Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes
Phase: NA
Conditions: Pre Diabetes, Weight Loss
Sponsor: NYU Langone Health

Official Title: 
Integrated Community-Clinical Linkage Model to Promote Weight Loss 
among South Asians with Pre-Diabetes
NCT Number:
NCT03188094
Study Number:
17-00693 
Document Type:
Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
October 12, 2021 

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Study Title: Integrated Community-Clinical Linkage Model to Promote Weight Loss among South Asians 
with Pre-Diabetes 
Principal Investigator (NYU Site): Nadia Islam, PhD  
 
 
I.  PURPOSE OF THE STUDY AND BACKGROUND 
 
A. 
Purpose of the Study 
The proposed study “Integrated Community-Clinical Linkage Model to Promote Weight Loss among 
South Asians with Pre-Diabetes” aims to test the effectiveness and assess the implementation process of 
an integrated intervention to support weight loss for South Asian patients at-risk for type-2 diabetes 
mellitus (T2DM) in primary care settings. The primary outcome is >5% weight loss among South Asian 
patients at-risk for T2DM. The integrated intervention involves: 
1. An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing 
embedded alerts to increase screening and identification of South Asian patients at-risk for T2DM 
with BMI >23 kg/m2 and registries to track outcomes: and 
2. Registry-driven community health worker (CHW)-led health coaching for patients.  Using a 
stepped-wedge design, we will implement the study in 20 NYC PCPs enrolling 1040 South Asian 
patients at- risk for T2DM.  
In addition, using a mixed-methods approach and the RE-AIM evaluation framework23, we aim to 
systematically assess the implementation process and delineate factors that influence adoption, 
sustainability, and scalability of the integrated EHR-CHW intervention within applied practice settings. 
This will be achieved through the completion of: 
3. Provider Surveys (n=80) to capture data on satisfaction with workflow before and after 
intervention, information sources for EHR-CHW initiatives before and after intervention, 
acceptability of and satisfaction with the integrated EHR-CHW intervention, and barriers and 
facilitators of point-of-care use of the tools. 
4. Key Informant Interviews (n=100) with physician champions at each site and/or administrator of 
each site, Healthfirst representatives, community advisory board members, research staff, and 
CHWs.  At baseline, the interviews will be incorporated into the workflow analysis to assess 
current satisfaction and usage of EHR and health coaching. At follow-up, the interviews will 
assess barriers and facilitators to the implementation and adoption process of the integrated EHR-
CHW intervention, fidelity to the interventions, and to solicit recommendations for the replication 
and scalability of the intervention to other sites and insurer organizations.   
Impact: The proposed study will inform efforts to prevent diabetes and promote weight loss in a high-
risk population and generate a reproducible, scalable, and sustainable model for use with other insurer 
groups and clinical settings that work in immigrant populations with a high burden of chronic disease. 
The contributions of this study to generalizable knowledge are further described in the “Background”. 
B. 
Background 
B1.   South Asians in the U.S. and NYC are a rapidly growing population.  Asian Americans 
currently comprise 5% of the U.S. population and make up approximately 40% of the immigrants 
entering the country.24 By 2050, the number of Asian Americans nationally is projected to grow to over 
43 million.25 In this proposal, we focus on the South Asian community, who are among the largest and 
fastest growing Asian subgroups in the U.S. and NYC. South Asian Americans are comprised of 
individuals from India, Bangladesh, Pakistan, Sri Lanka, Nepal, and Bhutan.26-28  The NYC South Asian 
community grew by 49% during the years 2000 to 2010, from 216,179 to 323,675.(Asian American 
Federation, 2013a, 2013b, 2013c) Though there is substantial diversity in the socio-economic profile of 
South Asians across various subgroups, a significant portion of South Asians live in poverty (ranging 
from 17% of Asian Indians to 32% of Bangladeshis), have limited English proficiency (ranging from 25% 
of Asian Indians to 53% of Bangladeshis), and have access to fewer culturally appropriate community 
resources.24 For the purposes of our study, South Asians will be defined as individuals who self-identify 

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as South Asian, including those from India, Bangladesh, Pakistan, Sri Lanka, Nepal, and Bhutan, Guyana, 
Trinidad. 
B2.  Diabetes & Pre-Diabetes is significantly higher among South Asians  compared with Non-
Hispanic Whites. Among Asian Indians in the U.S., cardiovascular disease (CVD) is the leading cause 
of death, and mortality due to T2DM has been increasing over time.29 Rates of T2DM and pre-diabetes in 
the U.S. South Asian community are high, with national data revealing the highest prevalence of 
diagnosed diabetes among Asian Indians compared to other Asian groups16 and compared to Non-
Hispanic whites.5,6 In NYC, both population-based self-report and clinically measured rates of T2DM are 
high among South Asians.  Rajpathak and colleagues report that foreign-born South Asians have a 
significantly higher prevalence of T2DM (35.4% vs 10.8%) compared to Whites, and had five times the 
odds of having T2DM compared to whites after adjustment for demographics and other potential 
confounders (AOR: 4.88, 95% CI (1.52, 15.66)).30 Similarly Gupta et al found that prevalence of self-
reported diabetes diagnosis among South Asians of normal weight (using adjusted-BMI guidelines for 
Asians) in NYC were more than triple the rates of diabetes among Whites of normal weight (10.2% vs 
2.9%, respectively).31 Estimates of clinically measured pre-diabetes in population-based studies and large 
community-based cohorts of South Asians in the U.S. have ranged between 16% to high as 33%.30,32
Thus, scalable and translatable interventions that promote the early identification and prevention of 
diabetes in this population have significant potential for public health impact. 
B3. South Asians develop diabetes at a lower BMI compared to other group. South Asians report 
some of the highest BMI levels compared to other Asian groups and other minority/ethnic groups,33-39
ranging from 27% to 89% higher than the national average.34 A recent analysis of National Health & 
Nutrition Examination Survey (NHANES) data revealed that the average BMI for all Asian Americans 
kg/m2, and yet they had the highest proportion of undiagnosed T2DM among all ethnic 
and racial subgroups surveyed.13  Due to these differences, in 2014 the American Diabetes Association 
(ADA) re
2 for testing for T2DM in Asian American 
adults, including South Asians.14,40  Lowering BMI cutoff points as advised by the ADA could result in 
earlier identification of pre-diabetes and T2DM in Asian Americans, leading to improved primary and 
secondary prevention in these communities.21 However, ADA recommendations have not been formally 
adopted in clinical settings for T2DM screening purposes despite compelling evidence for Asian 
American populations.12,14,41 
B4. Diabetes Prevention Program (DPP) is effective in in reducing incident diabetes in South Asians 
by achieving modest weight loss through behavior change. Results from the U.S. Diabetes Prevention 
Program (DPP) indicated that modest weight loss through dietary changes and increased physical activity 
significantly reduced the incidence of T2DM in study participants.42 The Indian Diabetes Prevention 
Programme, modeled after the U.S. DPP, found that study participants who had modest weight loss 
(<5%) were more likely to achieve normal fasting glucose at 6 and 24-month follow-up, which was 
associated with a 75% lower risk of developing incident T2DM after 2 years.  Similarly, weight loss 
interventions conducted among South Asian immigrants in the United Kingdom and US have reported 
lower rates of developing incident T2DM and lower rates of insulin resistance.43,44 Though there have 
been few adaptations of DPP for the South Asian community, existing studies have demonstrated DPP’s 
efficacy in increasing weight loss, diabetes knowledge, and positive behavioral changes such as healthful 
eating and/or engaging in physical activity.22,44,45 Our own work has tested the efficacy, feasibility, and 
acceptability of a cultural adaption of DPP for Bangladeshis and Asian Indians, demonstrating significant 
weight loss and behavior change among study participants.46
B5.  DPP adaptations have utilized Community Health Workers (CHWs) for program delivery.  
Numerous studies have adapted and translated the DPP to different settings and contexts, with specific 
efforts to tailor program delivery for varied racial and ethnic groups.20,47,48 Many of these programs have 
adapted the original DPP structure and length, and have utilized CHWs or peer educators. These studies 
are typically less expensive and/or more feasible to administer in community-based settings49-52 and some 
studies have demonstrated health improvement similar to the original DPP.53 Our cultural adaptation of 

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DPP for South Asians also utilized and demonstrated high acceptability of the CHW model, lending 
support to the concept of adapting DPP to be delivered by CHWs for this population. 
B6.  Incorporating CHWs into clinical teams can improve patient health outcomes.  The importance 
of CHWs in improving health outcomes for underserved communities has long been recognized by 
federal agencies and organizations,54-56 and by the Patient Protection and Affordable Care Act,57 in which 
CHWs have been identified as important members of the health care workforce.57  By acting as bridges 
between the community and health care system, CHWs have the potential to address health disparities and 
disseminate efficacious interventions to underserved communities.  With the advent of the patient-
centered medical home model, primary care practices increasingly aim to work in an integrated manner to 
coordinate care for a patient.58 There is a significant evidence base demonstrating the addition of CHWs 
to the primary care team can improve care for patients with chronic disease at low cost.59-61  There have 
been recent efforts to reimburse clinical settings for referral of pre-diabetic patients to YMCA-led DPP 
programs62,63; thus, the delivery of diabetes prevention by CHWs in clinical settings, coupled with 
reimbursement opportunities for this workforce, offers a unique opportunity for sustainable, scalable 
models for prevention. 
B7.  Electronic health records (EHRs) can improve primary and secondary prevention of diabetes.   
The US Preventive Services Taskforce (USPSTF) recommends screening adults in primary care settings 
with known risk factors T2DM, including high-risk racial and ethnic minority populations.64
Data 
available through EHRs can be used to identify candidates for needed follow-up65, targeted risk-reducing 
interventions66-68 and can be designed to allow primary care physicians (PCPs) to easily refer patients to 
counseling and other services.69,70
The use of clinical decision support systems (CDSS) or alerts can 
increase provider adherence to screening and monitoring guidelines for diabetes management and 
prevention, such as foot and retinal exams, as well as cholesterol & hemoglobin A1c testing.71-73 EHRs 
can also assist providers in counseling patients through EHR-based goal-setting modules, intention 
exercises, and tailored reminders to encourage behavior change during clinical encounters with 
appropriate patients.74 There have also been recent efforts to utilize EHRs to identify and refer patients to 
community-based diabetes prevention programs, though none in small primary care settings that target 
high-risk immigrant communities.75-77 The proposed project will build on this evidence-base by 
implementing EHR interventions to identify patients at-risk for T2DM using ADA adjusted BMI 
guidelines, and link them to CHW-led coaching to achieve weight loss.     
B8.  The effect of integrating EHR and CHW interventions has not been well-tested.  Despite the 
tremendous potential that both CHW and EHR-based interventions can have on improving health 
outcomes in minority communities, there have been few studies that have examined the impact of 
integrating the two interventions, and how best to engage both physician and non-physician members of 
the healthcare team, including CHWs,66 in effectively integrating EHR-based interventions into care 
planning.  Studies are now beginning to demonstrate that EHR access and communication between the 
PCP and the CHW can facilitate the acceptance and effectiveness of emerging care management models 
and lead to improved patient outcomes, and no studies have been conducted in small primary care 
settings.78-80 However, scalable and sustainable models that assess the cost, adoption, and maintenance 
process of integrating EHR and CHW intervention in clinical practice settings are needed. 
Contributions 
The goal of this study is to test the effectiveness and assess the implementation process of an 
multi-level, integrated intervention to promote weight loss among South Asians at risk of T2DM, 
including two components: an EHR-based alert and registry function to increase identification of South 
Asian patients who are at-risk of diabetes, and CHW-led health coaching of registered patients with pre-
diabetes to increase weight loss.  This study is innovative in four main areas.  First, the proposed 
intervention will foster the uptake and adoption of an evidence-based ADA recommendation for diabetes 
screening at lower BMI14 into clinical practice using HIT strategies (an alert and registry function) to 
enhance identification of pre-diabetes among South Asians,  offering a scalable and replicable model to 
decrease disparities in a community with a high diabetes burden.  Because the revised guidelines have not 
been systematically integrated into clinical practice, the implementation and testing of the proposed HIT 

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strategies represents an innovation of our project.  Second, this is the first study to examine integration of 
a multi-level approach that combines EHR based tools to identify high risk patients, culturally adapted 
CHW-led coaching, and CHW-physician feedback to increase diabetes prevention in a high risk 
community.  Though a limited number of studies have integrated EHR-CHW approaches and conducted 
referral to DPP programs, our study would represent the first to implement such a multi-level approach in 
small primary care practice settings in a high risk immigrant community. Our study uniquely assesses 
both effectiveness outcomes and implementation processes, thus informing the replication of integrated 
models in other primary care settings.  Third, our culturally adapted DPP model has demonstrated 
efficacy, feasibility, and acceptability among South Asians at-risk for T2DM in community settings, and 
the proposed study offers a replicable model for clinical settings. Fourth, the project  informs both the 
effectiveness and calculates costs of these interventions in team-based care approaches, thereby helping to 
develop potentially reimbursable and relevant sustainability strategies.  Finally, given our partnership 
with a large payer organization and local health department, best practices for implementation of 
integrated EHR-CHW models at clinical sites will be generated that may be scalable to other insurer 
organizations and healthcare systems working with large immigrant populations facing a significant 
burden of chronic disease.   
 
C. Study Design 
C1. Overall Design/Site Selection/Site Enrollment 
We will use a randomized controlled trial design with staggered-entry and a waitlist controlled group   to 
compare the effectiveness of an alert and registry-driven CHW-led coaching compared with usual care 
among patients with BMI at baseline of >23 kg/m2. Randomization will be at the individual-level and 
stratified by PCP, meaning eligible intervention and control participants will be randomized for each 
PCP.  PCPS will be clustered into waves, aligning with the original stepped-wedge design. Entry into the 
study will be staggered in three waves, with each wave consisting of six to seven PCPs (See Figure 1). All 
20 PCPs will be recruited and enrolled by month 6 of Year 2 (study period 6, Figure 1), and we will 
assign 6-7 practices into each of the 3 waves upon enrollment. For each PCP, there will be a total of two 
rounds of consecutive six-month CHW intervention periods: 1 month for recruitment and enrollment of 
intervention participants and five months of community health worker-led group education sessions 
(approximately one session per month). Data related to the study outcomes will be extracted from EHR 
systems a total three times (baseline, 6 month, and 12 month) for each PCP. Randomization at each PCP 
will occur during the first round. Prior to allocation into treatment group, each treatment participant will 
be matched to a control participant based on age, gender, and BMI. Intervention participants will be split 
into two groups and assigned to either first or second round. All control participants will be waitlisted 
during the first round and will be offered the full CHW group education sessions during the second round. 
PCPs will be placed into waves based on geographic location and CHW caseload considerations.   
PCPs will be eligible for participation if they have a) an overall patient volume of N>1000 ; b) at least 
70% of the patient population is South Asian;  and c) the practice has used EHR for at least 12 months.  
All PCPs will sign a Memorandum of Understanding (MOU) between the PCP and NYU outlining study 
commitments.   
 
 

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Figure 1. Recruitment, Enrollment, and CHW Intervention Timeline  
 

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C2. EHR-CHW Intervention  
The implementation and content of EHR and CHW components of the intervention at each PCP align 
with the Chronic Care Model.   
EHR Components:  The EHR component of the integrated EHR-CHW intervention will include: 1) An 
alert to identify South Asian patients with elevated BMI (>23 kg/m2) and recommendation to PCPs to 
order an HbA1c test as part of standard of care; and 2) Generation of registry lists of individuals with 
A1C 5.7-6.4% (individuals with incident pre-diabetes).  Building upon existing protocols the study team 
will coordinate the implementation of the proposed EHR modifications at each PCP.  The implementation 
process will be characterized by: 1) Workflow analysis; 2) Procedures for identifying system 
requirements; and 3) Adequate training and support for users upon and following go-live.  
Workflow analysis. Using a rapid assessment process,93-98 baseline workflow analysis will be 
conducted at each PCP. The workflow analysis consists of an iterative process including ethnographic 
observation and key informant interviews (see below) to provide contextual data on organizational 
workflow, culture, and practice.  Results from the analysis will be used to improve alert and registry 
functions and to align with the workflow of each PCP. 
Implementation of System Requirements for the Intervention. System requirement definition and 
implementation ensures that various EHR systems across PCPs are configured to provide the functionality 
called for by the study design.   The research team will work with a PCIP specialist to develop a 
framework for creating the proposed EHR enhancements. This process includes specifying and 
confirming the system’s functional requirements based on the users’ needs as well as the study design. 
The EHR modifications will be made at each PCP, and providers and staff will be trained.  Functional and 
technical specifications (and any updates) will be maintained and documented for training, workflow 
development, troubleshooting and dissemination purposes.   
Training.  The training will be designed to enable clinicians to use the decision-supports and/or alerts 
independently, proficiently, and effectively. At the start of the intervention period, clinicians will receive 
an estimated 8 hours of didactic and interactive training. Individualized training will also be available 
during the initial implementation period for all users. Clinic staff will also be provided with user 
documentation.  
CHW Component: 
CHW Protocol. Patients that meet eligibility criteria will be drawn from registry lists and randomized to 
intervention or waitlisted control. Patients assigned to the intervention group will be sent an invitation 
letter to participate in the CHW intervention (See Recruitment Letter for CHW Intervention). Invitation 
letters will be followed up with phone calls by CHWs (See Script for Telephone Screening for CHW 
Intervention). In addition, a screening form (See Telephone Screening Form for CHW Intervention) will 
be completed to verify eligibility. CHWs will call patients a maximum of 10 times over a two-week 
period at varying times of day to invite them to enroll into the study. Patients assigned to the waitlisted 
control group will be recruited and contacted in the same manner as intervention participants except after 
completion of intervention rounds. 
 
Consenting and data collection with Intervention participants  
Consent forms will be completed with intervention participants in an in-person meeting. Baseline surveys 
will also be conducted by NYU study staff  with intervention participants within two weeks after consent. 
(See CHW Participant Baseline Survey). A CHW Participant Followup Survey will be completed with 
intervention participants approximately six months after the start of intervention in order to evaluate the 
effectiveness of the CHW intervention.  
Participants enrolled during the COVID-19 pandemic will be asked questions on vaccine hesitancy and 
COVID19 vaccination; as well as questions on mental health and mobile/technology use in order to 
understand how participants’ chronic conditions and mental health was affected in during the pandemic 
and to understand how best to tailor remote intervention strategies to encourage vaccination among 
patients with overweight and pre-diabetes who are at higher risk for complications from COVID-19. 

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The CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education 
sessions, providing the tools and strategies to prevent diabetes. All sessions employ adult learning 
techniques and group-based learning and activities. All session materials have been culturally and 
linguistically adapted into Bengali, Urdu, Hindi, Punjabi, and Nepali. Sessions will be held in remotely 
via audio phone calls via telephone, MCIT NYU approved Webex and Zoom platform or in community 
spaces identified by partner agencies, and multiple sessions will be held weekly to accommodate patient’s 
varying schedules.  Links to the health education sessions will be created via NYU approved Webex and 
Zoom platforms that are provided for use across the institution. These NYU Webex and Zoom links will 
be shared to participants via text message through NYU MCIT secured phones(see Text Message Script). 
The study team has developed training materials on how to use the NYU Webex and Zoom platforms to 
provide to research participants. Use of the Zoom will be used solely for the purpose of delivering the 
health education materials and will not involve discussion of PHI.  In order to maintain anonymity for 
Zoom, for each session, the study staff will create Zoom waiting rooms for participants to be renamed as 
“Participant 1, Participant 2, etc.) prior to individuals joining the larger session with other research 
participants.   
 In addition to these group sessions, patients will receive  up to 9 follow-up phone calls from CHWs, 
during which individualized challenges, strategies, and action plans for improving diet and physical 
activity will be discussed (See Action Plan, Progress Note Form for CHW Intervention).  In addition to 
phone calls, CHWs will also contact patients via a secure NYULMC phone through text messages to 
communicate study activities(see Text Message Scipt).  CHWs will also work with partner agencies to 
conduct community-level activities, such as culturally tailored physical fitness classes and healthy 
cooking demonstrations, that patients will be invited to attend. The CHWs will make necessary referrals 
to other services available in the community (i.e. exercise classes, social services, mental health, tobacco 
cessation, etc.). CHWs will complete an  Encounter Report to document unscheduled encounters with 
study participants (ie. such as when a participant calls the CHW to request referrals to services or to 
report an illness or new diagnosis.) In order to understand the COVID-related impact and needs of study 
participants in managing their health and to improve CHW referrals during the COVID19 pandemic, 
CHWs will complete a Rapid COVID Assessment via phone up to once per month or as needed (see 
study forms for: Rapid COVID Assessment, Rapid COVID Assessment – Repeating Form). 
 
Multiple sessions will be hosted at varying times/days of the week to accommodate schedules of both 
working individuals and at-home caretakers.  Small incentives will be provided throughout the 
intervention to  encourage ongoing attendance, and incentives  will be distributed at program completion 
for individuals who attended all 5 sessions. 
 
 
Consenting and data collection with waitlisted control participants  
For control participants, the study will collect EHR data on clinical measures only that will be linked to a 
unique identifier housed at the primary care practices; there will be no survey data collection with control 
participants. In other words, the study will not be evaluating changes in study outcomes via non-EHR 
data among waitlisted control participants who receive the CHW intervention. For these reasons, we are 
requesting a waiver of authorization (see Section IVb Process of Consent). After completion of Round 1 
intervention with intervention participants, CHWs will call contact waitlisted control participants 
regarding the group education sessions. Control participants will be offered the same content and dosage 
of education sessions.  
 
 
C4. Provider Survey 
At baseline and follow-up, brief surveys will be administered to all participating physicians (n=80) by the 
NYU study team to capture data on: satisfaction with workflow before and after intervention, information 

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sources for EHR-CHW initiatives before and after intervention, acceptability of and satisfaction with the 
integrated EHR-CHW intervention, and barriers and facilitators of point-of-care use of the tools (See 
Provider Survey and Provider Survey – Follow-up). The follow up provider survey will also include 
additional variables of organizational climate and priority and effects of the COVID-19 pandemic at the 
individual practices (eg. including questions to assess impact of COVID-19 on the practice and if 
providers are providing and/or tracking COVID-19 vaccination among patients in order to inform 
tailoring of remote intervention to support vaccination efforts and assist follow-up by CHWs to encourage 
vaccination among patients with overweight and pre-diabetes who are at higher risk for complications 
from COVID-19) 
Survey items with response scales will be designed to capture data on each of the research questions. For 
instance, participants may be asked to respond on a five-point scale from strongly agree to strongly 
disagree to the following statements: “Pre-diabetes testing recommendations are useful to me in my 
practice”, or “The HbA1c testing alerts in the EHR are helpful to me”, or to indicate how frequently they 
use each in a set of common information sources for clinical decision support. Provider Surveys will be 
administered via online survey software or paper copy if requested. Surveys will take approximately 15 
minutes to complete. 
 
C5. Key Informant Interviews 
Qualitative key informant interviews will be conducted with physician champions at each site and/or 
administrator of each site, Healthfirst representatives, community advisrory board members, study staff, 
and CHWs (n=100) (See Key Informant Interview Guide).  At baseline, the interviews will be 
incorporated into the workflow analysis to assess current satisfaction and usage of EHR and health 
coaching. At follow-up, the interviews will assess barriers and facilitators to the implementation and 
adoption process of the integrated EHR-CHW intervention, fidelity to the interventions, and to solicit 
recommendations for the replication and scalability of the intervention to other sites and insurer 
organizations. Follow-up interviews completed during the pandemic will assess impact of COVID-19 on 
the practice, attitudes towards the remote CHW intervention adapted for their patients during the 
pandemic, and if providers are providing and/or tracking COVID-19 vaccination among patients. These 
questions are intended to assess satisfaction with the remote intervention and inform strategies to support 
vaccination efforts and assist follow-up by CHWs to encourage vaccination among patients with 
overweight and pre-diabetes who are at higher risk for complications from COVID-19 (See Key 
Informant Interview Guide - provider – remote intervention). A member of the NYU study team will 
conduct the interviews.  Questions will be adapted from existing validated measures on acceptability, 
feasibility, adoption, organizational culture, and scalability.105-110 What organizational barriers and 
facilitators appear to influence implementation and how?  Did members of the practice understand and 
respect the respective roles of physicians, CHWs, and other members of the team? How did this 
organization customize the intervention to better serve its own local needs? How were users involved in 
design and implementation? What are recommendations for replicating this model for other clinical 
settings and communities? Do project findings motivate payer organizations to reimburse CHW services? 
Key Informant Interviews will take approximately 30 minutes to complete. 
 
 
II.  CHARACTERISTICS OF THE RESEARCH POPULATION 
The overall number of subjects expected to participate in this study is 1220.  
This includes a total of 1040 participants in the EHR-CHW Intervention, 80 subjects who participate in 
the surveys and 100 particpants in the key informant interviews.  
 
CHW Intervention 
Inclusion Criteria: Participants will be eligible for study participation if they meet the following criteria:  
a) self identify as South Asian; b) are at least 21 years of age and younger than age 75, c) had an 
appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 

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months; d) have a BMI of >23; and e) have incident pre-diabetes as determined by HbA1c test (last A1c 
test date in the last 12 months).  
Exclusion Criteria: Patients under the age of 21 and older than 75 will be excluded. Individuals with a 
diagnosis of diabetes or pre-diabetes during the 12 months prior to intervention implementation will be 
excluded. Pregnant women and all visits with an obstetrician gynecologist are excluded.   
No children or vulnerable subjects will be enrolled in this study.  
Provider Assessment Surveys 
The inclusion criteria for the surveys are as follows: adult (18 years and over); clinicians employed by 
independent primary care practice that are members of HealthFirst’s network and have enrolled into the 
study. 
Exclusion criteria include the following: participants who are unable to complete the survey in the 
English language.
Key Informant Interviews 
The inclusion criteria for the interviews are as follows: adult (18 years and over); must be a provider, 
clinic manager, Healthfisrt staff, community advisory board member, study staff, or community health 
worker. Exclusion criteria include the following: participants who are unable to participate in the 
interview conducted in the English language. 
 
III. METHODS and PROCEDURES 
A. Methods and Procedures 
A1. Integrated EHR-CHW Intervention 
PCP Enrollment 
Practices that express interest in participating in the intervention will sign a Memorandum of 
Understanding (MOU) that outlines the nature of the evaluation and the uses of any data collected, 
including: 
i. 
Training requirements 
ii. 
CHW intervention components to be implemented 
iii. 
Individual-level participant data to be extracted routinely from EHR and provided to study team 
iv. 
Confidentiality and data storage procedures   
All relevant parties will then sign the MOU. 
 
Intervention Components 
A minimum set of proposed intervention components will be implemented at all participating practices, 
including: 
 
An alert to identify South Asian patients with elevated BMI (>23 kg/m2) and recommendation to 
order an HbA1c test 
 
Generation of registry lists of individuals with A1C 5.7-6.4% (individuals with incident pre-
diabetes).   
 
5 group-based health education sessions on diabetes prevention  
 
Provision of culturally and linguistically tailored health information and resources 
 
 Up to 9 follow-up calls/meetings to engage in goal-setting activities regarding changes to health 
behaviors, medication adherence, or other issues related to diabetes prevention as identified 
jointly by patient and CHW.  
 
Participants will develop with the CHW and receive a copy of their long-term and short-term 
Participant Action Plan.  
 
Referrals to other services available in the community (i.e. exercise classes, social services, 
mental health, tobacco cessation, etc. 

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EHR-CHW integration supporting team-based care and feedback between PCPs and CHWs 
within the clinic, including: 
o First, providers will be sent Enrollment Update Letters during the recruitment phase of 
the intervention regarding the status of enrollment at their site (see Provider Enrollment 
Update Letter). This document will be sent as a password protected file with the 
password sent in a separate file from the enrollment status.  
o Second, templates will be created that CHWs can complete and upload into the EHR.  
Providers will be able to access these templates which will include the following:  1) 
CHW action planning documents and individualized counseling conducted during 
protocolized phone calls; and 2) Patient progress in reaching goals related to weight loss 
and behavior change.   
o Third, health coaching and referral materials will be made available to providers through 
the EHR, including 1) Culturally adapted CHW curriculum materials; and 2) Systems to 
link patient to community resources and activities.78-80
o Fourth, CHW communication with the healthcare team will be facilitated by participation 
and report-backs from CHWs during regular team “huddles” or staff meetings at least 
once per month.  Further frequency of participation will be site-specific and guided by 
input from the provider and workflow analysis findings in order to avoid provider burn-
out.  
 
 
CHW Curriculum 
Participants enrolled in the CHW intervention will receive group-based health education sessions: 
Curriculum Session Title & 
Content 
Tailored cultural components
Session 1: Diabetes Overview
 Diabetes information 
 Prevention of diabetes 
 Myths and Facts about diabetes 
 Goal-setting 
religion/culture) 
abetes 
in Asians 
 
-risk BMI in Asian communities 
(eg. getting diabetes is a natural part of aging) 
rally appropriate images and language
Session 2: Healthy Eating
Nutrition and Food
 Eating a balanced diet:  
The Plate Method 
 Overcoming barriers to eating 
out/social situations 
 Reading a Nutrition Label 
 Goal-setting for healthy eating 
 
South Asian foods
grain options for rotis, incorporating fruits and vegetables) 
-fried snacks high in salt and 
sweets high in fat and sugar; substituting sweets with fruits  
 
 
 
Sikhs), etc. 
  
entire household 
Session 3: Physical activity
 Caloric intake and energy 
mental fitness (eg. encouragement to practice similar discipline 
in physical activity as in prayer)

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balance 
Benefits and types of exercise
 Injury prevention 
 Incorporating routines 
 Overcoming barriers 
Practice activity and goal-
setting 
-based exercise/activities 
 
 
Session 4: Diabetes Management
and Complications
• Diabetes complications
• Heart disease and stroke 
• Staying motivated and goal-
setting  
diabetes 
complications, heart disease, 
stroke 
inter-connectedness of chronic 
diseases  
fats in diet, blood pressure and 
salt in diet 
 
Review of popular South Asian foods high in salt and fat and 
limiting these foods 
 
Session 5: Stress and family 
support 
 Effects of stress on health 
 Stress and anger management 
 Strategies to manage depression  
Family support and goal-setting 
meditation practice 
 
associated with mental health (eg. depression) 
 
A2. Data Collection
EHR Data 
Data will be extracted from the PCPs’ EHR systems by an NYU staff member every 6 months. De-
identified EHR data will be collected from both intervention and control participants.  The process for 
collecting de-identified patient data is described here: This will entail NYU study staff exporting de-
identified patient information via a secure sftp site to a central repository managed by NYU. In order to 
de-identify patient information, unique study identifiers will be assigned to patients by associating a 
specific study number with a specific medical record number in the EHR system. The table of study 
identifiers and corresponding medical record numbers will be kept at each PCP for the duration of the 
study in a secure and locked location in their respective clinics.  All other potentially identifying data will 
also be stripped from the dataset prior to extraction. Only the PCPs will retain the table necessary to link 
patient identifiers and the study ID. Using this method, we will ensure that patient confidentiality is 
maintained, but that patients who are observed more than once will have the same study ID in each 
extraction, which is necessary for the planned analyses. Using the described approach, a pre-defined set of 
patient data will be exported every 6 months from the clinics’ EHR systems into a de-identified Excel 
spreadsheet or delimited text file. Data elements will be based on functionalities of EHR platforms and 
will include patient demographic information such as year of birth, gender, race/ethnicity, diagnoses, 
medications, laboratory dates, and Alc readings.  

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Follow-up height and weight measures will be obtained during routine office visit at six months. 
Scheduled office visits will be tracked via quarterly data pulls from the PCPs.  If no visit is scheduled 
during the follow-up period, project CHWs will conduct follow-up calls to schedule patients for a height 
and weight recording at the clinic.  Patient travel incentives will be provided to facilitate follow-up data 
collection. 
 
Extracted de-identified data on patients include the following:: 
i. 
De-identified EHR data will include the following:  
 
Practice site ID and demographics - gender, age, race/ethnicity (if available), Language 
(if available) 
 
Any diagnoses for:  hypertension, diabetes, pre-diabetes, and high cholesterol during the 
study period , including month and year of diagnosis 
 
Height and weight data during the data collection period, Month and year of 
measurement 
 
All lab results for: A1c, lipid profile during the study period, Month and year of 
measurement 
 
All BP measurements (systolic and diastolic) during the study period, Month and year of 
measurement 
 
Dates of clinic visits 
 
De-identified claims data obtained from the Healthfirst data warehouse to be provided to the study team 
includes: 
 
All hospital admissions and ED  visits during the intervention period (Study ID, Bill type, 
Encounter type, Admission Month/Year, Length of stay, DRG, Primary ICD 9/10 
diagnosis code, Secondary diagnosis codes, if available, ICD 9/10 procedure codes, 
Attending physician specialty, Allowed Amount, Discharge status, Admit type, Admit 
source) 
 
Pharmacy claims (Study ID, Drug generic names, Drug class, Dates of Fill (month/year 
only), Total Drug Cost Amount 
 
Outpatient claims (Study ID, Primary ICD 9/10 diagnosis code, Secondary diagnosis 
codes (up to 5), if available, ICD 9/10 procedure codes, Allowed Amount, Month/year of 
claim, Physician specialty)  
 
Lab claims  (Study ID, Allowed amount, Month/year of claim, Type of test) 
 
 
B. Data Analysis and Data Monitoring 
B1.  Aim 1 Analysis 
AIM 1: To compare the effect of the EHR/CHW intervention with usual care on weight loss. The 
primary outcome will be probability of eligible patients at a PCP to lose 5% or more of their body weight 
six months following the index office visit. 
Secondary outcomes include: Average reduction in  HbA1c, % sustained >5% weight loss at 12 months; 
improved lipids and blood pressure 6- and 12- months following the index office visit. 
Hypothesis: Individuals receiving care during the implementation of the EHR/CHW intervention 
will be more likely to lose 5% of their body weight six months following the index office visit than 
individuals receiving care as usual.  This will translate directly to a commensurate increase in the 
proportion of the study sample under the EHR/CHW intervention losing 5% of their body weight relative 
to the care as usual group. 
The analysis of the effect of EHR/CHW on the outcome measure will be based on a Generalized 
Linear Mixed Model (GLMM). In particular, we will use a random effects model that assumes a binomial 

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distribution with a logit link function.  The comparison will make no linear assumption about the time 
trend for each outcome over the course of the trial. The model will be as follows:
,
where 
if the th subject attached to the th site at time quarter loses 5% or more her body weight 
six months following the index visit, 
otherwise. 
is a random effect for site with mean 0 and 
variance 
. 
is a time-specific effect a quarter 
. 
is an indicator variable, and 
if individual receives care under the EHR/CHW intervention, 
if individual . 
represents the 
treatment effect of the intervention. The model will be fit using the LME4 package using R software.  The 
hypothesis will be tested using two-sided level of significance 
.  Because outcome data will be 
derived from administrative data, we do not anticipate missing data. However, in the event that there is 
missing data, we will use multiple imputation under the assumption of data missing at random (MAR). 
This is consistent with following intent-to-treat protocol.
Power Calculation:
We conservatively estimate an 8% difference in effect size (i.e., >5% weight loss) comparing 
intervention and control group participants. Accrual of 1040 participants, evenly randomized to 
intervention or control groups, provide greater than 80% power to detect this difference, using a 2-sided, 
0.05-level test (i.e., 52 participants (26 Intervention and 26 control participants per PCP). These 
calculations assume 15% loss to follow-up and enrollment of 20 PCP sites.
Sampling:  Preliminary data from our practice needs assessment indicates that approximately 444 unique 
patients for every six months will have an office visit.  Based on population estimates,21,30 we estimate 
that 29% of those individuals will be ineligible due to a pre-study period T2DM or pre-diabetes diagnosis 
(n=129) and approximately 69% of remaining patients will have a BMI >23 kg/m2, making them eligible 
for the study (n=217).  In our ongoing T2DM management CHW intervention among South Asians, 
screening to enrollment rate is 41%.111  For this study, we apply a conservative estimate that 30% of 
patients will consent to be contacted by a CHW and receive an HbA1c test (n=65).  Based on populations 
estimate17, we anticipate that 43% of those individuals will have pre-diabetes (n=28).  Based on retention 
rates from our CHW studies,22,46,84 we conservatively estimate that approximately 85% of individuals 
assigned to a CHW will be followed up at six months (n=24).  Thus, for each PCP, we will enroll 
approximately 24 patients every six months over a period of one year, resulting in total recruitment of 960
across 20 PCPs.  This equates to an approximate CHW caseload of 13 patients per month for a part-time 
CHW, consistent with caseloads from our previous studies.22,83
B2.  Aim 2 Analysis.
Analysis to address this aim will be guided by the following questions:
1.
Utilization Patterns:  How frequently do clinicians utilize the integrated EHR-CHW system? What 
is the percentage of adoption? Does the utilization pattern change over time? Does the intervention 
increase the utilization and quality of quality measurement reports?
The system utilization files from HF’s data warehouse will be used to analyze utilization patterns 
of the enhanced physician alert and registry functions, as well as the integrated EHR-CHW options. These 
data will yield descriptive trends for frequency of utilization across the participating PCPs as well as an 
estimate of the percentage of adoption in terms of patient visits for HbA1c screening. The frequency of 
quality measurement reports will be described and compared 12 months pre- and post- intervention.
2.
Physicians’ Attitudes Regarding the Integrated Intervention:  What are physicians’ attitudes 
regarding ADA recommendation for testing of pre-diabetes at BMI >23 kg/m2? How satisfied are the 
physician’s with the integrated EHR-CHW tools? What are the barriers and facilitators of point-of-care 
use of the tools? How does the intervention affect clinicians’ satisfaction with workflow around T2DM 
prevention and weight loss? 

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This set of research questions will be primarily addressed with data from brief surveys collected 
from the participating clinicians. Survey items with response scales will be designed to capture data on 
each of the research questions above. For instance, participants may be asked to respond on a five-point 
scale from strongly agree to strongly disagree to the following statements: “Pre-diabetes testing 
recommendations are useful to me in my practice”, or “The HbA1c testing alerts in the EHR are helpful 
to me”, or to indicate how frequently they use each in a set of common information sources for clinical 
decision support. The survey data come from a small sample (n=approximately 40) and are only intended 
to quantify descriptive information and will not be used in extensive statistical analyses. The data will be 
tabulated and summarized descriptively to address each research question listed above and to assess 
change in attitudes from baseline to 12 months.  
3. 
Barriers and Facilitators to Implementation Adoption and Implications for Scalability:  What 
organizational barriers and facilitators appear to influence implementation and how?  Did members of the 
practice understand and respect the respective roles of physicians, CHWs, and other members of the 
team? How did this organization customize the intervention to better serve its own local needs? How were 
users involved in design and implementation? What are recommendations for replicating this model for 
other clinical settings and communities? Do project findings motivate payer organizations to reimburse 
CHW services? 
Interview data will be transcribed and analysis transcribed data will follow "constant comparison" 
analytic approach.112 The “constant comparison” approach is a method of explanation building in which 
the findings of an initial case are compared to a provisional category, property or proposition, revised as 
necessary and then other details or new cases are then compared against the revision and revised again as 
needed. This process is continued until an area of interest is fully explicated, reaching theoretical 
saturation.112 Using "thematic" coding, we will develop an initial set of codes, which will be reviewed by 
the community-clinical coalition to ensure they are relevant and complete.  For each core code, we will 
ultimately develop one or more "secondary codes" that represent either more specific or restricted aspects 
of the phenomenon, to contextualize it, or to suggest underlying meanings.  The secondary codes will 
vary in specificity or subtlety depending on the judged substantive value of additional refinements. 
Transcripts will be coded by at least four coders. Discrepancies in coding will be discussed and resolved, 
then the process is repeated with a new set of transcripts until an acceptable level of inter-coder reliability 
between them has been by the achieved, estimated using an appropriate chance-corrected statistic (e.g., 
kappa for nominal data and T-index for ordinal data).113 The coded transcripts will be analyzed with 
Atlas.ti, a software package for qualitative data analysis.114 Analysis will be conducted to inform best 
practices for scalability that can be replicated by payer organizations and health care systems. 
4. Cost-Effectiveness/Sustainability:  What were the costs of the integrated intervention to the insurer 
organizations and physician practice and did these additional costs provide added value at patient and 
provider levels? What were the net costs and benefits of different combinations of CHW and EHR 
interventions?   
Using average resource utilization and costs per patient (in first 6 and 12 months of follow-up), 
we will compare resources incurred by the trial arms during the follow-up period at each time point. Our 
outcome will be the incremental cost per person achieving 5% weight loss.  Cost data will be used to 
inform HF leadership of program costs for consideration of sustainability of CHW models by payer 
organizations. 
 
Provider Survey 
The data will be tabulated and summarized descriptively to address research questions and to assess 
change in attitudes from baseline to 12 months. All quantitative data will be entered and analyzed in 
SPSS. 
 
Key Informant Interviews 
Interview data will be transcribed and analysis transcribed data will follow "constant comparison" 
analytic approach.112 The “constant comparison” approach is a method of explanation building in which 
the findings of an initial case are compared to a provisional category, property or proposition, revised as 

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necessary and then other details or new cases are then compared against the revision and revised again as 
needed. This process is continued until an area of interest is fully explicated, reaching theoretical 
saturation.112 Using "thematic" coding, we will develop an initial set of codes, which will be reviewed by 
the community-clinical coalition to ensure they are relevant and complete.  For each core code, we will 
ultimately develop one or more "secondary codes" that represent either more specific or restricted aspects 
of the phenomenon, to contextualize it, or to suggest underlying meanings.  The secondary codes will 
vary in specificity or subtlety depending on the judged substantive value of additional refinements. 
Transcripts will be coded by at least four coders. Discrepancies in coding will be discussed and resolved, 
then the process is repeated with a new set of transcripts until an acceptable level of inter-coder reliability 
between them has been by the achieved, estimated using an appropriate chance-corrected statistic (e.g., 
kappa for nominal data and T-index for ordinal data).113 The coded transcripts will be analyzed with 
Atlas.ti, a software package for qualitative data analysis.114 Analysis will be conducted to inform best 
practices for scalability that can be replicated by payer organizations and health care systems. 
 
 
C. Data Storage and Confidentiality 
Confidentiality will be maintained for participants according to mandatory Institutional Review Board 
regulations, under the supervision of Dr. Nadia Islam. 
 
EHR-CHW Intervention 
As described above, all patient data will be de-identified prior to transfer to a NYU MCIT managed 
network databases via a secure sftp site. All computer systems are protected from possible external 
access. No internet access is possible with the research systems. 
 
Intervention Participants and Provider Survey Data  
To safeguard confidentiality and anonymity, unique identifiers will be assigned to all participants for all 
portions of the study and all data collection instruments will identify participants only by these unique 
identifiers. On the baseline and follow-up surveys, the first page of the survey will ask participants for 
updated contact information so that CHWs can maintain contact throughout the intervention period  Data 
will be entered into REDCAP, a HIPPA-compliant a research database platform, by a study staff member 
and alldata will be housed on a secure MCTI managed network drives. Pages containing participants 
name and contacts information and logs linking subjects’ identifying information to study numbers will 
be kept locked in in a subject file per IRB regulation in a a file cabinet in a secure location. Baseline and 
followup survey data will be kept in individual subject files per IRB regulation. . Contact information 
from consented participants will be kept on file for the duration of the trial and will be destroyed (both 
electronic and hard copy) upon the dissemination of trial results (approximately 5 years). 
 
Key Informant Interview 
Unique study IDs will be assigned to each key informant in Excel, and these unique study IDs will   track 
interview logistics (including interview date/time/location), interview audio file names, and interview 
transcripts. The audio-recordings and interview transcripts will be housed on secure MCIT managed 
network drives. Only study staff will have access to these audio-recordings and study data. To safeguard 
confidentiality and anonymity, audio files are deidentified, and subject names will not be collected or 
included in interview transcripts.  
 
D. 
Data Sharing Policy 
The Principal Investigator, scientific advisors and research team staff will be responsible for developing 
publication procedures and establishing authorship policies. This study will comply with the NIH Public 
Access Policy, the public will have acess to the published results of this intervention. Manuscripts will be 
submitted to peer-reviewed journals and accepted manuscripts will be submitted to PubMed Central upon 
acceptance of publication. The study will be submitted to clinicaltrials.gov and updated as necessary in 
accordance with study development. The clinicaltrials.gov record id is NCT03188094 

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IV. RISK/BENEFIT ASSESSMENT 
Risks and protection against risks 
The proposed study poses minimal risk to participants.  Loss of confidentiality is the greatest potential 
risk to study subjects.  We will not obtain written consent from providers who participate in surveys and 
interviews; and, no identifying information is included on the transcripts of clinician interviews or 
surveys. The interviews will be taped using a digital recorder. No identifying information will be included 
in the audiotapes. All interviews will be stored on password protected documents housed within MCIT 
managed network drives.  . Once transcribed and entered onto a password protected Atlas TI© database, 
the recordings will be deleted from the study files. All provider survey data entered into the research 
database will be protected by confidential entry codes. Names will be replaced with identification 
numbers. Providers will have the right to refuse to participate without any compromise of their 
employment status. Also, if a participant is uncomfortable during an interview situation, they may stop 
the interview at any time without penalty. 
 
All patient data will be de-identified by NYU staff prior to transfer to NYU managed network drives. 
Locked file cabinets will be used to store materials with identifying information. All computer systems 
are protected from possible external access. No internet access is possible with the research systems. The 
data collected for this study will be used strictly for the purposes stated in this application and will only 
be available to NYU research staff.  
 
Potential Benefits to the Subjects 
CHW Intervention: By participating in the proposed research, participants may gain the benefit of 
augmented services related to their diabetes and CVD-related risk factors.  Some patients may 
individually experience no benefit.  This study will yield knowledge regarding methods for increasing 
adherence to evidence-based guidelines for treating diabetes among providers and health staff serving 
South Asian populations.  Overall, the benefits of understanding effective methods for helping patients 
reduce their risk of diabetes far outweigh the remote possibility of a breach of confidentiality.   
 
Provider Surveys/Staff Key Informant Interviews: Participating providers and staff may benefit from the 
interventions which are meant to assist them with improving the quality of care they provide for South 
Asian patients at-risk of diabetes.  The study may also have relevance to the US health care system by 
testing a practice facilitation model to enhance implementation of team-based care integrated with EHR 
systems for preventing diabetes. 
 
 
 
V. INVESTIGATOR’S QUALIFICATIONS AND EXPERIENCE 
 
NYU Personnel  
 
Nadia Islam, PhD will serve as PI of the proposed study.  Dr. Islam is an Early Stage Investigator and 
Assistant Professor in the Department of Population Health at NYU School of Medicine with substantial 
experience in leading R01-level research projects examining the efficacy of CHW efforts in the 
prevention and management of CVD and diabetes in Asian American communities.  Dr. Islam is the 
Project PI of the DREAM Project, a clinic-based CHW intervention to improve T2DM management in 
the Bangladeshi population, the core research for the NYU Center for the Study of Asian American 
Health.  She also is the research director of the NYU-CUNY Health Promotion and Prevention Research 
Center, where she serves as PI of the core research study, Project IMPACT, an integrated EHR-CHW 
intervention designed to increase hypertension control for South Asian patients conducted in partnership 
with HealthFirst.  She was also the PI of the core research for the NYU PRC, Project RICE, a culturally 
tailored CHW-led adaptation of DPP for Korean and South Asian individuals at risk of T2DM.  

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Previously, she was co-investigator on Project AsPIRE, an NIMHD-funded CHW-led hypertension 
intervention in the Filipino community. Most recently, Dr. Islam is the PI of a CDC-funded 
implementation and dissemination program project to increase access to healthy foods and beverages and 
increase hypertension management among Asian American communities in NY and NJ through policy, 
systems, and environmental level changes. 
 
Donna Shelley, MD will serve as a co-investigator on this study. Her research has focused in the areas of 
implementation science with a specific focus on studying health care system change to improve the 
quality of tobacco use treatment across a wide range of health care settings and developing efficacious 
cessation treatments for underserved populations, including smokers with comorbid conditions. She was 
recently awarded an AHRQ grant that is part of the AHRQ EvidenceNOW initiative, to recruit 250 small 
primary care sites to study the effectiveness of practice facilitation on increasing adoption of Million 
Hearts guidelines for optimizing cardiovascular health. She will provide her experience and expertise in 
implementation research in clinical and other physician settings. 
 
Heather Gold, PhD will serve as co-investigator and will implement the cost analysis component of the 
study.  Specifically, she will oversee the development of cost-related data collection tools and databases, 
and oversee the analysis of claims and programmatic cost data. Dr. Gold is an expert in cost-effectiveness 
analysis and costing out comparative behavioral interventions, particularly with respect to chronic 
diseases. 
 
Keith Goldfeld, DrPH is a biostatistician interested in health services research, cluster randomized trials, 
and causal inference for secondary data analysis. He will serve as co-investigator and will provide his 
biostatistical expertise. 
 
Sahnah Lim, PhD, MPH, MIA will serve as the Program Manger for the study. Dr. Lim began her 
career providing social services to immigrant communities in New York City at various community-based 
organizations. She then transitioned to doing research with marginalized communities (sexual minorities, 
sex workers, street youth) both domestically and internationally and in both governmental and non-
governmental settings. Her research focuses on various health inequities, including those that relate to 
gender, race/ethnicity, and class. She is experienced in mixed methods approaches and specializes in 
survey research and psychosocial statistical methods.  Dr. Lim’s work has been featured in various peer-
reviewed journals such as Journal of Acquired Immune Deficiency Syndromes, Journal of Urban Health, 
and Culture, Health, and Sexuality. She received her dual masters degree from Columbia University and 
her PhD from the Johns Hopkins Bloomberg School of Public Health. 
 
Shinu Mammen, MPH is Program Coordintor for the study. Ms. Mammen has three years of experience 
coordinating the first multi center longitudinal cohort study to research the risk factors for heart disease 
and diabetes among South Asians living in the United States based at Northwestern University. Ms. 
Mammen has experience collaborating with South Asian immigrant community based organizations, 
hospital health systems, and public health departments in order to successfully implement community 
based interventions. Ms. Mammen graduated from Benedictine University with her Masters in Public 
Health. 
 
Jennifer Zanowiak, MA is the Program Supervisor for the study. Ms. Zanowiak has seven years 
experience coordinating CHW interventions to improve cardiovascular health in NYC South Asian and 
Korean communities. She will supervise the community healthworkers and oversee the implementation of 
the CHW Intervention. Ms. Zanowiak graduated with a MA in International Affairs and has extensive 
experience with program development and interventions involving CBPR approaches among immigrant 
populations. 

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Laura Wyatt, MPH is the Research Data Manager for the NYU Center for the Study of Asian American 
Health.  She manages and oversees the data sources across CSAAH, which includes the NYU-CUNY 
PRC, and performs analyses and assists with the dissemination of study findings. In addition, she 
provides epidemiological and biostatistical support for grant development activities within the center. Ms. 
Wyatt received her MPH in Epidemiology from Columbia University, Mailman School of Public Health 
and also studied public health at the University of North Carolina at Chapel Hill.  
Mursheda Ahmed is a Community Health Worker (CHW) for this study. She is fluent in Bengali and is 
well connected to the Bengali community in New York City. She is also a certified IPA/Navigator by the 
New York State of Health Benefit Exchange. She provides research support for the project and is 
involved with practice outreach and engagement, as well as with group and one-on-one health education 
and coaching for participants of the CHW intervention. 
Gulnahar Alam is a Community Health Worker (CHW) for this study. She is fluent in Bengali and is 
well connected to the Bengali community in New York City. She provides research support for the 
project and is involved with practice outreach and engagement, as well as with group and one-on-one 
health education and coaching for participants of the CHW intervention. 
Mamnunul Haq is a Community Health Worker (CHW) for this study. He is fluent in Bengali and is 
well connected to the Bengali community in New York City. He provides research support for the project 
and is involved with practice outreach and engagement, as well as with group and one-on-one health 
education and coaching for participants of the CHW intervention. 
Md. Jalal Uddin is a Community Health Worker (CHW) for this study. He is fluent in Bengali and is 
well connected to the Bengali community in New York City. He is currently studying to receive his 
Masters degree in Statistics and Applied Mathematics from Hunter College.  He provides research 
support for the project and is involved with practice outreach and engagement, as well as with group and 
one-on-one health education and coaching for participants of the CHW intervention. 
Sidra Zafar is a Community Health Worker (CHW) for this study. She is fluent inPunjabi and Urdu, and 
is well connected to the Pakistani community in New York City. She provides research support for the 
project and is involved with practice outreach and engagement, as well as with group and one-on-one 
health education and coaching for participants of the CHW intervention. 
Haroon Zafar is a Community Health Worker (CHW) for this study. He speaks Punjabi and Urdu 
fluently and is connected with Pakistani organizations within the bourgouh of New York City. He
provides research support for the project and is involved with practice outreach and engagement, as well 
as with group and one-on-one health education and coaching for participants of the CHW intervention. 
Sabiha Sultana is a Community Health Worker (CHW) for this study. She  has her Bachelor of Sciene 
degree in Social Work from York Colleg in New York. She is fluent in Bengali and is well connected to 
the Bengali community in New York City. She provides research support for the project and is involved 
with practice outreach and engagement, as well as with group and one-on-one health education and 
coaching for participants of the CHW intervention. 
External Collaborators 
HealthFirst Personnel 
Rashi Kumar, MUP is the Healthfirst Program Manager for this study. She has extensive experience in 
health workforce development and training. At Healthfirst, she is Senior Program Manager, Clinical 
Partnerships, and is responsible for overseeing innovative grant-based programs that aim to reduce 
disparities in health outcomes and test diverse models of value based payment. She manages HealthFirst’s 

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involvement as a payer partner in the development and implementation of the research. She will help with 
PCP recruitment and dissemination of education material.  
 
Phoebe Laughlin, MS is the Healthfirst Program Coordinator for this study. She will be responsible for 
extracting individual level Healthfirst data from physician EMR systems and relationship management 
with the physician practices. 
 
Hang Pham-Sanger, Pharm.D. will participate in the training and intervention implementation of the 
study activities. She will also manage the quality improvement team who assists practices in establishing 
standard and consistent processes to promote chronic disease care management. She is the Director of 
Quality Improvement within the Primary Care Information Project (PCIP) at the New York City 
Department of Health and Mental Hygiene. 
 
VI.  SUBJECT IDENTIFICATION, RECRUITMENT, AND CONSENT/ASSENT 
 
A. Method of Subject Identification and Recruitment 
 
CHW Intervention  
Patients that meet eligibility criteria will be drawn from registry lists and randomized to intervention or 
waitlisted control. Patients assigned to the intervention group will be  sent an invitation letter and 
recruitment flyer (See Recruitment Letter for CHW Intervention and Recruitment Flyer) to participate in 
the CHW intervention.  Invitation letters and recruitment flyers will be followed up with phone calls by 
CHWs (See Script for Telephone Screening for CHW Intervention), during which CHWs will explain the 
study and elements of informant consent. Participant names, telephone numbers, and email addresses will 
be needed in order for CHWs to contact participants regarding participation in the intervention (Please see 
Application for Waiver of Authorization for Telephone Screening Form).  In addition, a screening form 
(See Telephone Screening Form for CHW Intervention) will be completed to verify eligibility. CHWs will 
call patients a maximum of 10 times over a two-week period at varying times of day to invite them to 
enroll into the study. Patients assigned to the waitlisted control group will be recruited and contacted in 
the same manner as intervention participants after completion of intervention rounds. CHWs will call 
waitlisted control patients a maximum of two times over a one-week period.  
 
Provider Surveys 
Providers at participating practices will be invited to complete the Provider Assessment via email link. 
Paper surveys will also be available for those who prefer to fill out the survey in hard copy. No undue 
pressure will be given to subjects for participation as the participation is entirely voluntary, and will be 
described via email or verbally to the invited participants (see Invitation and Elements of Informed 
Consent for Provider Survey). 
 
 
Key Informant Interviews 
Participating providers, Healthfirst staff, community advisrory board members, study staff, and 
community health workers will receive an invitation to participate in the interview (See Invitation and 
Elements of Informed Consent for Key Informant Interview). No undue pressure will be given to subjects 
for participation as the participation is entirely voluntary (See Verbal Consent Script for Key Informant 
Interview). 
 
B. Process of Consent  
All study personnel will have completed the NYU IRB Mandatory Tutorial and IRB HIPAA Training 
before commencing any data collection activities.  
 

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The informed consent form for this study have been created by the NYU Grossman School of Medicine 
Office of Science and Research in accordance with Federal guidelines, including the Health Insurance 
Portability and Accountability Act (HIPAA).  A verbal consent and HIPAA authorization will be obtained 
via telephone from participants(see Waiver of Authorization and Documentation of Consent and 
Telephone Script Form, Consent Brochure for CHW Intervention). The CHW will review all the elements 
of informed consent over this call using the Telephone Consent Script to introduce the study and then 
going over the Consent Brochure in detail to review all elements of consent. (see Telephone Script Form 
and  Consent Brochure ) The Consent Brochure will be mailed to the study participant.   
 
A verbal consent is preferable due to the 1) remote nature of the intervention 2) the South Asian 
immigrants have limited technological literacy and are unable to complete an electronic consent via 
REDCap as this will also require them to have email accounts which are used sparingly in this population; 
3) social-distancing contraints at PCP offices where health education sessions were previously being 
conducted.   
 
 
CHW Intervention Paticipants  
All potential intervention participants will receive a copy of the study consent form by the CHW. The 
format of the consent form consists of a 1-page consent signature form with an accompanying brochure 
fully detailing all components of the full informed consent (See Consent Brochure and Consent Signature 
Page for CHW Intervention). This layout is more appropriate for clinic-based and community-based 
recruitment. First, based on our experience in previous community-based studies, community members 
were discouraged by a multiple-page consent form, and we expect the same in a clinic setting.  Even 
though this format provides the same exact information as the standard consent form, we expect that it 
will be less intimidating for participants who are learning about the study in a community-based 
recruitment atmosphere. 
 
If screening is conducted in person, consent processes will take place at PCP offices in a manner that 
maximizes confidentiality and privacy and allows questions to be asked. All study staff will follow 
COVID-19 workplace safety and personal protective equipment policies at each PCP office and as 
required by NYUGSOM. Participants will be screened in advance for symptoms as per the PCP office 
guidelines and asked in advance to wear a mask/face covering. All study staff and participants will follow 
efforts for social distancing whenever possible. Eligible participants demonstrating interest in 
participating in the project will meet with a study team member who will explain the intervention and 
answer any questions. Informed consent, HIPAA authorization and signatures will be obtained.  
 
 
Participants are free to withdraw from participating in the study at any time without repercussions. 
Participants will be advised during the consent process that they have the right to withdraw entirely and 
that their refusal will not jeopardize their relationship with their CHW or primary care physician.  
 
Provider Assessment Surveys 

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A Waiver of Documentation of Consent is being requested for participants of the Provider Survey for this 
study (see Application for Waiver of Documentation of Consent for Provider Survey and Key Informant 
Interview). This request is being made because the consent form, if collected, would require names to be 
collected and in doing so would be the only record linking the subjects name to the research. The study 
will invite participation by email to complete the online survey, who will give implied consent if they 
click on the hyperlink to complete the survey, or if particpants wish to complete a paper-based survey, the 
study team will obtain verbal consent (see Invitation and Elements of Informed Consent for Provider 
Survey).  The consent email will be sent out by study staff. The study offers a hyperlink for participants if 
they agree to participate in the study. It will state clearly that participation is completely voluntary, and 
there is no penalty in declining to participate in the study. Participants will be informed they are free to 
withdraw from participating in the study at any time without repercussions. 
 
 
Key Informant Interviews 
A Waiver of Documentation of Consent is being requested for participants of the Key Informant Interview 
for this study (see Application for Waiver of Documentation of Consent for Provider Survey and Key 
Informant Interview).  This request is being made because the consent form, if collected, would require 
names to be collected and in doing so would be the only record linking the subjects name to the research.  
Verbal consent will be obtained prior to start of the interview, but we will not collect any personal 
information or identifiers. No names of individuals will be recorded or appear in interview notes.  
Participants will be free to withdraw from the interview at any time without repercussions. Participants 
will be provided with an invitation including the elements of the written consent as well as contact 
information for the study PI. Verbal consent will be obtained from the key informants prior to beginning 
the interview (See Verbal Consent Script for Key Informant Interview).  
 
C. Subject Capacity 
We anticipate that all subjects will have the capacity to give informed consent.  Language barriers will be 
minimized by having data collectors who speak Bengali, Urdu, and Punjabi and translated consent forms 
for the CHW Intervention (to be translated upon approval of the English version).   
 
 
E. Debriefing Procedures.  
Information will not be withheld from the subjects related to their participation in the study. 
 
F. Consent Forms. Please refer to consent forms: Consent Brochure/Signature Page for CHW 
Intervention and,Telephone Script, and Invitation and Elements of Consent and Verbal Consent Script 
documents for the Provider Survey and Key Informant Interviews. 
 
The subject will receive a mailed copy of the Consent Brochure/Signature Page. A translated verbal 
informed consent will be used for non-English speaking subjects, depending on their preferred 
language(upon approval of the Waivier of Authorization and Documentation of Consent, translated 
documents will be included in a subsequent modification). 
 
Study staff who have obtained the verbal consent will document the consent and the date of consent on a 
secure REDCap database. The REDCap database tracking form is the only record linking a participant’s 
name and Subject ID. 
 
Signed informed consent forms from participants consented in earlier versions of the protocol will be 
stored in a separate folder in a locked cabinet accessible only to study staff. 
 
 
G. Documentation of Consent 

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Intervention Participants 
 
Study staff will obtain consent and HIPAA authorization by reading the verbal informed consent script to 
the subject to introduce the study and will then proceed to obtain verbal consent by reviewing the Consent 
Brochure with the participoant. The participant will be given adequate opportunity to review and clarify 
questions before verbally consenting. The subject will receive a mailed copy of the Consent Brochure.  A 
translated verbal Telephone script will be used for non-English speaking subjects, depending on their 
preferred language(upon approval of the Waiver of Authorization and Documentation of Consent, 
translated doucments will be uploaded via a subsequent modification). 
 
Study staff who have obtained the verbal consent will document the consent and the date of consent on a 
secure REDCap database. The REDCap database tracking form is the only record linking a participant’s 
name and Subject ID. 
 
Signed informed consent forms from participants consented in earlier versions of the protocol will be 
stored in a separate folder in a locked cabinet accessible only to study staff. 
 
 
 
Patient survey data will be collected at baseline and at 6-months follow-up to evaluate the effectiveness of 
the CHW intervention. EHR data will be used to generate a registry of eligible participants for 
recruitment. EHR data will also be used to compare clinical outcomes (e.g., height and weight). EHR data 
will be collected at baseline, 6-months and 12 months. The informed consent for intervention participants 
will outline elements of the EHR data collection, CHW group education, one-on-one counseling, survey 
data collection, and Healthfirst claims data collection.  
 
Control Participants   
The study will only collect EHR data from control participants and will not collect survey data  or claims 
data. A Waiver of Authorization is being requested for EHR data collected from control participants (see 
Application for Waiver of Authorization for Consent Participant EHR data). Without the requested 
waiver, the study could not be practically carried out and would adversely affect the scientific rigor of the 
study. Although control participants will be offered the full CHW intervention at a later time point (i.e., 
waitlist control), experience from similar studies have shown that recruitment and retention of control 
participants would dramatically increase the CHW caseload. The study is only collecting clinical 
outcomes from control participants through the EHR and this data will be de-identified. All variables for 
extraction will be pre-approved by all participating PCPs. MOUs between PCPs and NYU will explicitly 
outline the process of de-identification of the data and the list of variables for extraction.  
 
 
Provider Assessment Surveys 
A Waiver of Documentation of Consent is being requested for participants of the Provider Survey for this 
study (see Application for Waiver of Documentation of Consent for Provider Survey and Key Informant 
Interview). This request is being made because the consent form, if collected, would require names to be 
collected and in doing so would be the only record linking the subjects name to the research. The study 
will invite participation by email to complete the online survey, who will give implied consent if they 
click on the hyperlink to complete the survey, or if particpants wish to complete a paper-based survey, the 
study team will obtain verbal consent (see Invitation and Elements of Informed Consent for Provider 
Survey).   
The consent email will be sent out by study staff. The study offers a hyperlink for participants if they 
agree to participate in the study. It will state clearly that participation is completely voluntary, and there is 
no penalty in declining to participate in the study. Participants will be informed they are free to withdraw 
from participating in the study at any time without repercussions. 

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Key Informant Interviews 
A Waiver of Documentation of Consent is being requested for participants of the Key Informant Interview 
for this study (see Application for Waiver of Documentation of Consent for Provider Survey and Key 
Informant Interview).  This request is being made because the consent form, if collected, would require 
names to be collected and in doing so would be the only record linking the subjects name to the research.  
Verbal consent will be obtained prior to start of the interview, but we will not collect any personal 
information or identifiers. No names of individuals will be recorded or appear in interview notes.  
Participants will be free to withdraw from the interview at any time without repercussions. Participants 
will be provided with an invitation including the elements of the written consent as well as contact 
information for the study PI. Verbal consent will be obtained from the key informants prior to beginning 
the interview (See Verbal Consent Script for Key Informant Interview).  
 
H. Costs to the Subject 
There are no costs to participate in this study.  Any doctor visits and laboratory tests, including the 
HbA1c test, are part of standard of care. 
 
I. Payment for Participation 
Participants will not receive payment for participation in this study. Participants may receive metro cards 
for travel associated with the project.  In addition, small prizes such as pedometers may be raffled at 
educational sessions.  Additionally, participants that complete all five educational sessions will be eligible 
for a raffle cash prize to be given after each six month study period.   
 
VII. APPENDIX 
A. Recruitment Letter for CHW Intervention 
B. Recruitment Flyer  
C. Script for Telephone Screening for CHW Intervention 
D. Telephone Screening Form for CHW Intervention 
E. Action Plan for CHW Intervention  
F. Progress Notes Form 1 for CHW Intervention 
G. Progress Note Form for CHW Intervention Additonal Followup 
H. CHW Participant Baseline Survey 
I. CHW Participant Followup Survey 
J. Enrollment Update Letter to Provider 
K. Provider Survey 
L. Key Informant Interview Guide 
M. Consent Brochure and Consent Signature Page for CHW Intervention 
N. Telephone Consent Script 
O. Invitation and Elements of Informed Consent for Provider Survey 
P. Invitation and Elements of Informed Consent Text for Key Informant Interview 
Q. Verbal Consent Script for Key Informant Interview 
R. Application of Waiver of Authorization for Control ParticipantsApplication for Waiver of 
Authorization for Telephone Screening Form 
S. Application for Waiver of Documentation of Consent for Provider Survey and Key 
Informant Interview 
T. Encounter Report 
U. Rapid COVID Assessment 
V. Rapid COVID Assessment – Repeating Form 
W. Application for Waiver of Authorization and Documentation of Consent CHW 
Intervention 
X. Text Message Script 

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Y. Key Informant Interview Guide – CAB 
Z. Key Informant Interview Guide – CHW 
AA. 
Key Informant Interview Guide – Staff 
BB. Key Informant Interview Guide – Provider – Remote Intervention 
CC. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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