An interventional study of AI Care Summary in Health Literacy, Comprehension and Patient Satisfaction, sponsored by Children's National Research Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Children's National Research Institute · Not applicable, Interventional, and Health services research
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.
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.
877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.
This study's planned enrollment of 100 is close to the median of 96 across 624 interventional studies indexed under Patient Satisfaction.
Browse Patient Satisfaction studies →Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Caregiver of a patient 10 years and younger admitted to Children's National Hospital, whose preferred language is English
Exclusion Criteria:
Standard hospital communication
Attending-approved written AI Care Summary provided to caregiver
Other: AI Care Summary
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.
Hospital Course Comprehension Score
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).
Time frame: Within 24 hours after receipt of the AI care summary or completion of standard care communication, during the index hospitalization
LOS
Length of stay
Time frame: Throughout study duration, on average one year
Readmission
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.
Time frame: During study duration, on average one year
ED reutilization
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.
Time frame: 7 days after index hospital discharge and 30 days after index hospital discharge, respectively
Tokens
Token burden: the number of tokens used per AI-generated care summary.
Time frame: WIthin 1 hour following generation of each AI care summary (during index hospitalization)
Energy usage
Energy use: estimated average kilowatt-hour use per AI-generated summary.
Time frame: WIthin 1 hour of generation of the AI care summary (during index hospitalization)
Acceptability: Physician
AI care summary rejection rate: the proportion of AI-generated summaries that attending physicians determine are not appropriate to share with caregivers.
Time frame: Within 1 hour of attending physician review of each AI-generated summary, prior to caregiver distribution, during index hospitalization
Reason for Rejection
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.
Time frame: WIthin 1 hour of attending physician review of the AI care summary, during the index hospitalization
Caregiver-Rated Usefulness of AI Care Summary (5-Point Likert Scale)
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.
Time frame: Within 24 hours after receipt of the AI care summary, during the index hospitalization
Engagement: Caregiver
Caregiver interest in AI summaries as standard care: whether caregivers would want this type of summary incorporated into routine care.
Time frame: Within 24 hours after receipt of the AI care summary, during the index hospitalization
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Our IRB protocol does not permit IPD sharing for subject privacy
Started May 2026 (actual). Primary completion is estimated for Jun 2027, 13 months after the start.
Of 368 non-industry interventional studies with no phase under Patient Satisfaction, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 13 months is close to that.
Counting every sponsor, half of 370 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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