Clinical trial NCT06112431: Eye Health Intervention Study in Upper Manhattan
Official title: Eye Health Intervention Study in Upper Manhattan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glaucoma, Suspect
Diabetic Retinopathy
Cataract
Refractive Errors
Vision Impairment and Blindness
Keywords: Randomized Clinical Trial
Implementation Outcomes
Eye Health Intervention
Glaucoma/Glaucoma Suspect
Eye Health Screenings and Optometric Exams
Leading Causes of Eye Disease
Telehealth Image Reading
Vision Health Policy Roadmap
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2023-11-01
Enrollment: 5840
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Individuals living in Upper Manhattan have limited access to eye care, high vision impairment rates, and poor ocular health outcomes. To improve eye care and vision health outcomes, the Eye Health Intervention Study in Upper Manhattan (EYES-UM) will conduct eye health screenings in accessible primary care health centers and senior centers and implement a behavioral intervention to improve adherence for those referred for in-office eye care. 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. Conducting Focus Groups with health policy stakeholders ensures iterative input during the study to bridge and translate EYES-UM findings into a Vision Health Policy Roadmap for scalable implementation of vision care delivery models, focusing on adherence.

Detailed description: Populations in urban settings such as Upper Manhattan, have limited access to eye care, high vision impairment rates, and poor ocular health outcomes. Our team of vision researchers designed the Eye Health Intervention Study in Upper Manhattan (EYES-UM) to provide eye health screenings directly in Upper Manhattan, in familiar and accessible settings. The proposed innovative, 2:1 cluster-randomized clinical trial, will recruit adults age 40 and older in Upper Manhattan with high rates of inadequate eye care.

A total of 10 settings in Upper Manhattan, comprised of health centers and senior centers, confirms access to 17,000 individuals. 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: In Aim 1, we will evaluate the effectiveness of an Eye Health Intervention to improve access to vision health services in 10 settings in Upper Manhattan. After eye health screenings and optometric exams, we will conduct a 2:1 cluster-randomized clinical trial using an Intervention to provide eye exam scheduling and transportation for those referred to ophthalmology to improve in-office eye exam adherence behavior over 2 years (primary implementation outcome) and eye disease detection (primary clinical effectiveness outcome). In Aim 2, using the RE-AIM Framework, we will evaluate the implementation of the Eye Health Intervention using mixed-methods. Aim 3 includes a proactive implementation science approach to produce a real-world Vision Health Policy Roadmap by conducting Focus Groups with health policy stakeholders to understand evidence needed to develop scalable and sustainable nationwide vision care delivery models and how to incentivize payors to ensure the success of these efforts. The Eye Health Intervention will protect and improve vision health outcomes and provide a sustainable model that can be scaled-up in many settings. By providing basic eye care services and eyeglasses to all participants, simplifying access and supporting utilization of in-office eye care, this innovative research strategy will generate important evidence and a roadmap for policy change to advance vision health. This innovative approach using Focus Groups ensures iterative input during the study to bridge and translate EYES-UM findings into a Vision Health Policy Roadmap for scalable implementation of vision care delivery models, focusing on adherence.

Eligibility criteria: Inclusion Criteria:

* Individuals age 40 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.

Primary outcomes:
measure: Primary Implementation Outcome: Adherence to IN-OFFICE Eye Exam for those referred to ophthalmology
timeFrame: 2 years
measure: Primary Clinical Effectiveness Outcome: Detection of Eye Disease
timeFrame: 2 years
Secondary outcomes:
measure: Return Attendance at Eye Health Screenings at 1, 2, and 3 Years
timeFrame: 1, 2, and 3 years
measure: Follow-up Adherence to Recommended In-office Eye Exams at 1 - 4 Years
timeFrame: 4 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Cuimc/Nyph
state: New York
Study officials:
affiliation: Columbia University Department of Ophthalmology
name: Lisa A. Hark, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: