AzTrials
AzTrials

Quality IndicatorsEQUINOKNCT07501494

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

An observational study of Quality Indicators, run by Charite University, Berlin, Germany at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Quality Indicators
How many people
35,000 participants
Where
1 siteGermany
Study dates
5 Mar 2026to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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 (01.01.2012- 31.12.2024).
  • 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: 2012- 2024: M101I, MPACU, WAN-S14I,WAN-S8I, WAN-PACU, 9i, WAC21i und W1i (2020-2022). Since the introduction of electronic patient records, some of these intensive care units have had different names (e.g., MAN-101i, MAN-103i, W1i).

Who cannot join

  • -none

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Claudia Spies, MD, Prof. contact

+49 30 450 55 11 02

claudia.spies@charite.de

Germany1 site, 1 recruiting

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

    Berlin, 10117

    Claudia Spies, MD, Prof., +49 30 450 55 11 02, claudia.spies@charite.de

    Claudia Spies, MD, Prof.

    Recruiting

Other trials in Germany

About this study

Official title: 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).

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2012-2024

  2. Case costs

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

    Measured: 2012-2024

Secondary outcomes (9)

  1. 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)

    Measured: 2012-2024

  2. 30-day readmission rate

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

    Measured: 2012-2024

  3. In-house mortality

    In-house mortality from routine data up to one year

    Measured: 2012-2024

  4. Infection rate

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

    Measured: 2012-2024

  5. Length of hospital stay (days)

    Length of hospital stay from routine data

    Measured: 2012-2024

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

    Length of intensive care unit stay from routine data

    Measured: 2012-2024

  7. 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.

    Measured: 2012-2024

  8. Measures of circadian rhythms

    Measures of circadian rhythms are determined using biometric routine data.

    Measured: 2012-2024

  9. Mortality

    Outpatient mortality data from the OLMERA registry

    Measured: 2012-2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start5 Mar 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
35,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07501494
Sponsor's protocol ID
EQUINOK
Acronym
EQUINOK
Status last verified
Oct 2026
First submitted
22 Jan 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Quality Indicators, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claudia Spies, MD, Prof. (+49 30 450 55 11 02, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proceeds (time frame: 2012-2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07501494.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in