LLM-Generated Medical Summaries During Hospitalization to Improve Patient Activation in High-Risk Pregnancies
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Avihu Krieger, MD
- Número de teléfono: +972547421909
- Correo electrónico: avihuey@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Abraham Tsur, MD
- Número de teléfono: +972525418828
- Correo electrónico: Avi.Tsur@sheba.health.gov.il
Ubicaciones de estudio
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Ramat Gan, Israel, 5262000
- Sheba medical center
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Contacto:
- Avihu Krieger, MD
- Número de teléfono: 0547421909
- Correo electrónico: avihuey@gmail.com
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Contacto:
- Correo electrónico: avihuey@gmail.com
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Investigador principal:
- Avihu Krieger, MD
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Sub-Investigador:
- Abraham Tsur, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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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.
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Sin intervención: Standard Care
Participants receive standard care, which does not include LLM-generated medical summaries.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Patient Activation Measure Score
Periodo de tiempo: From baseline (pre-intervention) to post-intervention during hospitalization, approximately 1-8 weeks.
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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.
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From baseline (pre-intervention) to post-intervention during hospitalization, approximately 1-8 weeks.
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Number of LLM-Generated Medical Summaries Requiring Physician Modification or Rejection
Periodo de tiempo: Throughout hospitalization, approximately 1-8 weeks
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Number of LLM-generated medical summaries that require physician modification or are rejected following physician review and prior to delivery to the participant.
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Throughout hospitalization, approximately 1-8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Edinburgh Postnatal Depression Scale Score
Periodo de tiempo: From admission to discharge, approximately 1-8 weeks
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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.
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From admission to discharge, approximately 1-8 weeks
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Gestational Age at Delivery
Periodo de tiempo: At delivery, up to approximately 6 months after enrollment.
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Gestational age at delivery, measured in weeks and days, collected from the medical record and compared between the intervention and control groups.
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At delivery, up to approximately 6 months after enrollment.
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Mode of Delivery
Periodo de tiempo: At delivery, up to approximately 6 months after enrollment.
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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.
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At delivery, up to approximately 6 months after enrollment.
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Indication for Cesarean Delivery
Periodo de tiempo: At delivery, up to approximately 6 months after enrollment.
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Indication for cesarean delivery among participants undergoing cesarean delivery, collected from the medical record.
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At delivery, up to approximately 6 months after enrollment.
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Maternal Fever or Chorioamnionitis
Periodo de tiempo: From enrollment through delivery, up to approximately 6 months.
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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.
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From enrollment through delivery, up to approximately 6 months.
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Length of Antepartum Hospitalization
Periodo de tiempo: From admission to discharge from the antepartum hospitalization, approximately 1-8 weeks.
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Duration of antepartum hospitalization in days, collected from the medical record and compared between the intervention and control groups.
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From admission to discharge from the antepartum hospitalization, approximately 1-8 weeks.
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Antepartum Readmission or Emergency Department Visit
Periodo de tiempo: From discharge from the index hospitalization through delivery, up to approximately 6 months after enrollment.
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Proportion of participants with hospital readmission or an emergency department visit following discharge from the index antepartum hospitalization and prior to delivery.
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From discharge from the index hospitalization through delivery, up to approximately 6 months after enrollment.
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Birth Weight
Periodo de tiempo: At delivery, up to approximately 6 months after enrollment.
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Neonatal birth weight in grams, collected from the medical record and compared between the intervention and control groups.
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At delivery, up to approximately 6 months after enrollment.
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Apgar Score at 1 Minute
Periodo de tiempo: At delivery.
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Apgar score at 1 minute after birth, ranging from 0 to 10, with higher scores indicating better neonatal condition.
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At delivery.
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Apgar Score at 5 Minutes
Periodo de tiempo: At delivery.
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Apgar score at 5 minutes after birth, ranging from 0 to 10, with higher scores indicating better neonatal condition.
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At delivery.
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Umbilical Arterial Cord Blood pH
Periodo de tiempo: At delivery.
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Umbilical arterial cord blood pH measured at delivery and collected from the medical record.
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At delivery.
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Umbilical Venous Cord Blood pH
Periodo de tiempo: At delivery.
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Umbilical venous cord blood pH measured at delivery and collected from the medical record.
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At delivery.
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Umbilical Arterial and Venous Cord Blood Base Excess
Periodo de tiempo: At delivery.
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Umbilical arterial and Venous cord blood base excess measured at delivery and collected from the medical record.
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At delivery.
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Neonatal Intensive Care Unit Admission
Periodo de tiempo: From birth through neonatal hospital discharge, assessed up to 6 months after birth.
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Proportion of newborns admitted to the neonatal intensive care unit (NICU), collected from the medical record and compared between the intervention and control groups.
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From birth through neonatal hospital discharge, assessed up to 6 months after birth.
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Postpartum Endometritis
Periodo de tiempo: From delivery through 6 weeks postpartum.
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Proportion of participants diagnosed with postpartum endometritis, collected from the medical record and compared between the intervention and control groups.
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From delivery through 6 weeks postpartum.
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Postpartum Hemorrhage
Periodo de tiempo: From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.
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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.
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From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.
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Length of Postpartum Hospitalization
Periodo de tiempo: From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.
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Duration of postpartum hospitalization in days, collected from the medical record and compared between the intervention and control groups.
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From delivery through postpartum hospital discharge, assessed up to 6 weeks postpartum.
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Postpartum Readmission or Emergency Department Visit
Periodo de tiempo: From postpartum hospital discharge through 6 weeks postpartum.
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Proportion of participants with hospital readmission or an emergency department visit during the postpartum period.
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From postpartum hospital discharge through 6 weeks postpartum.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Desordenes mentales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones del embarazo
- Trastornos del estado de ánimo
- Trastornos Puerperales
- Desorden depresivo
- Comportamiento
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Aceptación del paciente de la atención médica
- Depresión, Posparto
- Participación del paciente
Otros números de identificación del estudio
- SMC-25-2019
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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