Implementing Artificial Intelligence to Prevent Vision Loss From Diabetes

N/AEnrolling By InvitationNCT07559292

University of Wisconsin, Madison1,700 enrolled

Overview

This pragmatic clinical trial is being conducted to test the effectiveness of AI in improving screening and follow-up eye care compared to usual-care among patients with diabetes across 4 primary care clinics. This is an autonomous AI-based screening to detect diabetic eye disease at primary care visits.

Four clinics from two health systems will be recruited, with two clinics from each health system and randomly assigned to either usual-care or the AI Intervention with 2 clinics assigned to each arms. Beginning in month 3, a 6-week baseline period will be conducted in all clinics, followed by a 4-month intervention period for the two clinics assigned to AI. Primary Objective: Compare the odds of patients, who get eye screening in the AI and usual-care arms within 5 months of the recommendation Secondary Objective: 1. Compare the odds of patients, who completed follow-up with recommended eye care in the AI and usual-care arms within 5 months of the recommendation 2. Compare the odds of patients in different demographic groups who receive eye screening in the AI and usual-care arms within 5 months of the recommendation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

1,700

Conditions

Vision Disorders Diabetes

Interventions

AIOTHER

AI-based eye screening program

Usual PracticeOTHER

PCP recommends annual vision screening, a separate visit entirely

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

Clinic Inclusion Criteria: * Serve at least 267 patients with diabetes during the study period * No point-of-care screening system in use for diabetic eye disease * Agree to share limited identifiers data as requested Patient Inclusion Criteria: * Age 22 years or older * Diagnosis of type 1 or 2 diabetes * No known diabetic eye disease * No diabetic eye exam in the past 12 months Exclusion Criteria: * Have a documented eye exam 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

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Proportion of patients who get eye screening in the AI and usual-care arms within 5 months of the recommendation

Time frame: up to 5 months

Secondary Outcomes

Proportion of patients, who completed follow-up with recommended eye care in the AI and usual-care arms within 5 months of the recommendation

Time frame: up to 5 months

Proportion of patients in different demographic groups who receive eye screening in the AI and usual-care arms within 5 months of the recommendation

Time frame: up to 5 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.