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Health LiteracyNCT07831018

Impact of AI Care Summaries on Caregiver Comprehension

A study testing AI Care Summary in people with Health Literacy and Comprehension, run by Children's National Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AI Care Summary
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
5 May 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kristen E Johnson, MD, MS contact

571-235-6524

kejohnson@childrensnational.org

United States1 site, 1 recruiting

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010

    Kristen Johnson, MD, MS

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
AI Care Summary
Keywords
plain language, health literacy, communication
Medical subject headings
Patient Satisfaction, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI Care SummaryOther

    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.

Study groups in NCT07831018
Study groupRoleWhat they receive
Standard Hospital CommunicationNo interventionStandard hospital communication
Standard Hospital Communication Plus AI Care SummaryExperimentalAttending-approved written AI Care Summary provided to caregiver
Receives: Other: AI Care Summary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

Secondary outcomes (9)

  1. LOS

    Length of stay

    Measured: Throughout study duration, on average one year

  2. 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.

    Measured: During study duration, on average one year

  3. 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.

    Measured: 7 days after index hospital discharge and 30 days after index hospital discharge, respectively

  4. Tokens

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

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

  5. Energy usage

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

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

  6. Acceptability: Physician

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

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

  7. 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.

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

  8. 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.

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

  9. Engagement: Caregiver

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study start5 May 2026
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07831018
Sponsor's protocol ID
STUDY00001841
Status last verified
Sep 2026
First submitted
23 Jul 2026
Last updated
21 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Our IRB protocol does not permit IPD sharing for subject privacy

Publications

  • Bedi S, Liu Y, Orr-Ewing L, Dash D, Koyejo S, Callahan A, Fries JA, Wornow M, Swaminathan A, Lehmann LS, Hong HJ, Kashyap M, Chaurasia AR, Shah NR, Singh K, Tazbaz T, Milstein A, Pfeffer MA, Shah NH. Testing and Evaluation of Health Care Applications of Large Language Models: A Systematic Review. JAMA. 2025 Jan 28;333(4):319-328. doi: 10.1001/jama.2024.21700.

    PubMed 39405325

  • Schoonbeek RC, Workum JD, Schuit SCE, Hoekman AH, Mehri T, Doornberg JN, van der Laan TP, Bootsma-Robroeks CMHHT; Applied Artificial Intelligence in Healthcare Consortium. Quality and efficiency of integrating customised large language model-generated summaries versus physician-written summaries: a validation study. BMJ Open. 2025 Sep 4;15(9):e099301. doi: 10.1136/bmjopen-2025-099301.

    PubMed 40908007

  • Greenberg JA, Basapur S, Quinn TV, Bulger JL, Schwartz NH, Oh SK, Ritz EM, Glover CM, Shah RC. Daily Written Care Summaries for Families of Critically Ill Patients: A Randomized Controlled Trial. Crit Care Med. 2022 Sep 1;50(9):1296-1305. doi: 10.1097/CCM.0000000000005583. Epub 2022 May 23.

    PubMed 35607975

  • Johnson AM, Brimhall AS, Johnson ET, Hodgson J, Didericksen K, Pye J, Harmon GJC, Sewell KB. A systematic review of the effectiveness of patient education through patient portals. JAMIA Open. 2023 Jan 18;6(1):ooac085. doi: 10.1093/jamiaopen/ooac085. eCollection 2023 Apr.

    PubMed 36686972

  • Rea KE, Rao P, Hill E, Saylor KM, Cousino MK. Families' Experiences With Pediatric Family-Centered Rounds: A Systematic Review. Pediatrics. 2018 Mar;141(3):e20171883. doi: 10.1542/peds.2017-1883. Epub 2018 Feb 6.

    PubMed 29437931

Questions about this trial

What is this clinical trial studying?

A study testing AI Care Summary in people with Health Literacy and Comprehension, run by Children's National Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristen E Johnson, MD, MS (571-235-6524, kejohnson@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07831018, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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