Effect of Remote Physiologic Monitoring (RPM) on Outcomes in COPD Patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT05518981
- Lead Sponsor
- Spire, Inc.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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).
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-Cause Hospitalizations 1 year pre- and 1 year post-initiation of RPM (2 years total) The change in number of all-cause hospitalizations per patient
- Secondary Outcome Measures
Name Time Method Cardiopulmonary Emergency Room (ER) Visits 1 year pre- and 1 year post-initiation of RPM (2 years total) The change in number of cardiopulmonary ER visits per patient
Pulmonary Outpatient Visits 1 year pre- and 1 year post-initiation of RPM (2 years total) The change in number of pulmonary outpatient visits per patient
Systemic Corticosteroid Use 1 year pre- and 1 year post-initiation of RPM (2 years total) Number of new prescriptions of corticosteroids given by pulmonologist
Time to Visit up to 1 year Time from escalation to visit with provider
Length of Stay 1 year pre- and 1 year post-initiation of RPM (up to 2 years total) Length of hospitalization
Adherence to RPM 1 year Proportion of days during the intervention period where physiological sensors were worn for at least 8 hours
Cardiopulmonary Hospitalizations 1 year pre- and 1 year post-initiation of RPM (2 years total) The change in number of cardiopulmonary hospitalizations per patient
All-Cause Emergency Room (ER) Visits 1 year pre- and 1 year post-initiation of RPM (2 years total) The change in number of all-cause ER visits per patient
Trial Locations
- Locations (1)
Spire, Inc.
🇺🇸San Francisco, California, United States