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NCT Number: NCT04670744

Identification of Outcome Relevant Indicators in Routine Data

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.

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Key information

Age range

Up to 120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitaetsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location status: Recruiting

Location contact

Claudia Spies, MD

PRINCIPAL_INVESTIGATOR

Claudia Spies, MD, Prof.

CONTACT

[email protected]

+4930 450 55 11 02

Laerson Hoff, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Mortality I

    Time frame: 01.01.2016-30.04.2026

    Mortality is measured by inhouse mortality.

  2. Mortality II

    Time frame: 01.01.2016-30.04.2026

    Mortality is measured by long-term mortality (1 year)

Secondary outcomes

  1. Morbidity

    Time frame: 01.01.2016-30.04.2026

    Morbidity is evaluated by International Classification of Diseases (ICD) (10th version). /Operation codes (OPS)

  2. Accounting data

    Time frame: 01.01.2016-30.04.2026

    Accounting data are providid by the controlling department

  3. Functional status

    Time frame: 01.01.2016-30.04.2026

    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.

  4. Post Intensive Care Syndrome (PICS)

    Time frame: 01.01.2016-30.04.2026

    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.

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 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

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Dec 17, 2020
Registry last updated
Jun 5, 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.