Providing Financial Incentives to Improve Adherence to Referral Eye Care Visits

NCT ID: NCT04328207

Last Updated: 2025-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2024-07-01

Brief Summary

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Glaucoma is a blinding eye disease increasingly common in older adults, particularly in African Americans, and often diagnosed late in the disease course. It is essential to develop novel health care models, utilizing telemedicine, to improve the ability to detect glaucoma at an earlier stage, and to provide a platform to manage this disease in community-based clinics so that further vision loss is prevented. Our goal is to improve the quality and accessibility of glaucoma detection and management among a vulnerable and at-risk segment of our population.

Detailed Description

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The number of primary open angle glaucoma (POAG) cases will increase by 250% by 2050, directly affecting over 7 million lives. These numbers are specifically for POAG and do not include the many who are monitored and treated for elevated intraocular pressure or for glaucoma suspect status, which along with POAG can all be considered glaucoma associated diseases (GAD). Development of high-quality, accessible, and cost-effective strategies for eye care for these individuals is of critical importance. POAG is at least 4-5 times higher in African Americans, progresses more rapidly and appears about 10 years earlier as compared to those of European descent. This research plan seeks to implement and evaluate a telemedicine-based detection and management strategy for GAD and other eye diseases in patients seen at Federally Qualified Health Centers (FQHC's) located in the rural Alabama Black Belt Region. This region is characterized by one of the highest concentrations of African Americans in the US; high poverty, unemployment, and uninsured rates; inadequate educational systems, transportation and community resources; few optometrists who largely practice in retail settings; and no ophthalmologists specializing in glaucoma. The investigators have developed and tested a novel multimodal telemedicine approach in a prior Centers for Disease Control and Prevention (CDC) funded Eye Care Quality and Accessibility Improvement in the Community (EQUALITY) study that used comprehensive remote optic nerve assessment (RONA). This proposal will employ a modification of the EQUALITY approach using portable measurement of visual function and optic nerve and retinal structure that are more applicable to rural locations with limited resources. The investigators will also identify and evaluate remediation strategies for the barriers to patient adherence with referral and follow-up appointments by comparing the effectiveness of financial incentives along with a validated patient education program versus a validated patient education program alone. Using this program within FQHC's will enable expansion nationwide into rural and urban underserved locations as these centers provide primary health care services in underserved areas and treat more than 27 million people yearly at over 12,000 sites.

Conditions

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Glaucoma Diabetic Retinopathy Refractive Errors Cataract Behavior, Health

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

In the first half of enrollment in the program there will be no financial incentive offered to any patients. In the second half of enrollment, all patients needing referral will be notified that they will receive a payment upon the completion of their referral visit.
Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The investigators are masked as to which group the patient is in.

Study Groups

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No financial incentive

This group will receive standard of care eye health education alone and no financial incentive for completing a referral visit.

Group Type OTHER

No Financial Incentive

Intervention Type OTHER

Standard of care eye health education

Financial incentive

This group will receive a financial incentive once the referral visit is completed (if one was required) as well as eye health education.

Group Type EXPERIMENTAL

Financial Incentive

Intervention Type BEHAVIORAL

Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed.

Interventions

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No Financial Incentive

Standard of care eye health education

Intervention Type OTHER

Financial Incentive

Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed.

Intervention Type BEHAVIORAL

Other Intervention Names

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Standard of Care

Eligibility Criteria

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Inclusion Criteria

* African American or Hispanic ≥40 years
* Non-Hispanic white ≥50 years
* Anyone ≥ 18 years with diabetes
* Anyone ≥ 18 years with a glaucoma associated diagnosis
* Anyone ≥ 18 years with a family history of glaucoma
* All enrollees must be able to speak and understand English

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Cynthia Owsley

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher A Girkin, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Rhodes LA, Register S, Asif I, McGwin G Jr, Saaddine J, Nghiem VTH, Owsley C, Girkin CA. Alabama Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (AL-SIGHT): Study Design and Methodology. J Glaucoma. 2021 May 1;30(5):371-379. doi: 10.1097/IJG.0000000000001794.

Reference Type DERIVED
PMID: 33492893 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://sightstudies.org/

Website describing the research program as well as two other research programs funded by the same mechanism.

Other Identifiers

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1U01DP006441-01-00

Identifier Type: OTHER

Identifier Source: secondary_id

1U01DP006441-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300004921

Identifier Type: -

Identifier Source: org_study_id

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