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NCT Number: NCT06272110

Promoting Equitable Access to Language Services in Health and Human Services

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health + Hospitals Diagnostic/Treatment Centers, New York, United States

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About this study

The preparatory work phase (Non-Human Subjects Research) will collect information on policies and procedures related to language access (LA) services use. Educational and patient-facing materials will also be reviewed. This information will be collected pre- and post-implementation.

During the pre-implementation phase surveys and in-depth interviews with key stakeholders will be conducted to assess their views on barriers and facilitators to LA services and preventive services use and ideas about potential intervention strategies and resources to improve these services. Additionally, patients seen for ambulatory care preventive visit at one of the 4 study locations will be invited to complete an anonymous post-visit survey to assess their views on LA services use and provider-patient communication. Community members will also be invited to complete an anonymous survey to assess knowledge of LA rights and satisfaction with LA services. NYC Health & Hospitals (H+H) EHR reports will also be generated to collect visit-level information.

The implementation phase will include the development of 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.

During the post-implementation phase surveys and in-depth interviews will be conducted with key stakeholders to assess their views on barriers and facilitators to LA services and preventive services use and ideas about future potential intervention strategies and resources to improve these services. We will also examine perceived appropriateness, acceptability, feasibility, and sustainability of the intervention. We will assess use and adoption of the intervention toolkit. Additionally, patients seen for ambulatory care preventive visit at one of the 4 study locations will be invited to complete an anonymous post-visit survey to assess views on LA services use and provider-patient communication. Community members will be invited to complete an anonymous survey to assess knowledge of LA rights and satisfaction with LA services. H+H EHR reports will also be generated to collect visit-level information.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of appropriate interpreter use

    Time frame: up to Year 2

  2. Percentage of appropriate interpreter use

    Time frame: up to Year 3

Secondary outcomes

  1. Percentage of patients up to date with preventive screenings and vaccinations

    Time frame: up to Year 2

  2. Percentage of patients up to date with preventive screenings and vaccinations

    Time frame: up to Year 3

  3. Percentage of patients with knowledge of federal rights related to LA services

    Time frame: up to Year 2

  4. Percentage of patients with knowledge of federal rights related to LA services

    Time frame: up to Year 3

  5. Percentage using untrained interpreters

    Time frame: up to Year 2

  6. Percentage using untrained interpreters

    Time frame: up to Year 3

  7. Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back)

    Time frame: up to Year 2

  8. Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back)

    Time frame: up to Year 3

  9. Percentage of patients with satisfaction with LA services preventive health services utilization

    Time frame: up to Year 2

  10. Percentage of patients with satisfaction with LA services preventive health services utilization

    Time frame: up to Year 3

Study contacts

Contact information is provided by the study sponsor or research team.

Andy Weng Zheng

CONTACT

[email protected]

212-562-2821

Hsiang Yin, MD

CONTACT

[email protected]

212-562-2821

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

Community and NYC Public Healthcare System Partnership to Promote Equitable Access to Language Services and Optimal Preventive Health Services Use Among Individuals With Limited English Proficiency

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.