Impact of AI Care Summaries on Caregiver Comprehension

NCT07831018 | Recruiting

• 1 other identifier: STUDY00001841
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Health Literacy; Comprehension; Patient Satisfaction

Keywords

plain language; health literacy; communication

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (9)

• LOS

  Throughout study duration, on average one year

• Readmission

  During study duration, on average one year

• ED reutilization

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

• Tokens

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

• Energy usage

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

Study Arms (2)

Standard Hospital Communication

NO INTERVENTION

Standard hospital communication

Standard Hospital Communication Plus AI Care Summary

EXPERIMENTAL

Attending-approved written AI Care Summary provided to caregiver

Other: AI Care Summary

Interventions

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.

Standard Hospital Communication Plus AI Care Summary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Hospital

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

RECRUITING

Related Publications (5)

• 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.

  PMID: 39405325 BACKGROUND

• 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.

  PMID: 40908007 BACKGROUND

• 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.

  PMID: 35607975 BACKGROUND

• 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.

  PMID: 36686972 BACKGROUND

• 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.

  PMID: 29437931 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Communication

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Kristen E Johnson, MD, MS

CONTACT

571-235-6524; kejohnson@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Hospitalist; Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: September 21, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)