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

June 24, 2026 updated by: Portsmouth Hospitals NHS Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In-hospital death
Time Frame: At 24 hours after an observation assessment or physiological measurement
Death during hospital admission
At 24 hours after an observation assessment or physiological measurement
In-hospital death
Time Frame: 30 days after admission
Death during hospital admission
30 days after admission
Unanticipated ICU admission
Time Frame: At 24 hours after an observation assessment or physiological measurement
Unanticipated ICU admission during hospital stay
At 24 hours after an observation assessment or physiological measurement
Unanticipated ICU admission
Time Frame: 30 days after admission
Unanticipated ICU admission during hospital stay
30 days after admission
Cardiac arrest
Time Frame: At 24 hours after an observation assessment or physiological measurement
Cardiac arrest during hospital stay
At 24 hours after an observation assessment or physiological measurement
Cardiac arrest
Time Frame: 30 days after admission
Cardiac arrest during hospital stay
30 days after admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnosis of Corona Virus Disease (COVID) infection
Time Frame: 48 hours after presentation
Diagnosis of COVID-19
48 hours after presentation
Diagnosis of Corona Virus Disease (COVID) infection
Time Frame: At 48 hours after an observation assessment or physiological measurement
Diagnosis of COVID-19
At 48 hours after an observation assessment or physiological measurement
Detection of Acute Organ Dysfunction
Time Frame: 24 hours after presentation
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
Time Frame: 48 hours after presentation
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
Time Frame: 72 hours after presentation
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
Time Frame: 1 week after presentation
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
Time Frame: 30 days after presentation
Detection of acute organ dysfunction as measured by components of the Sequential Organ Failure Assessment (SOFA) Score
30 days after presentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Portsmouth Hospitals NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul E Schmidt, MRCP, Portsmouth Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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