Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Standard Hospital Communication
Standard hospital communication
  • 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.
Experimental
Standard Hospital Communication Plus AI Care Summary
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.

Recruiting Locations

Children's National Hospital
Washington D.C., District of Columbia 20010
Contact:
Kristen Johnson, MD, MS

More Details

Status
Recruiting
Sponsor
Children's National Research Institute

Study Contact

Kristen E Johnson, MD, MS
571-235-6524
kejohnson@childrensnational.org

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.