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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03438045
Enrollment
75
Registered
2018-02-19
Start date
2018-05-09
Completion date
2020-09-11
Last updated
2021-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Oral Disease

Keywords

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

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.

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.

Interventions

BEHAVIORALPartnered 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.

Sponsors

NYU School of Medicine
CollaboratorUNKNOWN
State University of New York at Buffalo
CollaboratorOTHER
National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
NYU College of Dentistry
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Feasibility and acceptability study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
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 monthsNumber 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

MeasureTime frameDescription
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 monthsNumber 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.
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 monthsNumber 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.
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 monthsNumber 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.

Countries

United States

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 details

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

Participants by arm

ArmCount
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. 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.
75
Total75

Baseline characteristics

CharacteristicPartnered Intervention
Age, Continuous58.9 years
STANDARD_DEVIATION 19.3
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
74 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Preferred language
Chinese
74 Participants
Preferred language
English
0 Participants
Preferred language
Missing
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
74 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
United States
75 participants
Sex: Female, Male
Female
62 Participants
Sex: Female, Male
Male
12 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 75
other
Total, other adverse events
0 / 75
serious
Total, serious adverse events
0 / 75

Outcome results

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.

Time frame: up to 6 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Partnered InterventionNumber 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.Strongly agree21 Participants
Partnered InterventionNumber 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.Agree50 Participants
Partnered InterventionNumber 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.Disagree1 Participants
Partnered InterventionNumber 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.Strongly disagree0 Participants
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.

Time frame: up to 6 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Partnered InterventionNumber 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.Strongly agree16 Participants
Partnered InterventionNumber 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.Agree50 Participants
Partnered InterventionNumber 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.Disagree1 Participants
Partnered InterventionNumber 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.Strongly disagree0 Participants
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.

Time frame: up to 6 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Partnered InterventionNumber of Patients Who Agree or Strongly Agree With the Statement, The Information and Topics Were Informative Based on a 4-point Likert Scale.Agree52 Participants
Partnered InterventionNumber of Patients Who Agree or Strongly Agree With the Statement, The Information and Topics Were Informative Based on a 4-point Likert Scale.Strongly agree17 Participants
Partnered InterventionNumber of Patients Who Agree or Strongly Agree With the Statement, The Information and Topics Were Informative Based on a 4-point Likert Scale.Disagree0 Participants
Partnered InterventionNumber of Patients Who Agree or Strongly Agree With the Statement, The Information and Topics Were Informative Based on a 4-point Likert Scale.Strongly disagree0 Participants
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.

Time frame: up to 6 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Partnered InterventionNumber 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.Strongly agree17 Participants
Partnered InterventionNumber 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.Agree52 Participants
Partnered InterventionNumber 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.Disagree0 Participants
Partnered InterventionNumber 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.Stronly disagree0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026