The Effect of Large Language Model-Generated Medical Summaries on Patient Activation During Antepartum Hospitalization: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Patient Activation Measure Score
研究概览
简要总结
The goal of this clinical trial is to learn if AI-generated medical summaries help hospitalized pregnant participants better understand and actively participate in their own care. The main questions it aims to answer are:
Do AI-generated summaries increase participant activation (knowledge, skills, and confidence in managing their health)? How accurate are the AI-generated summaries, as assessed by physicians? Do AI-generated summaries affect depressive symptoms during hospitalization?
Researchers will compare participants who receive periodic AI-generated summaries of their medical care with participants who receive standard care to determine whether the summaries improve patient activation during hospitalization.
Participants will:
Be randomly assigned to receive AI-generated medical summaries or standard care.
Complete the Patient Activation Measure (PAM-13) at baseline before the intervention and again after the intervention.
Complete the Edinburgh Postnatal Depression Scale (EPDS) at baseline and again after the intervention.
Receive up to 3 summaries during their hospitalization (intervention group only).
详细描述
Hospitalized pregnant participants in high-risk antepartum units may face complex medical conditions and treatment plans and may have difficulty understanding all of the medical information provided during hospitalization. This may reduce their ability to actively participate in their own care.
In this study, participants will be randomly assigned in a 1:1 ratio to one of two groups. Randomization will be stratified by gestational age at enrollment (<32+0 weeks vs. ≥32+0 weeks) using permuted blocks with randomly varying block sizes.
Participants in the intervention group will receive periodic medical summaries generated by a large language model (LLM) using a secure, privacy-protected AI environment at Sheba Medical Center. Each summary will be reviewed by a physician for medical accuracy before being provided to the participant. If a summary is considered inadequate, the physician may correct it before providing it to the participant or reject it, in which case it will not be provided.
The first summary will be generated on days 3-5 of hospitalization. Updated summaries will subsequently be generated every 3-5 days, with a maximum of 3 summaries per participant during hospitalization.
Participants in the control group will receive standard care without LLM-generated medical summaries.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Admitted to the antepartum high-risk department at Sheba Medical Center
- •Able to provide written informed consent
- •Able to read and understand Hebrew, English, or Arabic
排除标准
- •Expected hospitalization of less than 3 days
研究组 & 干预措施
LLM-Generated Medical Summaries
Participants receive periodic patient-facing written medical summaries generated by a large language model (LLM) using a secure, privacy-protected AI environment at Sheba Medical Center. This is an informational intervention and does not involve a drug, medical device, or medical procedure. Each summary is reviewed by a physician for medical accuracy before delivery. Summaries are generated every 3-5 days, beginning on days 3-5 of hospitalization, with a maximum of 3 summaries per participant.
干预措施: LLM-Generated Medical Summaries (Other)
Standard Care
Participants receive standard care, which does not include LLM-generated medical summaries.
结局指标
主要结局
Change in Patient Activation Measure Score
时间窗: From baseline (pre-intervention) to post-intervention during hospitalization, approximately 1-8 weeks.
Change in Patient Activation Measure (PAM-13) score from baseline (pre-intervention) to post-intervention, compared between the intervention and control groups. The PAM-13 is a 13-item instrument assessing patient knowledge, skills, and confidence in managing their own health. Scores range from 0 to 100, with higher scores indicating greater patient activation.
Number of LLM-Generated Medical Summaries Requiring Physician Modification or Rejection
时间窗: Throughout hospitalization, approximately 1-8 weeks
Number of LLM-generated medical summaries that require physician modification or are rejected following physician review and prior to delivery to the participant.
次要结局
- Change in Edinburgh Postnatal Depression Scale Score(From admission to discharge, approximately 1-8 weeks)
- Gestational Age at Delivery(At delivery, up to approximately 6 months after enrollment.)
- Mode of Delivery(At delivery, up to approximately 6 months after enrollment.)
- Indication for Cesarean Delivery(At delivery, up to approximately 6 months after enrollment.)
- Maternal Fever or Chorioamnionitis(From enrollment through delivery, up to approximately 6 months.)
- Length of Antepartum Hospitalization(From admission to discharge from the antepartum hospitalization, approximately 1-8 weeks.)
- Antepartum Readmission or Emergency Department Visit(From discharge from the index hospitalization through delivery, up to approximately 6 months after enrollment.)
- Birth Weight(At delivery, up to approximately 6 months after enrollment.)
- Apgar Score at 1 Minute(At delivery.)
- Apgar Score at 5 Minutes(At delivery.)
- Umbilical Arterial Cord Blood pH(At delivery.)
- Umbilical Venous Cord Blood pH(At delivery.)
- Umbilical Arterial and Venous Cord Blood Base Excess(At delivery.)
- Neonatal Intensive Care Unit Admission(From birth through neonatal hospital discharge, assessed up to 6 months after birth.)
- Postpartum Endometritis(From delivery through 6 weeks postpartum.)
- Postpartum Hemorrhage(From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.)
- Length of Postpartum Hospitalization(From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.)
- Postpartum Readmission or Emergency Department Visit(From postpartum hospital discharge through 6 weeks postpartum.)
研究者
Avihu Krieger
Principal Investigator and Physician, Department of Obstetrics and Gynecology
Sheba Medical Center