NCT05860777

Brief Summary

This is a pragmatic trial that will measure if the use of AI to identify patients with complex care needs and language barriers, as well as active reaching out to clinicians to offer the use of interpreter services will improve the frequency of interpreter use and reduce the time to first interpreter use

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,923

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

May 8, 2023

Last Update Submit

October 1, 2024

Conditions

Keywords

Limited English ProficiencyMachine LearningLanguage BarrierComplex Medical Needs

Outcome Measures

Primary Outcomes (1)

  • Number of interpreters

    the number of interpreters used among patients with LEP and complex care needs

    12 months

Secondary Outcomes (1)

  • Change in time to interpreter use

    12 months

Study Arms (2)

Control

NO INTERVENTION

This is the control group who receive standard of care

Intervention

EXPERIMENTAL

This is the group in units who are identified via AI model and in which interpreter services are actively reaching out to clinicians

Other: Complexity score and implementation

Interventions

AI machine learning model to identify patients with complex care needs and implementation with active reaching out to clinicians to offer interpreter services

Also known as: AI machine learning model and implementation with reaching out to clinicians
Intervention

Eligibility Criteria

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

You may qualify if:

  • Adults with limited English proficiency and requiring an interpreter and having complex medical care needs (includes admitted to the ICU, prolonged hospital stay, requiring palliative care)
  • Have research authorization

You may not qualify if:

  • \- Do not require an interpreter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Barwise A, Strechen I, Eltalhi T, Piche K, Wilson P, Tschida-Reuter D, Liu E, Herasevich S, Schulte PJ, Sutor B, Pickering B. Improving In-person Interpreter Utilization in Complex Care: Findings from a Stepped-Wedge Cluster Randomized Trial of Integrated Artificial Intelligence. J Gen Intern Med. 2026 Jan 5. doi: 10.1007/s11606-025-10104-9. Online ahead of print.

  • Strechen I, Wilson P, Eltalhi T, Piche K, Tschida-Reuter D, Howard D, Sutor B, Tiong I, Herasevich S, Pickering B, Barwise A. Harnessing health information technology to promote equitable care for patients with limited English proficiency and complex care needs. Trials. 2024 Jul 4;25(1):450. doi: 10.1186/s13063-024-08254-y.

Related Links

Study Officials

  • Brian Pickering, MB, B.Ch

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: This is a pragmatic clinical trial-a stepped wedge cluster randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 16, 2023

Study Start

May 1, 2023

Primary Completion

June 21, 2024

Study Completion

September 30, 2024

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations