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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07296952
Acronym
PRONTO-EYE
Enrollment
60
Registered
2025-12-22
Start date
2026-02-03
Completion date
2027-06-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy (DR)

Keywords

diabetic retinopathy (DR), transportation, Medicaid

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.

Interventions

BEHAVIORALPRONTO-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.

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER
National Eye Institute (NEI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Hybrid Type 3 effectiveness-implemementation pilot feasibility trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients that adhere to their scheduled ophthalmology visitsBaseline up to 6 monthsProportion of patients who attend their scheduled ophthalmology visit compared to pre-implementation historical controls.

Secondary

MeasureTime frameDescription
Adoption of PRONTO-EYEAssessed 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.
Appropriateness of PRONTO-EYEImplementation outcomes will be assessed throughout the duration of the studyPerceived 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.
Feasibility of PRONTO-EYEAssessed upon completion of the up to 6-month feasibility trialThe number of rides successfully completed divided by the number of rides scheduled, as assessed via ride logs and observation.
Fidelity of PRONTO-EYEAssessed 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.
Penetration of PRONTO-EyEAssessed 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.
Acceptability of PRONTO-EYEAssessed 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.

Countries

United States

Contacts

CONTACTAngelica Scanzera, OD, MPH
ascanz@uic.edu312-996-3937
CONTACTBhavana Kolli, DHA
312-996-7182

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026