Clinical trial NCT05518981: Effect of Remote Physiologic Monitoring (RPM) on Outcomes in COPD Patients
Official title: The Clinical Significance of Patient Care Escalations From a Remote Monitoring Service
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Acute Exacerbation of COPD
Hospitalization
Exacerbation
Remote Patient Monitoring
COPD
Lead sponsor: Spire, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pulmonary Associates of Richmond
name: The University of Texas Health Science Center at San Antonio
First posted: 2022-08-29
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients at a large outpatient pulmonology practice in the mid-Atlantic region of the United States. They were all candidates for RPM and were offered a voluntary participation in a service tailored to chronic respiratory disease patients.

Brief summary: This pre/post study was a retrospective analysis of unplanned hospitalization rates in a cohort of COPD subjects started on remote physiologic monitoring (RPM) at a large, outpatient pulmonary practice. The study included all subjects with high healthcare utilization (≥1 hospitalization or emergency room visit in the prior year) who had elected to enroll in an RPM service for assistance with clinical management. Additional inclusion criteria included being on RPM for at least 12 months and a patient of the practice for at least two years (12 months pre- and post-initiation of RPM).

Detailed description: This study included a retrospective analysis of data collected from subjects at a large outpatient pulmonology practice in the mid-Atlantic region of the United States between May 2019 and February 2022. At this clinic, patients who were candidates for RPM had been offered voluntary participation in service tailored to chronic respiratory disease patients (Spire Health, San Francisco, CA, USA). They continued regular follow-ups with their pulmonologists and received usual care according to the direction of their primary pulmonary physician for their COPD.

Inclusion criteria for the present study included a clinical diagnosis of COPD (COPD, chronic bronchitis, obstructive lung/airways disease, or emphysema), subscribed to RPM for at least 12 months as of February 28, 2022, full electronic medical records (EMR) at the site in question for one year before and one year after the start of RPM, and high healthcare utilization (≥1 ER visit or hospitalization in the year prior to enrollment). All such patients were included in the analysis.

The primary endpoint was unplanned, all-cause hospitalizations per subject. Secondary endpoints included unplanned cardiopulmonary hospitalizations, respective lengths of stay, ER visits, outpatient pulmonary visits, and systemic corticosteroid use, adherence to RPM, and time-to-visit (RPM escalation to provider visit).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD (COPD, chronic bronchitis, obstructive lung/airways disease, or emphysema)
* ≥1 hospitalization or emergency visit in the year prior to enrollment
* enrolled in the Spire RPM patient monitoring service for at least 12 months
* a patient of the practice for at least two years (12 months pre- and 12 months post-initiation of RPM).

Exclusion Criteria:

* None

Primary outcomes:
measure: All-Cause Hospitalizations
timeFrame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Secondary outcomes:
measure: Cardiopulmonary Hospitalizations
timeFrame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
measure: All-Cause Emergency Room (ER) Visits
timeFrame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
measure: Cardiopulmonary Emergency Room (ER) Visits
timeFrame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
measure: Pulmonary Outpatient Visits
timeFrame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
measure: Length of Stay
timeFrame: 1 year pre- and 1 year post-initiation of RPM (up to 2 years total)
measure: Systemic Corticosteroid Use
timeFrame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
measure: Adherence to RPM
timeFrame: 1 year
measure: Time to Visit
timeFrame: up to 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Spire, Inc.
state: California
Study officials:
affiliation: Spire Health
name: Neema Moraveji, PhD
role: PRINCIPAL_INVESTIGATOR
References: