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

12 września 2026 zaktualizowane przez: 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).

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

200

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Izrael
      • Ramat Gan, Izrael, 5262000
        • Sheba medical center
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Avihu Krieger, MD
        • Pod-śledczy:
          • Abraham Tsur, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: 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.
Brak interwencji: Standard Care
Participants receive standard care, which does not include LLM-generated medical summaries.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Patient Activation Measure Score
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Edinburgh Postnatal Depression Scale Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At delivery.
Umbilical arterial cord blood pH measured at delivery and collected from the medical record.
At delivery.
Umbilical Venous Cord Blood pH
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Sheba Medical Center

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2028

Ukończenie studiów (Szacowany)

23 lipca 2028

Daty rejestracji na studia

Pierwszy przesłany

15 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 września 2026

Pierwszy wysłany (Rzeczywisty)

16 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SMC-25-2019

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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