Undiagnosed Diabetic Retinopathy: Using Participatory Science to Design an Intervention for Patients at High-Risk for Blindness
Phase: NA
Conditions: Diabetic Retinopathy, Diabetic Blindness
Sponsor: Yale University

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CLINICAL STUDY PROTOCOL
Observational Study of Individual or Group Template
Undiagnosed Diabetic Retinopathy: Using Participatory Science to Design an 
Intervention for Patients at High-Risk for Blindness
 Protocol Number
2000031731
 
Protocol Version
03/25/2022
 Version 3
Confidentiality Statement:
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NCT05188703   

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Protocol Number 2000031731
11/17/2021 version 1
2
Synopsis
Purpose
Evidence-based treatment for Diabetic retinopathy (DR) established 30 years 
ago decreases the likelihood of blindness by 50%.4 Outcomes are even better now with 
emerging therapies and technology.45 Diabetes remains the leading cause of new cases 
of legal blindness.1,2 This study is significant because it investigates the gap between 
published guidelines and the population that continues to go blind despite well-established 
recommendations for screening. Our current model of screening for DR screens much of 
the population appropriately. There is an opportunity to improve DR screening by timely 
identification of persons at risk for preventable blindness. DR disproportionately impacts 
Non-Hispanic Blacks, Latinos, Native Americans, and lower socioeconomic 
communities.14-16,46,47 Racial and ethnic minorities are less likely to be screened for DR,9,10 
have a higher prevalence of disease,11-13 and more severe disease.12-25 There is not a 
clear path toward decreasing these disparities beyond these data. This study addresses 
barriers to the implementation of evidenced-based treatment protocols by identifying 
modifiable patient and population-level challenges and building an intervention 
informed by community members and national data. It is a direct response to the 
“population health imperative” described by the National Academies of Science, 
Engineering, and Medicine.48 Our study answers the National Eye Institute’s Strategic 
Plan request to evaluate disparities by identifying barriers that prevent optimal treatment.49 
It is aligned with the NEI’s mission to support research and training with respect to the 
preservation of sight. The National Institute on Minority Health and Health Disparities 
Research Framework provides the conceptual foundation for our work.50 Our proposal 
identifies facets of the biologic, built, and sociocultural environments of the national 
population with undiagnosed DR. The national analysis informs a local individual-level 
intervention that addresses determinants associated with DR screening. The scientific 
premise of this study is the forty percent of persons with diabetes not screened despite 
established sight-saving treatment,9 the known disparities in screening for DR,9,10 and 
the increased prevalence of sight-threatening DR in Black, Latino, Native, and lower 
income Americans.11
Primary Objective
The primary objective of this study is to design and pilot a patient navigator program to 
increase screening for DR in a high-risk population.
Secondary Objective
To determine the feasibility and accessibility of a patient navigation program for persons 
at high-risk for DR.
Study Design
This is a pilot study of a patient navigator intervention for people living with diabetes and 
at high risk of diabetic blindness. We are assessing the feasibility and acceptability of the 
intervention in preparation for a clinical trial. 
Components. 
The SEEN Program will consist of three components: a clinical assessment, an 
educational experience, and patient navigator assessment and follow-up. 
Clinical assessment. At the initial clinical visit, participants will be presented with the risks 
and benefits of the program and an informed consent will be obtained. Participants will 
undergo a complete dilated eye exam, fundus photography, and a point of care HbA1c 
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test. The eye examination will include visual acuity, intraocular pressure, slit lamp 
examination, and funduscopic examination. Fundus photography will be performed by a 
trained ophthalmic photographer on an Optos California widefield fundus camera. 
Funduscopic images will be read by a board-certified vitreoretinal surgeon. This is all 
considered standard of care for patients with diabetes. Classification of retinopathy will be 
determined by the international clinical diabetic retinopathy severity scale.105 
Educational experience. Participants will be shown the educational audiovisual prototype. 
The content will provide education about DR and the importance of eye exams. The 
prototype will include text and audio. It will provide 10 minutes of content at a 5th grade 
level. A research assistant will be available to answer questions following the 
presentation. Questions beyond the knowledgebase of the research assistant will be 
directed to the principal investigator. 
Patient navigator assessment and follow-up. A trained patient navigator from Project 
Access-New Haven, a local patient navigator organization, will conduct initial 
assessments and follow-up evaluations for participants. Initial visits will include an in-
person assessment and the Rapid Estimate of Adult Literacy in Medicine-Short Form 
literacy evaluation106. Individual barriers to DR screening will be documented. Challenges 
will be addressed to the best of the navigator’s abilities. For example, if the participant is 
experiencing transportation difficulties, the patient navigator team will offer public 
transportation options and transportation alternatives covered by the participant’s 
insurance. The SEEN patient navigator will contact participants quarterly via telephone to 
evaluate ongoing challenges for the first year. After the first year, participants will be 
contacted semi-annually. Contact will be tracked using the Klara secure patient 
management system. After 2 years in the program, participants will be asked to complete 
an exit interview survey (Exit Interview Survey). During the interview, participants will be 
asked to give their thoughts on the structure of the program, the benefits of the program, 
and areas for improvement.
Study Date Range and Duration
The study will begin January 2022 and we anticipate recruitment will continue for 12 
months. Participants enrolled in the study will be followed for 24 months post enrollment.
Number of Study Sites 
Single site, Yale Eye Center
Primary Outcome Variables
The primary independent variable of interest will be eye care utilization at 18 months. 
Participants that have not returned for an eye examination by 18 months will be 
considered underutilizers. Those that have seen an eye care provider in the period after 
the initial assessment before 18 months will be considered normal utilizers. 
Sociodemographic covariates will include age, gender, education level, and health 
insurance status. Clinical covariates will include visual acuity, intraocular pressure, 
presence and stage of diabetic retinopathy, non-healing foot ulcers, kidney failure, 
dialysis, and laboratory values: HbA1c, systolic and diastolic blood pressure. Covariates 
not included in clinical assessment will be abstracted by EMR chart review. Neighborhood 
level variables will be obtained from available census data based on participant address. 
Patient navigation variables include time spent navigating individual participants, number 
of touches (phone calls, meetings, etc.) required to address needs, and outstanding 
barriers not addressed by patient navigators.
Secondary and Exploratory Outcome Variables (if applicable)
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Feasibility. Feasibility will be determined by the ease of enrollment and recruitment, the 
time required for patient navigators to appropriately address participant needs, and the 
ability to meet the needs of the participants. The ease of recruitment will be determined by 
the number available potential participants identified in the EMR, the ease of eligible 
participant identification, and the amount of time required to recruit participants. The first 
ten participants recruited will provide initial data on participant needs. The time required 
by patient navigators to navigate each participant, the number of touches required to 
address participant needs, and the outstanding barriers left unaddressed by patient 
navigators will be identified using the Klara patient management system. At the end of the 
program, we will calculate the percentage of the participants remaining in the program 
and attempt to identify the reasons we were unable to maintain their enrollment. 
Acceptability. The first ten participants will be administered a semi-structured interview to 
assess acceptability at the second quarterly patient navigator follow-up. The interview 
guide (Participant Acceptability Interview Guide) will address barriers to and facilitators of 
participation in the program and opportunities for improvement. Interviews will be 
recorded, transcribed, and organized into themes for evaluation by the research team. 
The patient navigators will be asked to evaluate the program in a semi-structured format 
after 6 months (Patient Navigator Interview Guide). These data will be shared in 
aggregate with the stakeholder design team and the Center for Research and 
Engagement Steering Committee. The Program will be optimized based on findings and 
the committee assessments.
Study Population
Patients ages greater than or equal to 18 years with diabetes in the Yale-New Haven 
Health system are eligible. Patients who have not seen an eye care provider within the 
last year, but have seen other providers, will be designated as under-utilizers of eye care. 
Those that have seen an eye care provider within the last year will be designated as 
normal utilizers. 
New Haven is most demographically similar to the United States based on age, 
educational attainment, and race and ethnicity.107 New Haven is 33% Black, 27% 
Hispanic, and 32% White according to the 2016 Greater New Haven Community Index.108 
These demographics support the generalizability of our results and the probability that we 
will recruit a diverse sample of participants.
Number of Participants
Sixty participants will be recruited. This is a pilot program to evaluate feasibility and 
accessibility. Power calculation will be reserved for randomized controlled clinical trial 
preparation in the future. We used a confidence interval approach109 to determine our 
pilot sample size based on an α=0.05, upper one-sided 80% confidence-limit, 15% 
estimated difference detected, and a final control group participation of 50%. The pilot 
sample size at an 80% confidence interval is 32 participants. Sample size for a future 
main trial is 338 participants. We will recruit sixty participants to allow for drop-out and 
loss to follow-up in a population with a history of underutilization.
Study Schedule
Baseline assessment
Follow-up 3, 6, 9, 12, 18 months post enrollment
Exit interview from the program 24 months post enrollment
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Protocol Revision History
Version 
Date
Summary of Substantial Changes
11/17/2021
Initial application
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Statement of Compliance 
This document is a protocol for a human research study. The purpose of this protocol is to 
ensure that this study is to be conducted according to the Common Rule at 45CFR46 
(human subjects) and other applicable government regulations and Institutional research 
policies and procedures.
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Abbreviations
Abbreviation 
Explanation
DR
Diabetic retinopathy
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Glossary of Terms
Glossary
Explanation
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Table of Contents
Preface....................................................................................................................................2
Synopsis ..................................................................................................................................3
Purpose................................................................................................................................3
Primary Objective.................................................................................................................3
Secondary Objective ............................................................................................................3
Study Design........................................................................................................................3
Study Date Range and Duration ..........................................................................................4
Number of Study Sites .........................................................................................................4
Primary Outcome Variables .................................................................................................4
Secondary and Exploratory Outcome Variables (if applicable)............................................4
Number of Participants.........................................................................................................5
Study Schedule ....................................................................................................................5
Protocol Revision History.....................................................................................................6
Statement of Compliance.........................................................................................................7
Abbreviations ...........................................................................................................................8
Glossary of Terms....................................................................................................................9
1
Background/Literature Review........................................................................................13
1.1
Background .............................................................................................................13
1.2
Prior Experience (if applicable)................................................................................13
2
Rationale/Significance ....................................................................................................14
2.1
Rationale and Study Significance............................................................................14
2.2
Purpose of Study/Potential Impact ..........................................................................14
2.3
Potential Risks and Benefits....................................................................................14
2.3.1
Potential Risks..................................................................................................14
2.3.2
Potential Benefits .............................................................................................15
3
Study Purpose and Objectives .......................................................................................15
3.1
Hypothesis...............................................................................................................15
3.2
Primary Objective ....................................................................................................15
3.3
Secondary Objective (if applicable).........................................................................15
4
Study Design ..................................................................................................................16
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4.1.1
General Design Description .............................................................................16
4.1.2
Study Date Range and Duration ......................................................................16
4.1.3
Number of Study Sites .....................................................................................16
4.2
Outcome Variables..................................................................................................16
4.2.1
Primary Outcome Variables .............................................................................16
4.2.2
Secondary and Exploratory Outcome Variables (if applicable)........................16
4.3
Study Population .....................................................................................................16
4.3.1
Number of Participants.....................................................................................17
4.3.2
Eligibility Criteria/Vulnerable Populations.........................................................17
5
Study Methods/Procedures .........................................................................................18
5.1
Study Procedures....................................................................................................18
5.1.1
Data Collection.................................................................................................18
5.1.2
Adverse Events Definition and Reporting.........................................................18
5.2
Study Schedule .......................................................................................................18
5.3
Informed Consent....................................................................................................19
5.3.1
Screening (if applicable)...................................................................................19
5.3.2
Recruitment, Enrollment and Retention (if applicable).....................................19
5.3.3
Study Visits (is applicable) ...............................................................................19
5.4
Statistical Method ....................................................................................................20
5.4.1
Statistical Design..............................................................................................20
5.4.2
Sample Size Considerations ............................................................................20
5.4.3
Planned Analyses.............................................................................................20
5.4.4
Analysis of Subject Characteristics (if applicable)............................................20
5.4.5
Interim Analysis (if applicable)..........................................................................20
5.4.6
Handling of Missing Data .................................................................................20
6
Trial Administration.........................................................................................................20
6.1
Ethical Considerations: Informed Consent/Assent and HIPAA Authorization .........21
6.2
 Institutional Review Board (IRB) Review................................................................22
6.3
Subject Confidentiality.............................................................................................22
6.4
Deviations/Unanticipated Problems.........................................................................23
6.5
Data Quality Assurance...........................................................................................25
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6.6
Study Records.........................................................................................................25
6.7
Access to Source.....................................................................................................25
6.8
Data or Specimen Storage/Security ........................................................................25
6.9
Retention of Records...............................................................................................25
6.10
Study Monitoring......................................................................................................26
6.11
Study Modification ...................................................................................................26
6.12
Study Completion ....................................................................................................26
6.13
Funding Source .......................................................................................................26
6.14
Conflict of Interest Policy.........................................................................................26
6.15
Publication Plan.......................................................................................................27
Appendices ............................................................................................................................28
List of Tables..........................................................................................................................29
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1 Background/Literature Review
1.1
Background
RESEARCH STRATEGY
SIGNIFICANCE
Evidence-based treatment for DR established 30 years ago decreases the likelihood of 
blindness by 50%.4 Outcomes are even better now with emerging therapies and 
technology.45 Diabetes remains the leading cause of new cases of legal blindness.1,2 This 
study is significant because it investigates the gap between published guidelines and the 
population that continues to go blind despite well-established recommendations for 
screening. Our current model of screening for DR screens much of the population 
appropriately. There is an opportunity to improve DR screening by timely identification of 
persons at risk for preventable blindness. DR disproportionately impacts Non-Hispanic 
Blacks, Latinos, Native Americans, and lower socioeconomic communities.14-16,46,47 Racial 
and ethnic minorities are less likely to be screened for DR,9,10 have a higher prevalence of 
disease,11-13 and more severe disease.12-25 There is not a clear path toward decreasing these 
disparities beyond these data. This study addresses barriers to the implementation of 
evidenced-based treatment protocols by identifying modifiable patient and population-level 
challenges and building an intervention informed by community members and national data. 
It is a direct response to the “population health imperative” described by the National 
Academies of Science, Engineering, and Medicine.48 Our study answers the National Eye 
Institute’s Strategic Plan request to evaluate disparities by identifying barriers that prevent 
optimal treatment.49 It is aligned with the NEI’s mission to support research and training with 
respect to the preservation of sight. The National Institute on Minority Health and Health 
Disparities Research Framework provides the conceptual foundation for our work.50 Our 
proposal identifies facets of the biologic, built, and sociocultural environments of the national 
population with undiagnosed DR. The national analysis informs a local individual-level 
intervention that addresses determinants associated with DR screening. The scientific 
premise of this study is the forty percent of persons with diabetes not screened despite 
established sight-saving treatment,9 the known disparities in screening for DR,9,10 and the 
increased prevalence of sight-threatening DR in Black, Latino, Native, and lower income 
Americans.11
1. Centers for Disease Control and Prevention. National diabetes fact sheet: general 
information and national estimates on diabetes in the United States. Atlanta, GA: U.S. 
Department of Health and Human Services, Centers for Disease Control and Prevention; 
2005.
2. Fong DS, Aiello L, Gardner TW, et al. Diabetic retinopathy. Diabetes Care. 
2003;26(1):226-229.
3. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy 
Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch 
Ophthalmol. 1985;103(12):1796-1806.
4. Techniques for scatter and local photocoagulation treatment of diabetic retinopathy: Early 
Treatment Diabetic Retinopathy Study Report no. 3. The Early Treatment Diabetic 
Retinopathy Study Research Group. Int Ophthalmol Clin. 1987;27(4):254-264.
5. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy 
Study Report no. 4. The Early Treatment Diabetic Retinopathy Study Research Group. Int 
Ophthalmol Clin. 1987;27(4):265-272.
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6. Treatment techniques and clinical guidelines for photocoagulation of diabetic macular 
edema. Early Treatment Diabetic Retinopathy Study Report Number 2. Early Treatment 
Diabetic Retinopathy Study Research Group. Ophthalmology. 1987;94(7):761-774.
7. Diabetic Retinopathy Clinical Research Network, Elman MJ, Aiello LP, et al. Randomized 
trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser 
for diabetic macular edema. Ophthalmology. 2010;117(6):1064-1077 e1035.
8. Diabetic Retinopathy Study Research Group. Report Number 6. Design, methods, and 
baseline results. Invest Ophthalmol Vis Sci. 1981; 21:147-226.
9. Shi Q, Zhao Y, Fonseca V, Krousel-Wood M, Shi L. Racial disparity of eye examinations 
among the U.S. working-age population with diabetes: 2002-2009. Diabetes Care. 
2014;37(5):1321-1328.
10. Elam AR, Lee PP. High-Risk Populations for Vision Loss and Eye Care Underutilization: 
A Review of the Literature and Ideas on Moving Forward. Survey of Ophthalmology. 
2013;58(4):348-358.
11. Zhang X, Saaddine JB, Chou CF, et al. Prevalence of diabetic retinopathy in the United 
States, 2005- 2008. Jama. 2010;304(6):649-656.
* The full reference list as included at the end of this application.
1.2
Prior Experience (if applicable) 
The PI, Dr. Nwanyanwu is a board-certified, subspecialty-trained vitreoretinal surgeon. Her 
past research in diabetic retinopathy 28,39,43 and her review articles on contextual factors 40 
and community engagement 44 have prepared her to carry out this pilot for her K23 career 
development award. 
Specific Aim 1 (completed) and Specific Aim 2 (IRB Protocol# 2000029860) were the 
foundation for this pilot study. 
Publication on Aim 1: Nwanyanwu KMJH, Nunez-Smith M, Gardner TW, Desai MM. 
Awareness of Diabetic Retinopathy: Insight From the National Health and Nutrition 
Examination Survey. Am J Prev Med. 2021 Dec;61(6):900-909. doi: 
10.1016/j.amepre.2021.05.018. Epub 2021 Aug 21. PMID: 34426057; PMCID: 
PMC8608699.
Specific Aim 1: Determine national prevalence of undiagnosed DR with a focus on 
racial and ethnic disparities and geospatial variation. 
Scientific premise for Specific Aim 1. The population with undiagnosed DR is the population 
that is not being screened appropriately. Undiagnosed DR is present in persons with 
diabetes who have not had an eye exam within one year, who have DR on examination, 
and who do not know that they have DR. Our hypothesis is that based on the natural history 
of DR51 this population is more vulnerable to advanced disease and blindness. These 
patients have not been diagnosed with DR. They are less likely to undergo appropriately 
timed treatment and are at increased risk for blindness. The disparities in screening9 and in 
the prevalence of DR11 underlie our hypothesis that there will be a disproportionate number 
of racial and ethnic minorities in the undiagnosed DR population.
Undiagnosed DR has not been examined on a national level. In a population-based, NEI-
funded, cross-sectional study, the Los Angeles Latino Eye Study (LALES) evaluated a 
largely Mexican-American population in six Los Angeles census tracts for undetected eye 
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disease.26 The study diagnosed undetected eye disease in participants who had diabetic 
retinopathy, age-related macular degeneration, glaucoma, cataracts, or refractive error 
on examination and did not report that history during the interview. Nearly 63% had 
undetected eye disease. This was a large, well-designed study that demonstrated the 
magnitude of undiagnosed aggregated eye disease in a minority population. We leverage 
this opportunity to disaggregate these diseases and focus on undiagnosed DR on a national 
level. Several large epidemiologic studies in ophthalmology have addressed the 
prevalence of DR52-57 and disparities in eye disease.56,58 A PubMed literature search did not 
reveal any others that evaluated undiagnosed DR.
Specific Aim 2: Design and pilot a patient navigator program for those at high-risk for 
DR.
Scientific premise of Specific Aim 2. Risk stratification facilitates screening in patients at 
the highest risk for disease. The Diabetes Control and Complications Trial demonstrated the 
benefit of intensive glycemic control in decreasing the likelihood of DR.59 Participants with 
the least glycemic control were at the highest risk for DR. Our group sought to determine 
which factors were associated with the most sight-threatening form of DR. We identified the 
factors associated with progression to the most sight-threatening form of DR using a large 
managed care database.28 We built and internally validated a risk calculator based on our 
findings and known risk factors from large epidemiologic studies. The risk calculator 
accurately predicted progression. There is a gap in the literature as to how risk stratification 
can benefit population-level DR screening in those at high-risk. Our proposal leverages the 
opportunity to use the risk calculator as a risk stratification tool.
The use of patient navigators has potential to increase DR screening and decrease disparities. 
Patient navigators facilitated cancer screen in low income communities60-70, racial and ethnic 
minority populations71-79, and other high-risk populations.80
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2 Rationale/Significance
2.1
Rationale and Study Significance 
Evidence-based treatment for DR established 30 years ago decreases the likelihood of 
blindness by 50%. 4 Outcomes are even better now with emerging therapies and technology. 
45 Diabetes remains the leading cause of new cases of legal blindness.1,2 This study is 
significant because it investigates the gap between published guidelines and the population 
that continues to go blind despite well-established recommendations for screening. Our 
current model of screening for DR screens much of the population appropriately. There is an 
opportunity to improve DR screening by timely identification of persons at risk for 
preventable blindness. DR disproportionately impacts Non-Hispanic Blacks, Latinos, Native 
Americans, and lower socioeconomic communities. 14-16,46,47 Racial and ethnic minorities are 
less likely to be screened for DR,9,10 have a higher prevalence of disease,11-13 and more 
severe disease.12-25 There is not a clear path toward decreasing these disparities beyond 
these data. This study addresses barriers to the implementation of evidenced-based 
treatment protocols by identifying modifiable patient and population-level challenges and 
building an intervention informed by community members and national data. It is a direct 
response to the “population health imperative” described by the National Academies of 
Science, Engineering, and Medicine. 48 Our study answers the National Eye Institute’s 
Strategic Plan request to evaluate disparities by identifying barriers that prevent optimal 
treatment.49 It is aligned with the NEI’s mission to support research and training with respect 
to the preservation of sight. The National Institute on Minority Health and Health Disparities 
Research Framework provides the conceptual foundation for our work.50 Our proposal 
identifies facets of the biologic, built, and sociocultural environments of the national 
population with undiagnosed DR. The national analysis informs a local individual-level 
intervention that addresses determinants associated with DR screening. The scientific 
premise of this study is the forty percent of persons with diabetes not screened despite 
established sight-saving treatment,9 the known disparities in screening for DR,9,10 and the 
increased prevalence of sight-threatening DR in Black, Latino, Native, and lower income 
Americans.11
2.2
Purpose of Study/Potential Impact 
The use of patient navigators has potential to increase DR screening and decrease 
disparities. Patient navigators facilitated cancer screening in low income communities 60-70, 
racial and ethnic minority populations 71-79, and other high-risk populations.80 Patient 
navigators for diabetic populations helped patients navigate the health care system 81-86, 
connected patients to community resources, 87 and improved glycemic control.82,88 
Unpublished institutional KL-2-funded research identified individual, institutional, and 
structural determinants of DR screening in a predominantly racial and ethnic minority patient 
population evaluated in local federally qualified health centers (See preliminary studies).31 
Barriers to care exist in patients at high-risk for DR. Patient navigators have been used in 
similar populations to address similar barriers. Our review of the literature did not reveal any 
studies of patient navigators in DR screening. Our pilot study examines the feasibility and 
accessibility of patient navigation program for persons at high-risk for DR.
2.3
Potential Risks and Benefits
2.3.1
Potential Risks 
The expected risks for each of these studies are minimal. The potential risks are loss of 
confidentiality and stress and anxiety related to interviews and survey evaluation. All audio 
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and survey information will be kept on password-protected, encrypted, University computers 
to decrease the likelihood of breach of confidentiality.
Any violation will be immediately reported to the Yale University Institutional Review Board. 
Participants will be informed that if they wish to stop the interview or survey at any time, they 
may without consequence.
2.3.2
Potential Benefits
Individual participants may benefit from engagement in eye care and screening for diabetic 
retinopathy. The development of an engagement strategy for those at high-risk for diabetic 
retinopathy has the potential to decrease blindness from diabetic eye disease.
3 Study Purpose and Objectives
3.1
Hypothesis
Our central hypothesis is that we can create a feasible and acceptable program to increase 
Diabetic Retinopathy screening in those at high-risk for DR.
3.2
Primary Objective 
The primary objective of this study is to design a patient navigator intervention for those at 
high risk for Diabetic Retinopathy, informed by a national analysis of undiagnosed DR and 
lock a community stakeholders. 
3.3
Secondary Objective
Feasibility. Feasibility will be determined by the ease of enrollment and recruitment, the time 
required for patient navigators to appropriately address participant needs, and the ability to 
meet the needs of the participants. The ease of recruitment will be determined by the 
number available potential participants identified in the EMR, the ease of eligible participant 
identification, and the amount of time required to recruit participants. The first ten 
participants recruited will provide initial data on participant needs. The time required by 
patient navigators to navigate each participant, the number of touches required to address 
participant needs, and the outstanding barriers left unaddressed by patient navigators will be 
identified using the Klara patient management system. At the end of the program, we will 
calculate the percentage of the participants remaining in the program and attempt to identify 
the reasons we were unable to maintain their enrollment. 
Acceptability. The first ten participants will be administered a semi-structured interview to 
assess acceptability at the second quarterly patient navigator follow-up. The interview guide 
(Appendix D, Participant Acceptability Interview Guide) will address barriers to and 
facilitators of participation in the program and opportunities for improvement. Interviews will 
be recorded, transcribed, and organized into themes for evaluation by the research team. 
The patient navigators will be asked to evaluate the program in a semi-structured format 
after 6 months (Appendix E, Patient Navigator Interview Guide). These data will be shared in 
aggregate with the stakeholder design team and the Center for Research and Engagement 
Steering Committee. The Program will be optimized based on findings and the committee 
assessments.
4 Study Design
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4.1.1
General Design Description
Components. The SEEN Program will consist of three components: a clinical assessment, 
an educational experience, and patient navigator assessment and follow-up. 
Clinical assessment. At the initial clinical visit, participants will be presented with the risks 
and benefits of the program and an informed consent will be obtained. Participants will 
undergo a complete dilated eye exam, fundus photography, and a point of care HbA1c test. 
The eye examination will include visual acuity, intraocular pressure, slit lamp examination, 
and funduscopic examination. Fundus photography will be performed by a trained 
ophthalmic photographer on an Optos California widefield fundus camera. Funduscopic 
images will be read by a board-certified vitreoretinal surgeon. This is all standard of care for 
people with diabetes. Classification of retinopathy will be determined by the international 
clinical diabetic retinopathy severity scale.105 Educational experience. Participants will be 
shown an educational audiovisual prototype. The content will provide education about DR 
and the importance of eye exams. The prototype will include text and audio. It will provide 10 
minutes of content at a 5th grade level. A research assistant will be available to answer 
questions following the presentation. Questions beyond the knowledgebase of the research 
assistant will be directed to the principal investigator. 
Patient navigator assessment and follow-up. A trained patient navigator from Project Access 
of New Haven, Inc., a local patient navigator organization, will conduct initial assessments 
and follow-up evaluations for participants. Initial visits will include an in-person assessment 
(Project Navigator In-Person Assessment) and the Rapid Estimate of Adult Literacy in 
Medicine-Short Form literacy evaluation 106. Individual barriers to DR screening will be 
documented. Challenges will be addressed to the best of the navigator’s abilities. For 
example, if the participant is experiencing transportation difficulties, the patient navigator 
team will offer public transportation options and transportation alternatives covered by the 
participant’s insurance. The SEEN patient navigator will contact participants quarterly via 
telephone to evaluate ongoing challenges for the first year. After the first year, participants 
will be contacted semi-annually. Contact will be tracked using the Klara secure patient 
management system. After 2 years in the program, participants will be asked to complete an 
exit interview survey (Exit Interview Survey). During the interview, participants will be asked 
to give their thoughts on the structure of the program, the benefits of the program, and areas 
for improvement.
4.1.2
Study Date Range and Duration
Recruitment will begin in January 2022. We anticipate recruitment will end 12 months after 
enrollment begins. Follow-up will continue until December 2024.
4.1.3
Number of Study Sites
This is a single site study conducted at the Yale Eye Center.
4.2
Outcome Variables
4.2.1
Primary Outcome Variables
The primary independent variable of interest will be eye care utilization at 18 months. 
Participants that have not returned for an eye examination by 18 months will be considered 
underutilizers. Those that have seen an eye care provider in the period after the initial 
assessment before 18 months will be considered normal utilizers. Sociodemographic 
covariates will include age, gender, education level, and health insurance status. Clinical 
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covariates will include visual acuity, intraocular pressure, presence and stage of diabetic 
retinopathy, non-healing foot ulcers, kidney failure, dialysis, and laboratory values: HbA1c, 
systolic and diastolic blood pressure. Covariates not included in clinical assessment will be 
abstracted by EMR chart review. Neighborhood level variables will be obtained from 
available census data based on participant address. Patient navigation variables include 
time spent navigating individual participants, number of touches (phone calls, meetings, etc.) 
required to address needs, and outstanding barriers not addressed by patient navigators.
4.2.2
Secondary and Exploratory Outcome Variables
Feasibility. Feasibility will be determined by the ease of enrollment and recruitment, the time 
required for patient navigators to appropriately address participant needs, and the ability to 
meet the needs of the participants. The ease of recruitment will be determined by the 
number available potential participants identified in the EMR, the ease of eligible participant 
identification, and the amount of time required to recruit participants. The first ten 
participants recruited will provide initial data on participant needs. The time required by 
patient navigators to navigate each participant, the number of touches required to address 
participant needs, and the outstanding barriers left unaddressed by patient navigators will be 
identified using the Klara patient management system. At the end of the program, we will 
calculate the percentage of the participants remaining in the program and attempt to identify 
the reasons we were unable to maintain their enrollment. 
Acceptability. The first ten participants will be administered a semi-structured interview to 
assess acceptability at the second quarterly patient navigator follow-up. The interview guide 
(Appendix D, Participant Acceptability Interview Guide) will address barriers to and 
facilitators of participation in the program and opportunities for improvement. Interviews will 
be recorded, transcribed, and organized into themes for evaluation by the research team. 
The patient navigators will be asked to evaluate the program in a semi-structured format 
after 6 months (Appendix E, Patient Navigator Interview Guide). These data will be shared in 
aggregate with the stakeholder design team and the Center for Research and Engagement 
Steering Committee. The Program will be optimized based on findings and the committee 
assessments.
4.3
Study Population
The study population are adults at high risk for diabetic retinopathy. This requires a 
diagnosis of diabetes and no eye exam in the past year. Adults with diabetes who do not 
have routine eye exams with dilation are at increased risk of preventable blindness.
4.3.1
Number of Participants
N = 60 
We do not know how many participants we will need to screen to enroll 60 participants but 
anticipate enrolling 1 out of every 4 participants screened.
4.3.2
Eligibility Criteria/Vulnerable Populations
The RA will be trained to determine eligibility. They will contact the research manager or PI if 
unsure if participant is eligible or not.
To be eligible for inclusion in the study, an individual must meet all the following criteria:

Adults aged 18 and over
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
Diagnosis of diabetes and record of diagnosis in YNHHS Epic

English-speaking

No documented eye examination within 1 year of study enrollment

High risk for diabetic retinopathy based on risk calculator evaluation
5 Study Methods/Procedures 
5.1
Study Procedures
Participants will be recruited a variety of ways since we are targeting individuals who are not 
currently receiving eye care. We will advertise the study via flyers posted in clinics, 
internet/web postings on our lab’s website, departmental newsletters, YCCI Recruitment 
Database, and social media. We will provide a Qualtrics survey link so a potential participant 
may “opt in” if they are interested in the study. An RA will then reach out via phone to screen 
for eligibility. Additionally, the Project Navigators employed by Project Access – New Haven 
will also refer potentially eligible patients who express interest in the study. Finally, we will 
request JDAT pull a list of all patients in EPIC who meet eligibility criteria. These are people 
in the health system diagnosed with diabetes who have not received eye exams in the past 
12 months. They may or may not be former patients of the Yale Eye Center and/or the PI. 
Via MyChart, a message will be sent to potentially eligible participants. Participants will be able to opt 
in if they wish to be contacted about the study. YCCI will also send a recruitment letter to all potential 
participants with a phone number for the YCCI research recruitment team if they are interested in the 
study. YCCI will then pass interested participants to the study team. Participants will meet with an 
RA at the Yale Eye Center. First, the RA will explain the study, give the participant a chance 
to ask questions and sign consent. The RA will then complete a brief face sheet and 
baseline data collection with the participant. This visit with the RA should take about 20 
minutes.
The RA will check the participant in for the A1c, eye exam, dilation, and fundus photography, 
as part of the standard of care for eye exams for people with diabetes. This part of the visit 
follows the operating procedures of the Yale Eye Center. Visits typically take 2-3 hours.
Before the participant leaves the Eye Center, the RA will give the participant the date and 
time of the appointment with the patient navigator at Project Access, register the participant 
in OnCore for study payment and answer any additional questions. This should only take 
about 5 minutes.
The participant will meet with a patient navigator and complete intake forms for Project 
Access. This visit will take about an hour.
At 3, 6, 9, 12, and 18 months after the enrollment visit, the participant will have an in-person 
or telephone visit with the patient navigator. These visits should take about 30 minutes each. 
After the completion of each of these visits, the visit will be recorded in OnCore and payment 
will be added to the participant’s reloadable Bank of America debit card. 
5.1.1
Data Collection 
Contact information and participant payments will be entered into and processed through 
OnCore. Data will be recorded on paper forms and entered into Qualtrics. Participants will be 
assigned an identifier code to be used on all paper forms and in Qualtrics. Only the PI, 
research manager and research team will have access to the data and the linking identifier 
code for participants. Paper forms will be stored in a locked cabinet in the PI’s locked office 
at 40 Temple Street.
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5.1.2
Adverse Events Definition and Reporting
We do not anticipate any adverse events because of this research. The Yale University 
Institutional Review Board must approve the study before recruitment begins. Participants 
will be engaged in interviews and surveys and a routine eye exam. Medical information will 
be extracted from the electronic medical record. There are no medical or surgical 
interventions in our research program. Nonetheless, if an adverse event occurs, the contact
information of the principal investigator and the research manager will be present on all 
informed consent documentation so that participants may easily contact the team.
5.2
Study Schedule
Intake/enrollment visit (120-180 minutes)
Patient navigator intake (30-60 minutes)
Patient navigation check ins at 3-, 6-, 9-, 12-, and 18-months post enrollment (15-30 
minutes)
5.3
Informed Consent
Consent forms describing in detail the study intervention, study procedures, and risks are 
given to the participant and written documentation of informed consent is required prior to 
starting intervention/administering study intervention. The following consent materials are 
submitted with this protocol:

Compound Authorization

      
5.3.1
Screening (if applicable) 
Potential participants will be screened by the study RA. The RA will speak to the individual to 
confirm diabetes diagnosis, date of diagnosis, date of last eye exam.
5.3.2
Recruitment, Enrollment and Retention
Participants will be recruited a variety of ways since we are targeting individuals who are not 
currently receiving eye care. We will advertise the study via flyers posted in clinics, 
internet/web postings on our lab’s website, departmental newsletters, YCCI Recruitment 
Database, and social media. We will provide a Qualtrics survey link so a potential participant 
may “opt in” if they are interested in the study. An RA will then reach out via phone to screen 
for eligibility. Additionally, the Project Navigators employed by Project Access – New Haven 
will also refer potentially eligible patients who express interest in the study. Finally, we will 
request JDAT pull a list of all patients in EPIC who meet eligibility criteria. These are people 
in the health system diagnosed with diabetes who have not received eye exams in the past 
12 months. They may or may not be former patients of the Yale Eye Center and/or the PI. 
Via MyChart, a message will be sent to potentially eligible participants. Participants will be able to opt 
in if they wish to be contacted about the study. YCCI will also send a recruitment letter to all potential 
participants with a phone number for the YCCI research recruitment team if they are interested in the 
study. YCCI will then pass interested participants to the study team.
Participants will meet with an RA at the Yale Eye Center. First, the RA will explain the study, 
give the participant a chance to ask questions and sign consent. The RA will then complete 
a brief face sheet and baseline data collection with the participant. This visit with the RA 
should take about 20 minutes.
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The RA will check the participant in for the eye exam, dilation, and fundus photography, as 
part of the standard of care for eye exams for people with diabetes. This part of the visit 
follows the operating procedures of the Yale Eye Center. Visits typically take 2-3 hours.
Before the participant leaves the Eye Center, the RA will give the participant the date and 
time of the appointment with the patient navigator at Project Access, give them the gift card 
for completing the intake assessment and answer any additional questions. This should only 
take about 5 minutes.
The participant will meet with a patient navigator and complete intake forms for Project 
Access. This visit will take about an hour.
At 3, 6, 9, 12, and 18 months after the enrollment visit, the participant will have an in-person 
or telephone visit with the patient navigator. These visits should take about 30 minutes each. 
After the completion of each of these visits, a gift card will be mailed to the participant.
5.3.3
Study Visits (if applicable)
Intake/enrollment visit (120 – 180 minutes)

consent reviewed and signed

contact information and baseline data collected

point of care finger stick to test HbA1c

eye exam with dilation and fundus photography
Patient navigator intake (30-60 minutes)

complete patient navigation intake for Project Access
Patient navigation check ins at 3-, 6-, 9-, 12-, and 18-months post enrollment (15-30 
minutes)

These appointments will take place either over the phone or in person with a patient 
navigator from Project Access
5.4
Statistical Method
5.4.1
Statistical Design
Analysis.
Qualitative analysis. Semi-structured interviews will be recorded, transcribed, and organized 
using NVivo software. 110,111 Our research team will code the interviews and comments will 
be categorized into themes.110-114 Themes will be presented to the stakeholder committee to 
guide the iterative development of the program. Community members will contribute their 
experiences and community members on the stakeholder committee will participate in the 
design of the intervention. The expected outcome of this analysis are themes associated
with utilization of DR screening to inform the design of the program.
SEEN Program Analysis. The percentage of underutilization will be calculated in the cohort 
at 18 months. The presenting and incident DR diagnoses and stages will be compared 
between the underutilizer and normal utilizer groups. The mean and standard deviation will 
be calculated for continuous variables and numbers and percentages will be calculated for 
categorical variables. The Pearson’s chi-squared test will be used to compare the 
underutilizers to the now normal utilizers. Multivariable logistic regression analyses will 
determine factors associated with underutilization. Models will be adjusted for age, race and 
ethnicity, gender, and health insurance status. All analyses will be performed using SAS 
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version 9.4 (SAS Institute Inc, Cary, NC). GIS will be used to analyze contextual factors 
associated with underutilization. Patient addresses will be geocoded, quantified, and
categorized, which will allow for overlay of data onto existing locations. US Census data will 
be used to provide neighborhood level data including a calculated Neighborhood deprivation 
index101. ArcGIS software will be used to map the databases. Multivariate statistical analysis 
will be applied to the observation of each unit. The data will be examined using additive 
models and analysis of variance. The expected outcomes of these analyses are
the identification of factors associated with underutilization, a comparison of the population 
of underutilizers and of normal utilizers, and a map of underutilization and normal utilization 
in our pilot population at a neighborhood level.
Underutilization cohort analysis. Participants identified retrospectively as underutilizers in the 
EMR will be compared to normal utilizers. The Pearson’s chi-squared test will be used to 
compare the unadjusted rate of underutilization and normal utilizers. Multivariable logistic 
regression analyses will be performed to determine factors associated with underutilization. 
Models will be adjusted for age, race and ethnicity, gender, health insurance status. All 
analyses will be performed using SAS version 9.4 (SAS Institute Inc, Cary, NC). The
expected outcome of this analysis will be identification of factors associated with utilization of 
DR screening and a comparison of utilization in a cohort of participants in the EMR.
Risk calculator external validation. A cohort of participants with DM will be identified at the 
beginning of the current EMR (2012). Those participants with normal utilization of eye care 
that do not have a diagnosis of DR will be followed through the EMR until the baseline 
assessment of the SEEN Program. Diagnosis of DR will be determined by ICD-9 and ICD-10 
codes. The outcome will be development of DR by the end of the study period. We will apply 
the risk calculator to the cohort and compare the outcomes predicted by the risk calculator to 
the observed outcomes determined by chart review. A statistical comparison of observed 
and predicted risk in this population will determine the R2 and the scaled Brier score, a 
measure of predictive accuracy, the concordance statistic, and discrimination slope.115 All 
analyses will be performed using SAS version 9.4 (SAS Institute Inc, Cary, NC). The 
expected outcome of this analysis is the external validation of this risk calculator in a cohort
without a baseline diagnosis of DR.
The expected outcomes of the approach to Specific Aim #2 are a piloted patient navigator 
program for those at high-risk for DR, a comparison of the factors associated with normal 
utilization and underutilization of DR screening in a retrospective cohort and a high-risk 
prospective cohort, and an external validation of our risk calculator.
5.4.2
Sample Size Considerations
SEEN Program sample size justification. Sixty participants will be recruited. This is a pilot 
program to evaluate feasibility and accessibility. Power calculation will be reserved for 
randomized controlled clinical trial preparation in the future. We used a confidence interval 
approach109 to determine our pilot sample size based on an α=0.05, upper one-sided 80% 
confidence-limit, 15% estimated difference detected, and a final control group participation
of 50%. The pilot sample size at an 80% confidence interval is 32 participants. Sample size 
for a future main trial is 338 participants. We will recruit sixty participants to allow for drop-
out and loss to follow-up in a population with a history of underutilization.
5.4.3
Planned Analyses
See section 5.4.1 above
5.4.4
Analysis of Subject Characteristics (if applicable)
See section 5.4.1 above
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5.4.5
Interim Analysis (if applicable)
N/A
5.4.6
Handling of Missing Data
Every effort will be made to minimize missing data. For analysis, we will impute participants 
are underutilizers if outcomes are missing.
6 Trial Administration 
6.1
Ethical Considerations: Informed Consent/Assent and HIPAA Authorization
Consent forms will be Institutional Review Board (IRB)-approved and the participant/legally 
authorized representative (LAR) will be asked to read and review the document. The 
Research Associate will explain the research study to the participant and answer any 
questions that may arise. This conversation will take place in a private room.
Participants/LAR will have the opportunity to carefully review the written consent form and 
ask questions prior to signing. The participants/LAR should have the opportunity to discuss 
the study with their family or surrogates, or think about it prior to agreeing to participate. The 
participant will sign the informed consent document prior to any procedures being done 
specifically for the study. Participants/LAR must be informed that participation is voluntary 
and that they may withdraw from the study at any time, without prejudice. A copy of the 
informed consent document will be given to the participants/LAR for their records.
Assent will not be conducted. 
6.2
 Institutional Review Board (IRB) Review
This is a prospective research pilot with some retrospective data collection using surveys 
already in use by an established program at Yale New Haven Hospital, a standard of care 
eye exam for people with diabetes, and a point of care finger stick for HbA1c. The protocol 
will be submitted to the IRB for review and approval. Approval of the protocol must be 
obtained before initiating any research activity. Any change to the protocol or study team will 
require an approved IRB amendment before implementation. The IRB will determine 
whether informed consent and HIPAA authorization are required.
A study closure report will be submitted to the IRB after all research activities have been 
completed.
6.3
Subject Confidentiality
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, and the sponsor(s) and their interventions. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party 
without prior written approval of the sponsor.
All research activities will be conducted in as private a setting as possible.
The study monitor, representatives of the Institutional Review Board (IRB), or regulatory 
agencies may inspect all documents and records required to be maintained by the 
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investigator, including but not limited to, medical records (office, clinic, or hospital) for the 
participants in this study. The clinical study site will permit access to such records.
The study participant's contact information will be securely stored at each clinical site for 
internal use during the study. At the end of the study, all records will continue to be kept in a 
secure location for as long a period as dictated by the reviewing IRB, Institutional policies, 
or, if applicable, sponsor requirements.
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored at Yale Secure Box. This will not include the 
participant's contact or identifying information. Rather, individual participants and their 
research data will be identified by a unique study identification number. The study data entry 
and study management systems used will be secured and password protected. At the end of 
the study, all study databases will be de-identified and archived at Yale Secure Box.
6.4
Deviations/Unanticipated Problems
We do not anticipate any adverse events because of this research.
A protocol deviation is any noncompliance with the study protocol. The noncompliance may 
be either on the part of the participant, the investigator, or the study site staff. As a result of 
deviations, corrective actions are to be developed by the site and implemented promptly.
It is the responsibility of the investigator to identify and report deviations within 5 working 
days of identification of the protocol deviation. All deviations must be addressed in study 
source documents, reported to the study sponsor, and the reviewing Institutional Review 
Board (IRB) per their policies.
Unanticipated problems involving risks to participants or others include, in general, any 
incident, experience, or outcome that meets all the following criteria:
•
Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the Institutional Review 
Board (IRB)-approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied;
•
Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and
•
Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously known 
or recognized.
The investigator will report unanticipated problems (UPs) to the reviewing Institutional 
Review Board (IRB) and to the study sponsor. The UP report will include the following 
information: 
•
Protocol identifying information: protocol title and number, PI's name, and the IRB project 
number;
•
A detailed description of the event, incident, experience, or outcome;
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•
An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP;
•
A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the UP.
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:
•
UPs that are serious adverse events (SAEs) will be reported to the IRB and study 
sponsor, if applicable within 5 days of the investigator becoming aware of the event.
•
Any other UP will be reported to the IRB and study sponsor within 5 days of the 
investigator becoming aware of the problem.
•
All UPs should be reported to appropriate institutional officials (as required by an 
institution's written reporting procedures), the supporting agency head (or designee), and 
the Office for Human Research Protections (OHRP) within 5 business days of the IRB's 
receipt of the report of the problem from the investigator.
6.5
Data Quality Assurance
Data will be collected on paper forms and entered into Qualtrics. All research staff will be 
trained by the research manager on data collection and data entry. The research manager 
will perform quality audits on the data collected and entered regularly and provide feedback 
and retraining, if necessary.
6.6
Study Records

JDAT data pulls from EPIC

EPIC data extraction by research staff

Compound Authorization

Interview recordings

SEEN face sheet

Seen intake assessment

Project Access intake assessment

Results from the HbA1c

Results from the eye exam, dilation, and fundus photography
6.7
Access to Source
Source data will be maintained per Medical Records policy in a password protected, secure, 
Health Insurance Portability and Accountability Act (HIPAA) compliant, web-based electronic 
database with a built-in audit trail.
Only Institutional Review Board (IRB) approved research team members who have current 
HIPAA and Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) 
and human subjects protection training will be authorized to access records.
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6.8
Data or Specimen Storage/Security
Contact information will be entered into OnCore. Data will be collected on paper forms and 
entered into Qualtrics managed by Yale. Paper forms will be stored in a locked cabinet in the 
PI’s locked office. Electronic records will be stored in Yale managed OnCore, Qualtrics and 
Secure Box.
6.9
Retention of Records
Research records will be deidentified after data analysis is completed. The linking key will be 
destroyed after main publications are submitted and accepted in case we need to make 
corrections to manuscripts at the requests of reviewers.
6.10 Study Monitoring
The PI and research manager will monitor the study for accuracy and data completeness. 
They will take responsibility for correcting errors in data collection and data entry and 
ongoing training and auditing of research study staff.
6.11 Study Modification
All study modifications will be submitted to IRB and approved by the IRB prior to 
implementing the change.
6.12 Study Completion
Primary data completion should be completed in December 2024. The study should end in 
December 2025. The IRB will be notified when the study 1. Has completed recruitment, 2. Is 
in data analysis only and 3. Is completed.  
6.13 Funding Source – Funded by National Eye Institute (NIH); 5K23EY030530
6.14 Conflict of Interest Policy
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who 
have a role in the design, conduct, analysis, publication, or any aspect of this trial will be 
disclosed and managed. Furthermore, persons who have a perceived conflict of interest will 
be required to have such conflicts managed in a way that is appropriate to their participation 
in the trial. The study leadership in conjunction with the appropriate conflict of interest review 
committee has established policies and procedures for all study group members to disclose 
all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest.
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) must have the 
conflict reviewed by Yale’s COI Committee with a Committee-sanctioned conflict 
management plan that has been reviewed and approved by the study sponsor prior to 
participation in this study. All investigators will follow the applicable conflict of interest 
policies.
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6.15 Publication Plan
Study results will be submitted to journals in the fields of ophthalmology, health 
equity/disparities, and implementation science. Additionally, the PI will submit presentations 
to national conferences in ophthalmology and implementation science.
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Appendices
Appendix #
Title
Section
Topic
N/A
List of Tables
N/A
Literature Review
1.
Centers for Disease Control and Prevention. National diabetes fact sheet: general 
information and national estimates on diabetes in the United States. Atlanta, GA: U.S. 
Department of Health and Human Services, Centers for Disease Control and 
Prevention;2005.
2.
Fong DS, Aiello L, Gardner TW, et al. Diabetic retinopathy. Diabetes Care. 
2003;26(1):226-229.
3.
Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy 
Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch 
Ophthalmol. 1985;103(12):1796-1806.
4.
Techniques for scatter and local photocoagulation treatment of diabetic retinopathy: 
Early Treatment Diabetic Retinopathy Study Report no. 3. The Early Treatment Diabetic 
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