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

• ClinicalTrials.gov Identifier: NCT05518981
• Recruitment Status: Completed
• First Posted: August 29, 2022
• Last Update Posted: August 29, 2022
• Sponsor: Spire, Inc.
• Collaborators: Pulmonary Associates of Richmond; The University of Texas Health Science Center at San Antonio
• Information provided by (Responsible Party): Spire, Inc.

Study Description

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).

Condition or disease	Intervention/treatment
Chronic Obstructive Pulmonary Disease	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 Design

• Study Type: Observational
• Actual Enrollment: 126 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Clinical Significance of Patient Care Escalations From a Remote Monitoring Service
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: February 28, 2022
• Actual Study Completion Date: February 28, 2022

Groups and Cohorts

Intervention Details:

• 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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, California

Spire, Inc.

San Francisco, California, United States, 94110

Sponsors and Collaborators

Spire, Inc.

Pulmonary Associates of Richmond

The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: Neema Moraveji, PhD; Spire Health

More Information

• Responsible Party: Spire, Inc.
• ClinicalTrials.gov Identifier: NCT05518981
• Other Study ID Numbers: 20210406
• First Posted: August 29, 2022
• Last Update Posted: August 29, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Keywords provided by Spire, Inc.:

Acute Exacerbation of COPD; Hospitalization; Exacerbation; Remote Patient Monitoring; COPD

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases