Oral DiseaseNCT03438045
Implementing a Participatory, Multi-level Intervention to Improve Asian American Health Study
A study testing Partnered intervention in people with Oral Disease and Dental Caries, run by NYU College of Dentistry at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Disease, Dental Caries
- What is being tested?
- Partnered intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 11 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Greater than or equal to 21 years of age
- Self-identify as being of Chinese ethnicity
- Live in any of the 5 boroughs of New York, NY and visit a participating outreach center
- Able and willing to provide informed consent to have their data entered into the remote EHR
Show all 20Show fewer
- 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:
- Greater than or equal to 21 years of age
- Self-identify as being of Chinese ethnicity
- Live in any of the 5 boroughs of New York, NY and visit a participating outreach center
- 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:
- Greater than or equal to 18 years of age
- Be employed or volunteers at participating outreach centers or employed at NYU
- For CHW-staff, speak and read Mandarin Chinese
- 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:
- Greater than 18 years of age
- Be employed or volunteers at participating outreach centers or employed at NYU
- Able and willing to provide informed consent
Who cannot join
- Individuals meeting any of the following criteria will not be enrolled as either EHR patient participants or interview patient participants:
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Oral Disease, Dental Caries
- Being tested
- Partnered intervention
- Keywords
- Chinese American, implementation science, feasibility, acceptability, oral health, dental care, health equity, urban health
- Medical subject headings
- Mouth Diseases, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partnered interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Partnered Intervention | Experimental | 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. Receives: Behavioral: Partnered intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (3)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start9 May 2018
- Primary completion13 Feb 2019
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility and acceptability study.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU College of Dentistry
- Sponsor type
- University, hospital or other
- Collaborators
- NYU School of Medicine, State University of New York at Buffalo, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Mary E. Northridge, NYU College of Dentistry
- Investigators
- Melissa W Riddle, PhD, Study chair, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438045
- Sponsor's protocol ID
- s17-01077
- Other IDs
- 1U56DE027447-01
- Status last verified
- Jul 2021
- First submitted
- 5 Feb 2018
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
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.
PubMed 29492400Northridge 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.
PubMed 28144833
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Participatory, Multi-level Intervention to Improve Asian American Health Study
- ClinicalTrials.gov ID
- NCT03438045
- Acronym / sponsor ID
- s17-01077
- Conditions
- Oral Disease, Dental Caries
- Keywords
- Chinese American, implementation science, feasibility, acceptability, oral health, dental care, health equity, urban health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- NYU College of DentistryUniversity, hospital or other
- Collaborators
- NYU School of Medicine, State University of New York at Buffalo, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 9 May 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 6 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility and acceptability study.
| Arm | Type | Receives |
|---|---|---|
| Partnered Intervention | Experimental | Behavioral: Partnered interventionThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- Greater than or equal to 21 years of age
- Self-identify as being of Chinese ethnicity
- Live in any of the 5 boroughs of New York, NY and visit a participating outreach center
Key exclusion criteria (5 listed)
- Individuals meeting any of the following criteria will not be enrolled as either EHR patient participants or interview patient participants:
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partnered interventionCHWs 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. | Behavioural | Partnered Intervention |
Primary outcome
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.
3 secondary outcomes
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, "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, "The In-person Demonstrations Were Helpful in Improving Oral Health" Based on a 4-point Likert Scale.
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29492400Northridge 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.
- Results publication: PubMed 28144833Northridge 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa W Riddle, PhD study chair
National Institute of Dental and Craniofacial Research (NIDCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partnered intervention in people with Oral Disease and Dental Caries, run by NYU College of Dentistry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438045, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.