New York City Eye Study (NYCES)

Columbia University

Status: Begins enrollment this month

Conditions: Vision Impairment and Blindness; Cataract; Glaucoma; Diabetic Retinopathy

Treatments: Other: Usual Care Without Patient Navigators; Other: Intervention Using Patient Navigators

Study type: Interventional

Funder types: Other

Identifiers

NCT05992415

AAAU8104

Details and patient eligibility

About

Dr. Lisa A. Hark (PI and Study Chair) and an interdisciplinary team have designed the New York City Eye Study (NYCES) to promote eye and vision health by conducting eye health screenings in adults age 21+ (PAR-23-009/NOT-EY-22-004).

Full description

The proposed innovative clinical trial will be a hybrid 2, masked, 2:1 cluster-randomized design (by housing development) comprised of adults age 21+ of diverse race/ethnicity (primarily African American and Hispanic/Latino) with high rates of inadequate eye care.(Curran 2012) A total of 14 NYCHA developments confirm access to 43,273 residents living at or below the NYC.gov poverty measure.(NYC Mayor Clinical measures (visual acuity, intraocular pressure, and fundus images), and quality-of-life will be assessed. To ensure that all community members receive the basic level of service, all participants who fail the eye health screening will be seen the same day by the study optometrist and eye glasses will be provided at no charge. All participant referred to ophthalmology will be assisted with scheduling their initial in-office eye exam appointment. Participants referred in the 9 developments randomized to the Intervention Arm will receive ongoing support from a patient navigator to assist with follow-up eye care; those referred in the 5 developments randomized to the Usual Care Arm + Automated Reminders, but will not receive support from patient navigators. The aims of the study are:

Aim 1) Using a type 2 hybrid design, evaluate the Effectiveness of a community-based intervention that begins with eye health screenings conducted at NYCHA affordable housing developments, followed by a 2:1 cluster-randomized clinical trial using Patient Navigators to increase: (a) Adherence to in-office eye exams for those referred to ophthalmology (Implementation outcome) and (b) Detection of eye disease(s) (glaucoma, retina, other) confirmed by the in-office eye exams (Clinical effectiveness outcome).

Aim 2: Assess Reach, Adoption, and Implementation using a mixed-methods study for those screened and referred to ophthalmology. Hypothesis: Assessing implementation outcomes and comparing among developments using a type 2 hybrid design will inform future intervention implementation.

Aim 3: Focusing on the Maintenance portion of RE-AIM, determine the costs and cost-effectiveness of eye health screenings and intervention, defined as cost per case detected, cost per participant achieving adherence, and sustainability at 1-4 years.

Impact: This community-based intervention addresses vision and eye health disparities by providing a basic level of services to all participants and addresses a structural issue of access to eye care by partnering with NYCHA. The evidence generated from this RCT has the potential to provide a roadmap for policy change.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals age 21 and older.
• Living independently in an affordable housing development and surrounding neighborhoods.

Exclusion criteria

• Self-reported terminal illness with life expectancy less than 1 year.
• Inability to provide informed consent due to dementia or other reasons.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10,000 participants in 2 patient groups, including a placebo group

Arm 1: Intervention Using Patient Navigators

Active Comparator group

Description:

Consented participants referred to ophthalmology from the 9 developments randomized to the Intervention Arm will receive ongoing support from patient navigators to assist with all aspects of follow-up eye care at either Columbia Harkness Eye Institute or Harlem Hospital Ophthalmology, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.

Treatment:

Other: Intervention Using Patient Navigators

Arm 2: Usual Care + Automated Appointment Reminders

Placebo Comparator group

Description:

Consented participants referred from the 5 developments randomized to the Usual Care Arm +Automated Appointment Reminders who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Columbia Harkness Eye Institute or Harlem Hospital Ophthalmology. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence. Arm 2 represents a realistic choice available for participants following screening over a 1-year period.

Treatment:

Other: Usual Care Without Patient Navigators