Appropriate Use of Language Across ServicesNCT06272110
Promoting Equitable Access to Language Services in Health and Human Services
An observational study of Appropriate Use of Language Across Services, run by NYU Langone Health at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appropriate Use of Language Across Services
- What is being tested?
- System level Language Access (LA) intervention
- How many people
- 17,500 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Apr 2024to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Health + Hospitals Diagnostic/Treatment Centers
New York, New York, 10016
- Recruiting
NYC Health + Hospitals/Bellevue
New York, New York, 10016
- Recruiting
NYC Health + Hospitals/Woodhull
New York, New York, 11206
About this study
Official 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
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).
Read the detailed description
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.
- Being tested
- System level Language Access (LA) intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
System level Language Access (LA) interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-visit survey of Patients/Caregivers (pre-implementation) | Not described | |
| H+H EHR reports of Patients (pre-implementation) | Not described | |
| Community survey of Community members (pre-implementation) | Not described | |
| Key stakeholder interviews of Patients/Caregivers/Community Members (pre-implementation) | Not described | |
| Key stakeholder interviews of NYC H+H Leadership/Providers/Staff (pre-implementation) | Not described | |
| Key stakeholder interviews of CBO Leadership/Staff (pre-implementation) | Not described | |
| Post-visit survey of Patients/Caregivers (post-implementation) | Not described Receives: Other: System level Language Access (LA) intervention | |
| H+H EHR reports of Patients (post-implementation) | Not described Receives: Other: System level Language Access (LA) intervention | |
| Community survey of Community members (post-implementation) | Not described Receives: Other: System level Language Access (LA) intervention | |
| Key stakeholder interviews of Patients/Caregivers/Community Members (post-implementation) | Not described Receives: Other: System level Language Access (LA) intervention | |
| Key stakeholder interviews of NYC H+H Leadership/Providers/Staff (post-implementation) | Not described Receives: Other: System level Language Access (LA) intervention | |
| Key stakeholder interviews of CBO Leadership/Staff (post-implementation) | Not described Receives: Other: System level Language Access (LA) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of appropriate interpreter use
Measured: up to Year 2
Percentage of appropriate interpreter use
Measured: up to Year 3
Secondary outcomes (10)
Percentage of patients up to date with preventive screenings and vaccinations
Measured: up to Year 2
Percentage of patients up to date with preventive screenings and vaccinations
Measured: up to Year 3
Percentage of patients with knowledge of federal rights related to LA services
Measured: up to Year 2
Percentage of patients with knowledge of federal rights related to LA services
Measured: up to Year 3
Percentage using untrained interpreters
Measured: up to Year 2
Percentage using untrained interpreters
Measured: up to Year 3
Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back)
Measured: up to Year 2
Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back)
Measured: up to Year 3
Percentage of patients with satisfaction with LA services preventive health services utilization
Measured: up to Year 2
Percentage of patients with satisfaction with LA services preventive health services utilization
Measured: up to Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start29 Apr 2024
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appropriate Use of Language Across ServicesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Hsiang Yin, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272110
- Sponsor's protocol ID
- 22-01303
- Status last verified
- Jan 2026
- First submitted
- 15 Feb 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Hsiang.Yin@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06272110
- Acronym / sponsor ID
- 22-01303
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 17,500 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (25 listed)
- 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
- Patient seen for ambulatory care preventive visit at one of the study locations
- Individual that attends community based organizations (CBO) events or uses CBOs' services
Key exclusion criteria (18 listed)
- Does not have a working phone number
- Uncorrected hearing impairment
- Enrolled to key stakeholder interviews
- Does not have a working phone number
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| System level Language Access (LA) interventionCulturally 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. | Other | 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) |
Primary outcome
Percentage of appropriate interpreter use
Time frame: up to Year 2
Percentage of appropriate interpreter use
Time frame: up to Year 3
10 secondary outcomes
Percentage of patients up to date with preventive screenings and vaccinations
Time frame: up to Year 2
Percentage of patients up to date with preventive screenings and vaccinations
Time frame: up to Year 3
Percentage of patients with knowledge of federal rights related to LA services
Time frame: up to Year 2
Percentage of patients with knowledge of federal rights related to LA services
Time frame: up to Year 3
Percentage using untrained interpreters
Time frame: up to Year 2
Percentage using untrained interpreters
Time frame: up to Year 3
Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back)
Time frame: up to Year 2
Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back)
Time frame: up to Year 3
Percentage of patients with satisfaction with LA services preventive health services utilization
Time frame: up to Year 2
Percentage of patients with satisfaction with LA services preventive health services utilization
Time frame: up to Year 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Hsiang.Yin@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsiang Yin, MD principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appropriate Use of Language Across Services, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiang Yin, MD (212-562-2821, Hsiang.Yin@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of appropriate interpreter use (time frame: up to Year 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.