NCT07296952

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Feb 2026Jun 2027

First Submitted

Initial submission to the registry

December 17, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 3, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

December 17, 2025

Last Update Submit

February 25, 2026

Conditions

Keywords

diabetic retinopathy (DR)transportationMedicaid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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.

  • +1 more secondary outcomes

Study Arms (1)

PRONTO-EYE rideshare intervention offered

EXPERIMENTAL

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

Interventions

PRONTO-EYEBEHAVIORAL

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.

PRONTO-EYE rideshare intervention offered

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UI Health

Chicago, Illinois, 60647, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Angelica Scanzera, OD, MPH

CONTACT

Bhavana Kolli, DHA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Hybrid Type 3 effectiveness-implemementation pilot feasibility trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology and Visual Sciences

Study Record Dates

First Submitted

December 17, 2025

First Posted

December 22, 2025

Study Start

February 3, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

There are no plans to make IPD available to other researchers.

Locations