Diabetic Retinopathy (DR)PRONTO-EYENCT07296952
Using Implementation Science to Adapt a Targeted Transportation Intervention for Patients With Diabetic Retinopathy (PRONTO-EYE)
A study testing PRONTO-EYE in people with Diabetic Retinopathy (DR), run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy (DR)
- What is being tested?
- PRONTO-EYE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established patient
- Medicaid insurance
- History of diabetic retinopathy
- Lives within 25 miles of the clinic
- English speaking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bhavana Kolli, DHA contact
United States1 site, 1 recruiting
- Recruiting
UI Health
Chicago, Illinois, 60647
Angelica Scanzera, OD, MPH, 8474012074, ascanz@uic.edu
Bhavana Kolli, DHA, 312-996-7182, bkolli2@uic.edu
About this study
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.
Read the 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.
- Conditions
- Diabetic Retinopathy (DR)
- Being tested
- PRONTO-EYE
- Keywords
- diabetic retinopathy (DR), transportation, Medicaid
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRONTO-EYEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PRONTO-EYE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 6 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start3 Feb 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Hybrid Type 3 effectiveness-implemementation pilot feasibility trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Angel Scanzera, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296952
- Sponsor's protocol ID
- 2023-0960
- Other IDs
- K23EY034602
- Acronym
- PRONTO-EYE
- Status last verified
- Feb 2026
- First submitted
- 17 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Implementation Science to Adapt a Targeted Transportation Intervention for Patients With Diabetic Retinopathy (PRONTO-EYE)
- ClinicalTrials.gov ID
- NCT07296952
- Acronym / sponsor ID
- PRONTO-EYE / 2023-0960
- Conditions
- Diabetic Retinopathy (DR)
- Keywords
- diabetic retinopathy (DR), transportation, Medicaid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hybrid Type 3 effectiveness-implemementation pilot feasibility trial
| Arm | Type | Receives |
|---|---|---|
| PRONTO-EYE rideshare intervention offered | Experimental | Behavioral: PRONTO-EYEAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Established patient
- Medicaid insurance
- History of diabetic retinopathy
- Lives within 25 miles of the clinic
- English speaking
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRONTO-EYEThe 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. | Behavioural | PRONTO-EYE rideshare intervention offered |
Primary outcome
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.
6 secondary outcomes
Adoption of PRONTO-EYE
Time frame: Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.
Appropriateness of PRONTO-EYE
Time frame: Implementation outcomes will be assessed throughout the duration of the study
Feasibility of PRONTO-EYE
Time frame: Assessed upon completion of the up to 6-month feasibility trial
Fidelity of PRONTO-EYE
Time frame: Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.
Penetration of PRONTO-EyE
Time frame: Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.
Acceptability of PRONTO-EYE
Time frame: Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. There are no plans to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bhavana Kolli, DHA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRONTO-EYE in people with Diabetic Retinopathy (DR), run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelica Scanzera, OD, MPH (312-996-3937, ascanz@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that adhere to their scheduled ophthalmology visits (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.