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NCT Number: NCT07501494

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Berlin, 10117, Germany

Location status: Recruiting

Location contact

Claudia Spies, MD, Prof.

CONTACT

[email protected]

+49 30 450 55 11 02

Claudia Spies, MD, Prof.

PRINCIPAL_INVESTIGATOR

Oliver Kumpf, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proceeds

    Time frame: 2012-2023

    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.

  2. Case costs

    Time frame: 2012-2023

    Per case costs in Euro [€] according to case-related analysis based on financial controlling data.

Secondary outcomes

  1. Charlson Comorbidity Index

    Time frame: 2012-2023

    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)

  2. 30-day readmission rate

    Time frame: 2012-2023

    30-day readmission rate from routine data up to one year

  3. In-house mortality

    Time frame: 2012-2023

    In-house mortality from routine data up to one year

  4. Infection rate

    Time frame: 2012-2023

    Infection rate form routine data, based on ICD-10 coding

  5. Length of hospital stay (days)

    Time frame: 2012-2023

    Length of hospital stay from routine data

  6. Length of intensive care unit stay (hours and days)

    Time frame: 2012-2023

    Length of intensive care unit stay from routine data

  7. Patient Related Outcome Measures (PROM)

    Time frame: 2012-2023

    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.

  8. Measures of circadian rhythms

    Time frame: 2012-2023

    Measures of circadian rhythms are determined using biometric routine data.

Other outcomes

  1. Degrees of fulfillment of process-based quality indicators

    Time frame: 2012-2023

    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.

  2. Quality indicator compliance

    Time frame: 2012-2023

    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"

  3. Outcome indicators

    Time frame: 2012-2023

    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"

  4. Bundle of process indicators

    Time frame: 2012-2023

    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"

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Spies, MD, Prof.

CONTACT

[email protected]

+49 30 450 55 11 02

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: EQUINOK

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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