New York City SIGHT Study-2

Study Overview
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Brief Summary
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Abundant evidence indicates that vision and eye health disparities exist due to a disproportionate eye disease burden among high-risk populations. Columbia University Department of Ophthalmology clinical researchers designed the New York City SIGHT Study (NYC-SIGHT-2) to evaluate Effectiveness of a Telehealth-Based Intervention to Detect and Manage Glaucoma Among High-Risk Populations in Community Health Settings in Upper Manhattan. The program begins with a telehealth-based eye health screening, optometric exam, eyeglasses, and referral to ophthalmology. The telehealth-based intervention uses patient navigators and peer ambassadors to improve eye care access, utilization, and adherence to in-office glaucoma evaluation appointment compared to Usual Care, while the study also explores the experiences of enrolled participants and program staff as well as cost-effectiveness of the intervention.

Detailed Description
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The investigators and an interdisciplinary team with experience in ophthalmology, optometry, biostatistics/data analysis, implementation science, mixed-methods epidemiology, and health outcomes/cost analysis designed NYC-SIGHT-2 to promote eye and vision health equity and address eye health disparities in adults. NYC-SIGHT-2 will be an innovative, comparative effectiveness study with a 2:1 cluster-randomized clinical trial enrolling primarily African American and Hispanic/Latino individuals with high rates of inadequate eye care. A total of 10 community health settings will be included to give access to 17,000 individuals at high-risk of eye disease. Clinical measures (visual acuity, intraocular pressure, fundus images, visual field test and contrast sensitivity), quality-of-life, and falls risk will be assessed. All participants referred to ophthalmology will receive assistance from a Patient Navigator with scheduling an initial in-office glaucoma evaluation appointment and motivational support from a Peer Ambassador (patient with glaucoma), who will calls 2x/year over 2 years.

Official Title
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Effectiveness of a Telehealth-Based Intervention to Detect and Manage Glaucoma Among High-Risk Populations in Community Health Settings (NYC-SIGHT-2)

Conditions
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Adherence to In-Office Glaucoma Evaluation Appointment

Intervention / Treatment
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* Behavioral: Telehealth-Based Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals age 50 years or older. Living independently. Exclusion Criteria: Self-reported terminal illness with life expectancy of less than 1 year. Inability to provide informed consent due to dementia or other reason.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth-Based Intervention Arm<br>Participants randomized to the Telehealth-Based Intervention Arm who require referral to ophthalmology will be teamed up with a Patient Navigator who will provide telehealth-based support with scheduling an in-office glaucoma evaluation at either Columbia University Harkness Eye Institute, Harlem Hospital, or their own eye care provider. Participants will also receive telehealth-based support from a Peer Ambassador, who are individuals from the community with glaucoma or other eye diseases who have expressed interest in sharing their experiences. Each referred participant will receive several telehealth-based calls from a Peer Ambassador over 2 years to discuss their understanding of their new ocular diagnosis and encourage adherence to in-office glaucoma evaluation. | Behavioral: Telehealth-Based Intervention<br>* Participants randomized to the Telehealth-Based Intervention Arm who require referral to ophthalmology will be teamed up with a Patient Navigator who will provide telehealth-based support with scheduling an in-office glaucoma evaluation at either Columbia University Harkness Eye Institute, Harlem Hospital, or their own eye care provider. Participants will also receive telehealth-based support from a Peer Ambassador, who are individuals from the community with glaucoma or other eye diseases who have expressed interest in sharing their experiences. Each referred participant will receive several telehealth-based calls from a Peer Ambassador over 2 years to discuss their understanding of their new ocular diagnosis and encourage adherence to in-office glaucoma evaluation.<br>|
| No Intervention: Usual Care Arm<br>Consented participants from community health centers randomized to the Usual Care Arm will receive all the basic level of services including the telehealth-based eye health screening, optometric exam if they fail the screening, and eyeglasses at no charge. Those who require referral to ophthalmology will be scheduled for the initial in-office glaucoma evaluation and their outcomes will be tracked. No additional support from Patient Navigators or Peer Ambassadors will be provided the the Usual Care participants during the study. The Usual Care Arm represents a realistic choice currently available for participants following eye health screening. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing Adherence to IN-OFFICE Glaucoma Evaluation Appointment | The primary outcome measure for Aim 1 is ADHERENCE TO IN-OFFICE glaucoma evaluation appointment for those referred to ophthalmology and will be measured by appointment attendance at the initial in-office eye exam appointment for those referred to ophthalmology. The unit of measure is the glaucoma evaluation appointment, which will be scheduled within 6-months (+/-4 months) of the referral at either Harkness Eye Institute, Harlem Hospital or their own eye care provider. The measure will assess the rate of adherence at the initial appointment. Comparisons will be made between the Telehealth-Based Intervention Arm and the Usual Care Arm. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Implementation Outcomes of the Telehealth-Based Intervention Arm | Assess implementation outcomes of the Telehealth-Based Intervention Arm, including reach, effectiveness, adoption, implementation, and maintenance (RE-AIM Framework), using mixed-methods for those screened and referred to ophthalmology. We will assess Reach: proportion and characteristics of participants who enrolled and do not enroll in the study; Effectiveness: detection of glaucoma and other eye diseases; Adoption: post-intervention surveys will determine acceptability of the intervention; Implementation: quality control measures will evaluate intervention fidelity and interviews with participants will identify determinants of and perceived barriers to implementation, guided by the Consolidated Framework for Implementation Research; and Maintenance: longitudinal data will evaluate sustained intervention effects. | 1 year | 
| Measures of glaucoma detection and progression | Glaucoma management is dependent on the progression or stability of the disease state. While detecting worsening using conventional methods can take several years, under the leadership of Dr. K. Thakoor's artificial intelligence (AI) laboratory, we have developed generative AI algorithms to predict the appearance of future visual field tests given a baseline visual field test. Thus, with the visual field data captured with the Olleyes system during the eye health screening, we can provide to the participant and provider the predicted appearance of the participant's visual field 1-2, 3-5, or 5-10 years into the future, offering AI-based guidance for next steps of the clinician's management plan as well as education for the patient. Additionally, decline in contrast sensitivity is associated with glaucoma progression. Contrast sensitivity measurements can be similarly extracted from the Olleyes system and tracked longitudinally during in-office glaucoma evaluation appointments. | 1 and 2 years | 
| Return Attendance at Community Eye Health Screening at 1, 2, and 3 Years | As a safety net, all participants will be informed of the future dates of the community eye health screenings, but not required to attend. We hypothesize that participants will return at various intervals (1, 2, and/or 3 times) and we want to understand the demographic, social determinants of health, and clinical characteristics of these participants as well as the frequency of attendance and why they returned and compare to those who do not participate again at the community health setting. The intervals will be 12, 24 or 36 months and we will measure the number and percentage of participants who attend the community eye health screenings over 4 years. We will provide descriptive statistics of participants who return to the eye health screenings at these intervals to understand the characteristics associated with return attendance. | 1, 2, and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community-Based Research, Comparative Effectiveness, Patient Navigator, Glaucoma/Glaucoma Suspect, Telehealth-Based Eye Screening, Peer Ambassador, Telehealth-Based Intervention