Implementing a Participatory, Multi-level Intervention to Improve Asian American Health Study
Phase: NA
Conditions: Oral Disease, Dental Caries
Sponsor: NYU College of Dentistry

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Implementing a Participatory, Multi-level 
Intervention to Improve Asian American Health
Lead Principal 
Investigator (NYU):
Mary E. Northridge, PhD, MPH
NYU College of Dentistry
Department of Epidemiology & Health Promotion
433 First Avenue, 7th Floor, Room 726
New York, NY 10010
men6@nyu.edu
(212)998-9728
Additional Investigators 
(NYU):
Chau Trinh-Shevrin, DrPH
NYU School of Medicine
Department of Population Health
227 East 30th Street, 8th Floor
New York, NY 10016
chau.trinh@nyumc.org
(212) 263-0482
Andrew B. Schenkel, DMD, MS
NYU College of Dentistry
Department of Cariology and Comprehensive Care
137 East 25th Street, Floor 5 
New York, New York 10010 
andrew.schenkel@nyu.edu
(212) 998-9722
Mark Wolff, DDS, PhD
NYU College of Dentistry
Department of Cariology and Comprehensive Care 
421 First Avenue, Room 1028W 
New York, New York 10010 
mark.wolff@nyu.edu
(212) 998-9666
Andrea B. Troxel, ScD
NYU School of Medicine
Department of Population Health
650 First Avenue, 5th Floor, Room 521
New York, NY 10016
Andrea.troxel@nyumc.org

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(212)263-6527
Nadia S. Islam, PhD
NYU School of Medicine
Department of Population Health
227 East 30th Street, 8th Floor
New York, NY 10016
nadia.islam@nyumc.org
(212) 263-7075
Stella S. Yi, MPH, PhD
NYU School of Medicine
Department of Population Health
227 East 30th Street, 8th Floor
New York, NY 10016
stella.yi@nyumc.org
(212) 263-5163
Modeling Site Principal 
Investigator (SUNY):
Sara S. Metcalf, PhD
The State University of New York at Buffalo
Department of Geography
115 Wilkeson Quad, Ellicott Complex
Buffalo, NY 14261-0055
smetcalf@buffalo.edu
(716) 645-0479
NYULMC Study Number:
S17-01077 
Funding Sponsor: 
National Institute of Dental and Craniofacial Research (NIDCR)
National Institutes of Health, DHHS
Behavioral and Social Sciences Research Branch
6701 Democracy Blvd
Bethesda, MD 20892-4878
(301) 451-3888
NIDCR Grant Number: U56 DE027447-01
NIDCR Protocol Number: 17-072-E
ClinicalTrials.gov 
Number                
In process
Version Number: 1.0
9 December 2017

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STATEMENT OF COMPLIANCE
The study will be conducted in accordance with the International Council on 
Harmonisation guidelines for Good Clinical Practice (ICH E6), the Code of Federal 
Regulations on the Protection of Human Subjects (45 CFR Part 46), and the NIDCR 
Clinical Terms of Award. All personnel involved in the conduct of this study have 
completed human subjects protection training. 

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TABLE OF CONTENTS
PAGE
STATEMENT OF COMPLIANCE ..................................................................................................3
TABLE OF CONTENTS ................................................................................................................4
SPECIAL TERMS..........................................................................................................................8
PROTOCOL SUMMARY .............................................................................................................10
1
KEY ROLES AND CONTACT INFORMATION ..................................................................15
2
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE .......17
2.1
Background Information..........................................................................................17
2.2
Rationale.................................................................................................................17
2.3
Potential Risks and Benefits ...................................................................................18
2.3.1
Potential Risks ............................................................................................18
2.3.2
Potential Benefits ........................................................................................18
3
OBJECTIVES .....................................................................................................................19
3.1
Study Objectives.....................................................................................................19
3.2
Study Outcome Measures ......................................................................................19
3.2.1
Primary........................................................................................................19
3.2.2
Secondary...................................................................................................19
4
STUDY DESIGN.................................................................................................................21
5
STUDY ENROLLMENT AND WITHDRAWAL....................................................................22
5.1
Subject Inclusion Criteria ........................................................................................22
5.2
Subject Exclusion Criteria.......................................................................................23
5.3
Strategies for Recruitment and Retention...............................................................23
5.4
Subject Withdrawal .................................................................................................24
5.4.1
Reasons for Withdrawal ..............................................................................24
5.4.2
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention .................................................................................................24
5.5
Premature Termination or Suspension of Study .....................................................24
6
STUDY INTERVENTION....................................................................................................25
6.1
Administration of Intervention .................................................................................25
6.2
Procedures for Training Interventionists and Monitoring Intervention Fidelity ........26
6.3
Assessment of Subject Compliance with Study Intervention..................................26
7
STUDY SCHEDULE...........................................................................................................27
7.1
Pre-intervention Activities .......................................................................................27
7.2
Outreach Center Activities ......................................................................................27
7.3
CHW Follow-up Contact with Interview Patient Participants (Feasibility Data 
Collection)...............................................................................................................29
7.4
Post-intervention Activities......................................................................................29
7.5
Knowledge Modeling Activities ...............................................................................30
8
STUDY PROCEDURES /EVALUATIONS..........................................................................31
8.1
Study Procedures/Evaluations................................................................................31
8.1.1
Workflow analysis .......................................................................................31
8.1.2
Pilot testing and live usability for remote EHR ............................................32

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8.1.3
Semi-structured interviews regarding the remote EHR and partnered 
intervention..................................................................................................32
8.1.4
Participatory modeling of non-patient participant knowledge......................33
9
ASSESSMENT OF SAFETY ..............................................................................................35
9.1
Specification of Safety Parameters.........................................................................35
9.1.1
Unanticipated Problems ..............................................................................35
9.1.2
Unanticipated Problem Reporting to IRB and NIDCR.................................35
9.2
Halting Rules...........................................................................................................36
10
STUDY OVERSIGHT .........................................................................................................37
11
CLINICAL SITE MONITORING ..........................................................................................38
12
STATISTICAL AND EVALUATIVE CONSIDERATIONS....................................................39
12.1
Study Hypotheses...................................................................................................39
12.2
Sample Size Considerations...................................................................................39
12.3
Planned Interim Analyses (if applicable).................................................................39
12.3.1 Safety Review .............................................................................................39
12.3.2 Efficacy Review...........................................................................................39
12.4
Final Analysis Plan..................................................................................................39
13
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS...................42
14
QUALITY CONTROL AND QUALITY ASSURANCE .........................................................43
15
ETHICS/PROTECTION OF HUMAN SUBJECTS ..............................................................44
15.1
Ethical Standard......................................................................................................44
15.2
Institutional Review Board ......................................................................................44
15.3
Informed Consent Process .....................................................................................44
15.4
Exclusion of Women, Minorities, and Children (Special Populations) ....................45
15.5
Subject Confidentiality ............................................................................................45
16
DATA HANDLING AND RECORD KEEPING ....................................................................47
16.1
Data Management Responsibilities ........................................................................47
16.2
Data Capture Methods............................................................................................47
16.3
Types of Data..........................................................................................................47
16.4
Schedule and Content of Reports...........................................................................48
16.5
Study Records Retention........................................................................................48
16.6
Protocol Deviations.................................................................................................48
17
PUBLICATION/DATA SHARING POLICY..........................................................................49
18
LITERATURE REFERENCES............................................................................................50
SUPPLEMENTAL MATERIALS ..................................................................................................50

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LIST OF ABBREVIATIONS
AAFE
Asian Americans for Equality
ABM
Agent-Based Modeling
AE
Adverse Event/Adverse Experience
AHRQ
Agency for Healthcare Research and Quality
CBPR
Community-Based Participatory Research
CAB
Community Advisory Board
CFIR
Consolidated Framework for Implementation Research
CFR
Code of Federal Regulations
CHW
Community Health Worker
Co-I
Co-Investigator
CONSORT
Consolidated Standards of Reporting Trials
CRF
Case Report Form
CPC
Chinese-American Planning Council
CTSI
Clinical and Translational Science Institute
DHHS
Department of Health and Human Services
EHR
Electronic Health Record
EPIC
Expert Recommendations for Implementing Change
FDA
Food and Drug Administration
FFR
Federal Financial Report
FWA
Federal-Wide Assurance
GCP
Good Clinical Practice
GIS
Geographic Information System
H+H
Health and Hospitals Corporation
HIPAA
Health Insurance Portability and Accountability Act
HMH
Hamilton-Madison House
ICH
International Conference on Harmonisation
ICMJE
International Committee of Medical Journal Editors
IOF
Implementation Outcomes Framework
IRB
Institutional Review Board
MedDRA
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
MPI
Multiple Principal Investigators

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N
Number (typically refers to subjects)
NIDCR
National Institute of Dental and Craniofacial Research, NIH, DHHS
NIH
National Institutes of Health
NYU
New York University
NYU Dentistry
New York University College of Dentistry
OCTOM
Office of Clinical Trials Operations and Management, NIDCR, NIH
OHRP
Office for Human Research Protections
PHI
Protected Health Information
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event/Serious Adverse Experience
SD
System Dynamics
SOP
Standard Operating Procedure
TBN
To Be Named
UB Geography
University at Buffalo Department of Geography
UP
Unanticipated Problem
US
United States
WHO
World Health Organization

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SPECIAL TERMS
Partnered 
Intervention
The partnered intervention consists of the following 4 evidence-based 
strategies: (1) written agreements of collaboration for dental screening at 
the site level; (2) culturally-tailored and language-specific adaptation of 
materials at the community and site levels; (3) demonstrations with role-
playing of proper brushing with fluoride toothpaste and flossing techniques 
at the site and provider levels; and (4) community health worker (CHW) 
follow-up with patients about oral health care receipt and dental hygiene 
behaviors at the family and patient levels.
Patient 
Participants
Patient participants refer to study participants who are also patients 
screened at the urban outreach centers. Patient participants are first 
enrolled as EHR patient participants as part of the feasibility and 
acceptability study of this form of patient tracking. A subset of the EHR 
patient participants also complete exit interviews after the intervention at 
urban outreach centers and are referred to as interview patient participants.

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Non-Patient 
Participants
Non-patient participants refer to all other study participants who are not 
patients screened at the urban outreach centers, including community 
advisory board (CAB) members, research staff, New York University (NYU) 
administrators, providers (dentists and CHWs), and outreach site directors.

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PROTOCOL SUMMARY
Title:
Implementing a Participatory, Multi-level Intervention to Improve Asian 
American Health
Abstract:
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. 
Objectives:
The ultimate goal of this study is to provide information for the design 
and implementation of a larger, randomized, controlled trial of a 
participatory, multi-level, partnered intervention to improve the oral 
and general health of low-income Chinese American adults. Toward 
this end, this study has 3 objectives:
Primary:

To evaluate and enhance the feasibility and acceptability of a 
partnered intervention designed to improve oral health for low-
income, urban Chinese American adults at 3 community sites
Secondary:

To evaluate and enhance the feasibility and acceptability of 
using remote data entry features of electronic health record 
(EHR) software at the New York University College of 
Dentistry (NYU Dentistry) to enter patient information at 3 
Chinese American community sites

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
To model knowledge held by non-patient participants about 
factors that influence access to oral health care and care-
seeking behaviors among low-income, urban Chinese 
American adults, in order to enhance the intervention during 
and/or after the study for use in future implementations
Population:
For the entire study, we plan to enroll a total of 182 human subjects: 
150 patient participants and 32 non-patient participants.
As we are utilizing a community-based participatory research (CBPR) 
approach, several different populations/units of analysis are included 
in this feasibility and acceptability (F & A) study. 
In accordance with CBPR principles, we will establish a community 
advisory board (CAB) comprised of 8 members to guide all aspects of 
the study.
The research staff (n = 10) is comprised of the 3 Multiple Principal 
Investigators (MPIs) (Drs. Northridge, Trinh-Shevrin, and Metcalf), the 
3 Co-Investigators (Co-Is) at the New York University School of 
Medicine (NYU Medicine) (Drs. Troxel, Islam, and Yi), 2 Project 
Coordinators (TBN), and 2 modelers (Ms. Zhang and TBN).
The NYU administrators (n = 3) include both Co-Is at NYU Dentistry 
(Drs. Schenkel and Wolff) and an IT Specialist (Dr. Perelman).
The providers (n = 8) include faculty dentists at NYU Dentistry who 
participate in local community outreach events (n = 6) and bilingual 
(English and Mandarin Chinese) CHWs (n = 2).
Outreach site directors at each of 3 participating community outreach 
centers (n = 3) serving low-income Chinese American populations in 
New York, NY.
EHR patient participants. At least 50 low-income Chinese American 
adult patients will undergo a dental screening at each of 3 community 
outreach centers (n = 150) and have their data remotely entered into 
the NYU Dentistry EHR. 
Interview patient participants. Approximately 30 Chinese American 
patients screened at each of 3 community outreach centers will be 
enrolled in the study as participants (n = 90) to complete interviews 
about their satisfaction with the partnered intervention and their use of 
dental services and evidence-based oral health behaviors.
Phase:
Not applicable
Study Sites:
The 2 study sites are New York University (intervention site) and the 

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State University of New York at Buffalo (modeling site).
Outreach Sites:
A total of 3 Chinese American community outreach centers will be 
selected by the research staff and the CAB members. As per the 
Office of Human Research Protections (OHRP) of the US Department 
of Health and Human Services, these sites whose employees or 
agents perform commercial or other services for the study 
investigators are not engaged in human subjects research since all of 
the following conditions are met:
(a) the services performed do not merit professional recognition or 
publication privileges;
(b) the services performed are typically performed by those 
institutions for non-research purposes; and
(c) the institution's employees or agents do not administer any study 
intervention being tested or evaluated under the protocol.
The following organizations provided letters of support, which will form 
the basis for selecting 3 community outreach centers and 8 CAB 
members for this F & A study: 

Asian Americans for Equality (AAFE)

Chinatown YMCA, a branch of the YMCA of Greater New York

Chinese-American Planning Council (CPC)

Coalition for Asian American Children and Families (CACF)

Hamilton-Madison House (HMH)
Moreover, 2 NYU centers provided letters of support for this 
feasibility and acceptability study.

Integrating Special Populations Unit, New York University 
Health and Hospitals Corporation (NYU-H+H) Clinical 
and Translational Science Institute (CTSI)

NYU-H+H CTSI  
Description of 
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 

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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. 
Study Duration:
1 year
Subject Participation 
Duration:
Participation duration refers specifically to the period of time when 
data are collected from individual participants. It does not capture 
periods of time when individual participants are remotely entering 
EHR data or administering aspects of the intervention or protocol. 
That information is captured elsewhere in this protocol.

1 year for the community outreach centers

1 or more days for each research staff member, NYU 
administrator, provider (dentist or CHW), CAB member, or 
outreach site director to respond to questions about the 
partnered intervention and/or the remote EHR implementation

Up to approximately 2 months (includes 1 in-person visit and 1 
telephone follow-up) for each enrolled interview patient 
participant

1 day for each research staff member, NYU administrator, 
provider (dentist or CHW), CAB member or outreach site 
director to provide their input about factors affecting health 
care utilization among the clients of the outreach centers
Estimated Time to 
Complete 
Enrollment:

Approximately 1 month to select the 3 participating outreach 
centers from the partners that have previously pledged their 
commitment to the study

Research staff, administrators, providers (dentists and CHWs) 
and clients/patients may be responding to feasibility and 
acceptability questions at any time during the study.  
Therefore, enrollment of these individuals can be open for the 
entire year of the study; participation in a particular set of 
questions can be completed in 1 day.

Enrollment of research staff, NYU administrators, providers 
(dentists and CHWs), CAB members and outreach site 
directors providing their knowledge about factors that influence 
access to oral health care and care-seeking behaviors among 
low-income, urban Chinese American adults can be open for 
the entire year of the study.

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Schematic of Study Design:
Establish Community Advisory 
Board (CAB)
CAB Members and 
Research Staff Review 
and Adapt Existing 
Materials
Community Health 
Workers (CHW) Training 
and Fidelity Evaluation
Obtain Informed Consent
Implement Partnered 
Intervention
Remote EHR  Set Up, with Study-
Specific Screens and Folders
Obtain Informed Consent
Enter EHR Data 
From Patient 
Participants at 3 
Participating 
Outreach Centers
Evaluate Remote EHR via Interviews 
with Dentists, CHWs, NYU 
Administrators, and Site Directors
Develop prototype scoping model 
Initial Interviews with Stakeholders to 
Elicit Modeling Input
Articulate a priori Dynamic Hypotheses 
of Causal Relationships and Feedback 
Loops
Conduct Group Model-Building 
Workshop with Non-Patient Project 
Stakeholders1
Formulate Shared Dynamic Hypotheses 
and Implement Model Structures from 
Workshop
Modify and Extend Simulation Modeling 
Platform to Accommodate New 
Structures
Follow-up Interviews with Non-Patient 
Project Stakeholders to Check and Clarify 
Model Assumptions
Verification of Simulation Model 
Structure and Behavior
Experimentation with Simulation 
Modeling Platform to Inform Future 
Intervention
Remote EHR
Knowledge Modeling
EvaluatePartnered Intervention 
via Interviews with Dentists, CHWs, NYU 
Administrators, and Site Directors
and via 
Exit Interview and 1 Month Follow-up 
with Patients
Partnered Intervention
1May occur either before or after the start of the implementation of the partnered intervention

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1
KEY ROLES AND CONTACT INFORMATION
Lead Principal 
Investigator:  
Mary E. Northridge, PhD, MPH
NYU College of Dentistry
433 First Avenue, 7th Floor, Room 726
New York, NY 10010
Telephone: 212-998-9728
Email: men6@nyu.edu
NIDCR Medical 
Monitor:
Kevin McBryde, MD
Medical Officer, Division of Extramural Research
National Institute of Dental and Craniofacial Research
National Institutes of Health, DHHS
6701 Democracy Blvd., Room 638
Bethesda, MD 20892-4878
Telephone:  301-594-0170
Email: mcbrydekd@mail.nih.gov
NIDCR Program 
Official:  
David Clark, DrPH
​Director, Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research
National Institutes of Health, DHHS
BG 1DEM RM 650
6701 Democracy Blvd
Bethesda, MD 20892-4878
Telephone: 301-594-4814
Fax: 301-480-8319
Email: david.clark2@nih.gov
Modeling Site:
University at Buffalo Department of Geography
115 Wilkeson Quad
Buffalo, NY 14261
Sara Metcalf, PhD
Telephone: 716-645-0479
Email: smetcalf@buffalo.edu
Responsibilities: Dr. Metcalf and her team will be primarily 
responsible for modeling the knowledge gained about factors at 
the community, site, family, provider, and patient levels to 
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delivery and improve health and health care. Dr. Metcalf will 
oversee all of the group model building and simulation activities.
Chau Trinh-Shevrin, DrPH – Co-I: As the lead investigator at the 
NYU School of Medicine, Dr. Trinh-Shevrin will oversee all 
CBPR and CHW components of the intervention.
Andrew Schenkel, DMD, MS – Co-I: As a Co-I and the Program 
Leader for the study, Dr. Schenkel will be primarily responsible 
for overseeing the Local Community Outreach Programs that will 
host the screening events for this implementation science 
research. He will also be key in planning and implementing the 
remote EHR system to enable tracking at the community, site, 
provider, and patient levels of receipt of oral health care visits, 
services, and health and health care measures. Finally, he will 
participate in the group model building exercises, interpretation 
of findings, and manuscript preparation for this study.
Mark Wolff, DDS, PhD – Co-I: As a Co-I and Project Champion 
for the study, Dr. Wolff will support, market, and drive through 
the implementation of the enhanced EHR community outreach 
program and contribute his expertise and experience to the 
group model building activities and the writing of manuscripts 
that emanate from this research.
Andrea Troxel, ScD – Co-I: As a Co-I and Biostatistician for the 
study, Dr. Troxel will provide guidance on all aspects of study 
design and analysis. 
Nadia Islam, PhD – Co-I: As a Co-I for the study, Dr. Islam will 
provide oversight and guidance on study implementation using a 
CBPR approach and intervention design using CHWs.
Stella Yi, MPH, PhD – Co-I: As a Co-I for the study, Dr. Yi will 
provide oversight and guidance on study implementation and 
design regarding the implementation of EHR-based referrals and 
data collection. 

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2
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
2.1
Background Information
Lack of access to oral health care contributes to profound and enduring oral health 
disparities in the United States and worldwide. Vulnerable and underserved populations 
who commonly lack access to oral health care include but are not limited to racial and 
ethnic minorities, including immigrants and non-English speakers. 
Asian Americans are the fastest growing minority group in the United States, yet are 
rarely included in oral health care research. The Center for the Study of Asian American 
Health (CSAAH) at the New York University School of Medicine (NYU Medicine) is the 
only National Institute for Minority Health & Health Disparities Center of Excellence in 
the United States solely dedicated to research and evaluation on Asian American health 
and health disparities. A Chinese Community Health Resources and Needs 
Assessment conducted by CSAAH and its community partners identified cardiovascular 
disease and oral disease to be the top health concerns among community members. 
Chinese are the largest Asian ethnic group in New York, NY, with higher poverty rates 
for working age and older adults relative to all residents and a higher proportion of 
foreign-born residents. NYU College of Dentistry (NYU Dentistry) and NYU Medicine 
have partnered on community-based participatory research (CBPR) initiatives to 
improve oral health and health care in Sikh American community-based settings using 
CHW models. 
Interventions often fail or even worsen the problems they are intended to solve due to a 
lack of understanding of real world structures and dynamic complexity. In longstanding 
collaboration with the University at Buffalo Department of Geography (UB Geography), 
our research team has examined how factors at multiple levels contribute to oral health 
and care-seeking behaviors for racial and ethnic minority older adults. To improve our 
mental models of the real world, we have employed system science methodologies 
such as system dynamics, agent-based modeling, geographic information science, and 
social network simulation. 
The 2011 report by the National Academies titled, Improving Access to Oral Health 
Care for Vulnerable and Underserved Populations is based on the following 2 well-
established and evidence-based principles: (1) Oral health is an integral part of overall 
health and, therefore, oral health care is an essential component of comprehensive 
health care. (2) Oral health promotion and disease prevention are essential to any 
strategies aimed at improving access to care. Our long-term goal is to improve Asian 
American health. 
2.2
Rationale
The study intervention, a partnering package of evidence-based intervention strategies, 
and the process of implementing remote EHR data entry and tracking in diverse 

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Chinese American community outreach sites are guided by 2 complementary, multi-
level frameworks: Consolidated Framework for Implementation Research (CFIR) and 
Implementation Outcomes Framework (IOF). Specifically, CFIR provides a menu of 
constructs that have been associated with effective implementation and have been used 
in a range of applications, whereas IOF is clear in distinguishing implementation, 
service, and patient outcomes. In other words, while IOF provides an evaluation 
framework that organizes the multiple facets that affect implementation of new 
interventions, CFIR provides a framework for understanding the multiple domains that 
influence implementation and adoption of these interventions. Because our proposed 
intervention is both multi-level and dynamic with numerous involved constructs, we 
intend to model knowledge about factors at the community, site, provider, family, and 
patient levels to improve oral health using a participatory group modeling approach.
This feasibility and acceptability study will make a vital contribution by conducting 
formative research intended to provide preliminary information about the feasibility and 
acceptability of the intervention and the data collection methodology. This information 
may be used to inform the design and implementation of a larger, randomized, 
controlled trial of the intervention to improve the oral and general health of low-income 
Chinese American adults and to identify the mechanisms by which these strategies may 
be scaled up and adapted for other Asian ethnic groups.  
2.3
Potential Risks and Benefits
2.3.1
Potential Risks
Despite the enhanced computer security (see Section16), patient data may be at a 
higher risk for computer hacking, leading to a loss of medical record confidentiality.
2.3.2
Potential Benefits
Outreach center clients/patients may benefit from the intervention, including the 
translated and culturally customized literature, by being influenced to pursue dental care 
and conduct twice-daily dental hygiene using evidence-based products and procedures.  

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3
OBJECTIVES
The ultimate goal of this study is to provide information for the design and 
implementation of a larger, randomized, controlled trial of a participatory, multi-level, 
partnered intervention to improve the oral and general health of low-income Chinese 
American adults. Toward this end, this study has 3 objectives.
3.1
Study Objectives
Primary:

To evaluate and enhance the feasibility and acceptability of a partnered 
intervention designed to improve oral health for low-income, urban Chinese 
American adults at 3 community sites
Secondary:

To evaluate and enhance the feasibility and acceptability of using remote entry 
features of electronic health record (EHR) software at NYU Dentistry to enter 
patient information at 3 Chinese American community sites. Note that the remote 
EHR referenced throughout this protocol will be set up and managed by NYU 
Dentistry information technology staff, under the direction of Drs. Wolff and 
Perelman.

To model knowledge held a priori by non-patient participants about factors that 
influence access to oral health care and care-seeking behaviors among low-
income, urban Chinese American adults, in order to enhance the intervention 
during and/or after the study for use in future implementations
3.2
Study Outcome Measures
3.2.1
Primary
Patient satisfaction with the partnered intervention components, based on exit 
interviews.
3.2.2
Secondary
Table 1 reflects the series of secondary outcome measures associated with the 
objectives of the study (i.e., the feasibility and acceptability of the partnered 
intervention).
Table 1. List of secondary outcome measures, with their corresponding constructs, 
levels of analysis, and data sources.

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Constructs
Levels of Analysis
Measures (Quantitative / Qualitative)
Data Sources
IMPLEMENTATION OUTCOME MEASURES
Acceptability 
Provider
satisfaction with the partnering components
and perceived ease of use of the remote 
entry EHR
exit interviews with 
patients; semi-structured 
interviews
Adoption
Provider
Institution
uptake and utilization of remote entry EHR 
and partnering components by providers 
and program
observation; semi-
structured interviews; 
EHR
Costs
Institution
intervention and implementation costs, 
including investment, supply, and 
opportunity costs 
semi-structured 
interviews; EHR
Feasibility
Provider
Site
extent to which the remote EHR entry and 
partnered intervention model are 
compatible with resources and training
semi-structured 
interviews; EHR
Fidelity
Provider
adherence to program protocol and quality 
of delivery
CHW logs; self-report
Sustainability
Institution
Site
sustained remote EHR use at outreach 
events and partnering package of 
interventions
semi-structured 
interviews; EHR
SERVICE OUTCOME MEASURES
Equity
Community
Provider
Family
Patient
support from community partners, providers 
(including NYU Dentistry), family members 
& patients to direct resources to less well-
served and less well-studied populations 
(Chinese American adults)
baseline survey; follow-
up patient interviews; 
semi-structured 
interviews; EHR
ORGANIZATIONAL CHARACTERISTICS
Engagement
Institution
Site
commitment, involvement & accountability 
of leaders with the implementation
semi-structured 
interviews

Work flow analysis of the interviews of research staff, NYU administrators, and 
providers (dentists and CHWs) is a secondary measure designed to evaluate and 
refine the use of the remote EHR.

Knowledge of the research staff, NYU administrators, providers (dentists and 
CHWs), outreach site directors, and CAB members about factors that influence 
access to oral health care and care-seeking behaviors among low-income, urban 
Chinese American adults are secondary measures designed to be used in 
simulations to represent dynamics at multiple levels (patient, family, provider, 
site, and community). 

The simulation modeling platform is a research product of the study that will be 
used to experiment with strategies to promote preventive care through regular 
dental visits and self-efficacy among Chinese Americans.

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4
STUDY DESIGN
This feasibility and acceptability study will be conducted at 3 community outreach 
centers serving an urban, low-income Chinese American 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 entry into an electronic health record (EHR). The evaluation will include 
group adaptation sessions and workflow analyses of the EHR implementation, involving 
multiple recorded sessions with NYU administrators, providers (dentists and CHWs), 
outreach site directors, and research staff. The study will also model a priori knowledge 
held by non-patient participants to evaluate and enhance the intervention during and/or 
after the study for use in future implementations.  
Approximately 50 patient participants who self-identify as Chinese American from each 
of 3 center (n = 150) will be consented to allow the entry of their data (e.g., demographic 
information, medical history, receipt of oral health care visits, dental hygiene behaviors, 
and health and health care measures) into the remote EHR by authorized NYU 
Dentistry staff (EHR patient participants). Of these 150 EHR patient participants, 
research staff will survey approximately 30 Chinese American patient participants from 
each of 3 outreach centers (n = 90) regarding their satisfaction with the intervention 
components (interview patient participants). The study team will also evaluate feedback 
from approximately 32 non-patient participants selected from the following groups: 
research staff, CAB members, outreach site directors, NYU administrators, and 
providers (dentists and CHWs); these individuals will be interviewed about various 
aspects of the partnered intervention and/or the remote EHR implementation process 
and/or their a priori knowledge of factors that influence access to oral health care and 
care-seeking behaviors among low-income, urban Chinese American adults.  

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5
STUDY ENROLLMENT AND WITHDRAWAL
5.1
Subject 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 interview. This is a subset of the 150 
EHR patient participants. We anticipate that about 60% of EHR patient participants will 
be able to complete an exit interview and a follow-up interview. 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

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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
5.2
Subject 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 the EHR patient and interview 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. 
5.3
Strategies for Recruitment and Retention
Five Chinese American community-based organizations have already volunteered to 
participate in this study. The 3 outreach centers for this study will be selected from 
among the affiliated outreach centers of these organizations.
Adults served by the outreach centers will be recruited by NYU research staff working 
with 3 Chinese American community sites in New York, NY.
EHR patient participants (of whom certain individuals are also interview patient 
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cover her/his comprehensive oral examination, treatment plan, and prophylaxis at no 
charge and with no co-payment required as compensation for participation. 
Non-patient participants--research staff, NYU administrators, providers (dentists and 
CHWs), outreach site directors, and CAB members--will receive no monetary 
compensation for their participation in the study, over and above their salaries/stipends.
5.4
Subject Withdrawal
5.4.1
Reasons for Withdrawal
Any of the various participants (i.e., CAB members, outreach site directors, EHR patient 
subjects, interview patient subjects, research staff, NYU administrators, dentists, and 
CHWs) may withdraw from the study at any time. Patients will have the right to refuse to 
participate without any compromise of their health or dental services. Also, if a 
participant is uncomfortable during an interview or survey administration, s/he may stop 
at any time without penalty. 
5.4.2
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention
If an EHR patient participant withdraws consent, no further data from that patient will be 
entered into the EHR for that participant. Depending on the nature of the request to 
withdraw, it may be necessary to remove existing data for that patient from the EHR.
5.5
Premature Termination or Suspension of Study
This study has no explicit stopping rules. The study may be suspended or prematurely 
terminated if there is sufficient reasonable cause. Written notification, documenting the 
reason for study suspension or termination, will be provided by the suspending or 
terminating party to the MPIs and/or the NIDCR, as applicable. If the study is 
prematurely terminated or suspended, the MPIs will promptly inform the Institutional 
Review Boards (IRBs) and provide the reason(s) for the termination or suspension. 
Circumstances that may warrant termination include, but are not limited to:

Determination of an unexpected, significant, or unacceptable risk to participants.

Insufficient adherence to protocol requirements.

Data that are not sufficiently complete and/or evaluable. 

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6
STUDY INTERVENTION
6.1
Administration of Intervention
Initially a CAB will be established to guide all aspects of the study. 
Partnered intervention: Our partnering package of interventions builds upon the 
evidence-based practices of the NYU Dentistry Local Community Outreach Programs 
and the results of our pilot study in the Sikh American community, and aligns with the 
implementation strategies from the Expert Recommendations for Implementing Change 
(EPIC) project. We will work closely with the directors of 3 Chinese American outreach 
sites to create written agreements of collaboration that outline the roles and 
responsibilities of the investigative team and the sites. An integral part of effectively 
implementing oral health activities with low-income, racial and ethnic minority, and 
immigrant populations, including Chinese Americans, is to develop program materials 
that are specific to the local community. Training lay individuals of the same cultural and 
linguistic background as participants, e.g., CHWs through train-the-trainer techniques, 
has been found to be an acceptable approach for delivering culturally-appropriate, 
community-based oral health interventions as well as for recruiting participants into 
interventions through community and social networks. CHWs have been found to be 
effective in providing dental education and counseling, leading interactive 
demonstrations of brushing with fluoride toothpaste and flossing, and improving access 
to dental care through dental coverage enrollment and linkage to local dentists.
Development of culturally-tailored and language-specific materials: The CAB will be 
responsible for reviewing existing program materials as an integral part of adapting 
them for the local Chinese American population. This will entail a multi-step process. 
Existing English and simplified Mandarin Chinese language materials will be presented 
to the CAB. Dr. Yi will then lead a guided discussion structured around the 4 P’s of 
social marketing. For product, CAB members will be asked if the materials encourage 
prevention of oral conditions through regular dental visits and brushing with fluoride 
toothpaste. For price, CAB members will be asked how much it will cost a person to 
take on the desired behaviors in terms of time and effort, not merely dollars and cents. 
For place, CAB members will be asked to help compile a list of local dental providers in 
addition to NYU Dentistry who provide culturally-tailored and language-specific oral 
health care to Chinese American families. For promotion, CAB members will be asked 
to identify other Chinese American community change agents to promote the program 
through word of mouth, social media, and neighborhood venues. CAB input will also be 
sought on incorporating appropriate imagery and cultural beliefs regarding oral health in 
the Chinese American community. This guidance will then be used to adapt both print 
and online materials. Finally, the adapted materials will be presented back to the CAB to 
ensure their input was accurately captured. 

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6.2
Procedures for Training Interventionists and Monitoring Intervention 
Fidelity
Both CHWs in this study were formerly trained as CHWs, have a history of engaging in 
health promotion with the Chinese American community, and are bilingual in English 
and Mandarin Chinese (the primary dialect of participating community outreach sites). 
Specifically, the project CHWs were previously trained in a core competency program 
that employed diverse training methods, guided by adult learning principles and popular 
education philosophy. We will further train the project CHWs in the oral health 
promotion demonstration protocol and on oral health services and programs available at 
local clinics and hospitals. The investigative team and CAB members will also collect, 
assess, and deliver to the CHWs updated information regarding health and dental 
insurance and access to oral health programs available for low-income and immigrant 
communities. NYU Dentistry investigators and staff will train the CHWs using models on 
evidence-based oral health practices, stressing the importance of drinking fluoridated 
water and brushing teeth for 2 minutes twice a day with a soft-bristled toothbrush and 
fluoride toothpaste. This train-the-trainer model will promote peer support and allow the 
project to be replicated and sustained across settings. Interactive educational 
techniques will be integrated into the demonstrations.  
At the end of the training, the CHWs will collaborate in groups to practice delivering 
short excerpts from the curriculum to their peers and project team members, with the 
trainers providing comments and assistance. Approximately 1 month before the CHW 
training is complete, the curriculum will be pilot tested to ensure its cultural 
appropriateness with patients. Two mock educational sessions and a final examination 
of knowledge and evaluation of trial encounters with mock participants will be conducted 
with project investigators and CAB members. Individuals who score below the threshold 
level of knowledge regarding oral health promotion will receive intensive 1-on-1 tutoring 
and be required to take a second examination of knowledge. Quality assurance controls 
will be built into the intervention. Drs. Northridge and Yi will meet with the CHWs on an 
approximately bi-weekly basis to ensure that the model components are being 
consistently applied. Each CHW will keep a log of activities and communication around 
their follow-up of patients. These logs will be reviewed as necessary to evaluate the 
type and nature of communications between the CHWs and their assigned study 
participants.
6.3
Assessment of Subject Compliance with Study Intervention
Not applicable. There is no assessment of subject compliance. 

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7
STUDY SCHEDULE
The study will extend for approximately 1 year.  An approximate timeline for 
implementation of the various aspects of this study is as follows:
Table 2. Timeline of study activities
7.1
Pre-intervention Activities

Create written agreements of collaboration that outline the roles and 
responsibilities of the investigative team and the outreach sites

Develop culturally-tailored and language-specific program materials

Train CHWs in the intervention protocol

Conduct a workflow analysis of remote EHR data entry at Chinese 
American outreach centers
7.2
Outreach Center Activities

Health Insurance Portability and Accountability Act (HIPAA) certified 
research staff members or volunteers will explain the consent form, 
confidentiality agreement, and liability release to each potential patient 
participant and obtain her/his signature

Remote EHR Data Collection and Dental Screening:
Study activities
Months 1-6
Months 7-12
Recruitment of CAB and outreach sites
Review, update, and finalize CHW training materials / IRB
Train CHW, evaluate fidelity, retrain as necessary
Implement partnered intervention
**Exit and 1 month follow-up interviews of enrolled patients who 
participated in the partnered intervention
**Semi-structured interviews of non-patient participants 
regarding partnered intervention (including materials review 
prior to implementation)
Workflow analysis for remote EHR entry
 
 
Pilot testing and live-usability for remote EHR
**Semi-structured interviews of non-patient participants in EHR 
implementation.
**Semi-structured interviews of non-patient participants to 
inform model
 
 
**Group model-building workshop
Development of simulation modeling platform 
 
 
**Data collection activity.

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o
Authorized NYU Dentistry personnel will directly enter the 
demographic information of patient participants into the customized 
EHR using the study-specific SCREENING option
o
EHR patient participants will complete a short paper intake form 
that will be scanned directly into a designated SCREENING folder 
in the EHR regarding medical conditions that could affect, or be 
affected by, their oral health (Yes / No checklist) and a brief 
questionnaire on self-reported receipt of a dental visit in the past 
year and dental hygiene behaviors (Oral Health Survey). These 
questions will be based on the World Health Organization (WHO) 
Oral Health Questionnaire for Adults: (1) How often do you clean 
your teeth? (Never, Once a month, 2-3 times a month, Once a 
week, 2-6 times a week, Once a day, Twice or more a day); (2) Do 
you use any of the following to clean your teeth? (Toothbrush, 
Wooden toothpicks, Plastic toothpicks, Thread (dental floss), 
Charcoal, Chewstick / miswak, Other (Please specify); (3) For 
those who nominate Toothbrush: What type of toothbrush do you 
use? (Hard-bristled, Medium-bristled, Soft-bristled) (4) Do you use 
toothpaste to clean your teeth? (5) For those who nominate 
Toothpaste, Do you use a toothpaste that contains fluoride? 
Correct responses to all 5 questions will indicate that EHR patient 
participants are following the guidance of the American Dental 
Association (ADA) on brushing with fluoride toothpaste. These 
measures will be collected in person via self-report to ascertain 
baseline status at the beginning of each screening event and 
scanned directly into the NYU Dentistry remote EHR customized for 
community outreach events. 
o
An NYU Dentistry faculty dentist will conduct a head and neck / oral 
examination on each EHR patient participant and directly enter the 
results into the customized EHR

The dentist will review the examination results with the EHR patient 
participant using a customized walkout statement with screening results 
and follow-up notes and answer any questions regarding oral health 
concerns

CHW Initial Intervention: Trained CHWs will deliver a culturally-tailored 
and language-specific oral health promotion program focusing on 
demonstrations with role-playing of proper brushing with fluoride 
toothpaste and flossing techniques. They will also provide culturally 
customized literature to the patients.

Acceptability Data Collection: Research staff will conduct a brief exit 
interview with each interview patient participant regarding acceptability of 

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the intervention and self-efficacy around oral health behaviors, requesting 
permission to contact her/his regular dental provider regarding receipt of a 
follow-up dental visit and providing a voucher worth $205.00 for oral health 
care at NYU Dentistry to cover her/his comprehensive oral examination, 
treatment plan, and prophylaxis at no charge and with no co-payment 
required.  The questions for this survey will be based on our previous oral 
health promotion program in the Sikh American community to assess 
acceptability. Prior to finalizing the survey for distribution to the interview 
patient participants, CAB members and research staff will adapt the 
questions as deemed appropriate for the Chinese American community 
and to be consistent with the ADA guidance on brushing with fluoride 
toothpaste.

Feasibility Data Collection: We will also develop a checklist of 10 key 
components based on process (e.g., patient engagement) and the 
curriculum (e.g., topics covered) and ask if each one was covered. 
Endorsement of 8 of the 10 checklist items (80%) by the non-patient 
participants will be considered as the bar for success for feasibility. Finally, 
we will allow for open-ended collection of feedback on the feasibility of 
each of the partnered program components.
7.3
CHW Follow-up Contact with Interview Patient Participants (Feasibility 
Data Collection)

CHW follow-up of oral health care receipt and dental hygiene behaviors will occur 
at approximately 1 month (window of -7 days to +1 month) after the partnered 
intervention. This contact may be via telephone or in person. 

Feasibility Data Collection: During this contact, the CHWs will assess whether or 
not each interview patient participant has received or has scheduled a dental 
visit. The CHWs will also inquire about use of fluoride toothpaste and frequency 
of teeth brushing since the last visit in a modified Oral Health Survey.

If no visit has occurred or been scheduled, the CHW will offer to help schedule a 
dental visit for the interview patient participant or her/his family members at NYU 
Dentistry, her/his regular dentist, or one of the project-approved local oral health 
care providers. 
7.4
Post-intervention Activities

Feasibility and Acceptability Data Collection: Semi-structured interviews with 
participating dentists, CHWs, and other non-patient participants will be conducted 
(see section 8.1.3)

Feasibility Data Collection: EHR data will be reviewed to assess feasibility

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7.5
Knowledge Modeling Activities

Create the interview guide for non-patient participant input into the modeling (pre-
intervention)

Conduct initial non-patient participant interviews to inform model development

Conduct the group model-building workshop

Conduct follow-up non-patient participant interviews to clarify assumptions

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8
STUDY PROCEDURES /EVALUATIONS
8.1
Study Procedures/Evaluations
8.1.1
Workflow analysis
The team will conduct a workflow analysis, adapted from the Agency for Healthcare 
Research and Quality (AHRQ) recommendations on workflow assessments, which 
includes:
1. Direct entry of patient demographic and appointment (site) information into 
the EHR by patient service representatives (PSRs) or other authorized users;
2. Ability to scan patient medical history (plus baseline oral health measures of 
self-reported receipt of a dental visit in the past year and brushing with 
fluoride toothpaste as recommended) directly into a designated SCREENING 
folder, followed by transcription and review by faculty dentists;
3. MiFi (Wi-Fi hotspot) configuration to each specific laptop (electronic tablet) 
that will only allow EHR access to the matching laptop (tablet);
4. Multiple layers of security embedded to comply with all applicable policies;
5. Dual authentication process through Citrix via NYU active directory followed 
by login to the EHR via NYU ID card;
6. Direct entry of screening results into the EHR by dentists; and
7. Customized walkout statements for interview patient participants with 
screening results and follow-up notes.
A matrix will be created with 3 categories: people, documents, and information content. 
The group adaptation session will be guided by a user-centered design facilitation 
protocol that sequentially leads the group through presentation of specific remote EHR 
use cases that include variations on the original EHR data entry screens adapted to the 
workflow characteristics of local community sites. For each presented use case, the 
group discussion will focus on the workflow at the site around the role responsibilities 
(people), documents, and information content (patient medical history, self-reported 
outcome measures, head and neck / oral examination results) with regard to reviewing 
customized EHR protocols based on the findings. The discussion will be digitally 
recorded and each non-patient participant will be given color-coded response sheets to 
record their perspectives on how to enhance the usefulness of the customized EHR 
protocols within the community outreach site setting. The digital recordings and 
response sheets will then be processed, summarized, and converted into adaptation 
recommendations by the study team. Next, the study team will transform the 
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workflow diagrams that build on established workflows to minimize changes at the sites 
or new work for the dental providers. The insights will then be used to adapt the 
customized EHR protocols and related workflows and will be validated in a follow-up 
group meeting at each site where the adapted EHR screens will be presented and 
assessed according to the IOF implementation outcome measures of acceptability and 
adoption. During these follow-up meetings, we will identify any additional workflow 
variations that the EHR protocols may need to support. Candidate workflows will then 
be discussed with the project team and other non-patient participants to finalize the 
adapted workflow integration approach.
8.1.2
Pilot testing and live usability for remote EHR
Pilot testing and live-usability: In order to account for real world conditions, the 
intervention will be pilot tested at 3 Chinese American outreach sites. Early formative 
observations / short interviews will be conducted with dental teams at each of the pilot 
sites regarding interaction with the customized EHR. This pilot testing will examine 
impact on workflow, uncover any new usability problems, and identify any educational 
needs to be included before large-scale implementation. As providers at the pilot sites 
engage with the EHR, live-usability testing will be conducted, consisting of direct 
observations by the research team. Live usability is ideal for observing the impact of 
new tools on real setting workflows and for observing alternative workflows that can be 
missed during simulations.
8.1.3
Semi-structured interviews regarding the remote EHR and partnered 
intervention
Semi-structured interviews will be conducted with participating dentists, CHWs and 
other non-patient participants in administrative and technical roles after the intervention. 
We anticipate conducting approximately 20 interviews before obtaining data saturation. 
The interviews will be informed by the Consolidated Framework for Implementation 
Research (CFIR) and Implementation Outcomes Framework (IOF) constructs and will 
assess specific barriers to sustaining the partnered intervention and strategies for 
addressing those barriers to facilitate integration of the intervention into the routine 
workflow of the NYU Dentistry Local Community Outreach Programs.
In addition to survey questions, acceptability will also be assessed using open-ended 
questions, such as: 
•
Please tell us what you liked most about the program.
•
Please tell us what you did not like about the program.
•
Please tell us what changes can be made to improve the program.
•
Overall program satisfaction (scale of 1-10 answer range)
•
How did you feel about the topics covered?

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•
How did you feel about the length of time of the dental screening and oral health 
promotion demonstrations?
Feasibility will be assessed among the dentists, CHWs, NYU administrators, and site 
directors at the 3 partnering organizations. The following questions will be asked:
•
How did you feel about the intake procedures?
•
How did you feel about the oral health demonstrations by CHWs?
•
How did you feel about the length of time of each dental screening?
8.1.4
Participatory modeling of non-patient participant knowledge 
The third aim of this study is to model knowledge held by non-patient participants about 
factors that influence access to oral health care and care-seeking behaviors among low-
income, urban Chinese American adults. This information will be used in designing 
simulation models at multiple levels, from multiple perspectives. A systems science 
approach will be undertaken to integrate knowledge held by non-patient participants into 
simulation models to explore alternative paths toward improved health and health care 
for low-income, urban Chinese American adults via community-based outreach followed 
by clinical care. These simulation models will be designed using a multi-method 
approach, in which principles of system dynamics (SD) are used to incorporate 
feedback effects and delays through stocks that accumulate flows (rates of change over 
time). The SD approach will be integrated with an agent-based modeling (ABM) 
framework that is used to appropriately represent dynamics at the community, site, 
provider, family, and patient levels. The model platform developed for this study will 
contain multiple model structures that characterize different dynamics and reflect 
participant input.
Modeling to anticipate effects of interventions. The models in this platform will simulate 
implications of hypotheses elicited a priori (before implementation of the partnered 
intervention) from non-patient participants. The a priori model platform will enable 
comparison to models that are later developed with hindsight from implementation of 
the remote EHR and partnered interventions. This model platform will therefore test the 
relative effectiveness of the interventions as anticipated under these a priori 
assumptions. Toward this end, this effort will involve design of scoping models that 
establish a baseline for simulating access at the community level and care-seeking 
behaviors at the individual level. 
A participatory SD modeling process will be undertaken via a group model-building 
workshop held with non-patient participants as well as semi-structured interviews with 
individual non-patient participants to elicit targeted model input and feedback on 
assumptions. The UB Geography Systems Science Modeling Team will work closely 
with non-patient participants to devise indices for input parameters and indicators for 
outcomes of simulation experiments. In addition to informing the design of model 
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assess the results of the simulation models developed in this a priori model platform for 
authenticity and identification of insights for subsequent implementation research. The 
resulting model platform will establish a multi-level agent-based GIS framework for 
simulation modeling of access to oral health care and care-seeking behaviors by low-
income, urban Chinese American adults at the community, site, provider, family, and 
patient levels.

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9
ASSESSMENT OF SAFETY
9.1
Specification of Safety Parameters
Safety monitoring for this study will focus on unanticipated problems involving risks to 
subjects, including unanticipated problems that meet the definition of a serious adverse 
event. 
9.1.1
Unanticipated Problems
The Office for Human Research Protections (OHRP) considers unanticipated problems 
involving risks to subjects or others to include, in general, any incident, experience, or 
outcome that meets all of the following criteria:

unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied;

related or possibly related to participation in the research (“possibly related” 
means there is a reasonable possibility that the incident, experience, or outcome 
may have been caused by the procedures involved in the research); and

suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized.
9.1.2
Unanticipated Problem Reporting to IRB and NIDCR
Incidents or events that meet the OHRP criteria for unanticipated problems require the 
creation and completion of an unanticipated problem report form. OHRP recommends 
that investigators include the following information when reporting an adverse event, or 
any other incident, experience, or outcome as an unanticipated problem to the IRB:

appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number;

a detailed description of the adverse event, incident, experience, or outcome; 

an explanation of the basis for determining that the adverse event, incident, 
experience, or outcome represents an unanticipated problem; 

a description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the unanticipated problem.

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To satisfy the requirement for prompt reporting, unanticipated problems will be reported 
using the following timeline:  

Unanticipated problems 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. 

Any other unanticipated problem will be reported to the IRB and to NIDCR within 
2 weeks of the investigator becoming aware of the problem. 

All unanticipated problems should be reported to appropriate institutional officials 
(as required by an institution’s written reporting procedures), the supporting 
agency head (or designee), and OHRP within one month of the IRB’s receipt of 
the report of the problem from the investigator.
All unanticipated problems will be reported to NIDCR’s centralized reporting system via 
Rho Product Safety:

Product Safety Fax Line (US):  1-888-746-3293

Product Safety Fax Line (International):  919-287-3998

Product Safety Email:  rho_productsafety@rhoworld.com 
General questions about SAE reporting can be directed to the Rho Product Safety Help 
Line (available 8:00AM – 5:00PM Eastern Time):  

US:  1-888-746-7231

International: 919-595-6486
9.2
Halting Rules 
This study includes no halting rules.

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10 STUDY OVERSIGHT
Dr. Northridge as the Lead Principal Investigator is responsible for study oversight, in 
collaboration with the NIDCR Program Official. 

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11 CLINICAL SITE MONITORING
Not applicable.

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12 STATISTICAL AND EVALUATIVE CONSIDERATIONS
12.1
Study Hypotheses
Primary: Based on exit interviews, patient participants in the program will be satisfied 
with the partnered intervention components.  
12.2
Sample Size Considerations
No formal sample size estimates were performed for this F & A study. The bar for 
success for both feasibility and acceptability is 80% of enrolled patient participants 
report being satisfied or very satisfied with the partnered intervention components.
12.3
Planned Interim Analyses (if applicable)
Because this is a feasibility study, there will be interim reviews of interview data in order 
to modify aspects of the partnered intervention and the remote EHR processes during 
the course of the study.
12.3.1
Safety Review
Not applicable.
12.3.2
Efficacy Review
Not applicable.
12.4
Final Analysis Plan
Acceptability of the partnered intervention will be assessed through exit interviews of the 
interview patient participants. 
As we did with the Sikh American project, we will utilize a pre-post retrospective 
evaluation design. In this format, all questions will be asked in a single exit interview, 
but where applicable, will use the phrasing, “Prior to the beginning of the program…” 
followed by, “At the present time…” Table 3 lists the questions/domains we will use, and 
expected % changes we hypothesize we will observe in the current study. The percent 
change from pre-post will be compared using t-tests for proportions. Given that many of 
the answer choices are non-binary, we will also compare the shift of responses from 
pre-post across the categories of response using chi-squared tests. Note that this is not 
an exhaustive list of questions that will be asked; we are simply highlighting those 
questions that we will use to quantify acceptability. The full planned questionnaire is 
attached.
Health care utilization and oral health promotion measures: Our ultimate health care 
utilization measure of interest is receipt of a dental visit within the last 12 months. This 
will be measured using the Medical Expenditure Panel Survey (MEPS) definition, where 
dental visit refers to care by or visits to any type of dental provider. This will allow for 

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direct comparison with Healthy People 2020 Leading Health Indicator OH-7 to increase 
the proportion of children, adolescents, and adults who used the oral health care system 
in the past year. 
Our central oral health promotion measure is self-reported brushing of teeth for 2 
minutes twice a day with a soft-bristled toothbrush and fluoride toothpaste at the 
interview patient participant’s 1 month follow-up visit. For the primary health care 
utilization measure of receipt of a dental visit within the last 12 months, we will also 
access the NYU Dentistry EHR database and follow-up with oral health care providers 
identified by participants in HIPAA approved procedures to ascertain receipt of a dental 
visit in the last 12 months.
Table 3 provides the measures and definitions of the oral health promotion, self-
efficacy, and acceptability measures used in our prior research with the Sikh American 
community that will be adapted for the present F & A study with the Chinese American 
community.
Table 3. Measures and definitions of oral health promotion, self-efficacy, and acceptability measures
Question/Domain
Observed Change in Sikh 
American Project
Expected Absolute 
Percent Change
Expected Relative 
Percent Change*
How often do you brush your 
teeth for at least two minutes?
Increase from 17.9% to 64.7% of 
those reporting “More than 
once a day”
+45%
+261%
How often do you floss?
Increase from 4.4% to 22.1% of 
those reporting “More than 
once a day”
+20%
+400%
How confident…
a)
are you that you know 
how to take good care 
of your mouth, teeth, 
and gums?
b)
do you feel asking your 
dentist or oral hygienist 
questions?
a)
Increase from 0% to 
65.7% of those 
reporting “Very 
confident”
b)
Increase from 7.4% to 
75% of those reporting 
“Very confident”
a)
+65%
b)
+65%
a)
+6500%
b)
+864%
Agreement with the following 
statements:
a)
CHW answered my 
concerns and questions
b)
CHW helped me to 
improve how I take 
care of my health
c)
Information and topics 
were informative
d)
In-person 
demonstrations helpful 
in improving oral health
Reported "Strongly Agree”
a)
57.4%
b)
60.3%
c)
69.1%
d)
76.1%
N/A
N/A
*We additionally list relative percent change in the case that baseline behaviors among the Chinese 
American community are very different from the Sikh American community.

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The threshold for success for acceptability of the partnered intervention will be that 80% 
or more of interview patient participants rate all 4 acceptability questions as agree or 
strongly agree.

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13 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS
Study staff will maintain appropriate research records for this study, in compliance with 
ICH E6, Section 4.9 and regulatory and institutional requirements for the protection of 
confidentiality of subjects. Study staff will permit authorized representatives of NIDCR to 
examine (and when required by applicable law, to copy) research records for the 
purposes of quality assurance reviews, audits, and evaluation of the study safety, 
progress and data validity.  
Patient participant data will be remotely entered directly into the EHR.  

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14 QUALITY CONTROL AND QUALITY ASSURANCE
The MPIs will be responsible for ensuring that the study is conducted according to the 
protocol and ensuring data integrity. The MPIs will review the data for safety concerns 
and data trends at regular intervals, and will promptly report to the IRB and NIDCR any 
Unanticipated Problem (UP), protocol deviation, or any other significant event that 
arises during the conduct of the study.

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15 ETHICS/PROTECTION OF HUMAN SUBJECTS
15.1
Ethical Standard
The MPIs will ensure that this study is conducted in full conformity with the principles set 
forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of 
Human Subjects of Research, as drafted by the US National Commission for the 
Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979) 
and codified in 45 CFR Part 46 and/or the ICH E6. 
15.2
Institutional Review Board
The protocol, informed consent form(s), recruitment materials, and all patient participant 
and non-patient participant materials will be submitted to the IRB for review and 
approval. Approval of both the protocol and the consent form must be obtained before 
any patient participant or non-patient participant is enrolled. Any amendment to the 
protocol will require review and approval by the IRB before the changes are 
implemented in the study.  
15.3
Informed Consent Process
Informed consent is a process that is initiated prior to the individual agreeing to 
participate in the study and continues throughout study participation. Extensive 
discussion of risks and possible benefits of study participation will be provided to patient 
participants and their families, if applicable. A consent form describing in detail the study 
procedures and risks will be given to the patient participant in English or Mandarin 
Chinese (primary dialect of participating community sites). Consent forms will be IRB-
approved, and the patient participant is required to read and review the document or 
have the document read to him or her. The investigator or designee will explain the 
research study to the patient participant and answer any questions that may arise. The 
patient participant will sign the informed consent document prior to any study-related 
assessments or procedures. Patient participants will be given the opportunity to discuss 
the study with their surrogates or think about it prior to agreeing to participate. They may 
withdraw consent at any time throughout the course of the study. A copy of the signed 
informed consent document will be given to patient participant for their records. The 
rights and welfare of the patient participants will be protected by emphasizing to them 
that the quality of their clinical care will not be adversely affected if they decline to 
participate in this study.
The consent process will be documented in the clinical or research record.  
Consent for non-patient participant interviews for the knowledge modeling will take 
place where the interview happens, verbally over the telephone. Dr. Metcalf, the 
Principal Investigator of the modeling site, will send the consent information sheet by e-
mail when scheduling the interview, which will be at least 2 days in advance of the 
interview. To ensuring ongoing consent for follow-up interviews, Dr. Metcalf will remind 

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the non-patient participants about their previous consent and will resend the consent 
document if needed. Dr. Metcalf will obtain verbal consent for any subsequent recording 
of information collected during follow-up interviews. Dr. Metcalf will send the consent 
document ahead of time. Before recording, Dr. Metcalf will ask: Have you reviewed the 
information? Do you have any questions? If the non-patient participant answers “yes” to 
the first question and “no” to the second question, then she will ask: Is it OK if we start 
the interview now? and if taping the telephone call: Is it OK if I begin audio recording? 
After the participant answers “yes,” the interview will begin.
15.4
Exclusion of Women, Minorities, and Children (Special Populations)
The proposed study will enroll Chinese adults aged 21 years and older. No children will 
be included since there are separate and targeted NYU Dentistry programs for this age 
group. The study population is Chinese American adults living in any of the 5 boroughs 
of New York, NY. We estimate that approximately 60% of our enrolled patient 
participants will be women, based on our experience with conducting community-based 
screening events. All enrolled patient participants will be of self-reported Chinese 
ethnicity, to ensure that our partnerships and materials are culturally and linguistically 
relevant. Study sites will be concentrated in lower Manhattan (Chinatown and the Lower 
East Side) and the Sunset Park area of Brooklyn, which include dense ethnic enclaves 
of Chinese Americans.
15.5
Subject Confidentiality
Subject confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to any study information relating to subjects.
The study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor.
The study monitor or other authorized representatives of the sponsor may inspect all 
study documents and records required to be maintained by the investigator, including 
but not limited to, medical records (office, clinic, or hospital) for the study subjects.  The 
clinical study site will permit access to such records.
Certificate of Confidentiality
To further protect the privacy of study participants, the Secretary, Health and Human 
Services (HHS), has issued a Certificate of Confidentiality (CoC) to all researchers 
engaged in biomedical, behavioral, clinical or other human subjects research funded 
wholly or in part by the federal government. Recipients of NIH-funded human subjects 
research are required to protect identifiable research information from forced disclosure 

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per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set 
forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-
supported research covered by this Policy are required to establish and maintain 
effective internal controls (e.g., policies and procedures) that provide reasonable 
assurance that the award is managed in compliance with Federal statutes, regulations, 
and the terms and conditions of award. It is the NIH policy that investigators and others 
who have access to research records will not disclose identifying information except 
when the participant consents or in certain instances when federal, state, or local law or 
regulation requires disclosure. NIH expects investigators to inform research participants 
of the protections and the limits to protections provided by a Certificate issued by this 
Policy.  

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16 DATA HANDLING AND RECORD KEEPING
Dr. Northridge as the Lead Principal Investigator is responsible for ensuring the 
accuracy, completeness, legibility, and timeliness of the data reported. All source 
documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data. The investigators will maintain adequate case histories of study 
patient participants and non-patient participants, including accurate case report forms 
(CRFs), and source documentation.
The remote EHR entry of data will be protected by means of dual authentication 
process through Citrix via NYU active directory followed by login to the EHR via NYU ID 
card. 
No research data will be stored on computer hard drives or USB drives. The following 
approved HIPAA-compliant data storage methods will be utilized:
1. REDCap is a secure web application for building and managing online surveys and 
databases. It provides automated export procedures for seamless data downloads to 
Excel as well as common statistical packages such as SPSS, SAS, Stata, and R. 
REDCap is available for both NYU internal and external users. Web-based REDCap for 
data storage is free to all NYU investigators at REDCap.nyumc.org; and
2. NYU Medical Center Information Technology managed network drives will be set up 
specifically for this study to provide offsite backup storage.
16.1
Data Management Responsibilities
Data collection and accurate documentation are the responsibility of the study staff 
under the supervision of the MPIs. All source documents and laboratory reports must be 
reviewed by the study team and data entry staff, who will ensure that they are accurate 
and complete. Unanticipated problems and adverse events must be reviewed by the 
MPIs or their designees.  
16.2
Data Capture Methods
Patient participant data will be entered remotely into the EHR. Other data will be 
collected on paper forms and/or digitally recorded.
16.3
Types of Data
Patient participant data will be captured in the EHR. Data from interviews of patients, 
research staff, NYU administrators, and providers (dentists and CHWs) will also be 
captured. 

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16.4
Schedule and Content of Reports
16.5
Study Records Retention
Study records will be maintained for at least 3 years from the date that the grant federal 
financial report (FFR) is submitted to the NIH. 
Study documents should be retained for a minimum of 2 years after the last approval of 
a marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the sponsor, if 
applicable. It is the responsibility of the sponsor to inform the MPIs when these 
documents no longer need to be retained.
16.6
Protocol Deviations
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical 
Practice, or Manual of Procedures requirements. The noncompliance may be on the 
part of the subject, the investigator, or study staff. As a result of deviations, corrective 
actions are to be developed by the study staff and implemented promptly.
These practices are consistent with investigator and sponsor obligations in ICH E6:

Compliance with Protocol, Sections 4.5.1, 4.5.2, 4.5.3, and 4.5.4.

Quality Assurance and Quality Control, Section 5.1.1.

Noncompliance, Sections 5.20.1 and 5.20.2.
All deviations from the protocol must be addressed in study subject source documents 
and promptly reported to NIDCR and the local IRB, according to their requirements.  

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17 PUBLICATION/DATA SHARING POLICY
This study will comply with the NIH Public Access Policy, which ensures that the public 
has access to the published results of NIH funded research. It requires scientists to 
submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital 
archive PubMed Central upon acceptance for publication.
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a clinical trials registration policy as a condition for publication. The ICMJE 
defines a clinical trial as any research project that prospectively assigns human subjects 
to intervention or concurrent comparison or control groups to study the cause-and-effect 
relationship between a medical intervention and a health outcome. Medical 
interventions include drugs, surgical procedures, devices, behavioral treatments, 
process-of-care changes, and the like. Health outcomes include any biomedical or 
health-related measures obtained in patients or participants, including pharmacokinetic 
measures and adverse events. The ICMJE policy requires that all clinical trials be 
registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the 
National Library of Medicine. Other biomedical journals are considering adopting similar 
policies. For interventional clinical trials performed under NIDCR grants and cooperative 
agreements, it is the grantee’s responsibility to register the trial in an acceptable 
registry, so the research results may be considered for publication in ICMJE member 
journals. The ICMJE does not review specific studies to determine whether registration 
is necessary; instead, the committee recommends that researchers who have questions 
about the need to register err on the side of registration or consult the editorial office of 
the journal in which they wish to publish.
U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or 
FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or 
designated principal investigator) register and report results of certain "applicable 
clinical trials:" 
Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I 
investigations, of a product subject to FDA regulation; and
Trials of Devices: Controlled trials with health outcomes of a product subject to FDA 
regulation (other than small feasibility studies) and pediatric postmarket surveillance 
studies.
NIH grantees must take specific steps to ensure compliance with NIH implementation of 
FDAAA.

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18 LITERATURE REFERENCES
SUPPLEMENTAL MATERIALS
These documents are relevant to the protocol, but they are not considered part of the 
protocol. They are stored and modified separately. As such, modifications to these 
documents do not require protocol amendments.