Recruiting NCT07118306

COPD Exacerbation Follow Up

— Observational COPD (Chronic Obstructive Pulmonary Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: COPD (Chronic Obstructive Pulmonary Disease). Basic parameters: from 40 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
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Official 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

Overview

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.

Primary outcome measures

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]
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]

Secondary outcome measures (12)

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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Case-control

Study locations

United States · 4 centers

Advocate Lutheran General Hospital — Park Ridge
Cooper University Health Care — Cherry Hill
Thomas Jefferson University — Philadelphia
Aurora St. Luke's Medical Center — Milwaukee

Identifiers

NCT: NCT07118306 · VIZCOPD03

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗