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

NCT07823517 | Not Yet Recruiting

• 1 other identifier: SMC-25-2019
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

High-risk Pregnancy; Hospitalization; Patient Activation; Artificial Intelligence (AI)

Keywords

Large Language Model; Artificial Intelligence; Patient Activation; High-Risk Pregnancy; Antepartum Hospitalization; Medical Summaries; Postnatal Depression; PAM-13; EPDS

Outcome Measures

Primary Outcomes (2)

• Change in Patient Activation Measure Score

  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.

  From baseline (pre-intervention) to post-intervention during hospitalization, approximately 1-8 weeks.

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

  Number of LLM-generated medical summaries that require physician modification or are rejected following physician review and prior to delivery to the participant.

  Throughout hospitalization, approximately 1-8 weeks

Secondary Outcomes (18)

• 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.

Study Arms (2)

LLM-Generated Medical Summaries

EXPERIMENTAL

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.

Other: LLM-Generated Medical Summaries

Standard Care

NO INTERVENTION

Participants receive standard care, which does not include LLM-generated medical summaries.

Interventions

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.

LLM-Generated Medical Summaries

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Expected hospitalization of less than 3 days

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

MeSH Terms

Conditions

Patient Participation; Depression, Postpartum

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Avihu Krieger, MD

CONTACT

+972547421909; avihuey@gmail.com

Abraham Tsur, MD

CONTACT

+972525418828; Avi.Tsur@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Physician, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 23, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)