Anesthesiological Risk ReductionNCT04670744
Identification of Outcome Relevant Indicators in Routine Data
An observational study of Anesthesiological Risk Reduction and Intensive Care Risk Reduction, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The availability of electronic documentation systems in patient care means that large amounts of clinical routine data are available from which conclusions can be drawn for improving patient care. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Anesthesiological Risk Reduction, Intensive Care Risk Reduction
- How many people
- 1,000,000 participants
- Where
- 1 siteGermany
- Study dates
- 3 Dec 2020to 31 Dec 2030
- 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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: At the department for anesthesiology with a focus on operative intensive care medicine, approximately 60,000 anaesthesias are performed annually. The data sets of documentation systems used in this context date back approximately to the year 2016 and are to be considered for the development of data science-based models depending on selected QI or SOPs.
Who may be able to join
- Age: 0 to 120 years
- Gender: female, male, diverse
- Electronically documented anesthesiological or intensive care treatment in the HIS (Hospital Information System) and PDMS (Patient Data Management System) of the Charité (Department of Anesthesiology and Intensive Care Medicine, CCM/CVK/CBF) since 2016
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.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitaetsmedizin Berlin
Berlin, State of Berlin, 10117
Claudia Spies, MD, Prof., +4930 450 55 11 02, claudia.spies@charite.de
Claudia Spies, MD
About this study
Official title: Retrospective Analysis for the Identification of Outcome Relevant Indicators ("Patterns") in Routine Data and Investigation of the Influence on Patient-centered Outcome for a Data-driven Improvement of Quality-based Treatment of Perioperative and Intensive Care Patients
The availability of electronic documentation systems in patient care means that large amounts of clinical routine data are available from which conclusions can be drawn for improving patient care. Compared to conventional research approaches, a data science-oriented approach offers the possibility of identifying patterns in routine data ("pattern recognition") that are relevant for patient-centered outcomes.
Numerous projects and sub-projects can be evaluated from this data set.
Read the detailed description
The patterns that are relevant for patient-centered outcomes (e.g. mortality) can be combinations of different parameters (e.g. vital signs, laboratory values, previous illnesses), which in themselves do not necessarily have a pathogenic effect, but in a specific combination may have a high relevance for the patient-centered outcome.
This project pursues as research goal the anesthesiological and intensive care risk reduction. To this end, the existing data sets of routine care are to be used to identify outcome-relevant patterns in order to derive recommendations for improving treatment in line with the patient's wishes. Standard Operating Procedures (SOPs) and Quality Indicators (QIs) in combination with the data of routine clinical care will be used as a basis. The approach outlined is closely linked to the development of quality-based treatment structures. In order to be able to offer medical treatment at a high level, associated processes must be known and operationalized, i.e. measurable. QIs (quality indicators) are an established instrument for measuring individual dimensions of treatment quality, and our clinic is a leading participant in this process at both national and international level (see Spies et al. Guidelines for Delirium, Analgesia and Sedation). The mapping of quality-based treatment structures as SOPs (Standard Operating Procedures) is also essential in this context (see Spies et al. SOPs in Anesthesiology and Pain Therapy, Thieme Verlag). By applying data science-based methods, this study pursues the overall goal of supporting the transfer of evidence-based findings in the form of QIs and SOPs into patient care.
Numerous projects and sub-projects can be evaluated from this data set.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality I
Mortality is measured by inhouse mortality.
Measured: 01.01.2016-30.04.2026
Mortality II
Mortality is measured by long-term mortality (1 year)
Measured: 01.01.2016-30.04.2026
Secondary outcomes (4)
Morbidity
Morbidity is evaluated by International Classification of Diseases (ICD) (10th version). /Operation codes (OPS)
Measured: 01.01.2016-30.04.2026
Accounting data
Accounting data are providid by the controlling department
Measured: 01.01.2016-30.04.2026
Functional status
The functional status of the patient is measured by routine score data. The scores, which measure physical, role, and social functioning, and mobility reflect worse/better outcome depending on the score construction.
Measured: 01.01.2016-30.04.2026
Post Intensive Care Syndrome (PICS)
The composite outcome measure "PICS" of the patient is measured according to Needham et al 2012: New or worsening physical, cognitive, and/or mental impairments that are collectively called PICS measured by Patient Health Questionnaires (PHQ-4), MiniCog, Animal Naming Test Timed Up-and-Go (TUG), Handgrip strength. The measurements will be performed, when patients present to the outpatient clinic for follow-up examinations.
Measured: 01.01.2016-30.04.2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start3 Dec 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesiological Risk ReductionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670744
- Sponsor's protocol ID
- QUALIPATT
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2020
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis for the Identification of Outcome Relevant Indicators ("Patterns") in Routine Data and Investigation of the Influence on Patient-centered Outcome for a Data-driven Improvement of Quality-based Treatment of Perioperative and Intensive Care Patients
- ClinicalTrials.gov ID
- NCT04670744
- Acronym / sponsor ID
- QUALIPATT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The availability of electronic documentation systems in patient care means that large amounts of clinical routine data are available from which conclusions can be drawn for improving patient care. Compared to conventional research approaches, a data science-oriented approach offers the possibility of identifying patterns in routine data ("pattern recognition") that are relevant for patient-centered outcomes.
Numerous projects and sub-projects can be evaluated from this data set.
Detailed description
The patterns that are relevant for patient-centered outcomes (e.g. mortality) can be combinations of different parameters (e.g. vital signs, laboratory values, previous illnesses), which in themselves do not necessarily have a pathogenic effect, but in a specific combination may have a high relevance for the patient-centered outcome.
This project pursues as research goal the anesthesiological and intensive care risk reduction. To this end, the existing data sets of routine care are to be used to identify outcome-relevant patterns in order to derive recommendations for improving treatment in line with the patient's wishes. Standard Operating Procedures (SOPs) and Quality Indicators (QIs) in combination with the data of routine clinical care will be used as a basis. The approach outlined is closely linked to the development of quality-based treatment structures. In order to be able to offer medical treatment at a high level, associated processes must be known and operationalized, i.e. measurable. QIs (quality indicators) are an established instrument for measuring individual dimensions of treatment quality, and our clinic is a leading participant in this process at both national and international level (see Spies et al. Guidelines for Delirium, Analgesia and Sedation). The mapping of quality-based treatment structures as SOPs (Standard Operating Procedures) is also essential in this context (see Spies et al. SOPs in Anesthesiology and Pain Therapy, Thieme Verlag). By applying data science-based methods, this study pursues the overall goal of supporting the transfer of evidence-based findings in the form of QIs and SOPs into patient care.
Numerous projects and sub-projects can be evaluated from this data set.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- At the department for anesthesiology with a focus on operative intensive care medicine, approximately 60,000 anaesthesias are performed annually. The data sets of documentation systems used in this context date back approximately to the year 2016 and are to be considered for the development of data science-based models depending on selected QI or SOPs.
Key inclusion criteria (3 listed)
- Age: 0 to 120 years
- Gender: female, male, diverse
- Electronically documented anesthesiological or intensive care treatment in the HIS (Hospital Information System) and PDMS (Patient Data Management System) of the Charité (Department of Anesthesiology and Intensive Care Medicine, CCM/CVK/CBF) since 2016
Key exclusion criteria (1 listed)
- -none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality I
Time frame: 01.01.2016-30.04.2026
Mortality is measured by inhouse mortality.
Mortality II
Time frame: 01.01.2016-30.04.2026
Mortality is measured by long-term mortality (1 year)
4 secondary outcomes
Morbidity
Time frame: 01.01.2016-30.04.2026
Accounting data
Time frame: 01.01.2016-30.04.2026
Functional status
Time frame: 01.01.2016-30.04.2026
Post Intensive Care Syndrome (PICS)
Time frame: 01.01.2016-30.04.2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Spies, MD Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesiological Risk Reduction and Intensive Care Risk Reduction, 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 3 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 5 Jun 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?
Mortality I (time frame: 01.01.2016-30.04.2026). 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?
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 5 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.