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NCT Number: NCT07823517

LLM-Generated Medical Summaries During Hospitalization to Improve Patient Activation in High-Risk Pregnancies

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).

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Key information

Conditions

High-Risk Pregnancy Artificial Intelligence (AI) Behavior Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Health Behavior Hospitalization Mental Disorders Mood Disorders Patient Acceptance of Health Care Patient Activation Patient Participation Pregnancy Complications Puerperal Disorders Treatment Adherence and Compliance Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

The researchers will investigate:

Whether LLM-generated summaries improve patient activation, defined as the knowledge, skills, and confidence participants have in managing their own health, as measured by the Patient Activation Measure (PAM-13).

Whether LLM-generated summaries affect depressive symptoms during hospitalization, as measured by the Edinburgh Postnatal Depression Scale (EPDS).

The accuracy of LLM-generated medical summaries as assessed by physicians, including whether summaries require modification or rejection before being provided to participants.

Obstetric, neonatal, and postpartum clinical outcomes collected from the medical record.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Expected hospitalization of less than 3 days

Treatment and study plan

LLM-Generated Medical Summaries

Other

Participants receive patient-facing written medical summaries generated by a large language model (LLM) using a secure, privacy-protected AI environment at Sheba Medical Center. The intervention is informational and does not involve administration of a drug, use of a medical device, or performance of a medical procedure. Each summary is reviewed by a physician for medical accuracy before being provided to the participant. If a summary is deemed inadequate, it may be corrected by the reviewing physician before delivery or rejected and not provided. The first summary is generated on days 3-5 of hospitalization, with updated summaries every 3-5 days and a maximum of 3 summaries per participant.

Primary outcomes

  1. Change in Patient Activation Measure Score

    Time frame: 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.

  2. Number of LLM-Generated Medical Summaries Requiring Physician Modification or Rejection

    Time frame: 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.

Secondary outcomes

  1. Change in Edinburgh Postnatal Depression Scale Score

    Time frame: From admission to discharge, approximately 1-8 weeks

    Change in EPDS score from baseline (admission) to end of hospitalization (prior to discharge), compared between the intervention and control groups. The EPDS is a 10-item self-report instrument with scores ranging from 0 to 30. A score of 10 or above indicates clinically significant depressive symptoms.

  2. Gestational Age at Delivery

    Time frame: At delivery, up to approximately 6 months after enrollment.

    Gestational age at delivery, measured in weeks and days, collected from the medical record and compared between the intervention and control groups.

  3. Mode of Delivery

    Time frame: At delivery, up to approximately 6 months after enrollment.

    Mode of delivery, categorized as spontaneous vaginal delivery, operative vaginal delivery, or cesarean delivery, collected from the medical record and compared between the intervention and control groups.

  4. Indication for Cesarean Delivery

    Time frame: At delivery, up to approximately 6 months after enrollment.

    Indication for cesarean delivery among participants undergoing cesarean delivery, collected from the medical record.

  5. Maternal Fever or Chorioamnionitis

    Time frame: From enrollment through delivery, up to approximately 6 months.

    Proportion of participants diagnosed with maternal fever or chorioamnionitis during pregnancy or delivery, collected from the medical record and compared between the intervention and control groups.

  6. Length of Antepartum Hospitalization

    Time frame: From admission to discharge from the antepartum hospitalization, approximately 1-8 weeks.

    Duration of antepartum hospitalization in days, collected from the medical record and compared between the intervention and control groups.

  7. Antepartum Readmission or Emergency Department Visit

    Time frame: From discharge from the index hospitalization through delivery, up to approximately 6 months after enrollment.

    Proportion of participants with hospital readmission or an emergency department visit following discharge from the index antepartum hospitalization and prior to delivery.

  8. Birth Weight

    Time frame: At delivery, up to approximately 6 months after enrollment.

    Neonatal birth weight in grams, collected from the medical record and compared between the intervention and control groups.

  9. Apgar Score at 1 Minute

    Time frame: At delivery.

    Apgar score at 1 minute after birth, ranging from 0 to 10, with higher scores indicating better neonatal condition.

  10. Apgar Score at 5 Minutes

    Time frame: At delivery.

    Apgar score at 5 minutes after birth, ranging from 0 to 10, with higher scores indicating better neonatal condition.

  11. Umbilical Arterial Cord Blood pH

    Time frame: At delivery.

    Umbilical arterial cord blood pH measured at delivery and collected from the medical record.

  12. Umbilical Venous Cord Blood pH

    Time frame: At delivery.

    Umbilical venous cord blood pH measured at delivery and collected from the medical record.

  13. Umbilical Arterial and Venous Cord Blood Base Excess

    Time frame: At delivery.

    Umbilical arterial and Venous cord blood base excess measured at delivery and collected from the medical record.

  14. Neonatal Intensive Care Unit Admission

    Time frame: From birth through neonatal hospital discharge, assessed up to 6 months after birth.

    Proportion of newborns admitted to the neonatal intensive care unit (NICU), collected from the medical record and compared between the intervention and control groups.

  15. Postpartum Endometritis

    Time frame: From delivery through 6 weeks postpartum.

    Proportion of participants diagnosed with postpartum endometritis, collected from the medical record and compared between the intervention and control groups.

  16. Postpartum Hemorrhage

    Time frame: From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.

    Proportion of participants experiencing postpartum hemorrhage, defined as estimated blood loss greater than 1000 mL, collected from the medical record and compared between the intervention and control groups.

  17. Length of Postpartum Hospitalization

    Time frame: From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.

    Duration of postpartum hospitalization in days, collected from the medical record and compared between the intervention and control groups.

  18. Postpartum Readmission or Emergency Department Visit

    Time frame: From postpartum hospital discharge through 6 weeks postpartum.

    Proportion of participants with hospital readmission or an emergency department visit during the postpartum period.

Study contacts

Contact information is provided by the study sponsor or research team.

Abraham Tsur, MD

CONTACT

[email protected]

+972525418828

Avihu Krieger, MD

CONTACT

[email protected]

+972547421909

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

The Effect of Large Language Model-Generated Medical Summaries on Patient Activation During Antepartum Hospitalization: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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