跳至主要内容
临床试验/NCT06995378
NCT06995378招募中不适用

Evaluation of Patient and Provider Facing EHR-embedded Risk Stratification Tools

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年5月27日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,200
试验地点
2
主要终点
Change in self-reported anxiety about lab results after using the personalized tool

研究概览

简要总结

This study evaluates whether adding machine learning-based risk information to electronic health record (EHR) lab result messages helps older adults better understand their risk of developing diabetes and influences their emotional responses, quality of life, and healthcare use.

Eligible participants are adults aged 65 years and older with a UCLA primary care provider and a hemoglobin A1c level in the range (5.7-6.0%). Participants are identified automatically at the time their lab results are processed and are randomly assigned to receive either standard lab result messages or modified messages that include a "very low risk" label generated by a machine learning model.

All participants who are randomized are invited to complete two surveys: one shortly after their lab result is posted in MyChart and a follow-up survey approximately 30 days later. The study also uses de-identified EHR data to examine patterns of healthcare utilization and progression to diabetes. Provider comments related to lab result messaging will be analyzed to explore differences in response patterns between the two groups.

详细描述

Prediabetes thresholds based on hemoglobin A1c were originally developed using younger, healthier populations and may not reflect the slower and more variable glycemic changes observed in older adults. Evidence from large community-based cohorts suggests that adults aged 65 years and older with A1c values in the prediabetes range are often more likely to return to normal glycemia than to progress to diabetes, creating uncertainty for patients and providers when interpreting lab results.

Machine learning models developed using de-identified UCLA Health EHR data from multiple annual cohorts between 2020 and 2024 demonstrated strong performance in predicting progression to diabetes. The final model uses a CatBoost architecture and incorporates approximately 94 routinely collected clinical variables to generate patient-specific risk scores. Model performance was evaluated across yearly cohorts, and the selected model is locked for the duration of the study without updating or adapting to new data.

The study follows a real-world, randomized deployment design in which eligible individuals in the lowest 15% of model-predicted risk within the eligible study population are identified automatically at the time lab results are processed and assigned to either modified or standard lab result messaging. De-identified EHR data and free-text provider comments are used to examine healthcare utilization, disease progression, and provider response patterns over time.

All participants who are randomized are invited to complete two surveys. The first survey is administered shortly after receipt of the laboratory result and is designed to assess immediate patient understanding of the result and emotional responses such as anxiety or reassurance. A second survey is administered approximately one month later and uses validated instruments to measure health-related quality of life, food-related quality of life and eating behavior, and perceived burden of healthcare. Both study arms receive the same surveys, allowing comparison of patient-reported outcomes between standard and modified laboratory result messaging. Surveys are distributed only to participants who have been randomized to either modified or standard laboratory result messaging. Therefore, no additional eligibility criteria apply for survey participation beyond randomization.

By embedding model-generated risk information directly into routine EHR workflows, this study aims to generate evidence on whether precision-based communication can support more individualized, patient-centered care and inform future implementation across broader patient populations and clinical use cases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Age 65 years or older
  • Hemoglobin A1c in the prediabetes range (5.7- but not including 6.0%)

排除标准

  • Have lab results outside the defined inclusion range
  • No UCLA primary care provider
  • Age <65 years
  • Eligibility for Surveys:
  • All randomized participants are eligible to receive study surveys. No additional eligibility criteria apply for survey participation.
  • HgbA1c of 6.0 or above is not eligible.

研究组 & 干预措施

Personalized Lab Result Messaging

Experimental

Participants receive modified electronic health record (EHR) lab result communications in the patient portal (MyChart) and provider-facing EHR interface that include a qualitative "very low risk" label generated by a machine learning-based tool, along with brief explanatory text providing context about their current results and indicating a low level of concern at this time.

干预措施: Hemoglobin A1c Lab Result Communication Tool (Device)

Standard Lab Result Messaging

No Intervention

Participants receive standard electronic health record (EHR) lab result communications without any machine learning-generated risk labeling or explanatory text providing additional context about level of concern.

结局指标

主要结局

Change in self-reported anxiety about lab results after using the personalized tool

时间窗: Immediately after the user experience session

Participants will complete a structured post-session survey using a 5-point Likert scale titled "Emotional Response to Lab Results". The scale ranges from 1 (Strongly Disagree) to 5 (Strongly Agree). Higher scores indicate lower anxiety and greater emotional reassurance. Survey items will assess their emotional response, including levels of anxiety and reassurance, after viewing lab results through the new tool. Responses will be compared to participants' recalled or expected emotional responses based on past experiences with standard lab result communication formats.

次要结局

未报告次要终点

研究者

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

Catherine A. Sarkisian

Professor of Medicine

University of California, Los Angeles

研究点 (2)

Loading locations...

相似试验