Health CommunicationEANCT07874659
AI-Assisted Discharge Documents for Children and Families in a Pediatric Emergency Department
A study testing Conventional Discharge Documentation Workflow and LLM-Assisted Discharge Documentation Workflow in people with Health Communication and Patient Discharge, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Health Communication, Patient Discharge
- What is being tested?
- Conventional Discharge Documentation Workflow and LLM-Assisted Discharge Documentation Workflow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Sep 2025to 27 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- ERIOS Assistant infrastructure operational at inclusion.
Who cannot join
- Hospital admission.
- Transfer within or between institutions.
- Life-threatening emergency.
- Refusal to participate (described as refusal of consent in the eligibility list; the inclusion procedure specifies information and non-opposition).
- No means of contact.
- A clinical situation making data collection inappropriate, at the clinician's discretion.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Montpellier University Hospital - Pediatric Emergency Department
Montpellier, 34090
Montpellier University Hospital
Montpellier, 34090
About this study
Official title: ERIOS ASSISTANT - Pediatric Emergency Department - Phase 3 Study Protocol
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.
Read the detailed description
The study was conducted in the pediatric emergency department of Montpellier University Hospital, France. The protocol described a randomized parallel comparison of standard documentation and documentation assisted by ERIOS Assistant, with quantitative assessments and complementary qualitative observations and interviews. Its operational enrollment target was 120 children, 60 per main workflow. The completed study report records 153 randomized participants between September 4 and November 27, 2025.
In the conventional workflow, selected electronic health record fields were transferred by a deterministic office-automation module into a fixed word-processing template. In the ERIOS Assistant workflow, a structured questionnaire populated from the clinical record was provided to an on-premises conversational assistant using the open-weight GPT-OSS 120B model, August 2025 version. According to the completed study report, no patient data left the hospital infrastructure during operation of the evaluated assistant. This statement concerns the intervention system and not any subsequent processing used in preparing the report.
Participants were assigned to the two main workflows in a 1:1 ratio using an advance randomization list generated in R. Within the assistant workflow, a second randomization used a 1:1:1 ratio in blocks of nine to assign 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 eight years or unable to read who were assigned to the child-oriented strategy were re-randomized between the other two assistant strategies. The primary comparison pooled the three assistant strategies against conventional documentation.
A clinician reviewed, could edit, validated and signed the discharge documentation before delivery in both workflows. The clinician triggering production also validated it, without a systematically interposed second reader. The completed study report states that workflow allocation occurred after the clinical discharge decision and did not determine diagnosis, treatment or disposition. The supplied protocol described eligibility in terms of anticipated discharge home; the timing of screening, inclusion, randomization and the final discharge decision is to be documented in the study records.
Family understanding was assessed by comparing the family account with the source clinical record. The initial protocol scheduled the telephone interview for day 1, or day 2 after a non-working day; the completed study report describes actual follow-up between 24 hours and seven days. Its participant-level understanding measure averages six equally weighted binary concordance domains. These domains correspond to questions in the protocol interview schedule. The detailed scoring rules and their date of adoption should be distinguished from the broader outcome specified in the protocol.
Clinical-document safety assessment was planned as expert identification of residual errors, omissions and hallucinations, initially classified as factual, medical or serious severity. The completed study report uses a revised distinction between information domain and potential clinical consequence, and restricts fidelity assessment to physician-facing documents. Separate family-facing documents and the family-directed paragraph of integrated documents were not included in that fidelity assessment. Readability, perceived understanding, satisfaction and perceived usefulness were additional planned domains. Other protocol components included production and supervision times, clinician ratings, usability and acceptability questionnaires, and qualitative observations and interviews; the completed manuscript does not report all of these components.
The completed analysis is based on an evaluable population rather than a strict intention-to-treat population. The study report describes post-randomization exclusions and replacement within the same allocation slot, exclusion of two participants assigned to the assistant workflow who received conventional documents, and one further exclusion for an unscorable primary outcome. The reported analysis population is 59 conventional and 58 assistant-assisted episodes. Missing data were not imputed. The primary unadjusted comparison used a Mann-Whitney test, whereas the supplied protocol specified generalized linear models and intention-to-treat and per-protocol analyses.
Retrospective registration and outcome history: the protocol introduction and its dedicated outcome section identify effective family understanding as the primary outcome, while an overview paragraph retains overall satisfaction as the primary outcome. The completed study report identifies understanding as primary and satisfaction as secondary, and reports that this prioritization was decided before recruitment. That claim requires the dated decision record to be retained with the study documentation. The record is being registered after completion and does not constitute prospective registration.
The paired-document-state framework, detailed transformation and discrepancy taxonomy, stage-of-origin attribution, phenotype analyses and class-specific proportions of discrepancies resolved before document delivery were developed after data collection. They are exploratory post hoc analyses, not retrospectively designated prespecified outcomes. The investigators report that the study was initially handled under the French framework for research not involving the human person and CNIL reference methodology MR-004, and was not entered in a trial registry before enrollment. This account of delayed registration is subject to confirmation by the institution.
- Conditions
- Health Communication, Patient Discharge
- Being tested
- Conventional Discharge Documentation Workflow, LLM-Assisted Discharge Documentation Workflow
- Keywords
- Large Language Model, Generative Artificial Intelligence, Pediatric Emergency Department, Discharge Documentation, Family Understanding, Readability, Patient Satisfaction, Human Oversight
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Discharge Documentation WorkflowOther
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.
LLM-Assisted Discharge Documentation WorkflowOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: LLM-Assisted Discharge Documentation Workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The legal representative rates their understanding of the child's medical situation after the emergency department visit using the five-category scale in the study questionnaire: 1, not understood at all; 2, understood a little; 3, understood fairly well; 4, understood well; and 5, understood very well. Higher scores indicate greater perceived understanding. This is a post-discharge rating, not a change from a baseline score.
Measured: 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
The legal representative rates overall satisfaction with the information and explanations provided during the child's emergency department care, irrespective of whether information was oral or written. The study questionnaire uses five categories: 1, not at all satisfied; 2, slightly satisfied; 3, neither satisfied nor dissatisfied; 4, rather satisfied; and 5, very satisfied. Higher scores indicate greater satisfaction. This item does not rate overall hospital service quality or waiting times.
Measured: 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
The legal representative is asked whether the main discharge document is useful for them and other members of the household. The interviewer codes the response as useful or not useful, while retaining optional free-text comments. The outcome is the distribution of these two response categories among respondents with an interpretable answer; missing or unclassifiable responses are not automatically coded as not useful. This item is not a five-point usefulness scale.
Measured: 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
The completed study report operationalizes lexical readability as the Standard Frequency Index of open-class words represented in the French Manulex lexical database. Higher values indicate more frequent vocabulary. Document-level values are summarized separately for family-facing documents and for physician liaison letters. The protocol planned readability assessment but did not name the Standard Frequency Index or Manulex; the date of selection of this specific metric is not established by the supplied protocol. This metric is not a reader comprehension score and is not represented as a bounded 0-100 clinical scale.
Measured: Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.
Number of Residual Errors in Clinician-Validated Discharge Documents
The initial protocol planned medical-expert identification and counting of residual errors after clinician validation, with results distinguished by document type. The protocol planned separate factual, medical and serious severity categories: factual errors without an effect on management; medical errors affecting follow-up without a real patient risk; and serious errors potentially creating a health risk. The completed report revised this classification to distinguish information domain from potential clinical consequence and restricted fidelity assessment to physician-facing documents. Protocol categories and revised categories must not be treated as identical.
Measured: Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.
Number of Residual Omissions in Clinician-Validated Discharge Documents
The initial protocol planned medical-expert identification and counting of residual omissions after clinician validation, with results distinguished by document type. The protocol planned separate factual, medical and serious severity categories: factual errors without an effect on management; medical errors affecting follow-up without a real patient risk; and serious errors potentially creating a health risk. The completed report revised this classification to distinguish information domain from potential clinical consequence and restricted fidelity assessment to physician-facing documents. Protocol categories and revised categories must not be treated as identical.
Measured: Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.
Number of Residual Hallucinations in Clinician-Validated Discharge Documents
The initial protocol planned medical-expert identification and counting of residual hallucinations or fabricated content after clinician validation, with results distinguished by document type. The protocol planned separate factual, medical and serious severity categories: factual errors without an effect on management; medical errors affecting follow-up without a real patient risk; and serious errors potentially creating a health risk. The completed report revised this classification to distinguish information domain from potential clinical consequence and restricted fidelity assessment to physician-facing documents. Protocol categories and revised categories must not be treated as identical.
Measured: Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.
Number of Delivered Physician-Facing Documents With a Discrepancy Judged to Pose a Serious Health Risk
The completed study report counts physician-facing discharge documents with at least one discrepancy judged liable to create a serious health risk in retrospective medical assessment. Each document contributes once to the affected-document count. This is an assessment of potential consequence in documentation, not a count of clinical serious adverse events or observed patient harm. Separate family-facing documents and family-directed paragraphs of integrated documents are outside the assessed fidelity perimeter. The initial protocol included a serious severity category, but the final document-level operationalization and revised classification must be distinguished from that original plan.
Measured: Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start4 Sep 2025
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Morquin, MD;PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874659
- Sponsor's protocol ID
- 2025-01-186
- Acronym
- EA
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported results may be made available to qualified researchers upon reasonable request, subject to review and approval by the governance committee of Montpellier University Hospital and to applicable data-protection requirements. Data cannot be made publicly available because the regulatory framework under which the study was conducted and the information provided to participants did not permit unrestricted secondary sharing. Where access is approved, it will be restricted to the authorised research purpose and governed by an appropriate data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERIOS ASSISTANT - Pediatric Emergency Department - Phase 3 Study Protocol
- ClinicalTrials.gov ID
- NCT07874659
- Acronym / sponsor ID
- EA / 2025-01-186
- Conditions
- Health Communication, Patient Discharge
- Keywords
- Large Language Model, Generative Artificial Intelligence, Pediatric Emergency Department, Discharge Documentation, Family Understanding, Readability, Patient Satisfaction, Human Oversight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was conducted in the pediatric emergency department of Montpellier University Hospital, France. The protocol described a randomized parallel comparison of standard documentation and documentation assisted by ERIOS Assistant, with quantitative assessments and complementary qualitative observations and interviews. Its operational enrollment target was 120 children, 60 per main workflow. The completed study report records 153 randomized participants between September 4 and November 27, 2025.
In the conventional workflow, selected electronic health record fields were transferred by a deterministic office-automation module into a fixed word-processing template. In the ERIOS Assistant workflow, a structured questionnaire populated from the clinical record was provided to an on-premises conversational assistant using the open-weight GPT-OSS 120B model, August 2025 version. According to the completed study report, no patient data left the hospital infrastructure during operation of the evaluated assistant. This statement concerns the intervention system and not any subsequent processing used in preparing the report.
Participants were assigned to the two main workflows in a 1:1 ratio using an advance randomization list generated in R. Within the assistant workflow, a second randomization used a 1:1:1 ratio in blocks of nine to assign 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 eight years or unable to read who were assigned to the child-oriented strategy were re-randomized between the other two assistant strategies. The primary comparison pooled the three assistant strategies against conventional documentation.
A clinician reviewed, could edit, validated and signed the discharge documentation before delivery in both workflows. The clinician triggering production also validated it, without a systematically interposed second reader. The completed study report states that workflow allocation occurred after the clinical discharge decision and did not determine diagnosis, treatment or disposition. The supplied protocol described eligibility in terms of anticipated discharge home; the timing of screening, inclusion, randomization and the final discharge decision is to be documented in the study records.
Family understanding was assessed by comparing the family account with the source clinical record. The initial protocol scheduled the telephone interview for day 1, or day 2 after a non-working day; the completed study report describes actual follow-up between 24 hours and seven days. Its participant-level understanding measure averages six equally weighted binary concordance domains. These domains correspond to questions in the protocol interview schedule. The detailed scoring rules and their date of adoption should be distinguished from the broader outcome specified in the protocol.
Clinical-document safety assessment was planned as expert identification of residual errors, omissions and hallucinations, initially classified as factual, medical or serious severity. The completed study report uses a revised distinction between information domain and potential clinical consequence, and restricts fidelity assessment to physician-facing documents. Separate family-facing documents and the family-directed paragraph of integrated documents were not included in that fidelity assessment. Readability, perceived understanding, satisfaction and perceived usefulness were additional planned domains. Other protocol components included production and supervision times, clinician ratings, usability and acceptability questionnaires, and qualitative observations and interviews; the completed manuscript does not report all of these components.
The completed analysis is based on an evaluable population rather than a strict intention-to-treat population. The study report describes post-randomization exclusions and replacement within the same allocation slot, exclusion of two participants assigned to the assistant workflow who received conventional documents, and one further exclusion for an unscorable primary outcome. The reported analysis population is 59 conventional and 58 assistant-assisted episodes. Missing data were not imputed. The primary unadjusted comparison used a Mann-Whitney test, whereas the supplied protocol specified generalized linear models and intention-to-treat and per-protocol analyses.
Retrospective registration and outcome history: the protocol introduction and its dedicated outcome section identify effective family understanding as the primary outcome, while an overview paragraph retains overall satisfaction as the primary outcome. The completed study report identifies understanding as primary and satisfaction as secondary, and reports that this prioritization was decided before recruitment. That claim requires the dated decision record to be retained with the study documentation. The record is being registered after completion and does not constitute prospective registration.
The paired-document-state framework, detailed transformation and discrepancy taxonomy, stage-of-origin attribution, phenotype analyses and class-specific proportions of discrepancies resolved before document delivery were developed after data collection. They are exploratory post hoc analyses, not retrospectively designated prespecified outcomes. The investigators report that the study was initially handled under the French framework for research not involving the human person and CNIL reference methodology MR-004, and was not entered in a trial registry before enrollment. This account of delayed registration is subject to confirmation by the institution.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Documentation Workflow | Active comparator | Other: Conventional Discharge Documentation WorkflowParticipants received the physician liaison letter produced through the routine fixed-template workflow and reviewed, edited when necessary, validated and signed by the discharging clinician. |
| LLM: Liaison Letter + Family Document | Experimental | Other: LLM-Assisted Discharge Documentation WorkflowAssistant 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. |
| LLM: Integrated Clinician-Family Document | Experimental | Other: LLM-Assisted Discharge Documentation WorkflowAssistant 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. |
| LLM: Liaison Letter + Child Document | Experimental | Other: LLM-Assisted Discharge Documentation WorkflowAssistant 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. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
- ERIOS Assistant infrastructure operational at inclusion.
Key exclusion criteria (12 listed)
- Hospital admission.
- Transfer within or between institutions.
- Life-threatening emergency.
- Refusal to participate (described as refusal of consent in the eligibility list; the inclusion procedure specifies information and non-opposition).
- No means of contact.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Discharge Documentation WorkflowRoutine 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. | Other | Conventional Documentation Workflow |
| LLM-Assisted Discharge Documentation WorkflowDischarge 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. | Other | LLM: Integrated Clinician-Family Document, LLM: Liaison Letter + Child Document, LLM: Liaison Letter + Family Document |
Primary outcome
Record-Concordant Family Understanding After Discharge
Time frame: 24 hours to 7 days after discharge (actual follow-up; originally planned for day 1, or day 2 after a non-working day).
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.
8 secondary outcomes
Family-Reported Perceived Understanding
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.
Number of Residual Errors in Clinician-Validated Discharge Documents
Time frame: Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.
Number of Residual Omissions in Clinician-Validated Discharge Documents
Time frame: Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.
Number of Residual Hallucinations in Clinician-Validated Discharge Documents
Time frame: Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.
Number of Delivered Physician-Facing Documents With a Discrepancy Judged to Pose a Serious Health Risk
Time frame: Index emergency department visit (day 0), using discharge documents collected for retrospective assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported results may be made available to qualified researchers upon reasonable request, subject to review and approval by the governance committee of Montpellier University Hospital and to applicable data-protection requirements. Data cannot be made publicly available because the regulatory framework under which the study was conducted and the information provided to participants did not permit unrestricted secondary sharing. Where access is approved, it will be restricted to the authorised research purpose and governed by an appropriate data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Morquin, MD;PhD principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Discharge Documentation Workflow and LLM-Assisted Discharge Documentation Workflow in people with Health Communication and Patient Discharge, run by University Hospital, Montpellier at 2 sites in France.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Record-Concordant Family Understanding After Discharge (time frame: 24 hours to 7 days after discharge (actual follow-up; originally planned for day 1, or day 2 after a non-working day).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.