Clinical trial NCT04670744: Identification of Outcome Relevant Indicators in Routine Data
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anesthesiological Risk Reduction
Intensive Care Risk Reduction
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 1000000
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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 2006 and are to be considered for the development of data science-based models depending on selected QI or SOPs.

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.

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 2006

Exclusion Criteria:

-none

Primary outcomes:
measure: Functional status
timeFrame: 01.01.2016-31.12.2024
Secondary outcomes:
measure: Morbidity
timeFrame: 01.01.2016-31.12.2024
measure: Mortality I
timeFrame: 01.01.2016-31.12.2024
measure: Mortality II
timeFrame: 01.01.2016-31.12.2025
measure: Accounting data
timeFrame: 01.01.2016-31.12.2024
Other outcomes:
Locations:
city: Berlin,
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitaetsmedizin Berlin
state: Berlin
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD Prof.
role: STUDY_DIRECTOR
References: