About this trial
A 12 month interventional study of up to 1,050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events, reduces healthcare utilization, and lowers the total cost of care compared to a control cohort that receives standard care only.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Twelve months of claims data in the health insurer or provider's database for baseline
ICD10 code for COPD (including emphysema and chronic bronchitis) with a severe exacerbation of COPD in the previous 12 months (defined as ER visit or hospitalization related to COPD or severity score of 2 or 3)
Cooperative, i.e., subject should be able to follow and understand instructions
Access to a phone (smartphone, cell phone, or landline)
Disqualifiers
Does not have access to a a phone (smartphone, cell phone, or landline)
Lack of cooperation, subject cannot follow and understand instructions
Other serious medical illness that, in the opinion of the PI, would interfere with the patient's participation in the study or interpretation of their data (i.e., terminal illness, unstable psychiatric condition, etc.)
Does not understand English
Trial design
Parallel
Treatments tested in this trial
NuvoAir clinical service
Other interventionPatients with COPD receiving usual care plus NuvoAir clinical services.
Treatment groups
Trial outcomes
Primary outcomes
Moderate & Severe Exacerbations
Rate of moderate and severe exacerbations of COPD, measured by the health insurer or provider's records
Secondary outcomes
Severe COPD Exacerbations
Proportion of patients with at least one episode of severe COPD exacerbation within a 12-month period, NuvoAir cohort vs standard care cohort
Major Adverse Cardiac Event
Proportion of patients using the NuvoAir clinical service who have experienced a major adverse cardiac event (including CHF exacerbations, ACS/AMI, stroke) or all cause death, compared with the standard care cohort, measured using health insurer or provider records and assessed each year of the study
30-Day COPD Related Readmissions
Number of readmissions due to COPD exacerbation within a 30 day period following a COPD exacerbation (NuvoAir cohort only), compared to baseline and the number of 30-day readmissions after hospitalisation due to a COPD exacerbation compared to the standard care cohort
All-Cause Hospitalizations
Proportion of patients using the NuvoAir clinical service who have experienced an all-cause admission to hospital, compared with the standard care cohort, measured using health insurer or provider records and assessed each year of the study
Other outcomes
Short-Acting Beta-Agonists Used
Number of short-acting beta-agonists used in one year from health insurer or provider records compared with the standard care cohort
Courses of Oral Antibiotics/Steroids
Number of courses of oral antibiotics/steroids in one year from health insurer or provider records compared with the standard care cohort
Self-efficacy
Self-efficacy for managing chronic disease scale score baseline vs end of study in NuvoAir cohort only
Patient Activation
Patient activation measure score baseline vs end of study in NuvoAir cohort only
Locations
Sponsors and contacts
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NuvoAir Medical PC
Lead sponsor
Optum, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options: