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LLM-Assisted vs Manual Writing for Clinical Documentation: Effects on Time and Quality

Evaluating an LLM-Assisted Workflow for Clinical Documentation: A Pilot Randomized Controlled Trial on Time and Quality

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07187050
Enrollment
21
Registered
2025-09-22
Start date
2025-02-18
Completion date
2025-07-16
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Documentation, Clinician-in-the-loop, Large Language Model

Keywords

clinician-in-the-loop, Large Language Model, Clinical Documentation, Electronic Health Record

Brief summary

The goal of this clinical trial is to learn whether an LLM-assisted writing workflow can reduce the time to complete hospital discharge summaries and discharge referrals and maintain or improve document quality compared with writing from scratch by clinicians. The study used six simulated patient records (no real patient data). The main questions it aims to answer are: * Does the LLM-assisted writing workflow reduce the time needed to complete each document compared with manual writing? * Does the LLM-assisted writing workflow improve (or at least maintain) document quality compared with manual writing, as rated by blinded experts? Researchers will compare LLM-assisted versus manual writing to see if the LLM-assisted approach is faster and has equal or better quality. LLM-only drafts (unedited first drafts) will be evaluated as a separate third group to understand the baseline quality of LLM output without clinician edits. Participants will create two documents-a discharge summary and a discharge referral-for each of six simulated cases. Those assigned to CocktailAI & Modification group will use an LLM assistant (called CocktailAI) to generate a first draft for each document and then review and edit it to finalize; those assigned to the control group will write each document from scratch without LLM assistance.

Interventions

OTHERTemplate-Based LLM Assistant

This study uses CocktailAI, a template-based LLM assistant co-developed by the Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, and Fitting Cloud Inc. (Kyoto, Japan). It is designed to extract relevant information from EHRs using LLMs and embed the extracted content into predefined templates. In this trial, the inputs are six simulated patient records (no real patient data). Text generation uses Gemini-2.0-flash-lite. Templates for discharge summaries and discharge referrals are pre-defined by a team member.

OTHERManual Writing

The same document templates are provided; however, all LLM instruction prompts are removed in advance. Clinicians manually write the documents, following the template structure, for each of the six simulated cases.

Sponsors

Fitting Cloud Inc.
CollaboratorUNKNOWN
Kyoto University, Graduate School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

This is a prospective, randomized, open-label, blinded-endpoint (PROBE) trial.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Ophthalmologists at Kyoto University Hospital * Junior residents, senior residents, graduate students, board-certified ophthalmologists * Physicians who confirm that they do not routinely use CocktailAI for clinical documentation and provide informed consent after receiving an explanation of the study.

Design outcomes

Primary

MeasureTime frameDescription
Average time spent creating each documentOn one study day within 2 weeks after enrollmentIn the CocktailAI & Modification group and the Control group, the time spent creating documents is measured in seconds. In the CocktailAI group, the time required for document generation is measured in seconds.

Secondary

MeasureTime frameDescription
Document quality assessmentOn one study day within 2 weeks after enrollmentBlinded to group allocation, ophthalmology experts evaluate the documents using pre-specified criteria defined before study initiation. These criteria are developed based on six domains: Medical Accuracy, Language, Conciseness, Presence of Hallucinations, Validity for Clinical Use, and Possibility of Harm. Most domains are assessed on a three-point scale, whereas Presence of Hallucinations is evaluated dichotomously (present or absent). In addition to these domain-specific ratings, experts provide a subjective overall score on a 10-point scale (with higher scores indicating better quality) and are asked to guess which study group the document belongs to.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026