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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05518981
• Other study ID #: 20210406
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2022
• Source: Spire, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Spire, Inc.	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Spire, Inc.	Pulmonary Associates of Richmond, The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause Hospitalizations	The change in number of all-cause hospitalizations per patient	1 year pre- and 1 year post-initiation of RPM (2 years total)
Secondary	Cardiopulmonary Hospitalizations	The change in number of cardiopulmonary hospitalizations per patient	1 year pre- and 1 year post-initiation of RPM (2 years total)
Secondary	All-Cause Emergency Room (ER) Visits	The change in number of all-cause ER visits per patient	1 year pre- and 1 year post-initiation of RPM (2 years total)
Secondary	Cardiopulmonary Emergency Room (ER) Visits	The change in number of cardiopulmonary ER visits per patient	1 year pre- and 1 year post-initiation of RPM (2 years total)
Secondary	Pulmonary Outpatient Visits	The change in number of pulmonary outpatient visits per patient	1 year pre- and 1 year post-initiation of RPM (2 years total)
Secondary	Length of Stay	Length of hospitalization	1 year pre- and 1 year post-initiation of RPM (up to 2 years total)
Secondary	Systemic Corticosteroid Use	Number of new prescriptions of corticosteroids given by pulmonologist	1 year pre- and 1 year post-initiation of RPM (2 years total)
Secondary	Adherence to RPM	Proportion of days during the intervention period where physiological sensors were worn for at least 8 hours	1 year
Secondary	Time to Visit	Time from escalation to visit with provider	up to 1 year