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).
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Avihu Krieger, MD
- Número de telefone: +972547421909
- E-mail: avihuey@gmail.com
Estude backup de contato
- Nome: Abraham Tsur, MD
- Número de telefone: +972525418828
- E-mail: Avi.Tsur@sheba.health.gov.il
Locais de estudo
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Ramat Gan, Israel, 5262000
- Sheba medical center
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Contato:
- Avihu Krieger, MD
- Número de telefone: 0547421909
- E-mail: avihuey@gmail.com
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Contato:
- E-mail: avihuey@gmail.com
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Investigador principal:
- Avihu Krieger, MD
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Subinvestigador:
- Abraham Tsur, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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Sem intervenção: Standard Care
Participants receive standard care, which does not include LLM-generated medical summaries.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Patient Activation Measure Score
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Edinburgh Postnatal Depression Scale Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Transtornos Mentais, Desordem Mental
- Doenças urogenitais femininas e complicações na gravidez
- Complicações na Gravidez
- Transtornos de Humor
- Distúrbios puerperais
- Desordem depressiva
- Comportamento
- Adesão e Cumprimento do Tratamento
- Comportamento de saúde
- Aceitação dos Cuidados de Saúde pelo Paciente
- Depressão, Pós-parto
- Participação do paciente
Outros números de identificação do estudo
- SMC-25-2019
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