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| ID | Type | Description | Link |
|---|---|---|---|
| K23EY034602 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion. |
| Appropriateness of PRONTO-EYE |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angelica Scanzera, OD, MPH | Contact | 312-996-3937 | ascanz@uic.edu | |
| Bhavana Kolli, DHA | Contact | 312-996-7182 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UI Health | Recruiting | Chicago | Illinois | 60647 | United States |
There are no plans to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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Hybrid Type 3 effectiveness-implemementation pilot feasibility trial
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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. |
| 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. | 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. | 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. | 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. | Assessed continuously throughout the up to 6-month feasibility trial, with a final summary at trial completion. |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |