Promoting Equitable Access to Language Services in Health and Human Services

NCT06272110 | Recruiting

• 1 other identifier: 22-01303
• Study Type: observational
• Target: 17,500
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Percentage of appropriate interpreter use

  up to Year 2

• Percentage of appropriate interpreter use

  up to Year 3

Secondary Outcomes (10)

• Percentage of patients up to date with preventive screenings and vaccinations

  up to Year 2

• Percentage of patients up to date with preventive screenings and vaccinations

  up to Year 3

• Percentage of patients with knowledge of federal rights related to LA services

  up to Year 2

• Percentage of patients with knowledge of federal rights related to LA services

  up to Year 3

• Percentage using untrained interpreters

  up to Year 2

Study Arms (12)

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)

Other: System level Language Access (LA) intervention

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

Other: System level Language Access (LA) intervention

Community survey of Community members (post-implementation)

Other: System level Language Access (LA) intervention

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

Other: System level Language Access (LA) intervention

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

Other: System level Language Access (LA) intervention

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

Other: System level Language Access (LA) intervention

Interventions

System level Language Access (LA) intervention OTHER

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.

Community survey of Community members (post-implementation); H+H EHR reports of Patients (post-implementation); Key stakeholder interviews of CBO Leadership/Staff (post-implementation); Key stakeholder interviews of NYC H+H Leadership/Providers/Staff (post-implementation); Key stakeholder interviews of Patients/Caregivers/Community Members (post-implementation); Post-visit survey of Patients/Caregivers (post-implementation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Post-visit survey: Patients or caregivers of pediatric patients seen for ambulatory care preventive visits. (systematic sampling) 2. H+H EHR Reports: Patients or caregivers of pediatric patients seen for ambulatory care preventive visits. (systematic sampling) 3. Community surveys: Individuals that use CBO services or attend their events. (convenience sampling) 4. Key stakeholder interviews: A purposive variation sample of healthcare staff, CBO staff, patients/caregivers/community members. (purposive sampling)

You may qualify if:

• 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.
• 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
• years of age and older
• Willingness and ability to participate
• Key Stakeholder interviews:
• Prefers to speak in Bengali, French, Spanish, Mandarin, or Polish
• 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

You may not qualify if:

• 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):
• Community survey (Community members):
• Does not have a regular doctor in the US.
• Key Stakeholder interviews:
• Speaks English very well (non-LEP)
• Does not have a working phone number
• Uncorrected hearing impairment
• Does not have a working phone number
• Uncorrected hearing impairment

Sponsors & Collaborators

• NYU Langone Health: lead
• Department of Health and Human Services: collaborator

Study Sites (3)

Health + Hospitals Diagnostic/Treatment Centers

New York, New York, 10016, United States

RECRUITING

NYC Health + Hospitals/Bellevue

New York, New York, 10016, United States

RECRUITING

NYC Health + Hospitals/Woodhull

New York, New York, 11206, United States

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Hsiang Yin, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiang Yin, MD

CONTACT

212-562-2821; Hsiang.Yin@nyulangone.org

Andy Weng Zheng

CONTACT

212-562-2821; Andy.WengZheng@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Hsiang.Yin@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (3)