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Copd Exacerbation AcuteNCT04192175

Identification of Patients Admitted With COPD Exacerbations and Predicting Readmission Risk Using Machine Learning

An observational study of Copd Exacerbation Acute and Readmission, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
65,000 participants
Where
1 siteCanada
Study dates
1 Jun 2019to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • All admissions to General Internal Medicine between 2012-2018

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University Health Network

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: Identification of Patients Admitted With COPD Exacerbations and Stratification of Those at High Risk of Readmission Using Natural Language Processing and Machine Learning

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.

Read the detailed description

One fifth of patients discharged from hospital for COPD exacerbations are readmitted within 30 days.(1, 3, 4) While therapies and care guidelines have improved, guideline implementation remains poor.(5) Implementing appropriate standards through usual hospital workflow presents significant challenges. One of the top challenges is ensuring all eligible patients with COPD exacerbations are identified in a timely manner.(6) Another top challenge is that staff are often too busy and do not have time to execute evidence-based practices that reduce readmissions.(6) Furthermore, intensive case management can not be offered to everyone because of limited resources. Therefore, it is important that we are able to identify both people who are admitted with COPD early as well as those who are at high risk for readmission.

COPD exacerbations may, at times, not be easily recognized at first and take days to become apparent. Symptoms of exacerbations such as shortness of breath are not specific and signs such as chest radiograph infiltrates can be due to one or more diagnoses. Furthermore, COPD exacerbations can trigger or be triggered by other diseases. As a result, it is not uncommon for admitting physicians to admit patients with multiple provisional diagnoses of heart failure, pneumonia, COPD exacerbation and more. Distinguishing people with COPD exacerbations is further confounded by Electronic Health Records (EHRs) that do not have diagnoses listed as coded elements. The end result is that it is difficult for the rest of the interprofessional team to find COPD patients early in admission. This has been addressed in some U.S. hospitals by having non-health care providers review charts to identify patients admitted with for COPD.(7) An alternate approach has been machine learning and natural language processing. This has been implemented with some success for patients with heart failure but little has been done for people with COPD.(13) In one pilot program, natural language processing helped identify patients admitted with COPD.(7)

To target scarce resources for those who need it most, it would be helpful to further identify patients at high risk of readmission. This would be the first step in determining how to implement effective strategies to reduce readmission rates. There are readmission prediction models developed for medical and surgical patients including the LACE score and the HOSPITAL score.(8, 9) Unfortunately, those that have been studied do not appear to perform well in the COPD population.(10) While factors have been identified that help predict COPD readmission, the models have not been fully validated.(11, 12) The performance could be improved through the use of unstructured data such as clinician progress notes and discharge summaries.

Early identification of people with COPD and knowledge of those who are at risk of readmission can improve health outcomes. Zafar et al. demonstrated that a comprehensive COPD care bundle that consisted of 1. inhaler assessment, 2. appropriate inhaler regimen, 3. early discharge follow up and 4. patient-centered discharge instructions reduced readmissions.(14) Identification of those at high risk of readmission could facilitate enrollment into intensive case management. Therefore, we will conduct the current study to identify patients admitted with acute exacerbations of COPD and stratify patients according to risk of readmission

Methods:

Using retrospective data from the University Health Network (UHN), we will create a data set of admissions to General Internal Medicine for the past 5 years. We estimate this will include approximately 40,000 admissions of which 2,000 will have a most responsible diagnoses of a COPD exacerbation. The data set will contain both structured coded data as well as unstructured text data. Coded data will include age, gender, medications ordered, co-morbidities, laboratory values, and pulmonary function tests. Unstructured text data will include notes in EHR: physician clinic notes, discharge summaries, admission diagnoses, progress notes, and notes from our signover system.

Analysis: We will use several different methods to develop the model including logistic regression, deep neural networks, and convolutional neural networks. Specifically, we will also use statistical machine learning algorithms for event detection using bi-directional long-short term memory neural networks across a variety of input types (e.g., Fourier filter banks, Mel-frequency cepstral coefficients, wavelets, and raw audio). We will also use traditional methods such as dynamic Bayes networks and conditional random fields. On the text analytics side, we will identify key phrases that predict readmission. One approach will be to use discourse analysis to single out "nucleus" phrases from background text. We will also build "joint" predictive models that combine features from the unstructured text and features from the structured coded data. We will use the standard Area under the ROC Curve to assess model performance and use cross validation to minimize the impact of overfitting. Finally, we will then validate our models using a dataset from different centres to determine whether these results are valid and generalizable.

Anticipated results: The development of two validated models based on EHR data: one to accurately identify patients with AECOPD and the second to accurately identify patients at high risk of readmission within 30 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of COPD exacerbation

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

    Measured: Within admission

  2. 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)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start1 Jun 2019
  3. Primary completion31 Aug 2021
  4. Study completion31 Dec 2023

Resources

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
65,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04192175
Sponsor's protocol ID
19-5124
Status last verified
Jan 2025
First submitted
6 Dec 2019
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Copd Exacerbation Acute and Readmission, run by University Health Network, Toronto at 1 site in Canada.

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 1 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: finished, as of the sponsor's last update on 27 Jan 2025. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of COPD exacerbation (time frame: Within admission). The study lists 2 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 27 Jan 2025.

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