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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Avihu Krieger, MD
- Numéro de téléphone: +972547421909
- E-mail: avihuey@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Abraham Tsur, MD
- Numéro de téléphone: +972525418828
- E-mail: Avi.Tsur@sheba.health.gov.il
Lieux d'étude
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Ramat Gan, Israël, 5262000
- Sheba medical center
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Contact:
- Avihu Krieger, MD
- Numéro de téléphone: 0547421909
- E-mail: avihuey@gmail.com
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Contact:
- E-mail: avihuey@gmail.com
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Chercheur principal:
- Avihu Krieger, MD
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Sous-enquêteur:
- Abraham Tsur, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Aucune intervention: Standard Care
Participants receive standard care, which does not include LLM-generated medical summaries.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Patient Activation Measure Score
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Edinburgh Postnatal Depression Scale Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Les troubles mentaux
- Maladies urogénitales féminines et complications de la grossesse
- Complications de grossesse
- Troubles de l'humeur
- Troubles puerpéraux
- Dépression
- Comportement
- Adhésion et conformité au traitement
- Comportement de santé
- Acceptation des soins de santé par le patient
- Dépression, post-partum
- Participation des patients
Autres numéros d'identification d'étude
- SMC-25-2019
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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