Adult Hospital Patients at Risk of Adverse OutcomesCORE-DNCT04983082
Portsmouth CORE-D Routine Care Data Repository
An observational study of Adult Hospital Patients at Risk of Adverse Outcomes, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Adult Hospital Patients at Risk of Adverse Outcomes
- How many people
- 750,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Aug 2021to Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Adult presenting at the acute hospital or receiving services from the hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
Paul E Schmidt
Paul E Schmidt
About this study
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
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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital death
Death during hospital admission
Measured: At 24 hours after an observation assessment or physiological measurement
In-hospital death
Death during hospital admission
Measured: 30 days after admission
Unanticipated ICU admission
Unanticipated ICU admission during hospital stay
Measured: At 24 hours after an observation assessment or physiological measurement
Unanticipated ICU admission
Unanticipated ICU admission during hospital stay
Measured: 30 days after admission
Cardiac arrest
Cardiac arrest during hospital stay
Measured: At 24 hours after an observation assessment or physiological measurement
Cardiac arrest
Cardiac arrest during hospital stay
Measured: 30 days after admission
Secondary outcomes (7)
Diagnosis of Corona Virus Disease (COVID) infection
Diagnosis of COVID-19
Measured: 48 hours after presentation
Diagnosis of Corona Virus Disease (COVID) infection
Diagnosis of COVID-19
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days after presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start19 Aug 2021
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Hospital Patients at Risk of Adverse OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 750,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Paul E Schmidt, MRCP, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983082
- Sponsor's protocol ID
- PHU/2021/11
- Acronym
- CORE-D
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04983082
- Acronym / sponsor ID
- CORE-D / PHU/2021/11
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750,000 participants (estimated)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult presenting at the acute hospital or receiving services from the hospital
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital death
Time frame: At 24 hours after an observation assessment or physiological measurement
Death during hospital admission
In-hospital death
Time frame: 30 days after admission
Death during hospital admission
Unanticipated ICU admission
Time frame: At 24 hours after an observation assessment or physiological measurement
Unanticipated ICU admission during hospital stay
Unanticipated ICU admission
Time frame: 30 days after admission
Unanticipated ICU admission during hospital stay
Cardiac arrest
Time frame: At 24 hours after an observation assessment or physiological measurement
Cardiac arrest during hospital stay
Cardiac arrest
Time frame: 30 days after admission
Cardiac arrest during hospital stay
7 secondary outcomes
Diagnosis of Corona Virus Disease (COVID) infection
Time frame: 48 hours after presentation
Diagnosis of Corona Virus Disease (COVID) infection
Time frame: 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
Time frame: 48 hours after presentation
Detection of Acute Organ Dysfunction
Time frame: 72 hours after presentation
Detection of Acute Organ Dysfunction
Time frame: 1 week after presentation
Detection of Acute Organ Dysfunction
Time frame: 30 days after presentation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul E Schmidt, MRCP principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Hospital Patients at Risk of Adverse Outcomes, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Meredith, PhD (023 92286000 ext. 3774, paul.meredith@porthosp.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital death (time frame: At 24 hours after an observation assessment or physiological measurement). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.