COPD Exacerbation Follow Up
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorViz.ai, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients on bronchodilator inhaler monotherapy.
Patients leaving against medical advice or expiring during hospitalization.
Patients with tracheostomy.
Patients with advanced cancer.
Trial population
Target of five geographically dispersed U.S. hospital systems to capture a diverse patient population and COPD clinical workflow.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
485 Participants
are grouped into 3 trial groupsGroup A: Experimental Cohort
Group B: Control Cohort
Group C: Exploratory Cohort
Trial outcomes
Primary outcomes
1
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.
Time frame
From time of exacerbation to 30 days after discharge2
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.
Time frame
Up to 1 yearSecondary outcomes
1
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.
Proportion of patients with a respiratory specialist follow-up visit within 90 days after discharge in the experimental cohort compared to the control cohort.
Time frame
Enrollment to 90 days after discharge2
To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.
Proportion of patients with all-cause readmission within 30 days after discharge in the experimental cohort compared to the control cohort.
Time frame
Enrollment to 30 days after discharge3
To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.
Proportion of patients with all-cause readmission within 90 days after discharge in the experimental cohort compared to the control cohort.
Time frame
Enrollment to 90 days after discharge4
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.
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
Time frame
Enrollment to 30 days after dischargeSponsors and contacts
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Source ClinicalTrials.gov