LLM-Generated Medical Summaries During Hospitalization to Improve Patient Activation in High-Risk Pregnancies

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorSheba Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • LLM-Generated Medical Summaries

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: LLM-Generated Medical SummariesExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From baseline (pre-intervention) to post-intervention during hospitalization, approximately 1-8 weeks.
2

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.

Time frame
Throughout hospitalization, approximately 1-8 weeks

Secondary outcomes

1

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.

Time frame
From admission to discharge, approximately 1-8 weeks
2

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.

Time frame
At delivery, up to approximately 6 months after enrollment.
3

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.

Time frame
At delivery, up to approximately 6 months after enrollment.
4

Indication for Cesarean Delivery

Indication for cesarean delivery among participants undergoing cesarean delivery, collected from the medical record.

Time frame
At delivery, up to approximately 6 months after enrollment.

Other outcomes

Sponsors and contacts

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