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

12 settembre 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Israele
      • Ramat Gan, Israele, 5262000
        • Sheba medical center
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Avihu Krieger, MD
        • Sub-investigatore:
          • Abraham Tsur, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Nessun intervento: Standard Care
Participants receive standard care, which does not include LLM-generated medical summaries.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Patient Activation Measure Score
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Edinburgh Postnatal Depression Scale Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At delivery.
Umbilical arterial cord blood pH measured at delivery and collected from the medical record.
At delivery.
Umbilical Venous Cord Blood pH
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sheba Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

23 luglio 2028

Date di iscrizione allo studio

Primo inviato

15 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 settembre 2026

Primo Inserito (Effettivo)

16 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SMC-25-2019

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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