Diabetes Management Intervention For South Asians
Phase: NA
Conditions: HbA1c, Diabetes
Sponsor: NYU Langone Health

Official Title:
Diabetes Management Intervention For South Asians  
NCT Number: 
NCT03333044 
Study Number:
17-01479
Document Type:  
 Protocol and Statistical Analysis Plan 
Date of the 
Document: 
July 8, 2021

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Study Title: Integrated Community-Clinical Linkage Model to Manage Diabetes among South Asians 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 Manage Diabetes among South Asians” aims to test the effectiveness of a 
multi-level diabetes management intervention compared to usual care. The primary outcome is reduction in hemoglobin A1c (HbA1c) for patients 
with baseline HbA1c of >7%. The secondary outcomes include enhanced use of community and social services and increased self-efficacy. 
 
The integrated intervention involves:  
 
1. An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to identify South Asian 
patients with uncontrolled diabetes. 
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 PCP clinics enrolling 886 South Asian patients at- risk for Type 2 Diabetes Mellitus (T2DM).  
3. Linkage to culturally relevant community-level resources 
4. CHW-integration into primary care teams. The project will leverage Health Information Technology (HIT) tools to support integration of 
CHWs in healthcare teams, feedback between healthcare providers and CHWs, and establish a referral mechanism between CHWs, 
patients, and community resources 
 
In addition, using a mixed-methods approach and the RE-AIM evaluation framework26, 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: 
 
5. 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. 
6. Key Informant Interviews (n=100) with physician champions at each clinic and/or administrator of each clinic, 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 clinics and insurer organizations.   
 

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Impact: This multi-level study will inform efforts to manage diabetes in a high-risk population and generate a reproducible and sustainable model 
for use in healthcare and community settings that engage vulnerable 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 are a rapidly growing population in the US and NYC. Asian Americans currently compose 5% of the US population and 
approximately 32% of the immigrants entering the country. 66 The US Census Bureau projects that by 2060 the number of Asian Americans 
nationally will grow to over 39 million, approximately 9.3% of the US population.11, 19In this proposal, we focus on the South Asian community 
(persons with ancestry from India, Bangladesh, Pakistan, or other parts of the South Asian continent). This community is among the largest and 
fastest growing Asian subgroups in the nation. In NYC, the South Asian community grew by 49% from 2000 to 2010 (216,179 to 323,675, 
respectively). Across South Asian groups, a significant portion of the community live in poverty (ranging from 17% of Asian Indians to 32% of 
Bangladeshis), have limited English proficiency (LEP) impacting access to care (ranging from 25% of Asian Indians to 53% of Bangladeshis), and 
have poor access to culturally appropriate community resources. 8-10, 67 For the purposes of our study, South Asians will be defined as individuals 
who self-identify as South Asian, including those from India, Bangladesh, Pakistan, Sri Lanka, Nepal, and Bhutan, Guyana, Trinidad. 
 
 
B2. South Asians in the US experience diabetes disparities. Diabetes prevalence in the US South Asian community are high, with national data 
revealing the highest prevalence of diagnosed diabetes among Asian Indians compared to other Asian groups and compared to non-Hispanic 
whites. 38, 72,36, 46, 61 In NYC, population-based studies reveal strikingly high diabetes rates among South Asians. 33, 61 South Asians in NYC have 
significantly higher prevalence of clinically measured diabetes (35.4% vs 10.8%) and nearly five times the odds of having diabetes compared to 
whites (Adjusted Odds Ratio: 4.88, 95% CI [1.52, 15.66]).57 Additionally, the prevalence of self-reported diabetes diagnosis among South Asians 
of normal weight (using adjusted-BMI guidelines for Asians) in NYC is more than triple the rates of diabetes among non-Hispanic whites of 
normal weight (10.2% vs 2.9%, respectively).28 Thus, scalable and translatable interventions that promote diabetes management in this population 
may have significant potential for public health impact. 
 
B3. Asian Americans have lower rates of diabetes screening and poorer provider- and self-management of diabetes than other 
communities. Nationally representative data indicates that Asian Americans are the least likely racial and ethnic group to receive recommended 
diabetes screening, with a 34% lower adjusted odds compared to non-Hispanic whites.65 In a population-based study in NYC, we have found that 
Asian Indians have lower average rates of diabetes management practices. 22 Providers were significantly less likely to perform recommended 
guidelines for diabetes management, including feet checks or eye examinations.32 Interventions targeting health systems, primary care physicians, 
and patients are salient for improving diabetes management and outcomes in this community. 
 
B4. Team-based care and intensive diabetes self-management programs in clinical settings are effective in improving Hemoglobin A1c 
(HbA1c). The US Preventive Services Taskforce has found sufficient evidence for three key strategies to improve diabetes management among 
patients including 1) Multi-disciplinary team-based care21 2) Intensive lifestyle (diet or physical activity) interventions coupled with counseling;22
and 3) Identification and tracking of diabetic patients at risk through electronic health record (EHR)-based platforms according to risk and use 

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guidelines. Despite the evidence for these interventions, questions still remain as to the most effective members of the healthcare team to deliver 
lifestyle interventions, mechanisms for the coordination of care within healthcare settings, and the effectiveness of these strategies in LEP 
communities. Further, studies have found that social determinants of health, including low self-efficacy, low social support, food insecurity, and 
poor built environment 15, 70are associated with higher levels of HbA1c (a key clinical marker for diabetes management), suggesting that clinically-
oriented interventions should be coupled with interventions that address patients’ social context. 
 
B5. Incorporating Community health workers (CHWs) into healthcare teams can improve diabetes related outcomes. A substantial body of 
evidence demonstrates that CHWs are viewed as trusted sources of information and can be a natural bridge and effective strategy to disseminate 
efficacious interventions between underserved communities and the health care system. With the advent of the patient-centered medical home 
model, primary care practices (PCPs) increasingly aim to work in an integrated coordinated care manner for patients.31 A growing evidence base 
suggests that the addition of CHWs to the primary care team is a low-cost and cost-effective approach to improve care and adherence for patients 
with chronic disease. 4, 35, 42, 73 A recent review of the impact of CHWs on diabetes management found that on average, CHW interventions 
produce 0.2% reduction in HbA1c with the greatest reduction (>0.5%) among individuals at the most elevated levels.51 A 0.2% reduction in 
HbA1c is associated with 10% reduction in mortality, and 0.5% reductions in HbA1c considered clinically significant.49, 60 In African American 
and Latino communities, studies that have integrated CHWs into clinical teams have demonstrated higher reductions in HbA1c. 25 Our own work 
has demonstrated that a culturally adapted CHW-led intervention in community-based settings is acceptable and efficacious in improving HbA1c 
control, weight loss, self-efficacy and social support, and health behaviors for South Asian 
patients with diabetes.34 The integration of CHWs in clinical settings to support team-based diabetes management for patients, and reimbursement 
options for this workforce, offers a unique opportunity for sustainable, scalable models for diabetes management and linkage to community-based 
resources. 
 
B6. Health information technology (HIT) strategies and EHR data can be leveraged to improve diabetes management and link patients to 
community resources. EHR data can identify candidates for recommended follow-up14 and targeted risk-reducing interventions27, 53, 54and 
facilitate physician referral of patients to counseling and other services. 24, 27, 37, 53, 54 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. 45, 47, 50 EHR-based goal-setting modules, intention exercises, and tailored reminders to encourage 
behavior change during clinical encounters has enhanced provider capacity to counsel patients.40 Recent efforts to use EHR systems and HIT 
strategies to identify, refer and link patients to community resources, including social services, have found it to be feasible, acceptable and 
effective. For example, an EHR-based e-prescribing model that linked patients to community resources according to patient needs generated 
253,479 personalized prescriptions for more than 113,000 participants. Nearly 83% of the recipients found the referral very useful, and 19% of 
them adhered to the referral.41 To date, such models have not been widely implemented in small primary care settings that serve high-risk 
immigrant communities. Furthermore, referral systems may be limited in their ability to appropriately connect to culturally appropriate services for 
linguistically isolated, LEP, and minority populations. 
 
B7. The effect of integrated, multi-level interventions to improve diabetes management has not been well-tested. Recent studies have 
demonstrated that EHR access and communication between the PCP and the CHW can facilitate the acceptance and effectiveness of emerging care 

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that is facilitated by health IT tools, thus expanding their reach, efficiency, and effectiveness. Finally, through a multi-sector partnership that 
represent community, healthcare, payers, and health information technology, the study will disseminate tools, products, and processes to inform 
scalable community-clinical linkage models. 
 
 
C. Study Design 
C1. Overall Design/Clinic Selection/Clinic Enrollment 
We will use a randomized controlled trial design with staggered-entry and a waitlisted control group   to compare the effectiveness of an alert and 
registry-driven CHW-led coaching compared with usual care among patients with HbA1c at > 7%. Randomization will be at the individual-level 
and stratified by PCP, meaning eligible treatment 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 1 (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 
for the treatment group: 1 month for recruitment and enrollment of treatment 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 four 
times (baseline, 6 month, 12 month, and 18 month) for each PCP; we will be comparing EHR data from 443 treatment participants with 443 
control participants. Prior to allocation into treatment group, each treatment participant will be matched to a control participant based on age, 
gender, and BMI. Treatment 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 as a point of service (i.e., not 
for research purposes).  
 
Randomization at each PCP will occur during the first 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.   
 
There are four primary research groups for this study: 1) 446 treatment participants who will receive the CHW intervention; 2) 446 waitlisted 
control participants who may receive the CHW intervention as a point of service at a later point (de-identified EHR data collection only); 3) 40 
subjects who will participate in provider surveys; and 4) 35 subjects who will participate in qualitative key informant interviews.   
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 clinic align 
with the Chronic Care Model.   
EHR Components: This component of the intervention will leverage clinical information systems and 
impact delivery system design by enhancing practice capacity and workflow to implement and use EHR-
based alerts to identify patients with uncontrolled diabetes. The EHR component of the integrated EHR-
CHW intervention will include: 1) An alert to identify South Asian patients with uncontrolled diabetes 
Hb1AC >7 and 2) Generation of registry lists of individuals with A1C >7).  Building upon existing 
protocols the study team will coordinate the implementation of the proposed EHR modifications at 
clinics.  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,6, 7, 20, 43, 44, 68 baseline workflow analysis will be 
conducted at each clinic. 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 clinic. 
Implementation of System Requirements for the Intervention. System requirement definition and 
implementation ensures that various EHR systems across PCP clinics are configured to provide the 
functionality called for by the study design.   The research team will work with a PCP clinics 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 study clinic, 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 the eligibility criteria will be drawn from registry lists and randomized 
to treatment or waitlisted control.  
1. Data collection and consenting with treatment participants 
 
Patients assigned to the treatment 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 screen and  invite them to enroll into the study.  
 
The CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education 
sessions, providing the tools and strategies to manage diabetes. All sessions employ adult learning 
techniques and group-based learning and activities. All session materials have been culturally and 

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linguistically adapted into Bengali, Urdu, Hindi, Punjabi, and Nepali. Sessions will be held remotely via 
audio phone calls via telephone, MCIT approved Zoom or Webex platforms, remote sessions will be 
conducted for the community health worker intervention as a result of the current COVID-19 pandemic. 
Remote sessions are preferred due to limited abilty to properly socially distance in the small offices of the 
participating PCP clinics and community organizations. When clinic restrictions and limitations due to 
COVID-19 have been lifted, a modification to the protocol will be submitted and in person health 
educations session will resume as initially underlined in the protocol. In that cirucumstance sessions will 
be implemented in PCP clinics and ., community spaces identified by partner agencies or at private 
residences with approval from tenants.  
 
Patients will also receive 2 one-on-one phone calls from CHWs to discuss individualized challenges, 
strategies, and action plans for diabetes management and referral to community resources. The tested 
curriculum also incorporates a family-centered approach; for example, family members are invited to 
attend sessions and participate in one-on-one calls. 
 
In addition to 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 Progress Note Form for CHW Intervention). CHWs will also contact patients via text 
messages to communicate study activities via a secure NYULMC phone..  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.).  Participants will also complete the Mobile Phone Use 
Questionnaire to assess the type of phone they use, use of messaging and data capabilities on the phone 
after the first session. This questionnaire will be used to allow the CHWs to communicate with the 
participant according to their preferences and to tailor future interventions. 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 diabetes related event 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 throughtout the 
intervention to encourage ongoing attendance, and incentives will be distributed at program completion 
for individuals who attended all 5 sessions. 
 
Verbal consent (See application for Waiver of Authorization and Documentation of Consent) will be 
obtained via telephone. 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.   
 
Upon completion of the verbal consent, CHW will offer to provide a key information page (see Key 
Information (Patients), this form contains all the elements of  consent and can be provided via text upon 
participant agreement. Clinical measures related to diabetes (e.g., HbA1c, BMI) will be obtained from 
regularly generated diabetes registry lists that practices generate as part of quality improvement initiatives 
and these measures will be tracked over time. In addition, baseline surveys will also be conducted by 
NYU study staff  within two weeks after consent. (See Patient Baseline Survey for CHW Intervention). 
(See CHW Participant Baseline Survey in English and Bengali). An Urdu baseline survey will be 

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submitted for approval in a subsequent modification as translation is in progress. A follow-up survey will 
be completed with treatment participants approximately six months after the start of intervention in order 
to evaluate the effectiveness of the CHW intervention. Survey questions include health access, 
socioeconomic status, personal and family history of Type II diabetes and its risk factors.  Measures will 
be drawn from nationally validated surveys such as the BRFSS survey.56 Translated Bengali and Urdu 
follow-up surveys will be submitted in a subsequent modification.  
 
•Self-efficacy: whether participants feel that they can successfully or competently complete the task of 
seeking screening or prevention services for diabetes and engage in self-management of diabetes.  
Measures will be drawn from the Personal Mastery Scale52, the Rosenberg Self-Esteem Scale (1965), and 
the Bandura Self-Efficacy Scale.     
 
•Social Support:  number of friends and family members in participants’ social network, type of support 
received (e.g., enabling, tangible, emotional support), the density and degree of homogeneity of their 
social network, the use of faith-based organizations or religious counselors for support.  Measures will be 
drawn from the Arizona Social Support Interview Schedule (Barrera 1980, 1981) and the UCLA Social 
Support Interview 23
 
•Spousal Support:  the degree and nature to which participants receive support and encouragement from 
spouses or partners to initiate and/or maintain screening and prevention services.  Measures will be drawn 
from Multi-dimensional Scale of Perceived Support. 74
 
•Knowledge and Health Behaviors:  
•Perceived severity – i.e., diabetes can lead to heart attacks and strokes 
•Perceived susceptibility – i.e., untreated diabetes can lead to renal complications 
•Perceived benefits – i.e., engaging in self-monitoring will reduce the risks of diabetes   
•Perceived barriers – i.e., negative side effects are worth enduring (i.e., barriers do not outweigh benefits) 
•Diabetes risk factors: We will include questions on the importance of self-monitoring, nutrition and diet, 
smoking habits, and exercise patterns.   
 
•COVID-19 Pandemic:  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 health and mental was affected in 
during the pandemic and to understand how best to tailor remote intervention strategies to encourage 
vaccination among patients with diabetes who are at higher risk for complications from COVID-19. 
 
Surveys will take approximately 30 minutes to complete. 
 
2. Data collection and consenting with waitlisted control participants  
The NYU study team will only be collecting de-identified EHR data with control participants 
(n=443). EHR data will include clinical measures related to diabetes (e.g., HbA1c, BMI) and will be 
obtained from regularly generated diabetes registry lists that practices generate as part of quality 
improvement initiatives and these measures will be tracked over time. The PCPs will be conducting 
the de-identification and the link to the unique identifier will remain with the PCP staff. NYU 
study team members will not have access to these links. Beyond EHR data collection, no other 
data collection will occur with control participants (e.g., no survey data collection) and the 
control group will not have any interaction with study personnel for the purposes of research. 
PCPs will invite control participants to CHW education sessions at a later time (post round 1 of 
CHW intervention with treatment participants) as a point of service (i.e., not for research 

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purposes). The PCPs themselves are not involved in the research aside from providing NYU with 
de-identified EHR data. 
C3. Care Coordination Component 
The intervention will support team-based care by creating structured mechanisms for feedback between 
PCPs and CHWs and increasing care coordination that includes three components, adapted from best 
practices noted in other studies. 31,16, 18, 63First, templates will be created that CHWs can complete -
Providers will be given access to these templates which will include: 1) CHW action planning documents 
and individualized counseling conducted during phone calls; and 2) Patient progress in reaching goals 
related to diabetes management. Second, health coaching and referral materials are available to providers 
through the EHR, including 1) Culturally adapted CHW curriculum materials; and 2) Systems to link 
patient to community resources and activities.5, 48, 71Healthify’s tools, as described above, will be used to 
facilitate these feedback mechanisms. Third, CHW communication with the healthcare team will be 
facilitated by participation and report-backs from CHWs.Frequency of participation will be clinic-specific 
and guided by input from the provider and workflow analysis findings to avoid provider burnout. 
 
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 
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. The 
follow up provider survey will also include 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 diabetes who are at higher risk for complications 
from COVID-19) 
The follow up survey will also include questions on cognitive impairment focused on use and knowledge 
of community resources for patients with cognitive impairment, as well as interest in information about 
referrals to resources and opportunities to provide feedback. These (SeeProvider Survey). 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: “Diabetes management 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 the 
online survey software, RedCap, or a paper copy if requested. Providers will be given the option of 
completing provider surveys electronically through a secure Redcap survey link. This data will be stored 
on New York University databases and will only be accessible through a unique secure link sent to an 
individual provider through RedCap’s secure database by a NYU staff. Surveys will take approximately 
15 minutes to complete. 
 
C5. Key Informant Interviews 
Qualitative key informant interviews will be conducted with physician champions at each clinic and/or 
administrator of each clinic, Healthfirst representatives, community advisory board members, research 
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 surveys 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 

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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 diabetes 
who are at higher risk for complications from COVID-19 (See Key Informant Interview Guide - provider 
– remote intervention). The NYU Study team will conduct the interviews.  Questions will be adapted 
from existing validated measures on acceptability, feasibility, adoption, organizational culture, and 
scalability.1-3, 39, 59, 69 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 1066  
This includes a total enrollment of 886 participants in the EHR-CHW Intervention (443 treatment 
participants and 443 wait-list control participants), 80 subjects who participate in the provider surveys and 
100 participants in the key informant interviews.  
 
CHW Intervention  
Inclusion Criteria: Participants will be eligible for study participation if they meet the following criteria:  
a) are of South Asian ethnicity; 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 
months; d) a diagnosis of diabetes and e) an HbA1c reading of >7 in the last 12 months.  
 
Exclusion Criteria: Patients under the age of 21 and older than 75 will be excluded. Pregnant women and 
all visits with an obstetrician gynecologist are excluded.  Patients will be excluded if they were enrolled in 
a CHW led hypertension or diabetes education intervention in the past five years.   
No children or vulnerable subjects will be enrolled in this study. 
Provider Assessment Surveys 
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: clinicians who are unable to complete the survey in the English 
language. 
Key Informant Interviews 
Inclusion criteria for the interviews are as follows: Adult (18 years and over); must be a provider, clinic 
manager, Healthfirst staff, community advisory board member, research 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 

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Clinic Enrollment 
Practices that express interest in participating in the CHW 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 uncontrolled diabetes with HbA1c of >7  
 
5 group-based health education sessions on diabetes management 
 
Provision of culturally and linguistically tailored health information and resources 
 
Two one-on-one in-person meetings and upto 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. 
 
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.5, 48, 71
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 clinic-specific and guided by 
input from the provider and workflow analysis findings in order to avoid provider burn-
out. CHWs will note any diabetes related events (high or low blood sugar events if 
encountered and communicated to the CHW), these will be noted in Encounter Reports.  
 
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
religion/culture) 

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Myths and Facts about diabetes 
 
Signs of Symptoms of Diabetes 
 
Goal-setting 
 
Blood Glucose Levels 
 
Basics on Eating Healthy 
 
Staying motivated and goal-
setting 
Asians 
-risk BMI in Asian communities 
getting diabetes is a natural part of aging) 
rally appropriate images and language 
Discussion of diabetes complications, heart disease, stroke 
-connectedness of chronic diseases  
diet 
foods 
 
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 
 
options for rotis, incorporating fruits and vegetables) 
-fried snacks high in salt and sweets high 
in fat and sugar; substituting sweets with fruits  
 
 
 
etc. 
 
household 
Session 3: Physical Activity 
 Caloric intake and energy balance 
 Benefits and types of exercise 
 Injury prevention 
 Incorporating routines 
 Overcoming barriers 
 Practice activity and goal-setting 
fitness (eg. encouragement to practice similar discipline in physical 
activity as in prayer) 
-based exercise/activities 
 
 
Session 4: Diabetes Management
Diabetes complications
 
Heart disease and stroke 
 
Communicating with the doctor 
 
Preparing for a doctor’s visit 
 
Heart disease and stroke 
 
Staying motivated and goal-
setting 
 
 
Discussion of diabetes 
complications, heart disease, 
stroke 
 
Discussion of prevention and 
inter-connectedness of chronic 
disease  
 
Discussion of cholesterol and 
fats in diet, blood pressure and 
salt in diet
 
Incorporation of culturally appropriates images

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Session 5: Stress and family support
Effects of stress on health
 Stress and anger management 
 Strategies to manage depression 
Family support and goal-setting
 
with mental health (eg. depression) 
 
A2. Data Collection
EHR Data 
Data will be extracted from the PCP clinics’ EHR systems every 6 months.    De-identified EHR data will 
be collected from both treatment and control participants.   
 
The process for collecting de-identified patient data is described here:   This will entail PCP 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, PCP staff will generate a set of unique study identifiers to 
assign to treatment and control 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 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, and laboratory results.   
 
Follow-up height, weight and HbA1c 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. 
 
De-identifed EHR data will include the following:  
o Clinic ID, patient study 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: HbA1c, lipid profile during the study period, Month and year of 
measurement 
 
 
 
All data collection measures and procedures will be the same for treatment participants as control patients 
with the exception that data will no longer be de-identified. PHI and other data will be collected from 
treatment participants and with their full consent only. Treament participants will also have the option to 
authorize staff to take photographs, video and audio for the purpose of disseminating health promotion 
and CHW led health intervention work in the audio/video consent form.  
 

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B. Data Analysis and Data Monitoring
B1.  Aim 1 Analysis
AIM 1: Specific Aim I: Test the effectiveness of a multi-level diabetes management intervention 
compared to usual care. The primary outcome is reduction in HbA1c for patients with baseline HbA1c of 
>7%. The secondary outcomes include enhanced use of community and social services and increased self-
efficacy.
Hypothesis: Individuals receiving the multi-level diabetes management intervention will be more 
likely to achieve >0.5% reduction in HbA1c 6 months following the index office visit than invididuals 
receiving care as usual.
The analysis of the effect of intervention on the outcome measure will proceed using a 
Generalized Linear Mixed Model (GLMM). In particular, we will use a random effects model that 
assumes a binomial 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 clinic at time quarter achieves an HbA1c reduction of 
0.5% or more within six months following the index visit, Y i jt = 0 otherwise. 
is a random effect for 
clinic
with mean 0 and variance 
2 . 
is a time-specific effect of quarter ,
(1,2,…,12). 
is an 
indicator variable, and 
=1 if individual 
receives care under the EHR/CHW intervention, 
=0 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 
=.05. 
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 an intent-to-treat protocol. Sex as a 
biological variable will be addressed by exploring gender as a potential moderator of intervention effects.
Power Calculation:
We conservatively estimate a 10% difference in effect size (i.e.,
) 
comparing treatment and control group participants. Accrual of 886 participants, evenly randomized to 
treatment or control groups, provide greater than 80% power to detect this difference, using a 2-sided, 
0.05-level test (i.e., 44 participants (22 treatment and 22 control participants per PCP). These calculations 
assume 15% loss to follow-up and enrollment of 20 PCPs.
Sampling. Preliminary data from our practice needs assessment indicates that approximately 375 unique 
patients for every six months will have an office visit. Based on our past research, we estimate 40% of 
those individuals will have a Type II Diabetes diagnosis (n=150), and conservatively estimate that only 
40% will meet our eligibility criteria for the study (n=60). In our previous diabetes management CHW 
intervention among South Asians, screening to enrollment rate is 41%. 58 For this study, we apply a 
similar estimate that 40% of patients will be interested in the study and will be contacted by a CHW 
(n=24). Based on retention rates from our CHW studies,9,10,60,68,69,71,89 we estimate that approximately 90% 
of individuals in control and treatment quarters will be followed up at six months (n=22). Thus, for each 
clinics, we will enroll approximately 22 patients every six months over a period of one year, resulting in 
total recruitment of approximately 886 participants across 20 clinics. Thus, approximate CHW caseload 
over a six-month period is 22 participants (about 4 patients per month for a part-time CHW), consistent 
with caseloads from our previous studies.
B2.  Aim 2 Analysis.
Analysis to address this aim will be guided by the following questions:

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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 PCP clinics as well 
as an estimate of the percentage of adoption in terms of patient visits for HbA1c testing. 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 diabetes management? 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 management and 
HbA1C reduction?  
 
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.17 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.17 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).62 The coded transcripts will be analyzed with 
Atlas.ti, a software package for qualitative data analysis.12 Analysis will be conducted to inform best 
practices for scalability that can be replicated by payer organizations and health care systems. 
 

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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. 
 
Treatment 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. A log of consented treatment participants will be stored on REDCap.On the baseline and 
follow-up surveys, the first page of the survey will ask treatment 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 all data 
will be housed on a secure MCIT managed network drives. Pages containing participants name and 
contacts information and logs linking subjects’ identifying information to study numbers will be kept in a 
subject file per IRB regulation in a locked in 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-recordinsg and interview transcrips 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 Prinicipal 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 NCT03333044.  
 
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 key informant audiotapes. All interviews will bestored 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 

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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 managing 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.  
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. 
 
Lorna Thorpe, PhD will serve as a scientific advisor to the study. She has extensive leadership and 
research experience in the field of epidemiology, particularly chronic disease epidemiology, as well as 
with population-based surveillance, interdisciplinary research collaboration, and translation of research 
into policy. Dr. Thorpe will assist with her expertise in intervention design, survey rsearch, and analysis 
of EHR data.  
 

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Andrea Troxel, Sc.D. will serve as the biostatistician for the study. She is the Director of Biostatistics at 
the NYU School of Medicine. She has extensive experience in the design, conduct and analysis of all 
phases of clinical studies. She is also an expert on randomized trials of behavioral economic interventions 
and on adaptive trial designs.  
 
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. 
 
Jennifer Zanowiak, MA is the Senior Project Coordinator 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. 
 
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. 
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 

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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 in Punjabi 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 collaboraters 
Stacy Lindau, MD will serve as a scienfic advisor on the study Steering Committee. . Her translational 
research lab in the biological sciences division at the University of Chicago focuses on the health and 
health care of marginalized populations, using an asset-based community engaged approach. She brings 
expertise in a wide range of quantitative and qualitative data collection and analytic methodologies and 
has used the tools of healthcare delivery science to develop and replicate healthcare-based interventions. 
Specialized areas of leadership and expertise include community-engaged, population-based and clinical 
survey research; national and international population- and and the integration of clinical trials with 
agent- based modeling to evaluate a community-wide, multi-site population health intervention. Dr. 
Lindau will contribute her  expertise to evaluate the facilitators and barriers to community-based self-care 
referrals, including factors influencing referral behaviors and experiences of providers, community health 
workers, and patients, to reduce diabetes disparities among South Asian communities. 
 
Healthify is a leading software provider to health plans, hospitals, and provider networks working in low-
income communities, and has worked with NYU Lutheran, New York Presbyterian Health Systems, and 
Westchester Medical Center to support care management with HIT tools. Healthify has developed 
multiple platforms used by care teams to make quick and accurate referrals to social services for patients 
which will be utilized by the study for the community referral component of the intervention. They will 
also provide reporting and analytics to understand use and adoption of tools and referral success.  
 
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 clinic recruitment and dissemination of educational material.  
 
 
VI.  SUBJECT IDENTIFICATION, RECRUITMENT, AND CONSENT/ASSENT 
 
A. Method of Subject Identification and Recruitment 
 
Treatment participants for CHW intervention  
Patients that meet eligibility criteria will be drawn from registry lists and randomized to treatment or 
waitlisted control. Patients assigned to the treatment group will be sent an invitation letter (See 
Recruitment Letter for CHW Intervention) to participate in the CHW intervention.  Invitation letters 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 informed 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. 
 
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 advisory board members, research 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 mandatory CITI human subjects research training before 
commencing any study-related activities.  
 
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 will be obtained via telephone from 
participants (see Waiver of Authorization and Documentation of Consent and Telephone Consent Form). 
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.   
The CHW will review all the elements of informed consent over this call and (see Telephone Consent 
Form) will offer to provide a key information page subsequently, (see Key Information (Patients)) via text 
message(See Text Message Script). Texts will be sent from a secure NYULMC phone A log of consented 
treatment participants will be stored on REDCap. 
 
CHW Treatment Participants 

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All potential treatment 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. 
 
When COVID 19 limitations and restrictions at the clinics are lifted, the study will return to the in person 
intervention, at that time point a modification will be submitted to revise the protocol to an in person 
intervention. 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. Verbal consent (see Telephone Consent) will be obtained in a location allowing 
privacy and appropriate social distancing, on a one-on-one basis.  
 
 
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. 
Treatment participants will have the option to authorize staff to take photographs, video and audio for the 
purpose of disseminating health promotion and CHW led health intervention work via the verbal consent. 
Videos will be used for the purpose of obtaining testimonials regarding the impact of the program. Video 
and photos will be kept for a period of 5 years after the study closes on MCIT secured drives, only NYU 
study staff will have access to these materials. Participants will have the right to retract permission of the 
use of video, audio, and photos. The retraction of permission will not affect participant involvement in the 
study. Upon retraction of permission, video, audio and or photos will be deleted from MCIT secured 
drives and will no longer be used in any form. 
 
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. 
 
Key Informant Interviews 

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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 and submitted to IRB for 
review and approval via a modification).   
 
 
E. Debriefing Procedures.  
Information will not be withheld from the subjects related to their participation in the study. 
 
F. Consent Forms. Eligible patients will provide verbal consent and enrolled to participate in the study.. 
Please refer to consent forms: Telephone Consent, Key Information (Patients) and Invitation and 
Elements of Consent and Verbal Consent Script documents for the Provider Survey and Key Informant 
Interviews. 
 
G. Documentation of Consent 
CHW Treatment Participants 
Study staff will obtain consent by reading the verbal informed consent script to the subject and the subject 
or will be given adequate opportunity to read it and clarify questions before verbally consenting. The 
subject will receive a copy of the key information sheet by text message with prior approval from the 
participant(See Text Message Script). Texts will be sent from a secure NYULMC phone. A translated 
verbal informed consent and key information sheet will be used for non-English speaking subjects, 
depending on their preferred language(upon approval of the Waiver of Authorization and Documentation 
of Consent Telephone Consent for CHW Intervention in English, Bengali and Urdu; Key Information 
(Patients) in English, Bengali and Urdu)). 
 
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. 
 
 
 
Baseline surveys will also be conducted by NYU study staff  with intervention participants within two 
weeks after consent. A follow-up 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, 
the CHW Intervention 6 month survey will be completed at the last education session.  

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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 treatment 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 NYU study team will only be collecting de-identified EHR data with control participants. 
The PCPs will be conducting the de-identification and the link to the unique identifier will 
remain with the PCP staff. NYU study team members will not have access to these links. Beyond 
EHR data collection, no other data collection will occur with control participants (e.g., no survey 
data collection) and the control group will not have any interaction with study personnel for the 
purposes of research. PCPs will invite control participants to CHW education sessions as a point 
of service (i.e., not for research purposes). For these reasons, we will not be obtaining consent 
with control participants. 
 
 
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. 
 
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 

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Participants will a giftcard for their participation in the 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.   
VII. APPENDIX 
A. Recruitment Letter for CHW Intervention 
B. Script for Telephone Screening for CHW Intervention 
C. Bengali Script for Telephone Screening for CHW Intervention 
D. Urdu Script for Telephone Screening for CHW Intervention 
E. Telephone Screening Form for CHW Intervention 
F. Action Plan 
G. Progress Notes Form for CHW Intervention 
H. One v. One Form  
I. Patient Baseline Survey (English) 
J. Patient Baseline Survey(Bengali) 
K. 6 Month Followup Survey 
L. Provider Survey(baseline and followup) 
M. Key Informant Interview Guide(baseline and followup) 
N.  Telephone Consent for CHW Intervention 
O. Telephone Consent for CHW Intervention Bengali 
P. Telephone Consent for CHW Intervention Urdu 
Q. Invitation and Elements of Informed Consent for Provider Survey 
R. Invitation and Elements of Informed Consent Text for Key Informant Interview 
S. Audio/Video Consent Form 
T. Verbal Consent Script for Key Informant Interview 
U. Application for Waiver of Authorization for Telephone Screening Form 
V. Application for Waiver of Documentation of Consent for Provider Survey and Key 
Informant Interviews 
W. Application for Waiver of Authorization Documentation of Consent 
X. Encounter Report 
Y. Key Information (Patients) 
Z. Key Information Form (Patients) Bengali 
AA. 
Key Information (Patients) Urdu 
BB. Rapid COVID Assessment 
CC. Rapid COVID Assessment – Repeating Form 
DD. 
Mobile Phone Use  
EE. Text Message Script  
FF. Key Informant Interview Guide – CAB 
GG. 
Key Informant Interview Guide – CHW 
HH. 
Key Informant Interview Guide – Staff 
II. Key Informant Interview Guide – Provider – Remote Intervention 
 
 
 
 
 
 
 
 
 
 

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