NCT06263855

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
5mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jan 2026Oct 2026

First Submitted

Initial submission to the registry

February 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

February 9, 2024

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

Clinicians who care for patients randomized to intervention will have access to CURE to assist with discharge summary writing.

Other: CURE

Control

NO INTERVENTION

Clinicians who care for patients randomized to control will continue with standard practice for discharge summary writing.

Interventions

CUREOTHER

A large language model (LLM) to help clinicians prepare discharge summaries for hospitalized patients.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Minor patients (\<18)
  • Patients admitted to a hospital service where CURE is not implemented
  • CLINICIANS
  • Clinicians who provide care to randomized patients included in this pilot
  • Clinicians who do not provide care to randomized patients included in this pilot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Xiaoxi Yao

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 16, 2024

Study Start

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations