Diabetes Mellitus, Diabetic Retinopathy
Conditions
Keywords
Artificial Intelligence, AI, diabetic eye disease, cluster randomized trial, pragmatic trial, eye screening
Brief summary
This pragmatic clinical trial is being conducted to test the effectiveness of AI-BRIDGE (Artificial Intelligence-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education), in improving screening and follow-up eye care compared to usual-care among patients with diabetes across 8 primary care clinics. AI-BRIDGE is an implementation program which includes an autonomous AI-based protocol that provides screening for diabetic retinopathy (DR) disease at primary care visits, as well as patient education on disease and, if a patient screens positive for referable DR or has insufficient quality image, or image unobtainable due to other technical issues, or does not get AI-screening for any reason, assistance with scheduling an in-person, follow-up eye-care visit.
Detailed description
This study is a parallel cluster randomized clinical trial to determine whether AI-BRIDGE, an autonomous AI-based protocol of screening for DR, improves DR screening and follow-up rates compared to usual care. In this study, DR screening refers to the detection of DR either via referral of patients for an eye-care appointment with an eye-care provider in usual-care or via point-of-care AI-based DR screening for patients in AI-BRIDGE. The trial will be conducted across 8 clinics from four health systems that are Federally Qualified Health Centers. Each clinic will be randomly assigned to either usual care or the AI-BRIDGE intervention. Randomization is done at the clinic level in this study. One of the two clinics within each of the four health systems will be randomly selected to be in the AI-BRIDGE arm (i.e., a total of four clinics will use AI-BRIDGE during the intervention period) and the other clinics will be in the control arm (i.e., a total of four clinics will be in usual care). Primary Objective: Compare the proportion of patients who follow-up with recommended eye care in the AI-BRIDGE and usual-care arms within 6 months of the recommendation. Secondary Objective: Compare the proportion of patients who complete DR screening, defined as: (AI-BRIDGE) an AI-interpretable image obtained at the primary care visit; or, for patients who did not complete AI screening or did not start AI-screening, an in-person screening eye care visit completed within 6 months of the primary care visit; (Usual-care) an in-person screening eye care visit completed within 6 months of the primary care visit.
Interventions
OTHERAI-BRIDGE
AI-BRIDGE intervention includes (1) acquisition of eye photos and autonomous (i.e. without human oversight) AI-based identification of referable or non-referable DR or insufficient image at the primary care clinic, (2) provision of patient educational material identical to that provided to the usual-care group, and (3) clinic champion-led assistance with scheduling eye-care follow-up visits for patients with referable DR or has insufficient quality image, or image unobtainable due to other technical issues, or does not get AI-screening for any reason.
OTHEREducational Materials
Participants in the Usual Care arm will receive educational materials about diabetic retinopathy during the intervention period.
Sponsors
University of Wisconsin, Madison
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Parallel cluster randomized controlled trial. Clinics will be recruited and randomized to either usual care or the AI-BRIDGE intervention. A 4-month baseline period (usual-care screening across all eight clinics) followed by up to 15-month intervention period in which four clinics (one from each health system) are randomized to AI-BRIDGE and four clinics (one from each health system) are randomized to usual-care. Total study duration is 5 years.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinics Inclusion Criteria: * Clinic must be from a health system with at least two clinics that meet eligibility criteria and will agree to join. * Number of unique patients with diabetes should be \>550 over any continuous 15-month period prior to the clinic providing a letter of support to participate in the trial. * No point-of-care screening system in use for DR. * Have an electronic health record to track patient data and agree to share limited data set as requested. * Have a member of the clinical team who can commit to serving as the clinic champion for this study. * Have the IT infrastructure to deploy an artificial-intelligence-based eye camera in the clinic. Patient Inclusion Criteria: * Diagnosis of type 1 or 2 diabetes * No known diabetic retinopathy * No diabetic retinopathy screening in the past 12 months Patient
Exclusion criteria
* Have a documented DR screening in the electronic health record within 12 months of the date of the primary care visit * Contraindication includes diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Follow Up With Recommended Eye Care | up to 6 months | Proportion of patients who follow-up with recommended eye care in the AI-BRIDGE and usual-care arms within 6 months of the recommendation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who complete DR screening | up to 6 months | Proportion of patients who complete DR screening, defined as: (AI-BRIDGE) an AI-interpretable image obtained at the primary care visit; or, for patients who did not complete AI screening or did not start AI-screening, an in-person screening eye care visit completed within 6 months of the primary care visit; (Usual-care) an in-person screening eye care visit completed within 6 months of the primary care visit. |
Countries
United States
Contacts
CONTACTMozhdeh Bahrainian
CONTACTRoomasa Channa
PRINCIPAL_INVESTIGATORRoomasa Channa
UW School of Medicine and Public Health
Outcome results
None listed