Effect of Large Language Model in Assisting Discharge Summary Notes Writing for Hospitalized Patients

Effect of Large Language Model in Assisting Discharge Summary Notes Writing for Hospitalized Patients: A Pilot Pragmatic Randomized Controlled Trial

This pilot study aims to assess the feasibility of carrying out a full-scale pragmatic, cluster-randomized controlled trial which will investigate whether discharge summary writing assisted by a large language model (LLM), called CURE (Checker for Unvalidated Response Errors), improves care delivery without adversely impacting patient outcomes.

Study Overview

• Status: Enrolling by invitation
• Conditions: Large Language Model
• Intervention / Treatment: Other: CURE

• Study Type: Interventional
• Enrollment (Estimated): 1015
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

PATIENTS

Inclusion Criteria:

• Adult patients admitted to one of three participating cardiology services at Mayo Clinic in Rochester, MN

Exclusion Criteria:

• Minor patients (<18)
• Patients admitted to a hospital service where CURE is not implemented

CLINICIANS

Inclusion Criteria:

• Clinicians who provide care to randomized patients included in this pilot

Exclusion Criteria:

• Clinicians who do not provide care to randomized patients included in this pilot

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Clinicians who care for patients randomized to intervention will have access to CURE to assist with discharge summary writing.	Other: CURE; A large language model (LLM) to help clinicians prepare discharge summaries for hospitalized patients.
No Intervention: Control; Clinicians who care for patients randomized to control will continue with standard practice for discharge summary writing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patient accrual	The first feasibility outcome will be the rate of patient accrual. An accrual of one patient per day will be considered acceptable, i.e., 91 patients discharged from a 91-day period who are appropriately randomized and can be included in the analyses.	Three months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Xiaoxi Yao, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 24-000352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No