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

NCT ID: NCT07296952

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2027-06-01

Brief Summary

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.

Detailed 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.

Conditions

Diabetic Retinopathy (DR)

Keywords

diabetic retinopathy (DR); transportation; Medicaid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PRONTO-EYE rideshare intervention offered

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.

Group Type: EXPERIMENTAL

PRONTO-EYE

Intervention Type: BEHAVIORAL

The PROgram for Non-emergency TranspOrtation (PRONTO) - EYE intervention is a rideshare transportation program designed for patients to get to and from their visits. The intervention includes the rideshare as well as a service blueprint of the offering and how all individuals in the health system interact with it.

Interventions

PRONTO-EYE

The PROgram for Non-emergency TranspOrtation (PRONTO) - EYE intervention is a rideshare transportation program designed for patients to get to and from their visits. The intervention includes the rideshare as well as a service blueprint of the offering and how all individuals in the health system interact with it.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Angel Scanzera

Associate Professor of Ophthalmology and Visual Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Angelica Scanzera, OD, MPH

Role: CONTACT

Phone: 312-996-3937

Email: ascanz@uic.edu

Bhavana Kolli, DHA

Role: CONTACT

Phone: 312-996-7182

Other Identifiers

2023-0960

Identifier Type: -

Identifier Source: org_study_id

K23EY034602

Identifier Type: NIH

Identifier Source: secondary_id

View Link