Clinical trial NCT06272110: Promoting Equitable Access to Language Services in Health and Human Services
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Appropriate Use of Language Across Services
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2024-02-22
Enrollment: 17500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of appropriate interpreter use
timeFrame: up to Year 2
measure: Percentage of appropriate interpreter use
timeFrame: up to Year 3
Secondary outcomes:
measure: Percentage of patients up to date with preventive screenings and vaccinations
timeFrame: up to Year 2
measure: Percentage of patients up to date with preventive screenings and vaccinations
timeFrame: up to Year 3
measure: Percentage of patients with knowledge of federal rights related to LA services
timeFrame: up to Year 2
measure: Percentage of patients with knowledge of federal rights related to LA services
timeFrame: up to Year 3
measure: Percentage using untrained interpreters
timeFrame: up to Year 2
measure: Percentage using untrained interpreters
timeFrame: up to Year 3
measure: Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back)
timeFrame: up to Year 2
measure: Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back)
timeFrame: up to Year 3
measure: Percentage of patients with satisfaction with LA services preventive health services utilization
timeFrame: up to Year 2
measure: Percentage of patients with satisfaction with LA services preventive health services utilization
timeFrame: up to Year 3
Other outcomes:
Locations:
city: New York
country: United States
facility: Health + Hospitals Diagnostic/Treatment Centers
state: New York
city: New York
country: United States
facility: NYC Health + Hospitals/Bellevue
state: New York
city: New York
country: United States
facility: NYC Health + Hospitals/Woodhull
state: New York
Study officials:
affiliation: NYU Langone Health
name: Hsiang Yin, MD
role: PRINCIPAL_INVESTIGATOR
References: