UI Health
Chicago, Illinois, 60647, United States
Location status: Recruiting
Location contact
Angelica Scanzera, OD, MPH
CONTACT
Bhavana Kolli, DHA
CONTACT
NCT Number: NCT07296952
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60647, United States
Location status: Recruiting
Angelica Scanzera, OD, MPH
CONTACT
Bhavana Kolli, DHA
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: Baseline up to 6 months
Proportion of patients who attend their scheduled ophthalmology visit compared to pre-implementation historical controls.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Angelica Scanzera, OD, MPH
CONTACT
Bhavana Kolli, DHA
CONTACT
University of Illinois at Chicago
Other
Acronym: PRONTO-EYE
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.
Published trials that share one or more normalized conditions with this study.
NCT06843499
Age-related Macular Degeneration (AMD), Cardiovascular Diseases
Taipei, Taiwan
View Trial DetailsNCT07069647
Age-related Macular Degeneration (AMD), Cardiovascular Diseases
Taipei, Taiwan
View Trial DetailsNCT07500324
Age-related Macular Degeneration (AMD), Cardiovascular Diseases
Roma, Italy
View Trial DetailsNCT07378956
Cardiovascular Diseases, Diabete Mellitus
Incheon, Gyeonggi-do, South Korea
View Trial Details