Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-30 @ 6:14 AM
Study NCT ID:
NCT07187050
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2025-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LLM-Assisted vs Manual Writing for Clinical Documentation: Effects on Time and Quality
Sponsor:
Kyoto University, Graduate School of Medicine
Organization:
Study Overview
Official Title:
Evaluating an LLM-Assisted Workflow for Clinical Documentation: A Pilot Randomized Controlled Trial on Time and Quality
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: