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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy (DR)
• Intervention / Treatment: Behavioral: PRONTO-EYE

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angelica Scanzera, OD, MPH; Phone Number: 312-996-3937; Email: ascanz@uic.edu
• Study Contact Backup: Name: Bhavana Kolli, DHA; Phone Number: 312-996-7182

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60647
      • Recruiting
      • UI Health
      • Contact: Angelica Scanzera, OD, MPH; Phone Number: 8474012074; Email: ascanz@uic.edu
      • Contact: Bhavana Kolli, DHA; Phone Number: 312-996-7182; Email: bkolli2@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients that adhere to their scheduled ophthalmology visits	Proportion of patients who attend their scheduled ophthalmology visit compared to pre-implementation historical controls.	Baseline up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption of PRONTO-EYE	Uptake and intention to employ the innovation, including percentage of patients who opt into rideshare and stakeholder buy-in, assessed via EHR data and interviews.	Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.
Appropriateness of PRONTO-EYE	Perceived fit, relevance, or compatibility of the intervention for the clinic's mission and patient needs, measured using questions adapted from the Intervention Appropriateness Measure (IAM) survey and interviews.	Implementation outcomes will be assessed throughout the duration of the study
Feasibility of PRONTO-EYE	The number of rides successfully completed divided by the number of rides scheduled, as assessed via ride logs and observation.	Assessed upon completion of the up to 6-month feasibility trial
Fidelity of PRONTO-EYE	Degree to which the PRONTO-EYE transportation intervention was implemented as originally proposed, including adherence to planned processes for ride scheduling, patient eligibility criteria, and staff roles. Assessed via EHR data, program logs, and semi-structured interviews with staff.	Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.
Penetration of PRONTO-EyE	Percentage of eligible patients using PRONTO-EYE among all eligible patients, assessed via EHR data.	Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.
Acceptability of PRONTO-EYE	Perception among implementation stakeholders that the intervention is satisfactory, measured using questions adapted from the Acceptability of Intervention Measure (AIM) survey and semi-structured interviews.	Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Eye Institute (NEI)

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Medicaid; transportation; diabetic retinopathy (DR)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 2023-0960; K23EY034602 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No