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Impact of AI Care Summaries on Caregiver Comprehension

15 september 2026 uppdaterad av: Kristen Elaine Johnson, Children's National Research Institute

Impact of AI Care Summaries on Caregiver Comprehension of Hospital Course

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • District of Columbia
      • Washington D.C., District of Columbia, Förenta staterna, 20010
        • Rekrytering
        • Children's National Hospital
        • Kontakt:
          • Kristen Johnson, MD, MS

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Standard Hospital Communication

Standard hospital communication
Experimentell: Standard Hospital Communication Plus AI Care Summary

Attending-approved written AI Care Summary provided to caregiver
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hospital Course Comprehension Score
Tidsram: 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).
Within 24 hours after receipt of the AI care summary or completion of standard care communication, during the index hospitalization

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
LOS
Tidsram: Throughout study duration, on average one year

Length of stay
Throughout study duration, on average one year
Readmission
Tidsram: 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.
During study duration, on average one year
ED reutilization
Tidsram: 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.
7 days after index hospital discharge and 30 days after index hospital discharge, respectively
Tokens
Tidsram: 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.
WIthin 1 hour following generation of each AI care summary (during index hospitalization)
Energy usage
Tidsram: WIthin 1 hour of generation of the AI care summary (during index hospitalization)

Energy use: estimated average kilowatt-hour use per AI-generated summary.
WIthin 1 hour of generation of the AI care summary (during index hospitalization)
Acceptability: Physician
Tidsram: 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.
Within 1 hour of attending physician review of each AI-generated summary, prior to caregiver distribution, during index hospitalization
Reason for Rejection
Tidsram: 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.
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)
Tidsram: 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.
Within 24 hours after receipt of the AI care summary, during the index hospitalization
Engagement: Caregiver
Tidsram: 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.
Within 24 hours after receipt of the AI care summary, during the index hospitalization

Samarbetspartners och utredare

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Sponsor

Children's National Research Institute

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 maj 2026

Primärt slutförande (Beräknad)

30 juni 2027

Avslutad studie (Beräknad)

30 juni 2027

Studieregistreringsdatum

Först inskickad

23 juli 2026

Först inskickad som uppfyllde QC-kriterierna

15 september 2026

Första postat (Faktisk)

21 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00001841

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IPD-planbeskrivning

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