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New York City Eye Study (NYCES) (NYCES)

Primary Purpose

Glaucoma, Vision Impairment and Blindness, Cataract

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Using Patient Navigators
Usual Care Without Patient Navigators
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Columbia University Irving Medical Center - 622 W. 168th St. Floor 18

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1: Intervention Using Patient Navigators

Arm 2: Usual Care Without Patient Navigators

Arm 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 and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.

Consented participants referred from the 5 developments randomized to the Usual Care Arm 2 who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. 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.

Outcomes

Primary Outcome Measures

Adherence to Follow-up Eye Care
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 9 developments randomized to the Intervention Arm compared to 5 developments randomized to the Usual Care Arm.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2023
Last Updated
August 7, 2023
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05992415
Brief Title
New York City Eye Study (NYCES)
Acronym
NYCES
Official Title
New York City Eye Study (NYCES)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2024 (Anticipated)
Primary Completion Date
June 30, 2029 (Anticipated)
Study Completion Date
June 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 equity and address eye health disparities in adults age 21+ (PAR-23-009/NOT-EY-22-004).
Detailed Description
The proposed innovative clinical trial will be a hybrid 1, 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), quality-of-life, and falls risk 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 will not receive support from patient navigators. Participants referred to ophthalmology will be followed prospectively for 2 years to evaluate the effectiveness of the intervention on adherence to in-office follow-up eye care (primary outcome), presenting visual acuity and vision-related quality-of-life (secondary outcomes). We will also assess implementation outcomes including acceptability, fidelity, barriers and facilitators with the eye health screenings and optometrist eye exams. The aims of the study are: Aim 1) Evaluate the effectiveness of a community-based intervention that begins with eye health screenings conducted in NYCHA affordable housing developments, followed by a hybrid 1 masked, cluster-randomized clinical trial using patient navigators to improve adherence to follow-up eye care. Aim 2) Assess implementation outcomes of the intervention including reach, adoption, implementation, maintenance, and health equity (RE-AIM) using mixed methodology for those screened and referred to ophthalmology. Aim 3) To determine the costs of the eye health screening and intervention and its cost effectiveness as cost per case detected and cost per participant achieving adherence as well as the intervention's health and social benefits to a densely urban community. Impact: This community-based intervention provides basic level of services to everyone and is specifically addressing a structural issue of access to healthcare by partnering with NYCHA. The study will address vision and eye health disparities by testing the effectiveness of patient navigators to improve follow-up adherence in those who need follow-up eye care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Vision Impairment and Blindness, Cataract, Diabetic Retinopathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The proposed innovative clinical trial will be a hybrid 1, 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.
Masking
Participant
Masking Description
Masking will be conducted by the study biostatistician and is "cluster" randomization by housing development. Using a random number generator, the 5 (masked) developments were chosen for the usual care arm, and the 9 (masked) developments for the intervention.
Allocation
Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Intervention Using Patient Navigators
Arm Type
Active Comparator
Arm 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 and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.
Arm Title
Arm 2: Usual Care Without Patient Navigators
Arm Type
Placebo Comparator
Arm Description
Consented participants referred from the 5 developments randomized to the Usual Care Arm 2 who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. 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.
Intervention Type
Other
Intervention Name(s)
Intervention Using Patient Navigators
Intervention 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 and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.
Intervention Type
Other
Intervention Name(s)
Usual Care Without Patient Navigators
Intervention Description
Consented participants referred from the 5 developments randomized to the Usual Care Arm 2 who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. 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.
Primary Outcome Measure Information:
Title
Adherence to Follow-up Eye Care
Description
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 9 developments randomized to the Intervention Arm compared to 5 developments randomized to the Usual Care Arm.
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa A. Hark, PhD, MBA
Phone
212-342-4586
Email
lah112@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A. Hark
Organizational Affiliation
Columbia University Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center - 622 W. 168th St. Floor 18
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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New York City Eye Study (NYCES)

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