Implementing a Participatory, Multi-level Intervention to Improve Asian American Health Study

NCT03438045 | Completed Results

• 2 other identifiers: s17-010771U56DE027447-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility and acceptability study will be conducted at 3 community outreach centers serving an urban, low-income Chinese population. The study will evaluate the feasibility and acceptability of implementing a partnered intervention to improve the oral and general health of low-income, urban Chinese American adults and of using remote data entry into an electronic health record (EHR). The research staff will survey a sample of Chinese American patients screened at each center about their satisfaction with the partnered intervention and about their oral health behaviors. An additional sample selected from providers \[dentists and community health workers (CHW)\], research staff, New York University (NYU) administrators, site directors, and community advisory board (CAB) members will participate in structured interviews about the partnered intervention. The remote EHR evaluation will include group adaptation sessions and workflow analyses via multiple recorded sessions with research staff, NYU administrators, outreach site directors, and providers (dentists and CHWs). The study will also model knowledge held by these non-patient participants (including CAB members) to evaluate and enhance the partnered intervention during and/or after the feasibility and acceptability study for use in future implementations.

Conditions

Oral Disease; Dental Caries

Keywords

Chinese American; implementation science; feasibility; acceptability; oral health; dental care; health equity; urban health

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Agree or Strongly Agree With the Statement, "The Community Health Worker (CHW) Helped me to Improve How I Take Care of my Health" Based on a 4-point Likert Scale.

  Number of patients who agree or strongly agree with the statement that the CHW helped me to improve how I take care of my health, based on exit interviews administered via in-person paper questionnaire at the end of the outreach event (4 possible responses: strongly agree, agree, disagree, strongly disagree) used in the Sikh American Families Oral Health Promotion Program.

  up to 6 months

Secondary Outcomes (3)

• Number of Patients Who Agree or Strongly Agree With the Statement, "The Community Health Worker (CHW) Answered my Questions or Concerns" Based on a 4-point Likert Scale.

  up to 6 months

• Number of Patients Who Agree or Strongly Agree With the Statement, "The Information and Topics Were Informative" Based on a 4-point Likert Scale.

  up to 6 months

• Number of Patients Who Agree or Strongly Agree With the Statement, "The In-person Demonstrations Were Helpful in Improving Oral Health" Based on a 4-point Likert Scale.

  up to 6 months

Study Arms (1)

Partnered Intervention

EXPERIMENTAL

The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors.

Behavioral: Partnered intervention

Interventions

Partnered intervention BEHAVIORAL

CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists.

Partnered Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outreach center patients will be enrolled into either or both of 2 groups.
• Approximately 50 patients from each of 3 centers (n = 150) will be consented to allow their data to be entered via the remote EHR. These EHR patient participants must meet all of the following criteria to be enrolled:
• Greater than or equal to 21 years of age
• Self-identify as being of Chinese ethnicity
• Live in any of the 5 boroughs of New York, NY and visit a participating outreach center
• Able and willing to provide informed consent to have their data entered into the remote EHR
• Approximately 30 patients from each of 3 centers (n = 90) will be consented to participate in an exit interview and a follow-up interviews. These interview patient participants must meet all of the following criteria:
• Greater than or equal to 21 years of age
• Self-identify as being of Chinese ethnicity
• Live in any of the 5 boroughs of New York, NY and visit a participating outreach center
• Able and willing to provide informed consent and participate in an exit interview and a follow-up interview
• Approximately 20 research staff, NYU administrators, outreach center directors, and providers (dentists and CHWs) will be enrolled to participate in interviews about the partnered intervention and/or remote EHR. These non-patient participants must meet all of the following criteria:
• Greater than or equal to 18 years of age
• Be employed or volunteers at participating outreach centers or employed at NYU
• For CHW-staff, speak and read Mandarin Chinese

You may not qualify if:

• Individuals meeting any of the following criteria will not be enrolled as either EHR patient participants or interview patient participants:
• Have an acute or terminal illness or a serious mental illness or any other severe health condition(s) that might preclude visiting an oral health care provider
• Are currently participating in another oral health study
• Individuals meeting any of the following criteria will not be enrolled to complete the interviews about the partnered intervention or remote EHR or to provide input to the knowledge modeling activities:
• \. Staff in functional areas that do not directly service patients (e.g., custodial staff) A patient participant may participate in either the EHR patient participant group only or both patient participant groups (interview patient participants are a subset of EHR patient participants). A non-patient participant may participate in any or all of the non-patient participant data collection activities. Co-participation in activities by any subject is not required.

Sponsors & Collaborators

• NYU College of Dentistry: lead
• NYU School of Medicine: collaborator
• State University of New York at Buffalo: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

NYU College of Dentistry

New York, New York, 10010, United States

Location

Related Publications (2)

• Northridge ME, Metcalf SS, Yi S, Zhang Q, Gu X, Trinh-Shevrin C. A Protocol for a Feasibility and Acceptability Study of a Participatory, Multi-Level, Dynamic Intervention in Urban Outreach Centers to Improve the Oral Health of Low-Income Chinese Americans. Front Public Health. 2018 Feb 14;6:29. doi: 10.3389/fpubh.2018.00029. eCollection 2018.

  PMID: 29492400 BACKGROUND

• Northridge ME, Kavathe R, Zanowiak J, Wyatt L, Singh H, Islam N. Implementation and dissemination of the Sikh American Families Oral Health Promotion Program. Transl Behav Med. 2017 Sep;7(3):435-443. doi: 10.1007/s13142-017-0466-4.

  PMID: 28144833 RESULT

MeSH Terms

Conditions

Mouth Diseases; Dental Caries

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases

Limitations and Caveats

A limitation of this pilot study is the small sample size, especially for completion of the 1-month follow-up phone calls. As of March 2020, all research activities were halted at New York University (NYU) in New York, NY, USA, so we ended enrollment on the current pilot study and analyzed the data at hand. Additional limitations of this research include potential recall bias regarding the retrospective assessments, and possible response bias associated with self-reported behaviors.

Results Point of Contact

• Title: Mary E. Northridge, PhD, MPH, Director of Dental Research
• Organization: NYU Grossman School of Medicine

Mary.Northridge@nyulangone.org

(347) 377-4342

Study Officials

• Melissa W Riddle, PhD

  National Institute of Dental and Craniofacial Research (NIDCR)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Feasibility and acceptability study.

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 19, 2018
• Study Start: May 9, 2018
• Primary Completion: February 13, 2019
• Study Completion: September 11, 2020
• Last Updated: August 13, 2021
• Results First Posted: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)