NCT04432961

Brief Summary

A retrospective cohort study investigating clinical notes using Natural Language Processing in combination with structured data from the Electronic Health Record (EHR) to create a database for analytics to identify features associated with outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

June 15, 2020

Last Update Submit

July 22, 2021

Conditions

Keywords

Natural Language Processing

Outcome Measures

Primary Outcomes (1)

  • research database of EHR records from COVID-19 patients processed using NLP tools for named entity recognition and linking adapted to CUH EMR data to identify variables of interest

    Our overarching hypothesis is that the NLP-extracted data from the free-text discharge summary can be combined with structured data from the EMR to yield insights into the development of complications. Patient with severe disease requiring ITU admission and non severe disease managed on an inpatient ward will be included. The variables of interest will include patient characteristics and specific encounter related information including length of stay and baseline investigations (e.g., blood tests) and interventions received

    1 year

Secondary Outcomes (2)

  • A set of annotation guidelines to produce human-expert (gold) labelled data for a subset of the EHR

    6 months

  • A comparison of the NLP output to terms in the structured problem list to identify missing terms in the structured problem list

    1 year

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to Cambridge University Hospitals NHS Foundation Trust with confirmed COVID-19

You may qualify if:

  • Male and female
  • Age range: 18 to 100 years
  • Patients admitted to Cambridge University Hospitals with confirmed COVID-19 on lab testing

You may not qualify if:

  • Children and patients with a negative COVID test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University NHS Foundation Trust

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 16, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations