A multi-level technology-enabled intervention to improve outcomes in patients with diabetic eye disease

The National Institute for Minority Health and Health Disparities awarded Massachusetts Eye and Ear Infirmary $1,009,557 on August 1, 2026, under the Minority Health and Health Disparities Research program (CFDA 93.307) to conduct a multi-level technology-enabled intervention study comparing hybrid telemedical visits and in-person visits for managing diabetic retinopathy.

The recipient will conduct a single-institution, block-stratified randomized prospective clinical trial enrolling 472 participants with diabetic retinopathy across four study arms: hybrid telemedical visits with or without care navigators, and in-person visits with or without care navigators, followed over three years. Hybrid telemedical visits consist of two-part encounters pairing on-site ophthalmic testing with physician or physician extender consultations delivered via telehealth. All participants will receive gold-standard testing and examinations. The study embeds care delivery models at the organizational level within an existing diabetic retinopathy screening and management program, partners with primary care practices to deliver standard-of-care testing at multiple primary care sites, and assesses the role of care navigators at the individual level. The trial will compare effectiveness of hybrid telemedical and in-person visits for managing diabetic retinopathy in both existing patients and newly identified patients from multiple sites, with progression defined by any advancement in severity stage from baseline.

The period of performance runs August 1, 2026 through July 31, 2031, with performance taking place in Boston, Massachusetts.

Abstract

Diabetic retinopathy (DR) is the leading cause of visual impairment in working-age adults, with many not receiving needed care . While DR can lead to vision loss and blindness, early detection and treatment of vision-threatening retinopathy prevents up to 98% of severe vision loss. T elemedicine can address access and care concerns. While ophthalmic telemedicine is now being used more broadly, IT has not been formally evaluated or compared to exclusively in-person care. We propose a single-institution (with multiple sites) block-stratified randomized prospective clinical trial to compare hybrid telemedical visits (htvs) to in-person visits (ipvs). We will randomize 472 participants with DR to one of four arms: a) HTV with or without care navigators or b) ipvs with or without care navigators and follow them for 3 years. Htvs are two-part encounters consisting of ophthalmic testing followed by a telehealth patients with DR will receive gold-standard tests and examinations in all groups. These interventions will take place at multiple levels. We will embed the care delivery models at the organizational level within an existing organization-wide DR screening and management program, partner with primary care practices, and assess the role of care navigators at the individual level. We designed the interventions with input from patients, and we will enroll patients from multiple primary care sites. S encounter with a physician or physician extender. Progression of DR will be defined by any progression from baseline in the severity stage of DR. Tandard-of-care testing for patients with DR will be available at primary care sites, thereby improving access to care. The specific aims of the study are: (1) to compare the effectiveness of HTV and IPV for managing DR within both existing MEE patients and newly identified patients from multiple sites with and without patient navigators; (2) to compare self-reported patient satisfaction and patient-reported outcomes between HTV and IPV; and (3) to assess access to ophthalmic care for patients receiving HTV and IPV; the primary clinical outcomes will be 1) progression of diabetic retinopathy, 2) incidence of diabetic macular edema (DME), and 3) change in visual acuity, while additional outcomes of interest include patient self-reported satisfaction and vision-related quality of life, as well as access to care as measured by patient travel time, in-person visit time, and rates of missed, canceled, or rescheduled appointments. This will be the first randomized clinical trial to address the critical questions of whether hybrid telemedical care provides non-inferior clinical outcomes, improves patient satisfaction, and improves access to care for patients with chronic eye disease compared to in-person visits. This will also be the first study to address improvements in access to eye care through telemedicine in a primary care setting and the added benefit of providing patient navigators to assist these at-risk patients.