Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT06272110

Conditions

Appropriate Use of Language Across Services

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

System level Language Access (LA) intervention

Study Details

Brief summary:

This is a community-based study that will engage community and health care stakeholders to develop, implement, and evaluate a Health Literacy (HL)-informed, culturally- and linguistically- sensitive approach to improving language access services for patients with limited English proficiency (LEP) to promote health equity and reduce disparities in preventive health services use and health outcomes in New York City (NYC). This study will have a total of 4 phases that include a preparatory work phase (Non-Human Subjects Research), a pre-implementation phase, an implementation phase, and a post-implementation phase.

Findings from the preparatory work and pre-implementation phase and discussions with key partners will inform the co-design of intervention strategies and endpoints for the later phases (implementation and post-implementation phase).

Conditions

Appropriate Use of Language Across Services

Study ID

NCT06272110

Start date

Apr 29, 2024

Status verified date

Jan, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria (pre- and post- implementation phase):

Post-visit survey (Patients/Caregivers):

  • Patient seen for ambulatory care preventive visit at one of the study locations OR caregiver of a pediatric patient seen for ambulatory preventive visit at one of the study locations.
  • 18 years of age and older
  • Willingness and ability to participate

H+H EHR Reports:

• Patient seen for ambulatory care preventive visit at one of the study locations

Community survey (Community members):

  • Individual that attends community based organizations (CBO) events or uses CBOs' services
  • 18 years of age and older
  • Willingness and ability to participate

Key Stakeholder interviews:

Patients/Caregivers/Community Members Inclusion Criteria: In order to be eligible to participate, an individual must meet all of the following criteria:

  • Prefers to speak in Bengali, French, Spanish, Mandarin, or Polish
  • 18 years of age or older
  • Patient seen for ambulatory care preventive visit at one of the 4 study locations, caregiver of a pediatric patient seen for ambulatory care preventive visit at one of the 4 study locations OR a community member referred by a CBO
  • Willingness and ability to participate

NYC H+H Leadership/Providers/Staff Inclusion Criteria:

  • Work at one of the 4 NYC H+H study locations that does language access related work or communicates with patients that prefer to speak a language other than English regularly.
  • Leadership (e.g., chief medical officer, Department Director, etc.), provider (Physician, Nurse, Resident), or staff (Interpreter, language access coordinator, clerical staff) at the NYC H+H location
  • 18 years of age or older
  • Willingness and ability to participate

CBO Leadership/Staff Inclusion Criteria:

  • CBO leadership (Director/Coordinator) or staff (Case manager, Patient navigator, etc.)
  • 18 years of age or older
  • Willingness and ability to participate

Exclusion Criteria (pre- and post- implementation phase):

CBO Leadership/Staff Exclusion Criteria:

  • Does not have a working phone number
  • Uncorrected hearing impairment

Post-visit survey (Patients/Caregivers):

  • Enrolled to key stakeholder interviews
  • Does not have a working phone number

H+H EHR Reports (Patients):

• No exclusion criteria

Community survey (Community members):

• Does not have a regular doctor in the US.

Key Stakeholder interviews:

Patients/Caregivers/Community Members Exclusion Criteria:

  • Speaks English very well (non-LEP)
  • Does not have a working phone number
  • Uncorrected hearing impairment

NYC H+H Leadership/Providers/Staff Exclusion Criteria:

  • Does not have a working phone number
  • Uncorrected hearing impairment

Study Design

Enrollment

17500 participants

Anticipated

Interventions and Outcome Measures

Arms

Post-visit survey of Patients/Caregivers (pre-implementation)

H+H EHR reports of Patients (pre-implementation)

Community survey of Community members (pre-implementation)

Key stakeholder interviews of Patients/Caregivers/Community Members (pre-implementation)

Key stakeholder interviews of NYC H+H Leadership/Providers/Staff (pre-implementation)

Key stakeholder interviews of CBO Leadership/Staff (pre-implementation)

Post-visit survey of Patients/Caregivers (post-implementation)

H+H EHR reports of Patients (post-implementation)

Community survey of Community members (post-implementation)

Key stakeholder interviews of Patients/Caregivers/Community Members (post-implementation)

Key stakeholder interviews of NYC H+H Leadership/Providers/Staff (post-implementation)

Key stakeholder interviews of CBO Leadership/Staff (post-implementation)

Interventions

System level Language Access (LA) intervention

Culturally and linguistically appropriate and HL informed strategies and materials/toolkit for community members, patients, and health care providers and staff. Findings from the preparatory work and pre-implementation phase and discussions with key partners will inform the co-design of intervention strategies.

Primary outcome measure

  • Percentage of appropriate interpreter use [ Time Frame: up to Year 2 ]
  • Percentage of appropriate interpreter use [ Time Frame: up to Year 3 ]

Central Contacts and Locations

Locations

Health + Hospitals Diagnostic/Treatment Centers

Recruiting

New York, New York, United States, 10016

NYC Health + Hospitals/Bellevue

Recruiting

New York, New York, United States, 10016

NYC Health + Hospitals/Woodhull

Recruiting

New York, New York, United States, 11206

More Information

Sponsor

NYU Langone Health

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-01-28.