A Non-Interventional Pragmatic Clinical Trial of NLP Models for the Detection of Immune-Related Adverse Events
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
Immunotherapies have improved cancer outcomes, but have a unique profile of immune-related adverse events (irAEs). Biorepositories have been established to collect data and samples to help improve our understanding of irAEs, however identifying patients who are eligible for these biorepositories in a timely fashion can be challenging. The goal of this study is to determine if an informatics system for automated irAE detection can improve registration to a prospective irAE biorepository (NCT04242095). The informatics system automatically "reads" participants' electronic health records (EHRs) and determines whether that patient may be experiencing an irAE. The main questions it aims to answer are:
- Is it feasible to implement an informatics system for daily analysis of EHR data to detect irAEs?
- Does the automated irAE detection system improve registration rates to an irAE biorepository at our institution following an eligible irAE?
Researchers will compare standard irAE monitoring to informatics-assisted irAE monitoring to see if using the informatics system increases the registration rate and improves data entry efficiency and quality.
Participants will:
- Be randomly assigned to standard monitoring or informatics-assisted monitoring for irAE detection.
- Have their EHR reviewed to collect demographic, medical, and cancer treatment history.
- Be monitored for irAEs through daily automated analysis of their EHR data for up to 12 months or until registration in the biorepository.
详细描述
This is a single institution, randomized controlled trial of an informatics system for automated immune-related adverse event (irAE) detection from the electronic health records (EHR) for eligibility monitoring for an Alliance prospective irAE biorepository (NCT04242095). This study will enroll approximately 100 patients receiving immunotherapy. Our co-primary endpoints test the hypothesis that informatics-assisted EHR monitoring for biorepository eligibility is feasible and improves registration rates onto the biorepository following an eligible irAE. Secondary endpoints evaluate time to data entry after an irAE, and irAE capture rate based on post-hoc subject matter expert review. This study will take place at Dana-Farber/Brigham Cancer Center.
Our co-primary objectives are:
- To establish the feasibility of implementing the informatics system for daily inferencing on EHR data
- To assess the ability of automated irAE detection to improve registration to a prospective irAE biorepository
Our secondary objectives are:
- To evaluate whether automated irAE detection reduces the time to data entry in a prospective biorepository data management system
- To evaluate whether automated irAE detection leads to differences in irAE capture rates of patients with an eligible irAE based on clinician expert review of the EHR
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received or receiving a regimen containing one or more immuno-oncology therapeutics
排除标准
- 未提供
研究组 & 干预措施
Standard monitoring
Standard irAE monitoring for an eligible registration event.
干预措施: Standard eligibility monitoring (Other)
Informatics-assisted monitoring
Informatics-assisted monitoring plus standard monitoring
干预措施: Informatics system for eligibility monitoring (Other)
Informatics-assisted monitoring
Informatics-assisted monitoring plus standard monitoring
干预措施: Standard eligibility monitoring (Other)
结局指标
主要结局
Feasibility
时间窗: 2 months
Feasibility is defined as successfully connecting the informatics system to subjects' relevant EHR data, carrying out inferencing on the records, and reporting newly identified automatically extracted irAEs in a tabular format daily for a minimum of 1 week. Feasibility is defined at the patient-level.
Registration
时间窗: 12 months
Registration rate is the proportion of subjects who are registered onto a prospective irAE biopository at Dana Farber/Brigham Cancer Center. Patients are eligible for biorepository registration within 96 hours of a severe (grade 3-4) irAE.
次要结局
- Time to data entry(12 months)
- irAE capture rate(12 months)
研究者
Danielle Bitterman, MD
Clinician Investigator
Brigham and Women's Hospital