Clinical trial NCT05384613: Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators
Official title: Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Pain
Keywords: Sedation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 20220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Electronically documented anesthesiological or intensive care treatment in the HIS (Hospital Information System) and PDMS (Patient Data Management System) of the Charité (Dep. for Anesthesiology with focus on operative intensive care, CCM/CVK) from 01.01.2012- 31.12.2021

Brief summary: Retrospective cohort study to investigate the adherence to the process indicators for pain management, sedation management and management of delirium on outcome indicators and cost/revenues in individual patients and subcohorts.

Detailed description: The evaluation of quality-related process indicators (in this case, Quality Indicator II of the Intensive Care Quality Indicators of the DIVI\*: Management of Analgesia, Sedation and Delirium) will be correlated with economic parameters of the treatment from economic data (DRG revenue, case costs). Data from clinical routine care from the Charite hospital systems will be used with further analysis of outcome indicators from routine data (e.g. 30-day readmission rate, mortality, infection rate, length of stay). The aim of the study is to identify and evaluate incentive mechanisms for the implementation of quality-relevant care processes using the example of adherence to a quality indicator regarding management of analgesia, sedation and delirium) on detailed cost shares and case proceeds. In addition, further routine data, which may represent influencing factors like comorbidities (Charlson Comorbitity Index) are calculated using the ICD-10 coding. Also procedures using the OPS system are evaluated.

In this retrospective cohort study, patient records from the clinical information systems from 2012 to 2021 will be analyzed.. The analysis is also intended to analyze whether alternatively, cross-treatment outcome indicators can be defined, which would demonstrate not only positive patient-oriented results but also positive economic results as a potential incentive for health care service providers.

(\* DIVI: Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin = German Interdisciplinary Association for Intensive Care and Emergency Medicine)

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years

Exclusion Criteria:

* Incomplete electronic records

Primary outcomes:
measure: Influence of compliance to a quality indicator (Monitoring sedation, analgesia, delirium)
timeFrame: 01.01.2012- 31.12.2021
Secondary outcomes:
measure: Comorbidity scores
timeFrame: 01.01.2012- 31.12.2021
measure: Outcome indicators
timeFrame: 01.01.2012- 31.12.2021
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zuber A, Rubarth K, Forster F, Balzer F, Spies C, Furstenau D, Kumpf O. The impact of adhering to a quality indicator for sedation, analgesia, and delirium management on costs, revenues, and clinical outcomes in intensive care in Germany: A retrospective observational study. PLoS One. 2024 Aug 15;19(8):e0308948. doi: 10.1371/journal.pone.0308948. eCollection 2024.