Patient Navigator Intervention for Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

— SEEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188703
• Other study ID #: 2000031731
• Secondary ID: 1K23EY030530-01
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: September 2023
• Source: Yale University
• Contact: Kristen Nwanyanwu, MD, MHS
• Phone: 203-785-2020
• Email: k.nwanyanwu[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 1, 2025
• Est. primary completion date: January 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blindness
• Diabetic Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	18 months
Primary	Number of participants who completed a follow-up eye exam 12+ months after baseline eye exam	The number of participants who completed a follow-up eye exam 12+ months after baseline eye exam will be determined using the electronic health record	up to 18 month