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

July 21, 2021 updated by: Mary E. Northridge, NYU College of Dentistry
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • NYU College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU College of Dentistry

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Dental and Craniofacial Research (NIDCR)
NYU School of Medicine
The State University of New York at Buffalo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Melissa W Riddle, PhD, National Institute of Dental and Craniofacial Research (NIDCR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • s17-01077
  • 1U56DE027447-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries

Clinical Trials on Partnered intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings