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临床试验/NCT05518981
NCT05518981已完成不适用

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

Spire, Inc.1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Spire, Inc.
入组人数
126
试验地点
1
主要终点
All-Cause Hospitalizations

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 未提供

结局指标

主要结局

All-Cause Hospitalizations

时间窗: 1 year pre- and 1 year post-initiation of RPM (2 years total)

The change in number of all-cause hospitalizations per patient

次要结局

  • Cardiopulmonary Emergency Room (ER) Visits(1 year pre- and 1 year post-initiation of RPM (2 years total))
  • Pulmonary Outpatient Visits(1 year pre- and 1 year post-initiation of RPM (2 years total))
  • Systemic Corticosteroid Use(1 year pre- and 1 year post-initiation of RPM (2 years total))
  • Time to Visit(up to 1 year)
  • Adherence to RPM(1 year)
  • Length of Stay(1 year pre- and 1 year post-initiation of RPM (up to 2 years total))
  • Cardiopulmonary Hospitalizations(1 year pre- and 1 year post-initiation of RPM (2 years total))
  • All-Cause Emergency Room (ER) Visits(1 year pre- and 1 year post-initiation of RPM (2 years total))

研究者

发起方
Spire, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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