Using Implementation Science to Adapt a Targeted Transportation Intervention for Patients With Diabetic Retinopathy (PRONTO-EYE)

University of Illinois

Status: Not yet enrolling

Conditions: Diabetic Retinopathy (DR)

Treatments: Behavioral: PRONTO-EYE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07296952

K23EY034602 (U.S. NIH Grant/Contract)

2023-0960

Details and patient eligibility

About

This is a a type 3 hybrid effectiveness-implementation pilot study to evaluate the PRONTO-EYE intervention, a rideshare transportation program, in patients with diabetic retinopathy with Medicaid insurance on adherence to ophthalmology visits.

Full description

Vision loss is a public health issue that can limit every aspect of an individual's daily life, including communication, education, independence, mobility, and career goals. Diabetes is the leading cause of new cases of blindness in adults aged 18-64 years, with 1 in 8 adults with diabetes reporting severe visual difficulty or blindness in 2019. Though early detection and treatment can prevent visual impairment by as much as 90%, it is estimated that diabetic retinopathy (DR) is prevalent in 28.5-40.3% of the 37.3 million adults with diabetes in the U.S.

Because enhanced treatment options are available, prompt diagnosis and referral can improve visual outcomes and reduce complications, making adherence to visits critical. While DR treatment options have been shown to reduce complications and improve visual outcomes, barriers to eye care disproportionately affect under-resourced communities, resulting in underutilization of eye care services, delays in treatment, and poorer eye health outcomes.This research addresses a critical gap in our knowledge of how to identify patients with known DR and Medicaid insurance and provide a transportation intervention to get such individuals to needed eye care.

Using human-centered design methods, including qualitative interviews and workshops, journey mapping, and prototyping, investigators co-designed a rideshare intervention, PRONTO-EYE, to improve adherence to eye care visits in Medicaid patients with diabetic retinopathy. Upon completion of user testing, the service blueprint will be updated to meet key design criteria, including viability, feasibility, and desirability.

Investigators plan to conduct a type 3 hybrid effectiveness-implementation pilot study using a pre-post intervention design to evaluate the PRONTO-EYE intervention in Medicaid patients with diabetic retinopathy. Investigators will assess our primary outcome, adherence (defined as completing a scheduled ophthalmology visit), and secondary implementation outcomes, informed by the Proctor model, including acceptability, adoption, appropriateness, feasibility, fidelity, and penetration, through EHR data, surveys, and interviews. Our working hypothesis is that PRONTO-EYE will be successfully integrated into clinical workflows and increase adherence to visits compared to historical controls.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Established patient
• Medicaid insurance
• History of diabetic retinopathy
• Lives within 25 miles of the clinic
• English speaking

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

PRONTO-EYE rideshare intervention offered

Experimental group

Description:

All eligible patients are invited to participate in PRONTO-EYE, a rideshare transportation program designed to improve adherence to eye care visits among Medicaid patients with diabetic retinopathy. All eligible patients are included in this arm regardless of if they decide to use PRONTO-EYE or not.

Treatment:

Behavioral: PRONTO-EYE