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以患者为中心的精密药物实验室结果对老年人的沟通

2026年7月7日 更新者:Catherine A. Sarkisian、University of California, Los Angeles

以患者为中心的实验室结果通信工具,用于升高血红蛋白A1C(A1C)或慢性肾脏疾病(CKD)的老年人

对于65岁及其提供者的成年人,我们将使用新的个性化EHR实验室结果交流工具来测试一种工具,以替换患者及其提供者的标准统一报告,以替代:1)从EHR中提取患者级别的数据; 2)计算个人风险; 3)对于风险非常低的患者,可以传达个性化的风险信息。 我们将采用一系列用户体验研究方法来了解患者和提供者用户如何与新实验室结果交流工具进行互动并评估他们对实验室结果的理解。

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

1200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • California
      • Los Angeles、California、美国、90049
        • 招聘中
        • UCLA Health System
        • 接触:
        • 接触:
        • 首席研究员:
          • Catherine Sarkisian, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

描述

纳入标准:

患者纳入标准:与UCLA初级保健提供者的老年人(年龄> 65岁):

  • 注册患者门户;
  • 说英语(因为该工具的语言目前仅以英语为单位,并且对工具模型的所有潜在变化和衍生物创建的验证翻译是不切实际的);和
  • 没有痴呆或其他神经认知疾病。

提供者的纳入标准:

-UCLA健康提供者,他们在门诊环境中关心大量老年人。

排除标准:

患者排除标准:

  • 在定义的包含范围之外具有实验室结果;
  • 没有UCLA PCP;
  • 年龄在65岁以下;
  • 不是说英语(因为工具的原型仅以英语为英文,直到确定最终的词汇为止);
  • 不在UCLA Mychart患者门户网站上注册;或者
  • 被诊断为痴呆

提供者排除标准:

- 在门诊环境中不在乎大量的老年人

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Personalized Lab Result Messaging
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.
A behavioral intervention delivered through a personalized Electronic Health Record (EHR)-integrated lab result communication tool designed to improve emotional and cognitive responses to lab results among adults aged 65+. The tool applies behavioral science principles such as risk personalization, simplified messaging, and visual framing to reduce patient anxiety, enhance understanding, and support informed decision-making.
无干预:Standard Lab Result Messaging
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prediabetes- Related Healthcare Utilization
大体时间:365 days after result
Total count of prediabetes-related healthcare utilization defined as the sum of outpatient visits to endocrinology, repeat hemoglobin A1c tests, and new prescriptions for diabetes-related medications following the index A1c result.
365 days after result

次要结果测量

结果测量
措施说明
大体时间
Number of Repeat Hemoglobin A1c Tests
大体时间:365 days after result
Total number of repeat hemoglobin A1c laboratory tests performed after the index test. This measure reflects follow-up glycemic testing and serves as an indicator of diabetes-related monitoring and healthcare utilization.
365 days after result
Number of Prescriptions for Diabetes-Related Medications
大体时间:180 days after result
Total number of prescriptions issued for medications commonly used for glycemic management (e.g., metformin) following the index hemoglobin A1c result. This outcome captures initiation of pharmacologic treatment related to diabetes risk.
180 days after result
Total Number of Outpatient Healthcare
大体时间:180 days after result
Total count of outpatient visits across all specialties following the index A1c result
180 days after result
Numbers of Referrals to Endocrinology
大体时间:14 days after initial result
Total number of outpatient referrals to an endocrinologist occurring after the index hemoglobin A1c laboratory result. This measure is used to quantify diabetes-related specialty care utilization potentially associated with interpretation of the laboratory result communication.
14 days after initial result
Number of Referrals to Nutrition Services
大体时间:14 days after initial result
Number of participants with an electronic referral order placed to clinical nutrition services documented in the electronic health record after release of the hemoglobin A1c result.
14 days after initial result
Number of Referrals to Diabetes Education
大体时间:14 days after initial result
Number of participants with an electronic referral order placed to diabetes education services documented in the electronic health record after release of the hemoglobin A1c result.
14 days after initial result
Number of Completed Endocrinology Visit
大体时间:180 days after result
Number of participants who complete an outpatient endocrinology encounter documented in the electronic health record after laboratory result notification. Visit completion will be identified using encounter records associated with endocrinology clinic services.
180 days after result
Completed Nutrition Services Visit
大体时间:180 days after result
Number of participants who complete an outpatient visit with clinical nutrition services documented in the electronic health record following laboratory result notification. Completion will be determined using encounter data associated with nutrition services.
180 days after result
Completed Appointments to Diabetes Education
大体时间:180 days after result
Number of participants who complete an outpatient visit with diabetes education services documented in the electronic health record following laboratory result notification. Completion will be determined using encounter data associated with diabetes education.
180 days after result
Number of Patient MyChart Messages
大体时间:7 days after viewing lab result
Count of MyChart Test Result Messages
7 days after viewing lab result
Numbers of Phone Calls Received after A1c Results
大体时间:7 days after viewing lab result
Count of telephone encounters to ordering provider
7 days after viewing lab result

其他结果措施

结果测量
措施说明
大体时间
Self-Reported Quality of Life
大体时间:30 days after initial survey invitation
Patient-reported quality of life assessed using survey responses evaluating overall physical, mental, and health-related well-being following receipt of lab result communication.
30 days after initial survey invitation
Self-Reported Physical Function Following Lab Result
大体时间:30 days after initial survey invitation
Self-reported physical function asking about ability to perform activities such as household chores, stair climbing, walking, and running errands following receipt of lab result communication. This measure uses structured survey items to evaluate whether receipt of A1c lab result communication is associated with changes in exercise.
30 days after initial survey invitation
Self-Reported Dietary Behaviors Following Lab Result
大体时间:30 days after initial survey invitation
Patient-reported dietary behaviors following receipt of lab result, including eating patterns, appetite, satiety, and food-related changes or restrictions due to concerns about lab results. These behaviors are assessed to understand potential impacts on health and weight-related decision-making. This measure uses structured survey items to evaluates whether receipt of A1c lab result communication is associated with changes dietary behaviors.
30 days after initial survey invitation
Patient Understanding and Anxiety Related to Lab Result Communication
大体时间:7 days after results
Patient-reported understanding of lab report and emotional response to result communication, including perceived clarity, reassurance, and level of concern, assessed using structured survey items designed to measure comprehension and anxiety following receipt of laboratory result messaging.
7 days after results
Number of Incidence of Diabetes
大体时间:3 years
Proportion of participants who progress from prediabetes to diabetes based on electronic health record data, defined by meeting diagnostic criteria for diabetes during follow-up. This outcome is included to monitor long-term clinical safety and progression.
3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月27日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2029年9月1日

研究注册日期

首次提交

2025年5月20日

首先提交符合 QC 标准的

2025年5月20日

首次发布 (实际的)

2025年5月29日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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