Clinical trial NCT04983082: Portsmouth CORE-D Routine Care Data Repository
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Hospital Patients at Risk of Adverse Outcomes
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2021-07-30
Enrollment: 750000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: In-hospital death
timeFrame: At 24 hours after an observation assessment or physiological measurement
measure: In-hospital death
timeFrame: 30 days after admission
measure: Unanticipated ICU admission
timeFrame: At 24 hours after an observation assessment or physiological measurement
measure: Unanticipated ICU admission
timeFrame: 30 days after admission
measure: Cardiac arrest
timeFrame: At 24 hours after an observation assessment or physiological measurement
measure: Cardiac arrest
timeFrame: 30 days after admission
Secondary outcomes:
measure: Diagnosis of Corona Virus Disease (COVID) infection
timeFrame: 48 hours after presentation
measure: Diagnosis of Corona Virus Disease (COVID) infection
timeFrame: At 48 hours after an observation assessment or physiological measurement
measure: Detection of Acute Organ Dysfunction
timeFrame: 24 hours after presentation
measure: Detection of Acute Organ Dysfunction
timeFrame: 48 hours after presentation
measure: Detection of Acute Organ Dysfunction
timeFrame: 72 hours after presentation
measure: Detection of Acute Organ Dysfunction
timeFrame: 1 week after presentation
measure: Detection of Acute Organ Dysfunction
timeFrame: 30 days after presentation
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals University NHS Trust
name: Paul E Schmidt, MRCP
role: PRINCIPAL_INVESTIGATOR
References: