COPD Exacerbation Follow Up

Viz.ai

Status: Not yet enrolling

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Study type: Observational

Funder types: Industry

Identifiers

NCT07118306

VIZCOPD03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 485 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

485 participants in 3 patient groups

Experimental Cohort

Description:

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

Control Cohort

Description:

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

Description:

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.