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Clinical Trials/NCT05518981
NCT05518981
Completed
Not Applicable

The Clinical Significance of Patient Care Escalations From a Remote Monitoring Service

Spire, Inc.1 site in 1 country126 target enrollmentMay 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Spire, Inc.
Enrollment
126
Locations
1
Primary Endpoint
All-Cause Hospitalizations
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
February 28, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

All-Cause Hospitalizations

Time Frame: 1 year pre- and 1 year post-initiation of RPM (2 years total)

The change in number of all-cause hospitalizations per patient

Secondary Outcomes

  • Cardiopulmonary Emergency Room (ER) Visits(1 year pre- and 1 year post-initiation of RPM (2 years total))
  • Pulmonary Outpatient Visits(1 year pre- and 1 year post-initiation of RPM (2 years total))
  • Systemic Corticosteroid Use(1 year pre- and 1 year post-initiation of RPM (2 years total))
  • Time to Visit(up to 1 year)
  • Adherence to RPM(1 year)
  • Length of Stay(1 year pre- and 1 year post-initiation of RPM (up to 2 years total))
  • Cardiopulmonary Hospitalizations(1 year pre- and 1 year post-initiation of RPM (2 years total))
  • All-Cause Emergency Room (ER) Visits(1 year pre- and 1 year post-initiation of RPM (2 years total))

Study Sites (1)

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