Patient Navigator Intervention for Diabetic Retinopathy (SEEN)

Undiagnosed Diabetic Retinopathy: Using Participatory Science to Design an Intervention for Patients at High-Risk for Blindness

This is a pilot study of a patient navigator intervention for people living with diabetes and at high risk of diabetic blindness. The investigators are assessing the feasibility and acceptability of the intervention in preparation for a clinical trial.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy; Diabetic Blindness
• Intervention / Treatment: Behavioral: Patient Navigation

Detailed Description

Evidence-based treatment for Diabetic retinopathy (DR) established 30 years ago decreases the likelihood of blindness by 50%. Outcomes are even better now with emerging therapies and technology. Diabetes remains the leading cause of new cases of legal blindness. 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. Racial and ethnic minorities are less likely to be screened for DR, have a higher prevalence of disease, and more severe disease. 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. Our study answers the National Eye Institute's Strategic Plan request to evaluate disparities by identifying barriers that prevent optimal treatment. 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. 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, the known disparities in screening for DR, and the increased prevalence of sight-threatening DR in Black, Latino, Native, and lower income Americans.

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 and over
• 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

Exclusion Criteria:

• Documented eye exam in the past year
• Not high risk for diabetic retinopathy
• Diabetes diagnosis not recorded in EPIC

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Intervention consists of standard of care eye exam and enrollment in a patient navigation program.	Behavioral: Patient Navigation; Participants will be assigned to a patient navigator and will have quarterly appointments. Patient navigators will assist with access and coordination of medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participant Who Had Baseline Eye Exam	The number of participants who had their baseline eye exam will be determined using the electronic health record	baseline
Percentage of Participants Who Completed a Follow-up Eye Exam 12-18 Months After Baseline Eye Exam	Percentage of participants who completed a follow-up eye exam 12-18 months after baseline eye exam will be determined using the electronic health record	up to 18 month

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Kristen Nwanyanwu, MD, MHS, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): September 19, 2024
• Study Completion (Actual): September 19, 2024

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: diabetic retinopathy; patient navigator; diabetic blindness
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Diabetic Retinopathy; Health Services Administration; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Patient Navigation
• Other Study ID Numbers: 2000031731; 1K23EY030530-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No