COPD Exacerbation Follow Up

Not yet recruiting

• Conditions: COPD (Chronic Obstructive Pulmonary Disease)

• Registration Number: NCT07118306
• Lead Sponsor: Viz.ai, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 485

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.	Up to 1 year	Time from discharge to respiratory specialist follow-up visit in the experimental cohort compared to the control cohort.

Secondary Outcome Measures

Name	Time	Method
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.	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 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	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 patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year.	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 effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.	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.	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 patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.	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 healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.	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 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	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	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	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 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.	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.