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Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT05384613
Collaborator
(none)
22,000
Enrollment
1
Location
31.7
Anticipated Duration (Months)
694.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective cohort study to investigate the adherence to the process indicators for pain management, sedation management and management of delirium on outcome indicators and cost/revenues in individual patients and subcohorts.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The evaluation of quality-related process indicators (in this case, Quality Indicator II of the Intensive Care Quality Indicators of the DIVI*: Management of Analgesia, Sedation and Delirium) will be correlated with economic parameters of the treatment from economic data (DRG revenue, case costs). Data from clinical routine care from the Charite hospital systems will be used with further analysis of outcome indicators from routine data (e.g. 30-day readmission rate, mortality, infection rate, length of stay). The aim of the study is to identify and evaluate incentive mechanisms for the implementation of quality-relevant care processes using the example of adherence to a quality indicator regarding management of analgesia, sedation and delirium) on detailed cost shares and case proceeds. In addition, further routine data, which may represent influencing factors like comorbidities (Charlson Comorbitity Index) are calculated using the ICD-10 coding. Also procedures using the OPS system are evaluated.

    In this retrospective cohort study, patient records from the clinical information systems from 2012 to 2021 will be analyzed.. The analysis is also intended to analyze whether alternatively, cross-treatment outcome indicators can be defined, which would demonstrate not only positive patient-oriented results but also positive economic results as a potential incentive for health care service providers.

    (* DIVI: Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin = German Interdisciplinary Association for Intensive Care and Emergency Medicine)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    22000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators
    Actual Study Start Date :
    May 12, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Influence of compliance to a quality indicator (Monitoring sedation, analgesia, delirium) [01.01.2012- 31.12.2021]

      Influence of compliance to a quality indicator (Quality Indicator II of the DIVI; Management of Analgesia, Sedation and Delirium) and the relationship to case specific revenues and case costs according to case-specific analysis based on hospital financial data

    Secondary Outcome Measures

    1. Comorbidity scores [01.01.2012- 31.12.2021]

      (Comorbidity scores are assessed according to Charlson comorbidity index (CCI) employing routine data, like icd-10 codes.

    2. Outcome indicators [01.01.2012- 31.12.2021]

      Outcome indicators from routine data are e. g. 30-day readmission rate, mortality, infection rate, length of stay, etc. )

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age ≥ 18 years
    Exclusion Criteria:
    • Incomplete electronic records

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité - University Medicine Berlin Berlin Germany 13353

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Principal Investigator: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claudia Spies, Head of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT05384613
    Other Study ID Numbers:
    • ECOPAD
    First Posted:
    May 20, 2022
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Claudia Spies, Head of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin, Charite University, Berlin, Germany
    Sedation
    Additional relevant MeSH terms:
    Delirium

    Study Results

    No Results Posted as of May 20, 2022