.6 B37.7 B49 O75.3 O85 P36 R65.0 R65.1 R57.2

Interventions

Group 1: Based on claims data, a stratified sample of 1200 cases per study center is drawn from the population of inpatient cases with billing based on DRG, and age of at least 15 years. The strata ar

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: Billing based on DRG, inpatient cases, age of at least 15 years, discharge from hospital in years 2015-2017

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Estimation of the validity (sensitivity, specificity, positive and negative predicitve value) of ICD-coding of sepsis with organ dysfunction including septic shock in German hospital claims data.	—

Secondary

Measure	Time frame
a) Proportion of sepsis (without organ dysfunction, with organ dysfunction, septic shock) based on old sepsis-definitions (sepsis-1) b) Proportion of sepsis (sepsis, septic shock) based on new sepsis-definitions (sepsis-3) c) Validity (sensitivity, specificity, positive and negative predictive value) of different methods to identify sepsis based on ICD-codes and German procedure (OPS) codes d) Validity (sensitivity, specificity, positive and negative predictive value) mortality risk-factors identified in claims data	—

Measure

Time frame

a) Proportion of sepsis (without organ dysfunction, with organ dysfunction, septic shock) based on old sepsis-definitions (sepsis-1) b) Proportion of sepsis (sepsis, septic shock) based on new sepsis-definitions (sepsis-3) c) Validity (sensitivity, specificity, positive and negative predictive value) of different methods to identify sepsis based on ICD-codes and German procedure (OPS) codes d) Validity (sensitivity, specificity, positive and negative predictive value) mortality risk-factors identified in claims data

—

Countries

Germany

Contacts

Public ContactDaniel Schwarzkopf

Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena

Daniel.Schwarzkopf@med.uni-jena.de+4936419323195

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026