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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 2/20/26 | Other Identifier | UW Madison | |
| A536000 | Other Identifier | UW Madison | |
| 2024-0030 | Other Identifier | UW Madison | |
| 1R01EY035994 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Screening | No Intervention | Primary care providers refer patients with diabetes to an eye care provider for a dilated eye exam. Patients are provided with culturally adapted diabetic eye disease educational materials similar to that provided to patients in the AI-BRIDGE group. | |
| AI-BRIDGE | Experimental | AI-based eye screening program called AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education (AI-BRIDGE). Eye photos of the patients will be obtained in the primary care clinic during a patient's regular primary care visit by a trained technician. Images will be reviewed using autonomous artificial-intelligence (AI) algorithm (Digital Diagnostics). Patients with referrable diabetic retinopathy are detected, and assisted with scheduling an in-person follow-up eye care visits. All patients irrespective of diabetic retinopathy status are also provided culturally adapted educational material on diabetic eye disease. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI | Other | AI-based eye screening program |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 6 months |
| Proportion of Participants By Race and Ethnicity Who Get Eye Screening |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Diabetic Retinopathy | The rate of diabetic retinopathy, count of unique diabetic retinopathy diagnosis divided by count of all enrolled patients, stratified by intervention, intervention and race and ethnicity groups, and intervention, race and ethnicity group, and clinic. | up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mozhdeh Bahrainian | Contact | 608-262-9955 | bahrainian@wisc.edu | |
| Roomasa Channa | Contact | rchanna@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Roomasa Channa | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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A stepped-wedge cluster randomized clinical trial will be conducted to evaluate the effectiveness of two standard diabetic retinopathy screenings across 9 underserved primary care clinics.
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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. |
| up to 6 months |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |