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NCT Number: NCT07296952

Using Implementation Science to Adapt a Targeted Transportation Intervention for Patients With Diabetic Retinopathy (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

PRONTO-EYE

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.

Primary outcomes

  1. 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

  1. Adoption of PRONTO-EYE

    Time frame: Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.

    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.

  2. Appropriateness of PRONTO-EYE

    Time frame: Implementation outcomes will be assessed throughout the duration of the study

    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.

  3. Feasibility of PRONTO-EYE

    Time frame: Assessed upon completion of the up to 6-month feasibility trial

    The number of rides successfully completed divided by the number of rides scheduled, as assessed via ride logs and observation.

  4. Fidelity of PRONTO-EYE

    Time frame: Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.

    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.

  5. Penetration of PRONTO-EyE

    Time frame: Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.

    Percentage of eligible patients using PRONTO-EYE among all eligible patients, assessed via EHR data.

  6. Acceptability of PRONTO-EYE

    Time frame: Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angelica Scanzera, OD, MPH

CONTACT

[email protected]

312-996-3937

Bhavana Kolli, DHA

CONTACT

312-996-7182

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Acronym: PRONTO-EYE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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