Eye Health Intervention Study in Upper Manhattan
- Conditions
- Glaucoma, SuspectDiabetic RetinopathyCataractRefractive ErrorsVision Impairment and Blindness
- Interventions
- Behavioral: Telehealth-Based Intervention
- Registration Number
- NCT06112431
- Lead Sponsor
- Columbia University
- Brief Summary
Our team of vision researchers have designed the Eye Health Intervention Study in Upper Manhattan (EYES-UM) to provide eye health screenings to individuals living in Upper Manhattan. The proposed innovative, 2:1 cluster-randomized clinical trial, will recruit adults age 40 and older in Upper Manhattan with known rates of inadequate eye care. A total of 10 settings in Upper Manhattan, comprised of primary care offices, senior centers, and organizations, confirms access to 17,000 individuals living at or below the NYC.gov poverty measure. This study will conduct ocular tests (visual acuity, intraocular pressure, fundus images) during screenings. To ensure that all participants receive the basic level of service, all participants who fail the eye health screening will be seen the same day by a study optometrist and eyeglasses will be provided at no charge. Educational workshops and an Advisory Board will support recruitment. Intervention Arm participants will receive ongoing support with scheduling eye exams and transportation by trained Study Coordinators. All participants will be followed prospectively for 2 years. The study is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework. An economic analysis will be conducted to evaluate the costs and benefits of the proposed multi-level Eye Health Screening Intervention. This will include calculating the cost per case of eye disease detected (such as glaucoma, cataracts, and retinal conditions) and assess the cost-effectiveness of the Intervention in comparison to Usual Care.
- Detailed Description
The investigators and an interdisciplinary team with experience in clinical research, ophthalmology, optometry, biostatistics/data analysis, implementation science, mixed-methods epidemiology, and health economics designed the study to promote eye and vision health in adults and their families. This is an innovative study with a 2:1 cluster-randomized clinical trial enrolling individuals living in Upper Manhattan with inadequate eye care.
A total of 10 settings, consisting of primary care offices, senior centers, and organizations, 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), and quality-of-life will be assessed. All participants referred to ophthalmology in the Intervention Arm will receive assistance from a Study Coordinator with scheduling an initial in-office eye exam appointment and arranging transportation to these appointments over 2 years.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 5840
- Individuals age 40 years or older.
- Living independently.
- Self-reported terminal illness with life expectancy of less than 1 year.
- Inability to provide informed consent due to dementia or other reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telehealth-Based Intervention Arm Telehealth-Based Intervention 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.
- Primary Outcome Measures
Name Time Method Primary Implementation Outcome: Adherence to IN-OFFICE Eye Exam for those referred to ophthalmology 2 years The primary outcome measure for Aim 1 is ADHERENCE TO IN-OFFICE eye exam 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 eye exam appointment, which will be scheduled within 6-months (+/-4 months) of the referral at either Columbia Ophthalmology, 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 System-Level Intervention Arm and the Usual Care Arm.Primary Clinical Effectiveness Outcome: Detection of Eye Disease 2 years The primary clinical effectiveness outcome measure for Aim 1 is detection of eye disease(s) (glaucoma, retina, other) confirmed by in-office eye exams and will be measured by rates of detection of eye disease(s) for those referred to ophthalmology. All initial in-office eye exams will be scheduled at the conclusion of eye health screenings. Outcome measures will assess rates of eye disease detection, specifically glaucoma/suspect, among those referred to ophthalmology. A comparison will be made between participants living in the 7 community health settings randomized to the System-Level Intervention Arm compared to 3 settings randomized to Usual Care Arm. Participants who request their own eye doctor, the medical release form will be signed, and we will schedule the eye exam, so we can also track attendance.
- Secondary Outcome Measures
Name Time Method Return Attendance at Eye Health Screenings at 1, 2, and 3 Years 1, 2, and 3 years As a safety net, all participants will be informed of the future dates of the 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 eye health screenings over 4 years. We will provide descriptive statistics of participants who re turn to the eye health screenings at these intervals to understand the characteristics associated with return attendance.
Follow-up Adherence to Recommended In-office Eye Exams at 1 - 4 Years 4 years A maintenance measure is adherence to recommended in-office eye exams for those who attend the initial eye exam to determine access to care sustainability and will be reported by randomization group. Adherence will be assessed annually on the basis of the expected follow-up schedule defined at the index visit for that year if the participant attends. In the first year, the follow-up recommendation given by the ophthalmologist will be classified into 1 of 4 categories: return within 2 months, return in 3 to 4 months, return in 6 months, or return in 12 months. This follow-up recommendation will be translated into the corresponding expected number of visits per year: 6, 3, 2, or 1.
Trial Locations
- Locations (1)
Cuimc/Nyph
🇺🇸New York, New York, United States