Providing Financial Incentives to Improve Adherence to Referral Eye Care Visits

April 12, 2024 updated by: Christopher Girkin, MD, University of Alabama at Birmingham

Using Telemedicine to Prevent Blindness in an At-risk Rural Alabama Population

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: No financial incentive
This group will receive standard of care eye health education alone and no financial incentive for completing a referral visit.
Other: No Financial Incentive
Standard of care eye health education
Other Names:
  • Standard of Care
Experimental: 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.
Behavioral: Financial Incentive
Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants that adhere to referral appointment
Time Frame: The time frame will be from baseline through 3 years of recruitment in the study.
The percentage of patients who adhere to attending their referral appointments who received a financial incentive and eye health education will be compared with the percentage of patients who adhere to attending their referral appointments who received standard of care eye health education alone and no financial incentive for completing a referral visit.
The time frame will be from baseline through 3 years of recruitment in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Christopher A Girkin, MD, MSPH, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Actual)

December 1, 2023

Study Completion (Estimated)

September 29, 2024

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300004921
  • 1U01DP006441-01-00 (Other Identifier: Centers for Disease Control)
  • 1U01DP006441-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To be determined at a later point.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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