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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| ||
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of appropriate interpreter use | up to Year 2 | |
| Percentage of appropriate interpreter use | up to Year 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria (pre- and post- implementation phase):
Post-visit survey (Patients/Caregivers):
H+H EHR Reports:
• Patient seen for ambulatory care preventive visit at one of the study locations
Community survey (Community members):
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:
NYC H+H Leadership/Providers/Staff Inclusion Criteria:
CBO Leadership/Staff Inclusion Criteria:
Exclusion Criteria (pre- and post- implementation phase):
CBO Leadership/Staff Exclusion Criteria:
Post-visit survey (Patients/Caregivers):
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:
NYC H+H Leadership/Providers/Staff Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsiang Yin, MD | Contact | 212-562-2821 | Hsiang.Yin@nyulangone.org | |
| Andy Weng Zheng | Contact | 212-562-2821 | Andy.WengZheng@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Hsiang Yin, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health + Hospitals Diagnostic/Treatment Centers | Recruiting | New York | New York | 10016 | United States | |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Community survey of Community members (post-implementation) |
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| Key stakeholder interviews of Patients/Caregivers/Community Members (post-implementation) |
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| Key stakeholder interviews of NYC H+H Leadership/Providers/Staff (post-implementation) |
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| Key stakeholder interviews of CBO Leadership/Staff (post-implementation) |
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| 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 |
| Percentage using untrained interpreters | up to Year 3 |
| Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back) | up to Year 2 |
| Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back) | up to Year 3 |
| Percentage of patients with satisfaction with LA services preventive health services utilization | up to Year 2 |
| Percentage of patients with satisfaction with LA services preventive health services utilization | up to Year 3 |
| NYC Health + Hospitals/Bellevue |
| Recruiting |
| New York |
| New York |
| 10016 |
| United States |
| NYC Health + Hospitals/Woodhull | Recruiting | New York | New York | 11206 | United States |