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临床试验/NCT07601802
NCT07601802已完成不适用

Acute Risk Monitoring for Oncology Therapy Regimens (ARMOR): A Silent Prospective Validation of a Machine Learning Model

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 4,740 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,740
试验地点
1

研究概览

简要总结

Patients undergoing outpatient infusion systemic therapy for cancer are at risk for potentially preventable, unplanned acute care in the form of emergency department (ED) visits and hospitalizations. These events impact patient outcomes, treatment decisions, and healthcare costs. To address this need, the Centers for Medicare & Medicaid Services developed the chemotherapy measure (OP-35). Recent randomized controlled studies indicate that electronic health record (EHR)-based machine learning (ML) approaches accurately direct supportive care to reduce acute care during radiotherapy. This study aims to develop and prospectively validate ML approaches to predict the risk of OP-35 qualifying, potentially preventable, acute care events within 30 days of infusion systemic therapy.

详细描述

OBJECTIVES:

I. Develop and retrospectively validate electronic health record-based machine learning models using routinely collected clinical data from patients receiving systemic therapy to predict risk of potentially preventable OP-35 qualifying acute care events. (Phase 1: Retrospective)

II. Prospectively validate machine learning models across distinct time periods. (Phase 2: Prospective)

III. Understand patterns of care by stratifying and analyzing model performance by treatment type, cancer diagnosis, and race/ethnicity to assess bias and disparities in outcomes.

OUTLINE:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years or older diagnosed with cancer who receive care at UCSF and/or one of the UCSF affiliate locations.

排除标准

  • Patients under the age of
  • Patients receiving care as part of a clinical trial.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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