Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629649
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AI-RONA
Brief Summary:
The goal of this clinical trial is to learn if implementation of an eye screening program at Federally Qualified Health Center FQHC clinics provides results that participants may have glaucoma andor other eye conditions diabetic retinopathy cataract visual acuity impairment The glaucoma screening will incorporate use of an artificial intelligence AI-assisted screening tool This project is called AI-RONA The main questions it aims to answer are
How does this eye screening program compare to the rate of glaucoma and other eye conditions detected at other FQHC clinics where the screening program has not been implemented
Do particpants who screen positive for these conditions adhere to the physicians recommendation for a follow-up examination by an optometrist or ophthalmologist
Are referral rates for a follow-up comprehensive eye exam by an optometrist or ophthalmologist similar to those implemented by an ophthalmologist using telemedicine that is using the results of the screening to make a diagnosis remotely
What is the cost-effectiveness of the AI-assisted screening program in diagnosing glaucoma as compared to a physician-guided program
Are participants completing the screening satisfied with it
Are physicians at the FQHC clinics administering the screening satisfied with it
Participants will
Undergo an ocular screening whose goal is to detect glaucoma diabetic retinopathy cataract andor impairment in visual acuity If the screening indicates that participants may have these conditions participants will be referred for a comprehensive eye examination by an optometrist or ophthalmologist
Following the screening participants and physicians will complete a survey on their satisfaction with the program
How does this eye screening program compare to the rate of glaucoma and other eye conditions detected at other FQHC clinics where the screening program has not been implemented
Do particpants who screen positive for these conditions adhere to the physicians recommendation for a follow-up examination by an optometrist or ophthalmologist
Are referral rates for a follow-up comprehensive eye exam by an optometrist or ophthalmologist similar to those implemented by an ophthalmologist using telemedicine that is using the results of the screening to make a diagnosis remotely
What is the cost-effectiveness of the AI-assisted screening program in diagnosing glaucoma as compared to a physician-guided program
Are participants completing the screening satisfied with it
Are physicians at the FQHC clinics administering the screening satisfied with it
Participants will
Undergo an ocular screening whose goal is to detect glaucoma diabetic retinopathy cataract andor impairment in visual acuity If the screening indicates that participants may have these conditions participants will be referred for a comprehensive eye examination by an optometrist or ophthalmologist
Following the screening participants and physicians will complete a survey on their satisfaction with the program
Detailed Description:
Federally Qualified Health Center FQHC clinics are excellent candidate clinics for eye disease screening programs for adults including glaucoma and also other glaucoma associated diseases GAD diabetic retinopathy cataract and refractive error These clinics are safety-net primary health care clinics in the United States designed to serve medically underserved areas and populations The physician will provide services regardless of the patients ability to pay using a sliding-scale fee based on the ability to pay Over half the patient population at FQHCs nationally is Black or Hispanic with 82 of patients uninsured or federally insured While FQHCs provide primary medical care in many health domains one domain that is not adequately addressed by FQHC clinics is eye care A recent report by the National Academies of Science Engineering and Medicine indicated that primary eye care services through optometrists or ophthalmologists are rarely available at FQHC clinics the report provided an estimate that less than 3 of FQHC patients actually receive vision care services at these clinics representing 089 of FQHC clinic visits
The screening methods used in this protocol are a modified version of our prior imaging-based ophthalmologist guided telemedicine screening protocol utilized in the previous CDC- funded Alabama Screening and Intervention for Glaucoma and eye Health through Telemedicine AL-SIGHT study In AL-SIGHT we used a telemedicine program to screen for glaucoma in 3 FQHCs located in a low-income under-resourced region of the state with a high proportion of Black residents Just as we did in AL-SIGHT investigators in the current protocol will target screening only for those FQHC patients at-risk for glaucoma The eligibility definition for screening in the current project is listed under Eligibility
After screening patients with a screening diagnosis of GAD diabetic retinopathy cataract or visual acuity impairment will be referred for an in-person follow-up exam by an ophthalmologist or optometrist located in the FQHC clinics region In the investigators previous project participants had excellent adherence to the follow-up appointment with the optometrist or ophthalmology at a rate of 767 of patients attending follow-up Thus Investigators are hopeful that in the current project they will also have this high level of adherence
There are two major differences between our previous project AL-SIGHT and the current project AI-RONA In AL-SIGHT we used research staff members to do the screening at the FQHCs In AI-RONA investigators will now use implementation science to do the screening This means that investigators will train the FQHC clinic staff to do the screening after a detailed training and certification program A second way AI-RONA differs from AL-SIGHT is that investigators will use an AI-assisted remote screening algorithm to generate the screening results for glaucoma Investigators will also focus on both the effectiveness of the program disease detection rate of referrals and primary care providers PCPs and patients attitudes about AI-RONA The latter will be achieved by administering a questionnaire to PCPs and to participants about their satisfaction with the screening program
The AI approaches to be deployed for AI-RONA have been previously developed and extensively tested by the AI-researchers at the University of California San Diego who are also investigators in AI-RONA It was found that glaucoma testing using AI based on retinal images taken of patients eyes lead to clinician-level accuracy These AI methodologies have been tested on diverse populations and publicly available datasets to facilitate their accuracy
The eye screen protocol that investigators are using includes the following All assessments are performed on each eye separately 1 retinal imaging including fundus photography and optical coherence tomography OCT 2 visual acuity measurement 3 refractive error measurement
The screening methods used in this protocol are a modified version of our prior imaging-based ophthalmologist guided telemedicine screening protocol utilized in the previous CDC- funded Alabama Screening and Intervention for Glaucoma and eye Health through Telemedicine AL-SIGHT study In AL-SIGHT we used a telemedicine program to screen for glaucoma in 3 FQHCs located in a low-income under-resourced region of the state with a high proportion of Black residents Just as we did in AL-SIGHT investigators in the current protocol will target screening only for those FQHC patients at-risk for glaucoma The eligibility definition for screening in the current project is listed under Eligibility
After screening patients with a screening diagnosis of GAD diabetic retinopathy cataract or visual acuity impairment will be referred for an in-person follow-up exam by an ophthalmologist or optometrist located in the FQHC clinics region In the investigators previous project participants had excellent adherence to the follow-up appointment with the optometrist or ophthalmology at a rate of 767 of patients attending follow-up Thus Investigators are hopeful that in the current project they will also have this high level of adherence
There are two major differences between our previous project AL-SIGHT and the current project AI-RONA In AL-SIGHT we used research staff members to do the screening at the FQHCs In AI-RONA investigators will now use implementation science to do the screening This means that investigators will train the FQHC clinic staff to do the screening after a detailed training and certification program A second way AI-RONA differs from AL-SIGHT is that investigators will use an AI-assisted remote screening algorithm to generate the screening results for glaucoma Investigators will also focus on both the effectiveness of the program disease detection rate of referrals and primary care providers PCPs and patients attitudes about AI-RONA The latter will be achieved by administering a questionnaire to PCPs and to participants about their satisfaction with the screening program
The AI approaches to be deployed for AI-RONA have been previously developed and extensively tested by the AI-researchers at the University of California San Diego who are also investigators in AI-RONA It was found that glaucoma testing using AI based on retinal images taken of patients eyes lead to clinician-level accuracy These AI methodologies have been tested on diverse populations and publicly available datasets to facilitate their accuracy
The eye screen protocol that investigators are using includes the following All assessments are performed on each eye separately 1 retinal imaging including fundus photography and optical coherence tomography OCT 2 visual acuity measurement 3 refractive error measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None