Effect of Remote Physiologic Monitoring (RPM) on Outcomes in COPD Patients

NCT ID: NCT05518981

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-02-28

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).

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Respiratory Remote Patient Monitor (Spire Health Tag)

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.

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulmonary Associates of Richmond

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

Spire, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neema Moraveji, PhD

Role: PRINCIPAL_INVESTIGATOR

Spire Health

Locations

Spire, Inc.

San Francisco, California, United States

Countries

United States

Other Identifiers

20210406

Identifier Type: -

Identifier Source: org_study_id