Providing Financial Incentives to Improve Adherence to Referral Eye Care Visits

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04328207
• Other study ID #: IRB-300004921
• Secondary ID: 1U01DP006441-01-
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: September 29, 2024

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: September 29, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Health
• Cataract
• Diabetic Retinopathy
• Glaucoma
• Refractive Errors

Intervention

Other:
• No Financial Incentive
Standard of care 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants that adhere to referral appointment	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.

External Links

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