Evaluation of Quality Indicators in Patients Receiving Intensive Care and Their Influence on Outcome Indicators and Economic Indicators (EQUINOK)

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

The aim of the study is to identify and evaluate incentive mechanisms for the implementation of quality-relevant care processes. The objective is to correlate adherence to individual process-based quality indicators or their combination with outcome data. In addition, cost shares and case revenues are evaluated. Indices are also derived from routine data that may represent additional influencing factors (Charlson Comorbidity Index or secondary diagnoses that increase case severity based on ICD-10 coding and procedures based on the Surgery and procedure codes system).

Study Overview

• Status: Recruiting
• Conditions: Quality Indicators

Detailed Description

Within the Department of Anesthesiology and Intensive Care Medicine CCM/CVK at Charité- University Medicine Berlin, the systematic evaluation of quality-related process indicators is standard practice. These are based on the intensive care quality indicators of the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI). These process-based indicators are to be correlated with the examination of outcome indicators from routine data transmission in accordance with §21 data record (e.g., 30-day readmission rate, mortality, infection rate, length of stay) and economic parameters of treatment from controlling data (Diagnosis Related Groups revenue, case costs). The §21 data record describes a standardized data format that hospitals are required to transmit to the Institute for the Hospital Remuneration System (InEK) in accordance with § 21 (4) and (5) Act on Fees for Full and Partial Inpatient Hospital Services (Hospital Fees Act - KHEntgG). Data on standard clinical care from the Charité hospital systems will be used.

• Study Type: Observational
• Enrollment (Estimated): 26000

Contacts and Locations

• Study Contact: Name: Claudia Spies, MD, Prof.; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Department of Anaesthesiolgy and Intensive Care Medicine (CCM/CVK), Charite- University Berlin
    • Sub-Investigator: Oliver Kumpf, MD
    • Principal Investigator: Claudia Spies, MD, Prof.
    • Contact: Claudia Spies, MD, Prof.; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Intensive care unit patients (2012-2022) from the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK) of Charité - University Medicine Berlin with a length of stay > 24 hours.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proceeds	Per Case Revenue in Euro [€] (Revenue = base rate x DRG-rate) according to the Diagnosis Related Groups (DRG) reimbursement flat rate catalogue and the base rate for the state of Berlin for the respective billing year.	2012-2023
Case costs	Per case costs in Euro [€] according to case-related analysis based on financial controlling data.	2012-2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Charlson Comorbidity Index	Charlson Comorbidity Indices are generated from the number and type of secondary diagnoses according to ICD-10 Diagnosis Related Groups coding.(Scale from 0-37; higher Score values indicating more severe comorbidities and less probability of 10-year survival)	2012-2023
30-day readmission rate	30-day readmission rate from routine data up to one year	2012-2023
In-house mortality	In-house mortality from routine data up to one year	2012-2023
Infection rate	Infection rate form routine data, based on ICD-10 coding	2012-2023
Length of hospital stay (days)	Length of hospital stay from routine data	2012-2023
Length of intensive care unit stay (hours and days)	Length of intensive care unit stay from routine data	2012-2023
Patient Related Outcome Measures (PROM)	Patient Related Outcome Measures (PROM) are collected from routine data of patients with Post Intensive Care Syndrome. Presence of PICS is based on ICD-10 codes and specific combinations.	2012-2023
Measures of circadian rhythms	Measures of circadian rhythms are determined using biometric routine data.	2012-2023

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degrees of fulfillment of process-based quality indicators	Degrees of fulfillment of process-based quality indicators based on Quality indicators the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) are measured in percentages.	2012-2023
Quality indicator compliance	German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI)-Quality indicator compliance is measured in dependence on primary and secondary diagnoses. The indicators are evaluated according to the following list: QI1: "Ward round" QI2: "PAD-Management" QI3: "Mechanical ventilation" QI4: "Weaning from ventilation" QI5: "infection prevention" QI6: "management of infections" QI7: "nutrition management" QI8: "communication with relatives" QI9: "mobilization"	2012-2023
Outcome indicators	Degree of fulfillment of individual other process indicators based on German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) Quality indicators. In-House Quality measures like length of hospital stay or infection rates following surgery and their dependence on the fulfillment of DIVI-quality indicators. The indicators are evaluated according to the following list: QI1: "Ward round" QI2: "PAD-Management" QI3: "Mechanical ventilation" QI4: "Weaning from ventilation" QI5: "infection prevention" QI6: "management of infections" QI7: "nutrition management" QI8: "communication with relatives" QI9: "mobilization"	2012-2023
Bundle of process indicators	Degree of fulfillment of individual other process indicators based on a combination of German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) Quality indicators (known as a "bundle"). The indicators are evaluated according to the following list: QI1: "Ward round" QI2: "PAD-Management" QI3: "Mechanical ventilation" QI4: "Weaning from ventilation" QI5: "infection prevention" QI6: "management of infections" QI7: "nutrition management" QI8: "communication with relatives" QI9: "mobilization"	2012-2023

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: EQUINOK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No