NCT05591586

Brief Summary

Patients and families with limited English proficiency (LEP) and/or who use a language other than English for medical care (LOE) experience substantial barriers to communication in the healthcare setting, leading to medical care that is less safe, less efficient, less effective, and inequitable. Professional interpreter use has repeatedly been shown to improve outcomes and reduce disparities, yet it remains widely underused. This study will test two discrete, scalable implementation strategies for improving professional interpreter use in primary care, while collecting detailed information about mechanisms of action and costs that will be applicable to many sites of care and contribute meaningfully to the goal of reducing communication-based disparities. The investigators hypothesize that improving provider knowledge, confidence, and interpreter access will change behavior under real-world conditions.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
6,669

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress92%
Oct 2022Aug 2026

First Submitted

Initial submission to the registry

September 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 24, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

September 22, 2022

Last Update Submit

January 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Interpreter Use per Clinic Visit with Patient with LOE

    Dichotomous variable per visit for patients with a language other than English (LOE), constructed by matching professional interpreter vendor invoices to LOE clinic visits with enrolled providers; calculated overall and as assigned (e.g., mVI for mVI providers).

    at 9 months

Secondary Outcomes (1)

  • Patient/Parent Comprehension

    Within 7 days of the clinic visit

Study Arms (2)

Web based educational modules

ACTIVE COMPARATOR

This strategy will consist of 6 web-based modules, clinic-specific interpreter access information, and 4 booster modules, all delivered via the internet. The online modules will cover 5 topics: 1) the importance and fundamentals of good communication; 2) the importance of professional interpreter use and disparities for LEP populations; 3) how to use an interpreter effectively; 4) what to do when the encounter is not going well; and 5) special challenges and solutions related to remote interpreter use. Modules will be interactive, with tailoring to the learner, and each will be \<15 minutes long. All modules will be available at once, but assigned providers will be prompted to view a new one each week. Every month for months 3-6 after randomization, a booster module will be released. The brief (\<10 min) boosters will review crucial points from initial modules and feature video vignettes. Providers will be reminded to view these weekly until they are complete.

Behavioral: Web based educational modules

Mobile video interpreting access (mVI)

EXPERIMENTAL

This strategy will involve giving assigned providers access to mobile video interpreting (mVI) on a personal device, installation and support as needed, a tip sheet, and an extra charger, optional shock-resistant case, disposable antimicrobial sleeves, and a positioning stand to support use of their personal device for clinical care. mVI-assigned providers can opt for a study-issued smartphone in lieu of using their own. Access to mVI is achieved by downloading the application from the relevant location (e.g., Apple App Store), then entering an access code that links to a billing account. The study staff would then demonstrate use and answer questions. Technical support will be offered in-person following randomization; we will then email mVI-assigned providers weekly for the first month, then monthly, to offer additional support. A tip-sheet will be sent via email during the first week of the study that will include mVI instructions and best-practices.

Behavioral: mobile video interpreting (mVI) access

Interventions

This strategy will consist of 6 web-based modules, clinic-specific interpreter access information, and 4 booster modules, all delivered via the internet. The online modules will cover 6 topics: 1) the importance and fundamentals of good communication; 2) the importance of professional interpreter use and disparities for LEP populations; 3) how to use an interpreter effectively; 4) what to do when the encounter is not going well; and 5) special challenges and 6) solutions related to remote interpreter use. Modules will be interactive, with tailoring to the learner, and each will be \<15 minutes long. All modules will be available at once, but assigned providers will be prompted to view a new one each week. Every month for months 3-6 after randomization, a booster module will be released. The brief (\<10 min) boosters will review crucial points from initial modules and feature video vignettes. Providers will be reminded to view these weekly until they are complete.

Web based educational modules

This strategy will involve giving assigned providers access to mobile video interpreting (mVI) on a personal device, installation and support as needed, a tip sheet, and an extra charger, optional shock-resistant case, disposable antimicrobial sleeves, and a positioning stand to support use of their personal device for clinical care. mVI-assigned providers can opt for a study-issued smartphone in lieu of using their own. Access to mVI is achieved by downloading the application from the relevant location (e.g., Apple App Store), then entering an access code that links to a billing account. The study staff would then demonstrate use and answer questions. Technical support will be offered in-person following randomization; we will then email mVI-assigned providers weekly for the first month, then monthly, to offer additional support. A tip-sheet will be sent via email during the first week of the study that will include mVI instructions and best-practices.

Mobile video interpreting access (mVI)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Providers: * Primary clinical site at a participating clinic * needs interpretation for at least 7 visits per month For LOE population 1 (administrative cohort): * preferred language for care listed as anything besides English or sign language (e.g., ASL) * clinic visit (any reason) during study with an enrolled provider For LOE populations 2 and 3 (survey and interview respondents): * preferred language for care one of the top 7 non-English languages across enrolled clinics (listed in chart and confirmed by research coordinator) * clinic visit for an acute concern (e.g., sore throat, injured ankle, new headaches) during study with an enrolled provider * if patient under age 18, accompanied by a parent or legal guardian For LOE population 4 (video/audio-recording): * preferred language for care listed as anything besides sign language (e.g., ASL) * clinic visit for any reason during study with an enrolled provider * if patient under age 18, accompanied by a parent or legal guardian

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • Lion KC, Zhou C, Fishman P, Senturia K, Cole A, Sherr K, Opel DJ, Stout J, Hazim CE, Warren L, Rains BH, Lewis CC. A sequential, multiple assignment randomized trial comparing web-based education to mobile video interpreter access for improving provider interpreter use in primary care clinics: the mVOCAL hybrid type 3 study protocol. Implement Sci. 2023 Mar 13;18(1):8. doi: 10.1186/s13012-023-01263-6.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

September 22, 2022

First Posted

October 24, 2022

Study Start

October 24, 2022

Primary Completion

September 2, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations