NYC-SIGHT-2: New York City SIGHT Study-2
Study Details
Study Description
Brief Summary
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 Telehealth-Based Programs to Detect Glaucoma Among High-Risk Populations in Community Health Settings in Upper Manhattan. The program begins with an eye health screening, optometric exam, eyeglasses, and referral to ophthalmology. The intervention uses patient navigators versus peer ambassadors to improve eye care access, utilization, and adherence to in-office follow-up eye care compared to peer ambassadors, while the study also explores the experiences of enrolled participants and program staff as well as cost-effectiveness of the intervention.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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, hybrid type 1 effectiveness-implementation 2:1 cluster-randomized clinical trial design 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 10,000 community members at high-risk of eye disease. Clinical measures (visual acuity, intraocular pressure, and fundus images), quality-of-life, and falls risk will be assessed. All participants referred to ophthalmology will receive assistance with scheduling an initial in-office eye exam, and those in the Intervention Arm will receive ongoing patient navigator support compared to the Comparator Arm, who will receive phone calls 2x/year from a peer ambassador. The investigators will also assess implementation outcomes and cost-effectiveness.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patient Navigator Patient navigators will support participants referred to ophthalmology after the eye health screening with making, confirming, rescheduling, and reminding about in-office eye exam appointments over 3 years. |
Behavioral: Patient Navigator
Patient navigators will support participants referred to ophthalmology after the eye health screening with making, confirming, rescheduling, and reminding about in-office eye exam appointments over 3 years.
|
| Active Comparator: Peer Ambassador Peer ambassadors will provide 2 phone calls per year over 3 years to participants referred to ophthalmology to discuss their understanding of their new ocular diagnosis. |
Behavioral: Peer Ambassador
Peer Ambassadors who have glaucoma or other eye conditions will provide 2 phone calls per year over 3 years to participants referred to ophthalmology to discuss their understanding of their new ocular diagnosis.
|
Outcome Measures
Primary Outcome Measures
- Adherence to in office eye exam appointment [1 year]
The Outcome Measure is ADHERENCE TO FOLLOW-UP EYE EXAM APPOINTMENT, and will be measured by appointment attendance at the initial eye exam appointment. The unit of measure is the eye exam appointment, which will be scheduled within 6-months of the referral at either Harkness Eye Institute or Harlem Hospital. The measure will assess the rate of adherence at the initial appointment. Comparison will be made between the community health settings randomized to the Intervention Arm compared to community health settings randomized to the Comparator Arm.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals age 40 years or older.
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Living independently in Upper Manhattan
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Attend Community Health Setting Location at least 1 time per year
Exclusion Criteria:
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Self-reported terminal illness with life expectancy of less than 1 year.
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Inability to provide informed consent due to dementia or other reason.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Columbia University
Investigators
- Principal Investigator: Lisa A. Hark, PhD, MBA, Columbia University Department of Ophthalmology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAU9598