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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438045
• Other study ID #: s17-01077
• Secondary ID: 1U56DE027447-01
• Status: Completed
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: September 11, 2020

Study information

• Verified date: July 2021
• Source: NYU College of Dentistry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Introduction: While the US health care system has the capability to provide amazing treatment of a wide array of conditions, this care is not uniformly available to all population groups. Oral health care is one of the dimensions of the US health care delivery system in which striking disparities exist. More than half of the population does not visit a dentist each year. Improving access to oral health care is a critical and necessary first step to improving oral health outcomes and reducing disparities. Fluoride has contributed profoundly to the improved dental health of populations worldwide and is needed regularly throughout the life course to protect teeth against dental caries. To ensure additional gains in oral health, fluoride toothpaste should be used routinely at all ages. Evidence-based guidelines for annual dental visits and brushing teeth with fluoride toothpaste form the basis of this implementation science project that is intended to bridge the care gap for underserved Asian American populations by improving access to quality oral health care and enhancing effective oral health promotion strategies. The ultimate goal of this study is to provide information for the design and implementation of a randomized controlled trial of a participatory, multi-level, partnered (i.e., with community stakeholders) intervention to improve the oral and general health of low-income Chinese American adults.

Methods: This study will evaluate the feasibility and acceptability of implementing a partnered intervention using remote data entry into an electronic health record (EHR) to improve access to oral health care and promote oral health. The research staff will survey a sample of Chinese American patients (planned n = 90) screened at 3 outreach centers about their satisfaction with the partnered intervention. Providers (dentists and community health workers), research staff, administrators, site directors, and community advisory board 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, administrators, outreach site directors, and providers. The study will also model knowledge held by non-patient participants to evaluate and enhance the partnered intervention for use in future implementations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 11, 2020
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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:

1. Greater than or equal to 21 years of age

2. Self-identify as being of Chinese ethnicity

3. Live in any of the 5 boroughs of New York, NY and visit a participating outreach center

4. 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:

1. Greater than or equal to 21 years of age

2. Self-identify as being of Chinese ethnicity

3. Live in any of the 5 boroughs of New York, NY and visit a participating outreach center

4. 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:

1. Greater than or equal to 18 years of age

2. Be employed or volunteers at participating outreach centers or employed at NYU

3. For CHW-staff, speak and read Mandarin Chinese

4. Able and willing to provide informed consent

Approximately 32 non-patient participants (research staff, NYU administrators, CAB members, outreach site directors, and providers (dentists and CHWs) will be enrolled to participate in interviews and a group model-building workshop to inform model development by sharing their knowledge about factors that influence access to oral health care and care-seeking behaviors among low-income, urban Chinese American adults. These individuals must meet all of the following criteria:

1. Greater than 18 years of age

2. Be employed or volunteers at participating outreach centers or employed at NYU

3. Able and willing to provide informed consent

Exclusion Criteria:

Individuals meeting any of the following criteria will not be enrolled as either EHR patient participants or interview patient participants:

1. 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

2. 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:

1. 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.

Related Conditions & MeSH terms

• Dental Caries
• Mouth Diseases
• Oral Disease

Intervention

Behavioral:
• Partnered intervention
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.

Locations

Country	Name	City	State
United States	NYU College of Dentistry	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
NYU College of Dentistry	National Institute of Dental and Craniofacial Research (NIDCR), NYU School of Medicine, The State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Number of patients who agree or strongly agree with the statement that the CHW answered my questions or concerns, 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	Number of Patients Who Agree or Strongly Agree With the Statement, "The Information and Topics Were Informative" Based on a 4-point Likert Scale.	Number of patients who agree or strongly agree with the statement that the information and topics were informative, 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	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.	Number of patients who agree or strongly agree with the statement that the in-person demonstrations were helpful in improving oral 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