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Identification of Outcome Relevant Indicators in Routine Data

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04670744
Enrollment
1000000
Registered
2020-12-17
Start date
2020-12-03
Completion date
2030-12-31
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesiological Risk Reduction, Intensive Care Risk Reduction

Brief 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. 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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

-none

Design outcomes

Primary

MeasureTime frameDescription
Mortality I01.01.2016-30.04.2026Mortality is measured by inhouse mortality.
Mortality II01.01.2016-30.04.2026Mortality is measured by long-term mortality (1 year)

Secondary

MeasureTime frameDescription
Morbidity01.01.2016-30.04.2026Morbidity is evaluated by International Classification of Diseases (ICD) (10th version). /Operation codes (OPS)
Accounting data01.01.2016-30.04.2026Accounting data are providid by the controlling department
Functional status01.01.2016-30.04.2026The 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.
Post Intensive Care Syndrome (PICS)01.01.2016-30.04.2026The 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.

Countries

Germany

Contacts

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

Charite University, Berlin, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026