COPD Exacerbation Follow Up

NCT07118306 | Recruiting

• 1 other identifier: VIZCOPD03
• Study Type: observational
• Target: 485
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; Chronic obstructive pulmonary disease; Exacerbation; VizCOPD

Outcome Measures

Primary Outcomes (2)

• 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.

  Proportion of patients with a respiratory specialist follow-up visit within 30 days after discharge in the experimental cohort compared to the control cohort.

  From time of exacerbation to 30 days after discharge

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

  Up to 1 year

Secondary Outcomes (15)

• 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

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

  Enrollment to 30 days after discharge

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

  Enrollment to 90 days after discharge

• 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 30 days after discharge

• 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 90 days post discharge

Study Arms (3)

Experimental Cohort

Prospective patients presenting to sites after implementation of the digital health tool.

Control Cohort

Retrospective patients who presented to the same study sites under the standard of care clinical workflow before implementation of the digital health tool

Exploratory Cohort

Patients who had no prior respiratory specialist follow up before implementation of the digital health tool and are re-assessed for follow up after implementation of the digital health tool.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Target of five geographically dispersed U.S. hospital systems to capture a diverse patient population and COPD clinical workflow.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viz.ai, Inc.: lead
• Sanofi: collaborator
• Regeneron Pharmaceuticals: collaborator

Study Sites (2)

Cooper University Health Care

Cherry Hill, New Jersey, 08002, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

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 Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 12, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)