NCT04192175

Brief Summary

Patients with Chronic Obstructive Pulmonary Disease (COPD) who are admitted to hospital are at high risk of readmission. While therapies have improved and there are evidence-based guidelines to reduce readmissions, there are significant challenges to implementation including 1) identifying all patients with COPD early in admission to ensure evidence-based, high value care is provided and 2) identifying those who are at high risk of readmission in order to effectively target resources. Using machine learning and natural language processing, we want to develop models to 1) identify all patients with COPD exacerbations admitted to hospital and 2) stratify them to distinguish those who are at high risk of readmission b) How will you undertake your work? From Toronto hospitals, we will develop a very large dataset of patient admissions for all medical conditions including exacerbations of COPD from the electronic health record. This data will include both structured data such as age, gender, medications, laboratory values, co-morbidities as well as unstructured data such as discharge summaries and physician notes. Using the dataset, we will train a model through natural language processing and machine learning to be able to identify people admitted with COPD exacerbation and identify those patients who will be at high risk of readmission within 30 days. We will test the ability of these models to determine our predictive accuracies. We will then test these models at other institutions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 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

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

2.3 years

First QC Date

December 6, 2019

Last Update Submit

January 22, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Identification of COPD exacerbation

    To identify COPD exacerbations, we will use the most responsible diagnosis code for that visit.

    Within admission

  • Readmission risk

    To identify readmissions, we will include all cause readmissions within 30 days after an index admission for a COPD exacerbation, similar to previous studies.(3)

    30 days

Eligibility Criteria

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

Using retrospective data from the University Health Network (UHN), we will create a data set of admissions to General Internal Medicine for the past 7 years.

You may qualify if:

  • All admissions to General Internal Medicine between 2012-2018

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2019

First Posted

December 10, 2019

Study Start

June 1, 2019

Primary Completion

August 31, 2021

Study Completion

December 31, 2023

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations