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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesiological Risk Reduction; Intensive Care Risk Reduction

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000000

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
  • Berlin
    • Berlin,, Berlin, Germany, 10117
      • Recruiting
      • Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitaetsmedizin Berlin
      • Principal Investigator: Claudia Spies, MD
      • Contact: Claudia Spies, MD, Prof.; Phone Number: +4930 450 55 11 02; Email: claudia.spies@charite.de
      • Sub-Investigator: Felix Balzer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 120 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 (Dep. for Anesthesiology with focus on operative intensive care, CCM/CVK/CBF) since 2006

Exclusion Criteria:

-none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	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.	01.01.2016-31.12.2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Morbidity is evaluated by International Classification of Diseases (ICD) (10th version). /Operation codes (OPS)	01.01.2016-31.12.2024
Mortality I	Mortality is measured by inhouse mortality	01.01.2016-31.12.2024
Mortality II	Mortality is measured by long-term mortality (1 year)	01.01.2016-31.12.2025
Accounting data	Accounting data are providid by the controlling department	01.01.2016-31.12.2024

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: QUALIPATT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No