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Recruiting NCT04670744

Identification of Outcome Relevant Indicators in Routine Data

Observational Anesthesiological Risk Reduction Intensive Care Risk Reduction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Anesthesiological Risk Reduction, Intensive Care Risk Reduction. Basic parameters: up to 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • Mortality I [Time frame: 01.01.2016-30.04.2026]
  • Mortality II [Time frame: 01.01.2016-30.04.2026]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitaet — Berlin

Identifiers

NCT: NCT04670744 · QUALIPATT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗