Recruiting

NCT Number: NCT07118306

COPD Exacerbation Follow Up

The goal of this study is to evaluate the impact of implementing an AI-enabled clinical workflow tool (Viz COPD) on respiratory specialist follow up and clinical outcomes after an acute exacerbation.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advocate Lutheran General Hospital, Park Ridge, Illinois, United States

About this study

Time perspective: This study will collect data prospectively for the Experimental cohort and retrospectively for the Control cohort. There is also an Exploratory cohort which will collect retrospective and prospective data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients aged 40 years or older at the time of arrival to the emergency department.
Patients with a clinical diagnosis of COPD who present to the emergency department for a moderate or severe COPD exacerbation.
A moderate exacerbation is defined as an acute exacerbation requiring either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics.
A severe exacerbation is defined as an acute exacerbation requiring hospitalization, or observation for >24 hours in emergency department/urgent care facility or resulting in death.
Patients on dual (LABA/LAMA, LABA/ICS, LAMA/ICS) or triple (LABA/LAMA/ICS) long-acting bronchodilator inhalers.

Exclusion criteria

Patients on bronchodilator inhaler monotherapy.
Patients leaving against medical advice or expiring during hospitalization.
Patients with tracheostomy.
Patients with advanced cancer.
Patients who have received a lung transplant.
Discharge to hospice care.
Transfer to another hospital.

Treatment and study plan

Primary outcomes

To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 30 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Time frame: From time of exacerbation to 30 days after discharge

Proportion of patients with a respiratory specialist follow-up visit within 30 days after discharge in the experimental cohort compared to the control cohort.
To assess the effect of a digital health tool implementation on time to respiratory specialist follow-up after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Time frame: Up to 1 year

Time from discharge to respiratory specialist follow-up visit in the experimental cohort compared to the control cohort.

Secondary outcomes

To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 90 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Time frame: Enrollment to 90 days after discharge

Proportion of patients with a respiratory specialist follow-up visit within 90 days after discharge in the experimental cohort compared to the control cohort.
To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.

Time frame: Enrollment to 30 days after discharge

Proportion of patients with all-cause readmission within 30 days after discharge in the experimental cohort compared to the control cohort.
To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.

Time frame: Enrollment to 90 days after discharge

Proportion of patients with all-cause readmission within 90 days after discharge in the experimental cohort compared to the control cohort.
To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Time frame: Enrollment to 30 days after discharge

Proportion of patients with an acute exacerbation (moderate, moderate and severe, severe) within 30 days after discharge in the experimental cohort compared to the control cohort
To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Time frame: Enrollment to 90 days post discharge

Proportion of patients with an acute exacerbation (moderate, moderate and severe, severe) within 90 days after discharge in the experimental cohort compared to the control cohort
To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Time frame: Enrollment to 1 year post discharge

Rate of acute exacerbations (moderate, moderate and severe, severe) at 1 year after discharge in the experimental cohort compared to the control cohort.
To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Time frame: Enrollment through 30 days after discharge

Proportion of patients with a composite outcome consisting of emergency department visits, readmissions, or exacerbations within 30 days after discharge in the experimental cohort compared to the control cohort
To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Time frame: Enrollment through 90 days after discharge

Proportion of patients with a composite outcome consisting of emergency department visits, readmissions, or exacerbations within 90 days after discharge inthe experimental cohort compared to the control cohort.
To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year

Time frame: Enrollment through 1 year after discharge

Rate of a composite outcome consisting of emergency department visits, readmissions, or exacerbations at 1 year after discharge in the experimental cohort compared to the control cohort.
To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days

Time frame: Enrollment through 30 days after discharge

Proportion of patients with a cardiovascular event within 30 days after discharge in the experimental cohort compared to the control cohort.
To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year

Time frame: Enrollment through 1 year after discharge

Rate of cardiovascular events at 1 year after discharge in the experimental cohort compared to the control cohort.
To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days

Time frame: Enrollment through 30 days after discharge

Proportion of patients with allcause mortality within 30 days after discharge in the experimental cohort compared to the control cohort
To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Time frame: Enrollment through 90 days after discharge

Proportion of patients with allcause mortality within 90 days after discharge in the experimental cohort compared to the control cohort.
To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year.

Time frame: Enrollment through 1 year after discharge

Rate of all-cause mortality at 1 year after discharge in the experimental cohort compared to the control cohort.
To assess the impact of a digital health tool implementation on achieving pharmacological treatment that is consistent with the GOLD treatment recommendations after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Time frame: Enrollment through 90 days

The proportion of patients in the experimental cohort with pharmacological treatment consistent with the GOLD treatment recommendations at 30 and 90 days after discharge for the index exacerbation compared to the control cohort.

Sponsors and collaborators

Lead sponsor

Viz.ai, Inc.

Industry

Collaborators

Regeneron Pharmaceuticals
Sanofi

Registry information

Official study title

A Multicenter Study of the Impact of a COPD Identification and Referral System on Patient Follow Up and Outcomes After an Acute COPD Exacerbation Resulting in an Emergency Department Visit or Hospitalization

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 12, 2025
Registry last updated: Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting

Effectiveness of DITM Versus IMT in COPD Patients

NCT06958666

COPD (Chronic Obstructive Pulmonary Disease), Chronic Disease

Hangzhou, Zhejiang, China

View Trial Details

Recruiting

MoblO2 to Maintain Oxygenation

NCT07704567

COPD (Chronic Obstructive Pulmonary Disease), Chronic Disease

Denver, Colorado, United States

View Trial Details

Recruiting

Study That Will Evaluate the Brazilian Population With COPD.

NCT06780046

COPD (Chronic Obstructive Pulmonary Disease), Chronic Disease

Aparecida de Goiânia, Brazil

View Trial Details

Recruiting

Quantitative Chest CT and Multi-Omics to Distinguish Asthma From COPD and Predict Treatment Response

NCT07602192

Asthma, Asthma (Diagnosis)

Seoul, Dongjak-gu, South Korea

View Trial Details

Key information

Conditions

Age range

Sex eligibility

Study type

Primary location

About this study

Who can participate

Treatment and study plan

Primary outcomes

To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 30 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

To assess the effect of a digital health tool implementation on time to respiratory specialist follow-up after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Secondary outcomes

To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 90 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.

To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.

To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year

To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days

To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year

To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days

To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year.

To assess the impact of a digital health tool implementation on achieving pharmacological treatment that is consistent with the GOLD treatment recommendations after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.

Sponsors and collaborators

Lead sponsor

Collaborators

Registry information

Official study title

Important dates

Related clinical trials

Effectiveness of DITM Versus IMT in COPD Patients

MoblO2 to Maintain Oxygenation

Study That Will Evaluate the Brazilian Population With COPD.

Quantitative Chest CT and Multi-Omics to Distinguish Asthma From COPD and Predict Treatment Response