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

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ClinicalTrials.gov Identifier: NCT03438045
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : May 15, 2018
Sponsor:
Collaborators:
NYU School of Medicine
The State University of New York at Buffalo
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Mary E. Northridge, NYU College of Dentistry

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 Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Estimated Primary Completion Date : September 11, 2019
Estimated Study Completion Date : September 11, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Percentage 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 ]
    Percentage 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. Percentage 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 ]
    Percentage 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. Percentage 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 ]
    Percentage 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. Percentage 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 ]
    Percentage 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438045


Contacts
Contact: Mary E Northridge, PhD, MPH 2129989728 men6@nyu.edu
Contact: Stella S Yi, PhD, MPH 2122635163 stella.yi@nyumc.org

Locations
United States, New York
NYU College of Dentistry Recruiting
New York, New York, United States, 10010
Contact: Mary E Northridge, PhD, MPH    212-998-9728    men6@nyu.edu   
Contact: Andrew B Schenkel, DMD, MS    2129989722    andrew.schenkel@nyu.edu   
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)

Publications of Results:
Responsible Party: Mary E. Northridge, Associate Professor, NYU College of Dentistry
ClinicalTrials.gov Identifier: NCT03438045     History of Changes
Other Study ID Numbers: s17-01077
1U56DE027447-01 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mary E. Northridge, 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
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases