[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656725":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":58,"studyPopulation":49,"armGroups":59,"interventions":70,"overallOfficials":49,"centralContacts":75,"locations":81,"responsibleParty":99,"collaborators":49,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":49,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":49,"enrollmentInfo":112,"targetDuration":49,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":84,"whyStopped":49,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Children's National Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,22,26,30,34,38,42,46],{"measure":15,"description":16,"timeFrame":17},"LOS","Length of stay","Throughout study duration, on average one year",{"measure":19,"description":20,"timeFrame":21},"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.","During study duration, on average one year",{"measure":23,"description":24,"timeFrame":25},"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.","7 days after index hospital discharge and 30 days after index hospital discharge, respectively",{"measure":27,"description":28,"timeFrame":29},"Tokens","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)",{"measure":31,"description":32,"timeFrame":33},"Energy usage","Energy use: estimated average kilowatt-hour use per AI-generated summary.","WIthin 1 hour of generation of the AI care summary (during index hospitalization)",{"measure":35,"description":36,"timeFrame":37},"Acceptability: Physician","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",{"measure":39,"description":40,"timeFrame":41},"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.","WIthin 1 hour of attending physician review of the AI care summary, during the index hospitalization",{"measure":43,"description":44,"timeFrame":45},"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.","Within 24 hours after receipt of the AI care summary, during the index hospitalization",{"measure":47,"description":48,"timeFrame":45},"Engagement: Caregiver","Caregiver interest in AI summaries as standard care: whether caregivers would want this type of summary incorporated into routine care.",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":49,"primaryPurpose":53,"observationalModel":49,"timePerspective":49,"maskingInfo":54},"RANDOMIZED","PARALLEL","HEALTH_SERVICES_RESEARCH",{"masking":55,"maskingDescription":49,"whoMasked":56},"SINGLE",[57],"OUTCOMES_ASSESSOR","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.\n\nEligible 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.\n\nCaregiver 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.\n\nStatistical analyses will compare outcomes between randomized groups while controlling for relevant covariates when appropriate.",[60,64],{"label":61,"type":62,"description":63,"interventionNames":49},"Standard Hospital Communication","NO_INTERVENTION","Standard hospital communication",{"label":65,"type":66,"description":67,"interventionNames":68},"Standard Hospital Communication Plus AI Care Summary","EXPERIMENTAL","Attending-approved written AI Care Summary provided to caregiver",[69],"Other: AI Care Summary",[71],{"type":6,"name":72,"description":73,"armGroupLabels":74,"otherNames":49},"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.",[65],[76],{"name":77,"role":78,"phone":79,"phoneExt":49,"email":80},"Kristen E Johnson, MD, MS","CONTACT","571-235-6524","kejohnson@childrensnational.org",[82],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Children's National Hospital","RECRUITING","Washington D.C.","District of Columbia","20010","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-77.03637,38.89511,{"lat":94,"lon":93},[97],{"name":98,"role":78,"phone":49,"phoneExt":49,"email":49},"Kristen Johnson, MD, MS",{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"PRINCIPAL_INVESTIGATOR","Kristen Elaine Johnson","Pediatric Hospitalist; Assistant Professor of Pediatrics","100656725","impact-of-ai-care-summaries-on-caregiver-comprehension-100656725",false,"NCT07831018","Impact of AI Care Summaries on Caregiver Comprehension","Impact of AI Care Summaries on Caregiver Comprehension of Hospital Course","Inclusion Criteria: Caregiver of a patient 10 years and younger admitted to Children's National Hospital, whose preferred language is English\n\nExclusion Criteria:\n\n* Caregivers of patients older than age 10 years\n* Caregivers of patients not admitted to the Hospital Medicine service\n* Caregivers of admitted patients whose preferred language is non-English\n* Patients whose care summaries are deemed inaccurate by their attending physician and not eligible for sharing with their caregiver.","ALL","18 Years",{"count":113,"type":114},100,"ESTIMATED","INTERVENTIONAL",[117],"NA","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.\n\nSecondary 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.",[120,121,122],"Health Literacy","Comprehension","Patient Satisfaction",[124,125,126],"plain language","health literacy","communication","2026-09-15",{"date":129,"type":130},"2026-09-21","ACTUAL",{"date":132,"type":130},"2026-05-05",{"date":134,"type":114},"2027-06-30",{"name":5,"class":6},1]