Clinical trial NCT05188703: Patient Navigator Intervention for Diabetic Retinopathy
Official title: Undiagnosed Diabetic Retinopathy: Using Participatory Science to Design an Intervention for Patients at High-Risk for Blindness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Diabetic Blindness
Keywords: diabetic retinopathy
diabetic blindness
patient navigator
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2022-01-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm study. All participants will receive the intervention.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participant who had baseline eye exam
timeFrame: 18 months
measure: Number of participants who completed a follow-up eye exam 12+ months after baseline eye exam
timeFrame: up to 18 month
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Kristen Nwanyanwu, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.