Portsmouth CORE-D Routine Care Data Repository

Sponsor
Portsmouth Hospitals NHS Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04983082
Collaborator
(none)
750,000
56

Study Details

Study Description

Brief Summary

An integrated database of depersonalised routine hospital patient data consisting of demographic and disease attributes, physiological or laboratory measurements, care contacts and interventions along with associated clinical outcomes. The database is an essential resource for the development and testing of risk models and classification systems, modified as necessary for patient subgroups, which can then be introduced into clinical care to improve patient outcomes. It can also be used for large scale simulations to evaluate interventions.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aims and objectives of this database of depersonalised routinely collected hospital patient data are to:

    • Conduct epidemiological and observational studies of acute hospital care.

    • Develop and use algorithms and risk models to identify the deteriorating / sick adult so that interventions and enhanced care can be provided in a timelier manner with consequent resource and outcome improvements. This covers both the deteriorating inpatient at risk of adverse outcomes and people in the local community at risk of hospitalisation or in need of other health services.

    • Retrospectively evaluate interventions e.g. impact of system-wide clinical pathway introduction

    • Conduct simulations of clinical pathways

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    750000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Portsmouth Clinical Outcomes REsearch Database (CORE-D)- a Research Database of Routine Electronically Recorded Patient Data to Model Adverse Clinical Outcomes and Healthcare Resource Usage
    Anticipated Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2026
    Anticipated Study Completion Date :
    Apr 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. In-hospital death [At 24 hours after an observation assessment or physiological measurement]

      Death during hospital admission

    2. In-hospital death [30 days after admission]

      Death during hospital admission

    3. Unanticipated ICU admission [At 24 hours after an observation assessment or physiological measurement]

      Unanticipated ICU admission during hospital stay

    4. Unanticipated ICU admission [30 days after admission]

      Unanticipated ICU admission during hospital stay

    5. Cardiac arrest [At 24 hours after an observation assessment or physiological measurement]

      Cardiac arrest during hospital stay

    6. Cardiac arrest [30 days after admission]

      Cardiac arrest during hospital stay

    Secondary Outcome Measures

    1. Diagnosis of Corona Virus Disease (COVID) infection [48 hours after presentation]

      Diagnosis of COVID-19

    2. Diagnosis of Corona Virus Disease (COVID) infection [At 48 hours after an observation assessment or physiological measurement]

      Diagnosis of COVID-19

    3. Detection of Acute Organ Dysfunction [24 hours after presentation]

      Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score

    4. Detection of Acute Organ Dysfunction [48 hours after presentation]

      Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score

    5. Detection of Acute Organ Dysfunction [72 hours after presentation]

      Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score

    6. Detection of Acute Organ Dysfunction [1 week after presentation]

      Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score

    7. Detection of Acute Organ Dysfunction [30 days after presentation]

      Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Adult presenting at the acute hospital or receiving services from the hospital
    Exclusion Criteria:
    • Adults who have registered an opt out of research with National Health Service (NHS) Digital

    • Adults who have contacted the hospital to ask that their records are not to be included in this study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Portsmouth Hospitals NHS Trust

    Investigators

    • Principal Investigator: Paul E Schmidt, MRCP, Portsmouth Hospitals University NHS Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Portsmouth Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT04983082
    Other Study ID Numbers:
    • PHU/2021/11
    First Posted:
    Jul 30, 2021
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided

    Study Results

    No Results Posted as of Jul 30, 2021