Impact of AI Care Summaries on Caregiver Comprehension
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kristen E Johnson, MD, MS
- 電話番号：571-235-6524
- メール：kejohnson@childrensnational.org
研究場所
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20010
- 募集
- Children's National Hospital
-
コンタクト：
- Kristen Johnson, MD, MS
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Standard Hospital Communication
Standard hospital communication |
|
|
実験的：Standard Hospital Communication Plus AI Care Summary
Attending-approved written AI Care Summary provided to caregiver |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hospital Course Comprehension Score
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
LOS
時間枠：Throughout study duration, on average one year
|
Length of stay |
Throughout study duration, on average one year
|
|
Readmission
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00001841
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Our IRB protocol does not permit IPD sharing for subject privacy
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。