Impact of AI Care Summaries on Caregiver Comprehension of Hospital Course
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hospital Course Comprehension Score
研究概览
简要总结
The primary objective is to assess if an AI-generated plain language summary of an inpatient progress note can improve caregiver understanding of their child's hospitalization by measuring differences in Hospital Course Comprehension scores, based on their responses to a survey regarding their child's hospital course.
Secondary objectives include exploring the caregiver's perspective on the use of AI in clinical care, as well as 7-day and 30-day readmission rates, 7-day and 30-day emergency department (ED) re-utilization rates, length of stay, and environmental impact measures.
详细描述
This randomized controlled trial evaluates whether AI-generated plain-language summaries of inpatient progress notes improve caregiver understanding of a child's hospitalization. The intervention uses a Children's National HIPAA-compliant large language model hosted within the institution's Azure environment to generate caregiver-facing summaries from attending-signed inpatient progress notes.
Eligible caregivers are randomized to receive either standard hospital communication alone or standard communication plus an attending-approved AI-generated care summary. Before distribution to caregivers, attending physicians review generated summaries for clinical appropriateness and accuracy.
Caregiver understanding of the hospitalization is assessed using a structured survey administered during the hospitalization. Responses are compared with information documented in the medical record to evaluate comprehension. Additional exploratory analyses evaluate implementation outcomes, caregiver perceptions of AI-assisted communication, physician acceptance of generated summaries, healthcare utilization outcomes following hospitalization, and operational measures related to AI summary generation.
Statistical analyses will compare outcomes between randomized groups while controlling for relevant covariates when appropriate.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver of a patient 10 years and younger admitted to Children's National Hospital, whose preferred language is English
排除标准
- •Caregivers of patients older than age 10 years
- •Caregivers of patients not admitted to the Hospital Medicine service
- •Caregivers of admitted patients whose preferred language is non-English
- •Patients whose care summaries are deemed inaccurate by their attending physician and not eligible for sharing with their caregiver.
研究组 & 干预措施
Standard Hospital Communication
Standard hospital communication
Standard Hospital Communication Plus AI Care Summary
Attending-approved written AI Care Summary provided to caregiver
干预措施: AI Care Summary (Other)
结局指标
主要结局
Hospital Course Comprehension Score
时间窗: Within 24 hours after receipt of the AI care summary or completion of standard care communication, during the index hospitalization
Percentage of caregiver survey responses that align with information documented in the medical record (range 0%-100%; higher scores indicate greater caregiver understanding of the hospital course).
次要结局
- LOS(Throughout study duration, on average one year)
- Readmission(During study duration, on average one year)
- ED reutilization(7 days after index hospital discharge and 30 days after index hospital discharge, respectively)
- Tokens(WIthin 1 hour following generation of each AI care summary (during index hospitalization))
- Energy usage(WIthin 1 hour of generation of the AI care summary (during index hospitalization))
- Acceptability: Physician(Within 1 hour of attending physician review of each AI-generated summary, prior to caregiver distribution, during index hospitalization)
- Reason for Rejection(WIthin 1 hour of attending physician review of the AI care summary, during the index hospitalization)
- Caregiver-Rated Usefulness of AI Care Summary (5-Point Likert Scale)(Within 24 hours after receipt of the AI care summary, during the index hospitalization)
- Engagement: Caregiver(Within 24 hours after receipt of the AI care summary, during the index hospitalization)
研究者
Kristen Elaine Johnson
Pediatric Hospitalist; Assistant Professor of Pediatrics
Children's National Research Institute