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Clinical Trials/NCT07296952
NCT07296952Not yet recruitingNot Applicable

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

University of Illinois at Chicago0 sites60 target enrollmentStarted: January 15, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
Number of patients that adhere to their scheduled ophthalmology visits

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of patients that adhere to their scheduled ophthalmology visits

Time Frame: Baseline up to 6 months

Proportion of patients who attend their scheduled ophthalmology visit compared to pre-implementation historical controls.

Secondary Outcomes

  • Adoption of PRONTO-EYE(Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.)
  • Appropriateness of PRONTO-EYE(Implementation outcomes will be assessed throughout the duration of the study)
  • Feasibility of PRONTO-EYE(Assessed upon completion of the up to 6-month feasibility trial)
  • Fidelity of PRONTO-EYE(Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.)
  • Penetration of PRONTO-EyE(Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.)
  • Acceptability of PRONTO-EYE(Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Angel Scanzera

Associate Professor of Ophthalmology and Visual Sciences

University of Illinois at Chicago

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