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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH | Ophthal and Visual | Other Identifier | UW Madison | |
| Protocol Version 4/2/24 | Other Identifier | UW Madison |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Patients with diabetes will follow the clinic's usual practice, in which the primary care provider recommends an annual screening eye exam for patients with diabetes. This requires the patient to make a separate visit to see an eye care provider. Clinic staff will provide scheduling assistance per the standard scheduling procedure for the clinic. |
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| AI Intervention | Experimental | AI intervention includes (1) acquisition of eye photos and (2) autonomous (i.e. without human oversight) AI-based identification of referrable or non-referrable eye disease at the primary care clinic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI | Other | AI-based eye screening program |
| |
| Usual Practice |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who get eye screening in the AI and usual-care arms within 5 months of the recommendation | up to 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients, who completed follow-up with recommended eye care in the AI and usual-care arms within 5 months of the recommendation | 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 |
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Clinic Inclusion Criteria:
Patient Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roomsa Channa, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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Parallel cluster randomized control trial
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| Other |
PCP recommends annual vision screening, a separate visit entirely |
|
| up to 5 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |