Clinical trial NCT06379529: The COPD CARE Study: Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events
Official title: The COPD CARE Study: Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD Exacerbation
COPD
Cardio/Pulm: Heart Failure
Keywords: COPD
COPD Exacerbation
COPD Hospitalization
COPD Readmission
COPD Costs
Medicare
Medicare Advantage
Lead sponsor: NuvoAir Medical PC
Sponsor class: INDUSTRY
Collaborators: name: Optum, Inc.
First posted: 2024-04-23
Enrollment: 1050
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic evaluation of a clinical service using a prospective cohort comparison of intervention vs propensity matched controls.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: A virtual (decentralized), pragmatic, prospective, matched cohort study conducted in patients with COPD residing in the United States of America who are enrolled with one or more health insurers or providers supporting the study. The study aims to evaluate COPD outcomes with the addition of the NuvoAir virtual-first clinical service compared to a cohort receiving standard care (matched control - no intervention).

Each patient in the NuvoAir cohort will receive routine clinical care from their providers 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 clinical risk. The service involves virtual interaction with NuvoAir coaches who provide guidance and assistance in navigating and utilizing the service. Dedicated NuvoAir care coordinators are available to offer self-management support and educational resources, aiming to enhance the management of COPD and comorbidities such as cardiovascular conditions. In situations where patients encounter new or worsening symptoms, the NuvoAir clinical team is accessible to provide advice and triage, as required.

Each patient in the standard care cohort will receive their routine clinical care from their healthcare provider. Only de-identified 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 or disease severity score of 2 or 3 as defined by their health plan) and period of entry into the study. Eligible patients will be recruited from Medicare patients in Medicare Advantage plans that are administered by the private health insurance company or health care provider supporting the study.

Key Objectives: To determine if use of the NuvoAir clinical service results in a reduction in the rate and number of moderate and severe exacerbations of COPD; major cardiac events; hospitalizations and 30-day readmissions; days hospitalized; and lowers healthcare costs compared with the matched cohort of patients receiving standard care only.

Study duration: The overall study duration is expected to be two years with one year of active patient participation using the NuvoAir clinical service following the end of the baseline period. This will be followed by one year of follow-up by reference to health insurer or provider's records.

Enrollment: The study will enroll up to 350 patients for the NuvoAir intervention and 700 for the standard care cohort for a total of 1,050 patients.

Eligibility criteria: Inclusion Criteria:

* 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)
* Willingness to sign a medical release form for treating healthcare facilities

Exclusion Criteria:

* 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

Primary outcomes:
measure: Moderate & Severe Exacerbations
timeFrame: 12 months
Secondary outcomes:
measure: Severe COPD Exacerbations
timeFrame: 12 months
measure: Major Adverse Cardiac Event
timeFrame: 12 months
measure: 30-Day COPD Related Readmissions
timeFrame: 12 months
measure: All-Cause Hospitalizations
timeFrame: 12 months
measure: All-Cause Readmissions
timeFrame: 12 months
measure: Days Hospitalized due to COPD
timeFrame: 12 months
measure: Cost of Care Related to COPD
timeFrame: 12 months
measure: Medication Adherence
timeFrame: 12 months
measure: Quality of Life (QOL)
timeFrame: 12 months
Other outcomes:
measure: Short-Acting Beta-Agonists Used
timeFrame: 12 months
measure: Courses of Oral Antibiotics/Steroids
timeFrame: 12 months
measure: Self-efficacy
timeFrame: 12 months
measure: Patient Activation
timeFrame: 12 months
measure: Cat Score
timeFrame: 12 months
measure: mMRC Dyspnea Scale
timeFrame: 12 months
measure: Physical Activity
timeFrame: 12 months
Locations:
Study officials:
affiliation: Executive Director of Translational Research, OptumCare
name: Ken Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: