About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Expected hospitalization of less than 3 days
Trial design
Parallel
Treatments tested in this trial
LLM-Generated Medical Summaries
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Patient Activation Measure Score
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
Number of LLM-generated medical summaries that require physician modification or are rejected following physician review and prior to delivery to the participant.
Secondary outcomes
Change in Edinburgh Postnatal Depression Scale Score
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
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
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
Indication for cesarean delivery among participants undergoing cesarean delivery, collected from the medical record.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: