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临床试验/NCT04809740
NCT04809740进行中(未招募)不适用

Evaluating the Implementation and Impact of Navigator-delivered ePRO Home Symptom Monitoring and Management

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 3,090 人开始时间: 2021年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
3,090
试验地点
1
主要终点
Service Penetration

研究概览

简要总结

Evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites and assess the impact of Home ePRO on clinical and utilization outcomes.

详细描述

Randomized controlled trials demonstrated that weekly electronic home-based PRO symptom monitoring with automated alerts to clinicians (Home ePRO) in cancer patients was associated with reduced healthcare utilization, improved quality of life, and increased overall survival. However, these trials were administered using infrastructure supported by research funding. A knowledge gap remains about optimal implementation strategies for and effectiveness of Home ePROs in real-world settings. To address this gap, we will conduct a large-scale population-based implementation of an evidence-based Home ePRO intervention for all adult cancer patients receiving chemotherapy. The investigators' hypothesis is that the implementation of navigator-delivered Home ePRO will be successful and will improve both patient and health system outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

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

  • Patient Group:
  • Cancer patients at participating institution
  • Receipt of chemotherapy, targeted therapy, and immunotherapy at participating institution from 2019-2026.

排除标准

  • - Second opinion only at participating institution.

研究组 & 干预措施

Patient Group

Other

Patients from UAB/MCI enrolled

干预措施: Navigator-delivered Home ePRO (Other)

结局指标

主要结局

Service Penetration

时间窗: 5 years

% of eligible patients enrolled

Service Penetration

时间窗: up to 3 months of starting a treatment for cancer

% of eligible patients enrolled

次要结局

  • Proportion of Alerts Closed Within 48 Hours(up to 48 hours)
  • % of Patients Completing ≥1 ePRO Survey(up to 6 months)
  • % of Expected ePRO Surveys Completed Per Patient(up to 6 months)
  • % of Surveys Completed of Surveys Sent to Patient(up to 6 months)
  • Symptom Trajectory(up to 3 months; up to 6 months)
  • Number of ED Visits(up to 3 months, up to 6 months)
  • Number of Hospitalizations(up to 3 months, up to 6 months)
  • Number of ICU Visits(up to 3 months, up to 6 months)
  • Total Cost of Care(up to 3 months, up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabrielle Rocque

Associate Professor of Medicine, Division of Hematology & Oncology; Division of Gerontology, Geriatrics, & Palliative Care

University of Alabama at Birmingham

研究点 (1)

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