How ICU quality checks affect patient outcomes and hospital costs at Charité

Retrospective Observational Study - Evaluation of Quality Indicators in Patients Receiving Intensive Care and Their Influence on Outcome Indicators and Economic Indicators

This project will test whether following specific intensive care process steps for adult patients in selected Charité ICUs leads to better outcomes and different hospital costs.

Quick facts

• Study type: Observational
• Enrollment: 26000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Charite University, Berlin, Germany (other)
• Locations: 1 site (Berlin)
• Trial ID: NCT07501494 on ClinicalTrials.gov

What this trial studies

This observational project links routinely collected electronic ICU process data to clinical outcomes and economic records at Charité—using DIVI-derived process indicators and §21 routine data. Investigators will correlate adherence to individual and combined process indicators with outcome measures such as 30-day readmission, mortality, infection rates, and length of stay, and with economic parameters including DRG revenues and case costs. Adjustments and stratification will use indices derived from routine data (e.g., Charlson Comorbidity Index, ICD-10 secondary diagnoses, procedure codes). Eligible cases are adult ICU admissions longer than 24 hours with complete electronic monitoring, laboratory, clinical, and cost documentation from specified Charité units.

Who should consider this trial

Good fit: Adults (age ≥18) admitted to the specified Charité intensive care units for more than 24 hours who have complete electronic vital sign, laboratory, clinical, and hospital cost/revenue documentation are ideal candidates for inclusion.

Not a fit: Patients under 18, those with ICU stays of 24 hours or less, those lacking complete electronic clinical or cost records, or those treated outside the listed Charité units are unlikely to be included or to benefit from this analysis.

Why it matters

Potential benefit: If successful, the findings could identify which ICU care processes improve survival, reduce complications or length of stay, and help target resources to provide better care at lower or more appropriate cost.

How similar studies have performed: Process-based quality indicators from organizations like DIVI and similar programs have been associated with improved ICU care in prior reports, but large-scale linkage of these process measures to detailed economic data in German routine §21 records is less commonly reported.

Eligibility criteria

Inclusion Criteria:

* Patients with complete, electronically documented intensive care treatment data, including vital sign monitor data and laboratory data from the patient documentation system.
* Complete, electronically documented treatment data for these patients from the hospital information system.
* Data from cost and revenue accounting from the hospital information system, §21 routine data records.
* Age ≥ 18 years
* Length of stay \> 24 hours
* Intensive care units from the Department of Anesthesiology and Intensive Care Medicie (CCM/CVK) of Charité - University Medicine Berlin: "M101I", 'MPACU', "WAN-S14I", "WAN-S8I", "WAN-PACU". Since the introduction of electronic patient records, some of these intensive care units have had different names (e.g., MAN-101i, MAN-103i, W1i).

Exclusion Criteria:

-none

Where this trial is running

Berlin

• Department of Anaesthesiolgy and Intensive Care Medicine (CCM/CVK), Charite- University Berlin — Berlin, Germany (RECRUITING)

Study contacts

• Principal investigator: Claudia Spies, MD, Prof. — Charite University, Berlin, Germany
• Study coordinator: Claudia Spies, MD, Prof.

Conditions: Quality Indicators