Clinical trial NCT04328207: Providing Financial Incentives to Improve Adherence to Referral Eye Care Visits
Official title: Using Telemedicine to Prevent Blindness in an At-risk Rural Alabama Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Diabetic Retinopathy
Refractive Errors
Cataract
Behavior, Health
Keywords: telemedicine
teleophthalmology
telehealth
teleglaucoma
financial incentives
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-03-31
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants that adhere to referral appointment
timeFrame: The time frame will be from baseline through 3 years of recruitment in the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Christopher A Girkin, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.