Providing Financial Incentives to Improve Adherence to Referral Eye Care Visits

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04328207
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
1,000
Enrollment
1
Location
2
Arms
45.4
Anticipated Duration (Months)
22
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: No Financial Incentive
  • Behavioral: Financial Incentive
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
The investigators are masked as to which group the patient is in.
Primary Purpose:
Screening
Official Title:
Using Telemedicine to Prevent Blindness in an At-risk Rural Alabama Population
Actual Study Start Date :
Nov 18, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

ArmIntervention/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.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants that adhere to referral appointment [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Alabama at BirminghamBirminghamAlabamaUnited States35233

    Sponsors and Collaborators

    • University of Alabama at Birmingham
    • Centers for Disease Control and Prevention

    Investigators

    • Principal Investigator: Lindsay A Rhodes, MD, MSPH, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Lindsay A. Rhodes, Associate Professor, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT04328207
    Other Study ID Numbers:
    • 1U01DP006441-01-00
    • 1U01DP006441-01
    First Posted:
    Mar 31, 2020
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lindsay A. Rhodes, Associate Professor, University of Alabama at Birmingham
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2022