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Completed

NCT Number: NCT05518981

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

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).

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory Remote Patient Monitor (Spire Health Tag)

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Spire, Inc.

Industry

Collaborators

  • Pulmonary Associates of Richmond
  • The University of Texas Health Science Center at San Antonio

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2022
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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