Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

12 september 2026 bijgewerkt door: Avihu Krieger, Sheba Medical Center

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

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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Israël
      • Ramat Gan, Israël, 5262000
        • Sheba medical center
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Avihu Krieger, MD
        • Onderonderzoeker:
          • Abraham Tsur, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: LLM-Generated Medical Summaries
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.
Geen tussenkomst: Standard Care
Participants receive standard care, which does not include LLM-generated medical summaries.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Patient Activation Measure Score
Tijdsspanne: 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.
From baseline (pre-intervention) to post-intervention during hospitalization, approximately 1-8 weeks.
Number of LLM-Generated Medical Summaries Requiring Physician Modification or Rejection
Tijdsspanne: 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.
Throughout hospitalization, approximately 1-8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Edinburgh Postnatal Depression Scale Score
Tijdsspanne: 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.
From admission to discharge, approximately 1-8 weeks
Gestational Age at Delivery
Tijdsspanne: 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.
At delivery, up to approximately 6 months after enrollment.
Mode of Delivery
Tijdsspanne: 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.
At delivery, up to approximately 6 months after enrollment.
Indication for Cesarean Delivery
Tijdsspanne: At delivery, up to approximately 6 months after enrollment.
Indication for cesarean delivery among participants undergoing cesarean delivery, collected from the medical record.
At delivery, up to approximately 6 months after enrollment.
Maternal Fever or Chorioamnionitis
Tijdsspanne: 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.
From enrollment through delivery, up to approximately 6 months.
Length of Antepartum Hospitalization
Tijdsspanne: 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.
From admission to discharge from the antepartum hospitalization, approximately 1-8 weeks.
Antepartum Readmission or Emergency Department Visit
Tijdsspanne: 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.
From discharge from the index hospitalization through delivery, up to approximately 6 months after enrollment.
Birth Weight
Tijdsspanne: 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.
At delivery, up to approximately 6 months after enrollment.
Apgar Score at 1 Minute
Tijdsspanne: At delivery.
Apgar score at 1 minute after birth, ranging from 0 to 10, with higher scores indicating better neonatal condition.
At delivery.
Apgar Score at 5 Minutes
Tijdsspanne: At delivery.
Apgar score at 5 minutes after birth, ranging from 0 to 10, with higher scores indicating better neonatal condition.
At delivery.
Umbilical Arterial Cord Blood pH
Tijdsspanne: At delivery.
Umbilical arterial cord blood pH measured at delivery and collected from the medical record.
At delivery.
Umbilical Venous Cord Blood pH
Tijdsspanne: At delivery.
Umbilical venous cord blood pH measured at delivery and collected from the medical record.
At delivery.
Umbilical Arterial and Venous Cord Blood Base Excess
Tijdsspanne: At delivery.
Umbilical arterial and Venous cord blood base excess measured at delivery and collected from the medical record.
At delivery.
Neonatal Intensive Care Unit Admission
Tijdsspanne: 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.
From birth through neonatal hospital discharge, assessed up to 6 months after birth.
Postpartum Endometritis
Tijdsspanne: 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.
From delivery through 6 weeks postpartum.
Postpartum Hemorrhage
Tijdsspanne: 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.
From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.
Length of Postpartum Hospitalization
Tijdsspanne: 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.
From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.
Postpartum Readmission or Emergency Department Visit
Tijdsspanne: From postpartum hospital discharge through 6 weeks postpartum.
Proportion of participants with hospital readmission or an emergency department visit during the postpartum period.
From postpartum hospital discharge through 6 weeks postpartum.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sheba Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 januari 2028

Studie voltooiing (Geschat)

23 juli 2028

Studieregistratiedata

Eerst ingediend

15 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 september 2026

Eerst geplaatst (Werkelijk)

16 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2026

Laatste update ingediend die voldeed aan QC-criteria

12 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SMC-25-2019

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

This study is planned as a single-center trial, and at this stage, there are no plans or agreements in place for sharing individual participant data (IPD). Future considerations for data-sharing agreements may be evaluated based on future research collaborations and institutional policies.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren