This study aims to investigate whether a novel artificial intelligence based screening strategy (AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education or AI-BRIDGE), which allows primary care providers to screen patients for vision-threatening diabetic eye disease in the primary care clinic, improves screening and follow-up care rates across race/ethnicity groups and reduces racial/ethnic disparities in screening.
This is a multicenter clinical trial and University of Wisconsin is the coordinating center of the study. A stepped-wedge cluster randomized clinical trial will be conducted. The investigators will evaluate the effectiveness of two standard diabetic retinopathy screening strategies at primary care clinics; (1) AI-based eye screening program called AI-BRIDGE, eye photos of the patients will be obtained in the primary care clinic by trained clinic staff. Images will be reviewed using autonomous artificial-intelligence (AI) algorithm (Digital Diagnostics). Patients with referrable diabetic retinopathy are detected within minutes and patients with referrable disease will be assisted with scheduling an in-person follow-up eye care visit (2) usual care screening, primary care providers refer patients with diabetes to an eye care provider for an in-person dilated eye exam. After adapting AI-BRIDGE protocols to clinics and training of clinic personnel, stepped wedge randomized clinical trial begins with sites transitioning from usual-care to AI-BRIDGE in 4 steps. Primary Objective: * Compare the proportion of patients, by race and ethnicity, who follow-up with recommended eye care in the AI-BRIDGE and usual-care arms within 6 months of the recommendation. Secondary Objectives: * Compare the difference in proportion of White vs Hispanic and White vs Black patients who get screening in the AI-BRIDGE and usual-care arms within 6 months of the recommendation. * Compare proportion of patients, by race and ethnicity, who receive eye screening in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
AI-based eye screening program
UW School of Medicine and Public Health
Madison, Wisconsin, United States
Proportion of Participants Who Follow Up With Recommended Eye Care
Proportion of patients, by race and ethnicity, who follow-up with recommended eye care in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.
Time frame: up to 6 months
Difference in Proportion of White vs Hispanic and White vs Black Participants Who Get Eye Screening
Difference in proportion of White vs Hispanic and White vs Black patients who get AI-BRIDGE and usual-care screening within 6 months of the recommendation.
Time frame: up to 6 months
Proportion of Participants By Race and Ethnicity Who Get Eye Screening
Proportion of Participants by race and ethnicity who get eye screening in the AI-BRIDGE and usual-care arms within 6 months of the recommendation.
Time frame: up to 6 months
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NONE
Enrollment
4,000