Portsmouth CORE-D Routine Care Data Repository (CORE-D)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adult Hospital Patients at Risk of Adverse Outcomes

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 Type: Observational
• Enrollment (Anticipated): 750000

Contacts and Locations

• Study Contact: Name: Paul Meredith, PhD; Phone Number: 3774 023 92286000; Email: paul.meredith@porthosp.nhs.uk
• Study Contact Backup: Name: Alice Mortlock, PhD; Phone Number: 4042 023 92286000; Email: alice.mortlock@porthosp.nhs.uk

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Recruiting
      • Queen Alexandra Hospital
      • Contact: Paul E Schmidt
      • Principal Investigator: Paul E Schmidt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The research database will hold data on adults who are treated by Portsmouth Hospitals University National Health Service Trust (PHU), either as an outpatient, Accident and Emergency (A&E) attender, day case or inpatient or have investigations carried out by PHU services Adult patients are defined by the National Health Service (NHS) as individuals over 16 years old. Data on service contacts and use will only be included where the patient was more than 16 years old at that time. None of the data included in the Clinical Outcomes analyses are collected specifically for the purposes of research. All datasets are routinely collected clinical datasets, collected for clinical use and clinical audit.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital death	Death during hospital admission	At 24 hours after an observation assessment or physiological measurement
In-hospital death	Death during hospital admission	30 days after admission
Unanticipated ICU admission	Unanticipated ICU admission during hospital stay	At 24 hours after an observation assessment or physiological measurement
Unanticipated ICU admission	Unanticipated ICU admission during hospital stay	30 days after admission
Cardiac arrest	Cardiac arrest during hospital stay	At 24 hours after an observation assessment or physiological measurement
Cardiac arrest	Cardiac arrest during hospital stay	30 days after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of Corona Virus Disease (COVID) infection	Diagnosis of COVID-19	48 hours after presentation
Diagnosis of Corona Virus Disease (COVID) infection	Diagnosis of COVID-19	At 48 hours after an observation assessment or physiological measurement
Detection of Acute Organ Dysfunction	Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score	24 hours after presentation
Detection of Acute Organ Dysfunction	Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score	48 hours after presentation
Detection of Acute Organ Dysfunction	Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score	72 hours after presentation
Detection of Acute Organ Dysfunction	Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score	1 week after presentation
Detection of Acute Organ Dysfunction	Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score	30 days after presentation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Anticipated): April 1, 2026
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PHU/2021/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Bona fides United Kingdom (UK) researchers can make requests for access. They will be asked to detail their proposal in standard form which will be assessed by a Data Access Committee. Data will only be made available in a fully anonymous form and will be subject to a data sharing agreement.