Identification of Outcome Relevant Indicators in Routine Data

NCT ID: NCT04670744

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2026-12-31

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 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.

Conditions

Anesthesiological Risk Reduction; Intensive Care Risk Reduction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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

• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

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

Berlin, State of Berlin, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Claudia Spies, MD, Prof.

Role: CONTACT

Phone: +49 30 450 55 11 02

Email: claudia.spies@charite.de

Facility Contacts

Claudia Spies, MD, Prof.

Role: primary

Other Identifiers

QUALIPATT

Identifier Type: -

Identifier Source: org_study_id