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

• Sponsor: NYU College of Dentistry (Other)
• Overall Status: Completed
• CT.gov ID: NCT03438045
• Collaborator: NYU School of Medicine (Other), The State University of New York at Buffalo (Other), National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
• Enrollment: 75
• Location: 1
• Arm: 1
• Actual Duration (Months): 28.1
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Disease; Dental Caries	Behavioral: Partnered intervention	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Feasibility and acceptability study.Feasibility and acceptability study.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Implementing a Participatory, Multi-level Intervention to Improve Asian American Health Study
• Actual Study Start Date: May 9, 2018
• Actual Primary Completion Date: Feb 13, 2019
• Actual Study Completion Date: Sep 11, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Partnered Intervention 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; 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.

Outcome Measures

Primary Outcome Measures

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. [up to 6 months]

   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.

Secondary Outcome Measures

1. 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 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.

2. 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 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.

3. 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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU College of Dentistry	New York	New York	United States	10010

Sponsors and Collaborators

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

Investigators

• Study Chair: Melissa W Riddle, PhD, National Institute of Dental and Craniofacial Research (NIDCR)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 9, 2017
• Informed Consent Form - Dec 10, 2017

More Information

Publications

• 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.

• Responsible Party: Mary E. Northridge, Associate Professor, NYU College of Dentistry
• ClinicalTrials.gov Identifier: NCT03438045
• Other Study ID Numbers: s17-01077; 1U56DE027447-01
• First Posted: Feb 19, 2018
• Last Update Posted: Aug 13, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mary E. Northridge, Associate Professor, NYU College of Dentistry: Chinese American; implementation science; feasibility; acceptability; oral health; dental care; health equity; urban health
• Additional relevant MeSH terms: Dental Caries; Mouth Diseases

Study Results

Participant Flow

Recruitment Details

Five Chinese American community-based organizations have already volunteered to participate in this study: Asian Americans for Equality. Chinatown YMCA, a Branch of the YMCA of Greater New York. Chinese American Planning Council. Coalition for Asian American Children and Families. Hamilton-Madison House. The three outreach centers for this study will be selected from among the affiliated outreach centers of these organizations.

Pre-assignment Detail

No assignment to groups was part of this feasibility and acceptability study. All participants received the intervention.

Arm/Group Title	Partnered Intervention
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	75
COMPLETED	75
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Partnered Intervention
Arm/Group Description	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. 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.
Overall Participants	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.9 (19.3)
Sex: Female, Male (Count of Participants)
Female	62 82.7%
Male	12 16%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	74 98.7%
Unknown or Not Reported	1 1.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	74 98.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	1 1.3%
Region of Enrollment (participants) [Number]
United States	75 100%
Preferred language (Count of Participants)
Chinese	74 98.7%
English	0 0%
Missing	1 1.3%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Partnered Intervention
Arm/Group Description	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. 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.
Measure Participants	72
Strongly agree	21 28%
Agree	50 66.7%
Disagree	1 1.3%
Strongly disagree	0 0%

2. Secondary Outcome

Title	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.
Description	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.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Partnered Intervention
Arm/Group Description	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. 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.
Measure Participants	67
Strongly agree	16 21.3%
Agree	50 66.7%
Disagree	1 1.3%
Strongly disagree	0 0%

3. Secondary Outcome

Title	Number of Patients Who Agree or Strongly Agree With the Statement, "The Information and Topics Were Informative" Based on a 4-point Likert Scale.
Description	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.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Partnered Intervention
Arm/Group Description	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. 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.
Measure Participants	69
Strongly agree	17 22.7%
Agree	52 69.3%
Disagree	0 0%
Strongly disagree	0 0%

4. Secondary Outcome

Title	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.
Description	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.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Partnered Intervention
Arm/Group Description	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. 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.
Measure Participants	69
Strongly agree	17 22.7%
Agree	52 69.3%
Disagree	0 0%
Stronly disagree	0 0%

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	UPs that are serious adverse events will be reported to the IRB and to NIDCR within 1 week of the investigator becoming aware of the event.
Arm/Group Title	Partnered Intervention
Arm/Group Description	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. 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.
All Cause Mortality
	Partnered Intervention
	Affected / at Risk (%)	# Events
Total	0/75 (0%)
Serious Adverse Events
	Partnered Intervention
	Affected / at Risk (%)	# Events
Total	0/75 (0%)
Other (Not Including Serious) Adverse Events
	Partnered Intervention
	Affected / at Risk (%)	# Events
Total	0/75 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.