Artificial Intelligence (AI), High-risk Pregnancy, Hospitalization, Patient Activation
Conditions
Keywords
Large Language Model, Artificial Intelligence, Patient Activation, High-Risk Pregnancy, Antepartum Hospitalization, Medical Summaries, Postnatal Depression, PAM-13, EPDS
Brief summary
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).
Detailed description
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.
Interventions
OTHERLLM-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.
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Activation Measure Score | 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. |
| Number of LLM-Generated Medical Summaries Requiring Physician Modification or Rejection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Edinburgh Postnatal Depression Scale Score | 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. |
| Gestational Age at Delivery | 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. |
| Mode of Delivery | 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. |
| Indication for Cesarean Delivery | At delivery, up to approximately 6 months after enrollment. | Indication for cesarean delivery among participants undergoing cesarean delivery, collected from the medical record. |
| Maternal Fever or Chorioamnionitis | 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. |
| Length of Antepartum Hospitalization | 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. |
| Antepartum Readmission or Emergency Department Visit | 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. |
| Birth Weight | 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. |
| Apgar Score at 1 Minute | At delivery. | Apgar score at 1 minute after birth, ranging from 0 to 10, with higher scores indicating better neonatal condition. |
| Apgar Score at 5 Minutes | At delivery. | Apgar score at 5 minutes after birth, ranging from 0 to 10, with higher scores indicating better neonatal condition. |
| Umbilical Arterial Cord Blood pH | At delivery. | Umbilical arterial cord blood pH measured at delivery and collected from the medical record. |
| Umbilical Venous Cord Blood pH | At delivery. | Umbilical venous cord blood pH measured at delivery and collected from the medical record. |
| Umbilical Arterial and Venous Cord Blood Base Excess | At delivery. | Umbilical arterial and Venous cord blood base excess measured at delivery and collected from the medical record. |
| Neonatal Intensive Care Unit Admission | 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. |
| Postpartum Endometritis | 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. |
| Postpartum Hemorrhage | 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. |
| Length of Postpartum Hospitalization | 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. |
| Postpartum Readmission or Emergency Department Visit | From postpartum hospital discharge through 6 weeks postpartum. | Proportion of participants with hospital readmission or an emergency department visit during the postpartum period. |
Countries
Israel
Contacts
CONTACTAvihu Krieger, MD
CONTACTAbraham Tsur, MD
Outcome results
None listed