Identifying Early Chronic Obstructive Pulmonary Disease (COPD) Using Health Administrative Data

NCT04966637 | Completed

• 1 other identifier: Pro00097014
• Study Type: observational
• Target: 54,028
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) affects the airways that causes shortness of breath, cough. COPD gets worse over time, and often leads to emergency department visits, hospital visits, frequent doctor appointments and medications. This means COPD is expensive, and severely impacts patient quality of life. Unfortunately, patients are often not properly diagnosed until their disease is fairly advanced. We know a lot about the health care use of people with COPD once they have been diagnosed, but we do not know much about what happens to them leading up to their diagnosis. Through this project we want to better understand the time period prior to COPD diagnosis, so that we can learn more about what happens to people before they are diagnosed. This project will use health data to find out if we can identify trends in health care use by individuals newly diagnosed with COPD. We will identify people that have COPD based on health records, and look back to find out about their health care use prior to their diagnosis. We will look at data related to doctors' visits, emergency department visits, hospital stays and medications. We want to use these markers to better understand what happens to people before they are diagnosed, and to find out if we can identify risk factors for a COPD diagnosis. We hope by doing this research we can better identify people at risk for COPD and ensure that they receive treatment early, which may improve their health outcomes.

Conditions

Chronic Obstructive Pulmonary Disease (COPD

Outcome Measures

Primary Outcomes (1)

• determine factors associated with a new diagnosis of COPD

  Health care utilization (physician visits, hospitalizations, emergency department visits, dispensed medication for the cohort of patients five year prior to their diagnosis will be evaluated

  each patient's COPD incidence diagnosis date and a COPD incidence diagnosis date (minus 5 years)

Secondary Outcomes (2)

• prediction model for COPD

  each patient's COPD incidence diagnosis date and a COPD incidence diagnosis date (minus 5 years)

• machine learning prediction model for COPD

  each patient's COPD incidence diagnosis date and a COPD incidence diagnosis date (minus 5 years)

Study Arms (1)

Individuals with COPD

This retrospective annual analysis will use the following validated case definition to identify a cohort of individuals with COPD: an individual aged 35 years and older having at least one visit to a physician with a diagnosis of COPD (by ICD-9(-CM) 491-492, 496) or one hospital separation with a diagnosis of COPD (ICD-10-CA J41-44) between April 1, 2016 and March 31, 2019. This is a retrospective descriptive study with administrative data and no intervention will be administered to the cohort

Other: COPD cohort

Interventions

COPD cohort OTHER

as this a retrospective descriptive study no intervention will be administered to study participants

Individuals with COPD

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes all individuals in the province of Alberta that meet the inclusion criteria, and have accessed the provincial health care system during the study period. All individuals that have an incident case of COPD within the 3 year time period for study inclusion that reside in Alberta will have their data included in the study. Based on our pre-existing knowledge of the administrative data available, we would expect over 50,000 individual patients in the cohort. Given our health care is provided at a provincial level, we would expect this would capture all individuals in the province that had their incident diagnosis of COPD in the time period. The exception may be individuals that were diagnosed with COPD while out of province.

You may qualify if:

• Must have had at least one visit to a physician with a diagnosis of COPD (by ICD-9(-CM) 491-492, 496) or one hospital separation with a diagnosis of COPD (ICD-10-CA J41-44).
• Incidence criteria included 5 year washout period in which they were not in Alberta, Canada but did not have any diagnosis of COPD
• Individuals that meet this criteria with a new diagnosis in the last 3 years will be included in the cohort, thus individuals with their 'incident' diagnosis of COPD in the last three years will be included (01-APR-2016 to 31-MAR-2017, 01-APR-2017 to 31-MAR-2018; 01-APR-2018 to 31-MAR-2019)

You may not qualify if:

• Individuals that were diagnosed with COPD prior to or after the enrollment period.
• Individuals that did not live in Alberta (with access to Alberta health care) during the five year washout period

Sponsors & Collaborators

• University of Alberta: lead
• Boehringer Ingelheim: collaborator
• Alberta Health services: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: June 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: November 30, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

CA (1)