Predicting Adverse Outcomes Using Machine Learning of COPD Patients in Hong Kong

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05825014
Collaborator
(none)
100,000
1
48
2084.8

Study Details

Study Description

Brief Summary

This study aims to develop predictive models for patients with a diagnosis of COPD at discharge of an index admission on these outcomes using machine learning:

Primary outcome: Early admission

Secondary outcomes:
  1. Frequent readmission

  2. Composite outcome (Early + Frequent readmissions)

  3. Mortality

  4. Longstayers

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease that is characterised by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases and influenced by host factors including abnormal lung development. It was estimated 3.2 million people died from COPD worldwide in 2015 and there was an increase of 11.6% compared with 1990. COPD is the third leading cause of death globally in 2019.

In Hong Kong (HK), the prevalence rates of COPD in the elderly population aged ≥60years were 25.9% and 12.4% based on the spirometric definition of forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio <70% and the lower limit of normal of the FEV1/FVC respectively.4 From our recent study on COPD hospital admissions, there are a total of 67,628 COPD admissions Jan 2017 Week 1 to Jan 2020 Week 3 (before the COVID pandemic) and 11,065 admissions from Jan 2020 Week 4 to Dec 2020 Week 4 (during the COVID pandemic). 5 The burden of COPD hospitalizations is significant and it is important to understand the driver of these admissions for developing suitable strategies to solve the problem and improve the health outcomes of patients suffering from COPD.

Early readmission and frequent admissions resulting from COPD are commonly studied hospital outcomes because of the high financial burden to both individual and state and the high usage of public healthcare resources. With the advent of Artificial Intelligence (AI) and Machine Learning (ML), there has been considerable interest on its application to medicine. Recent metaanalysis showed compatibility of these models in predicting COPD outcomes.7 However, few studies have managed to show that AI/ML are superior to traditional statistical modeling methods, AI/ML are interpretable and can be clinically correlated, and AI/ML can have direct clinical application.

This study aims to develop predictive models for patients with a diagnosis of COPD at discharge of an index admission on these outcomes:

Primary outcome: Early admission

Secondary outcomes:
  1. Frequent readmission

  2. Composite outcome (Early + Frequent readmissions)

  3. Mortality

  4. Longstayers

The viability and purported superiority of Machine Learning (ML) models as alternatives to traditional statistical learning methods will be assessed. Apart from that top predictors of each outcome of interest would be identified for suggestions of possible interventions that will improve outcomes (i.e. reduce early admission, frequent admission and mortality rates). Clinical scores for deployment in clinical setting will also be developed.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100000 participants
Observational Model:
Ecologic or Community
Time Perspective:
Retrospective
Official Title:
Predicting Adverse Outcomes Using Machine Learning of COPD Patients in Hong Kong
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2026
Anticipated Study Completion Date :
Apr 30, 2027

Outcome Measures

Primary Outcome Measures

  1. Early Readmission [30 days]

    Patients were readmitted to hospital with the primary diagnosis of AECOPD* within 30 days since the discharge date of the index admission

Secondary Outcome Measures

  1. Frequent Admitters [365 days]

    - Patients with 3 or more admissions (Index Admission + 2 or more admissions) within 365 days from the admission date of the index admission

  2. 1-Year Mortality [365 days]

    - Patients who died within 365 days from the discharge date of the index admission

  3. Longstayers [365 days]

    - Patients who had admissions(s) with a cumulative length of stay of > 21 days within 1 year after the discharge date of the index admission

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ≥40 years

  • Patients are discharged from 2016 -2022

  • Discharge Diagnosis: Using the Discharge Diagnosis ICD Codes found in the Primary Diagnosis to determine if a patient has COPD

  • Validated against Spirometry results (for patient with a spirometry reading):

Spirometry reading taken from anytime point before. Patient should have Post FEV1/FVC ratio of < 0.7 in any one of the spirometry readings. If Post FEV1/FVC is not available, we will check if patients have a Pre FEV1/FVC value, and will also include patients with Pre FEV1/FVC ratio of < 0.7 in any one of the spirometry readings.

Exclusion Criteria:
  • Admission diagnosis due to causes other than COPD

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Chinese University of Hong Kong Hong Kong New Territories Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fanny W.S. Ko, Honorary Clinical Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05825014
Other Study ID Numbers:
  • CRE Ref_ No_ 2022_679
First Posted:
Apr 24, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 27, 2023