Clinical trial NCT05955482: Pragmatic Assessment of the NuvoAir Clinical Service in the Management of Patients With Chronic Obstructive Pulmonary Disease
Official title: PROMISE: Pragmatic Assessment of the NuvoAir Clinical Service in the Management of Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COPD
Comorbidities and Coexisting Conditions
Lead sponsor: NuvoAir Medical PC
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A propensity matched comparison group will be selected from the same insured population (Security Health Plan of Wisconsin): Patients with COPD of comparable COPD severity, age, gender from the same region and type of health insurance (Medicare Advantage).

Brief summary: This is a 12 month study of up to 500 people with COPD to determine if the NuvoAir clinical service leads to lower rates of severe COPD exacerbations, hospitalizations, emergency room visits, and total cost of care compared to a similar group that doesn't receive care from the NuvoAir clinical service.

Detailed description: Description: The program will be a virtual (decentralized), pragmatic evaluation of an implementation of the NuvoAir Clinical service for patients with COPD residing in the United States of America and who are enrolled with one or more health insurers or providers supporting the program. The evaluation will be organized around two cohorts; Patients with an ICD10 code for COPD (in the health insurer's or provider's database);

* Who use the NuvoAir Clinical service vs those
* Who undergo standard care (matched control - no intervention)

Each patient in the NuvoAir cohort will receive their routine clinical care from their primary care provider with the addition of the NuvoAir Clinical service. The NuvoAir Clinical service offers comprehensive monitoring of health parameters and patient-reported outcomes as well as personalized clinical and behavioral interventions tailored to the patients' unique needs and their clinical risk. Furthermore, it involves virtual interaction with a NuvoAir Coach who provides guidance and assistance in navigating and utilizing the service. A dedicated NuvoAir care coordinator is available to offer self-management support and educational resources, aiming to enhance the management of COPD and other comorbidities. In situations where patients encounter new or worsening symptoms, the NuvoAir clinical team is accessible to provide medical intervention, advice and triage as required.

Each patient in the standard care cohorts will receive their routine clinical care from their healthcare provider as usual. Only anonymized data that is usually collected by their health insurer or provider will be subject to analysis, no additional data will be collected for the standard care cohort.

NuvoAir and standard care cohorts will be matched on the basis of age, gender, disease severity (ICD10 code for COPD with a severe exacerbation of COPD in the previous 12 months), geographic place and period of entry into the program. The program period will include 1 year of active participation (for NuvoAir users) followed by 1 year of follow-up using health insurer or provider records.

Objectives: To determine if use of the NuvoAir clinical service results in a lower rate and number of moderate and severe exacerbations of COPD, lower readmissions due to COPD exacerbation within a 30-day period following a COPD exacerbation, lower days in hospital and lower healthcare costs compared with the matched cohorts of standard care patients who do not use the NuvoAir clinical service. To determine if use of the NuvoAir results in reduced readmissions due to COPD during the 30-day period following an exacerbation, improved health status and improved adherence compared with prior to the program/baseline.

Eligibility criteria: Inclusion Criteria:

Have COPD, including emphysema and chronic bronchitis, per relevant COPD diagnostic codes in the past 2 years

* Are age ≥30 years
* Have access to a smartphone, cell phone, or landline telephone

Exclusion Criteria:

Do not have serious medical illness that would interfere with cooperation or understanding of instructions, including terminal illness, active substance abuse, or unstable mental illness or psychiatric condition

* Does not have severe uncompensated heart failure, acute cor pulmonale, clinically unstable pulmonary embolism, history of syncope related to forced expiration/cough, cerebral aneurysm, presence of pneumothorax.
* Is not pregnant or known intention to become pregnant within 12 months

Primary outcomes:
measure: Moderate & Severe Exacerbations
timeFrame: 12 months
Secondary outcomes:
measure: Readmissions
timeFrame: 30 days post admission
measure: Hospital days
timeFrame: 12 months
measure: Cost of care
timeFrame: 12 months
Other outcomes:
Locations:
city: Marshfield
country: United States
facility: Marshfield Clinic Research Institute
state: Wisconsin
Study officials:
affiliation: Marshfield Clinic
name: Jeffrey VanWormer, PHD
role: PRINCIPAL_INVESTIGATOR
References: