AI-Assisted Discharge Documents for Children and Families in a Pediatric Emergency Department

NCT07874659 | Completed DMC

• 1 other identifier: 2025-01-186
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 2

Brief Summary

This study compared two ways of preparing discharge documents for children and families leaving a pediatric emergency department. In the usual workflow, information from the electronic health record was assembled into a fixed document template. In the alternative workflow, ERIOS Assistant, an artificial intelligence system hosted within the hospital, drafted documents for health professionals and for families or children. A clinician reviewed and validated the documents before they were handed to the family in both workflows. According to the completed study report, assignment concerned document production after the decision to discharge and did not determine diagnosis, treatment or disposition. Families were contacted by telephone after discharge to assess how their account of the care and instructions agreed with the medical record, as well as their perceived understanding, satisfaction and use of the documents. The protocol also planned assessment of document quality, readability, clinician experience, usability and human supervision. This study is being registered retrospectively after the randomized component was completed.

Conditions

Health Communication; Patient Discharge

Keywords

Large Language Model; Generative Artificial Intelligence; Pediatric Emergency Department; Discharge Documentation; Family Understanding; Readability; Patient Satisfaction; Human Oversight

Outcome Measures

Primary Outcomes (1)

• Record-Concordant Family Understanding After Discharge

  Family responses collected through a semi-structured telephone interview are compared with the clinical record across six domains: diagnosis, care/investigations performed, investigation results, treatments, follow-up plan, and conditions for returning to the emergency department. Each domain is coded as concordant or discordant, and the overall score is the mean of the six equally weighted domains. Scores range from 0 to 1, with higher values indicating greater concordance. All responding families are assessed, regardless of whether they reported reading the discharge document. The measure reflects understanding of the entire discharge process and is not a pre-post assessment of learning from the document alone.

  24 hours to 7 days after discharge (actual follow-up; originally planned for day 1, or day 2 after a non-working day).

Secondary Outcomes (8)

• Family-Reported Perceived Understanding

  24 hours to 7 days after discharge (actual follow-up; protocol schedule: day 1 or day 2 after a non-working day).

• Family Satisfaction With Information and Explanations Received

  24 hours to 7 days after discharge (actual follow-up; protocol schedule: day 1 or day 2 after a non-working day).

• Family-Reported Usefulness of the Main Discharge Document

  24 hours to 7 days after discharge (actual follow-up; protocol schedule: day 1 or day 2 after a non-working day).

• Lexical Readability of Discharge Documents: Standard Frequency Index

  Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.

• Number of Residual Errors in Clinician-Validated Discharge Documents

  Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.

Study Arms (4)

Conventional Documentation Workflow

ACTIVE COMPARATOR

Participants received the physician liaison letter produced through the routine fixed-template workflow and reviewed, edited when necessary, validated and signed by the discharging clinician.

Other: Conventional Discharge Documentation Workflow

LLM: Liaison Letter + Family Document

EXPERIMENTAL

Assistant Erios generated a physician liaison letter and a separate child-oriented discharge document from structured clinical information derived from the electronic health record. The generated documents were reviewed and could be edited by the clinician before validation, signature, and delivery.

Other: LLM-Assisted Discharge Documentation Workflow

LLM: Integrated Clinician-Family Document

EXPERIMENTAL

Assistant Erios generated a single integrated discharge document intended for both clinicians and families from structured clinical information derived from the electronic health record. The generated document was reviewed and could be edited by the clinician before validation, signature, and delivery.

Other: LLM-Assisted Discharge Documentation Workflow

LLM: Liaison Letter + Child Document

EXPERIMENTAL

Assistant Erios generated a physician liaison letter and a separate child-oriented discharge document from structured clinical information derived from the electronic health record. The generated documents were reviewed and could be edited by the clinician before validation, signature, and delivery.

Other: LLM-Assisted Discharge Documentation Workflow

Interventions

Conventional Discharge Documentation Workflow OTHER

Routine deterministic discharge-document production workflow used in the pediatric emergency department. An office-automation module transferred selected electronic health record fields into a predefined document template. The resulting document was reviewed, edited if necessary, validated, signed, and delivered by the clinician.

Conventional Documentation Workflow

LLM-Assisted Discharge Documentation Workflow OTHER

Discharge documentation was generated by Assistant Erios, a hospital-developed on-premises conversational assistant based on the open-weight GPT-OSS 120B language model. The assistant received structured clinical information derived from the electronic health record and generated discharge documentation according to the assigned document strategy. All generated documents were presented to a clinician for review, editing if necessary, validation, signature, and delivery. The intervention affected only document production and did not determine or modify diagnosis, treatment, or disposition.

LLM: Integrated Clinician-Family Document; LLM: Liaison Letter + Child Document; LLM: Liaison Letter + Family Document

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Younger than 18 years and attending the pediatric emergency department of Montpellier University Hospital.
• Anticipated discharge home.
• A legal representative present and able to respond to the study.
• An emergency physician participating in the protocol and trained to use ERIOS Assistant.

You may not qualify if:

• Hospital admission.
• Transfer within or between institutions.
• Life-threatening emergency.
• No means of contact.
• A clinical situation making data collection inappropriate, at the clinician's discretion.
• A planned change of legal representative at day 1.
• Additional Operational Restrictions Reported in the Completed Study:
• Psychiatric emergencies.
• Social emergencies.
• Families not speaking French.
• The completed study report states that randomization occurred after the decision to discharge home. The protocol used anticipated home discharge in its eligibility criteria. These differences are disclosed in this retrospective registration rather than silently combined into an amended initial protocol.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

Montpellier University Hospital - Pediatric Emergency Department

Montpellier, 34090, France

Location

Montpellier University Hospital

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• David Morquin, MD;PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and treating clinicians were not blinded to allocation. Assessment of the primary outcome was performed by an assessor blinded to study allocation, who compared family responses with the source clinical record. Telephone assessors were intended to remain blinded to allocation; maintenance of blinding could not be independently verified.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were first randomized 1:1 to the conventional documentation workflow or the LLM-assisted documentation workflow. Participants assigned to the LLM-assisted workflow underwent a second randomization (1:1:1, in blocks of nine) to one of three document strategies: a physician liaison letter plus a family-oriented document; a physician liaison letter plus a child-oriented document; or a single integrated document for clinicians and families. Children younger than 8 years or unable to read who were allocated to the child-oriented strategy were re-randomized 1:1 between the other two strategies. The primary comparison pooled the three LLM-assisted strategies and compared the LLM-assisted workflow with the conventional workflow.

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 15, 2026
• Study Start: September 4, 2025
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning after publication of the primary study report and for the duration of data retention under Montpellier University Hospital institutional policy.
• Access Criteria: Access may be granted to qualified researchers for a scientifically justified research purpose, subject to review and approval by the governance committee of Montpellier University Hospital. Only derived, de-identified analytic datasets necessary for the approved purpose may be made available. Access will require an appropriate data use agreement and compliance with applicable data-protection and institutional governance requirements. Direct identifiers, unrestricted electronic health record data, and unrestricted public access will not be provided.

Locations

FR (2)