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

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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Respiratory Remote Patient Monitor (Spire Health Tag)

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).

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Spire, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary Hospitalizations	The change in number of cardiopulmonary hospitalizations per patient	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	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	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	1 year pre- and 1 year post-initiation of RPM (2 years total)
Length of Stay	Length of hospitalization	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	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	1 year
Time to Visit	Time from escalation to visit with provider	up to 1 year

Collaborators and Investigators

• Sponsor: Spire, Inc.
• Collaborators: The University of Texas Health Science Center at San Antonio; Pulmonary Associates of Richmond
• Investigators: Principal Investigator: Neema Moraveji, PhD, Spire Health

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: COPD; Exacerbation; Hospitalization; Remote Patient Monitoring; Acute Exacerbation of COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 20210406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No