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NCT Number: NCT07831018

Impact of AI Care Summaries on Caregiver Comprehension

The primary objective is to assess if an AI-generated plain language summary of an inpatient progress note can improve caregiver understanding of their child's hospitalization by measuring differences in Hospital Course Comprehension scores, based on their responses to a survey regarding their child's hospital course.

Secondary objectives include exploring the caregiver's perspective on the use of AI in clinical care, as well as 7-day and 30-day readmission rates, 7-day and 30-day emergency department (ED) re-utilization rates, length of stay, and environmental impact measures.

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Key information

Conditions

Health Literacy Behavior Communication Comprehension Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location status: Recruiting

Location contact

Kristen Johnson, MD, MS

CONTACT

About this study

This randomized controlled trial evaluates whether AI-generated plain-language summaries of inpatient progress notes improve caregiver understanding of a child's hospitalization. The intervention uses a Children's National HIPAA-compliant large language model hosted within the institution's Azure environment to generate caregiver-facing summaries from attending-signed inpatient progress notes.

Eligible caregivers are randomized to receive either standard hospital communication alone or standard communication plus an attending-approved AI-generated care summary. Before distribution to caregivers, attending physicians review generated summaries for clinical appropriateness and accuracy.

Caregiver understanding of the hospitalization is assessed using a structured survey administered during the hospitalization. Responses are compared with information documented in the medical record to evaluate comprehension. Additional exploratory analyses evaluate implementation outcomes, caregiver perceptions of AI-assisted communication, physician acceptance of generated summaries, healthcare utilization outcomes following hospitalization, and operational measures related to AI summary generation.

Statistical analyses will compare outcomes between randomized groups while controlling for relevant covariates when appropriate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Caregiver of a patient 10 years and younger admitted to Children's National Hospital, whose preferred language is English

Exclusion criteria

  • Caregivers of patients older than age 10 years
  • Caregivers of patients not admitted to the Hospital Medicine service
  • Caregivers of admitted patients whose preferred language is non-English
  • Patients whose care summaries are deemed inaccurate by their attending physician and not eligible for sharing with their caregiver.

Treatment and study plan

AI Care Summary

Other

Written AI-generated plain-language summary of the patient's hospital course, reviewed and approved by the attending physician and provided to the caregiver during the hospitalization.

Primary outcomes

  1. Hospital Course Comprehension Score

    Time frame: Within 24 hours after receipt of the AI care summary or completion of standard care communication, during the index hospitalization

    Percentage of caregiver survey responses that align with information documented in the medical record (range 0%-100%; higher scores indicate greater caregiver understanding of the hospital course).

Secondary outcomes

  1. LOS

    Time frame: Throughout study duration, on average one year

    Length of stay

  2. Readmission

    Time frame: During study duration, on average one year

    7-day and 30-day readmission rates: readmissions within 7 or 30 days of the index hospitalization, when related to problems addressed during the initial hospitalization.

  3. ED reutilization

    Time frame: 7 days after index hospital discharge and 30 days after index hospital discharge, respectively

    7-day and 30-day ED re-utilization rates: return visits to the emergency department within 7 or 30 days for complaints related to the initial hospitalization.

  4. Tokens

    Time frame: WIthin 1 hour following generation of each AI care summary (during index hospitalization)

    Token burden: the number of tokens used per AI-generated care summary.

  5. Energy usage

    Time frame: WIthin 1 hour of generation of the AI care summary (during index hospitalization)

    Energy use: estimated average kilowatt-hour use per AI-generated summary.

  6. Acceptability: Physician

    Time frame: Within 1 hour of attending physician review of each AI-generated summary, prior to caregiver distribution, during index hospitalization

    AI care summary rejection rate: the proportion of AI-generated summaries that attending physicians determine are not appropriate to share with caregivers.

  7. Reason for Rejection

    Time frame: WIthin 1 hour of attending physician review of the AI care summary, during the index hospitalization

    Reason for rejection: the primary reason an attending rejects a summary. One of five categorical options for rejection (contains sensitive information, contains factual errors, tone is not right, prefer not to provide written information, concerned may cause confusion); or category "other" with a free text response.

  8. Caregiver-Rated Usefulness of AI Care Summary (5-Point Likert Scale)

    Time frame: Within 24 hours after receipt of the AI care summary, during the index hospitalization

    Caregiver rating of how helpful the AI-generated care summary was for understanding the child's hospitalization, measured on a 5-point Likert scale ranging from 1 (Not Helpful at All) to 5 (Extremely Helpful). Higher scores indicate greater perceived usefulness.

  9. Engagement: Caregiver

    Time frame: Within 24 hours after receipt of the AI care summary, during the index hospitalization

    Caregiver interest in AI summaries as standard care: whether caregivers would want this type of summary incorporated into routine care.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristen E Johnson, MD, MS

CONTACT

[email protected]

571-235-6524

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Official study title

Impact of AI Care Summaries on Caregiver Comprehension of Hospital Course

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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