An observational study in Chronic Obstructive Pulmonary Disease, sponsored by Spire, Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by Spire, Inc. · Observational
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).
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).
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 126 is below the median of 150 across 639 observational studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Spire, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
The RPM service, tailored to chronic respiratory disease patients, utilizes a system that includes three components: undergarment-adhered cardiorespiratory sensors, in-home data transmission hub, and web-based clinical dashboard. The sensors are a set of six proprietary, skin-safe devices that include sensors for intermittent photoplethysmography, continuous respiratory force, and tri-axis accelerometers for activity. Clinical liaisons monitor deviations from patient-specific baselines and contact subjects for a "risk assessment" call, including questions about symptoms. If a subject fails the risk assessment, they are escalated to the site to be seen, and potentially treated, by their pulmonologist.
All-Cause Hospitalizations
The change in number of all-cause hospitalizations per patient
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Cardiopulmonary Hospitalizations
The change in number of cardiopulmonary hospitalizations per patient
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
All-Cause Emergency Room (ER) Visits
The change in number of all-cause ER visits per patient
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Cardiopulmonary Emergency Room (ER) Visits
The change in number of cardiopulmonary ER visits per patient
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Pulmonary Outpatient Visits
The change in number of pulmonary outpatient visits per patient
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Length of Stay
Length of hospitalization
Time frame: 1 year pre- and 1 year post-initiation of RPM (up to 2 years total)
Systemic Corticosteroid Use
Number of new prescriptions of corticosteroids given by pulmonologist
Time frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)
Adherence to RPM
Proportion of days during the intervention period where physiological sensors were worn for at least 8 hours
Time frame: 1 year
Time to Visit
Time from escalation to visit with provider
Time frame: up to 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Spire, Inc.