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Providing Financial Incentives to Improve Adherence to Referral Eye Care Visits

Primary Purpose

Glaucoma, Diabetic Retinopathy, Refractive Errors

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Financial Incentive
Financial Incentive
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Glaucoma focused on measuring telemedicine, teleophthalmology, telehealth, teleglaucoma, financial incentives

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

No financial incentive

Financial incentive

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2020
Last Updated
March 23, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04328207
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
September 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Diabetic Retinopathy, Refractive Errors, Cataract, Behavior, Health
Keywords
telemedicine, teleophthalmology, telehealth, teleglaucoma, financial incentives

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigators are masked as to which group the patient is in.
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No financial incentive
Arm Type
Other
Arm Description
This group will receive standard of care eye health education alone and no financial incentive for completing a referral visit.
Arm Title
Financial incentive
Arm Type
Experimental
Arm Description
This group will receive a financial incentive once the referral visit is completed (if one was required) as well as eye health education.
Intervention Type
Other
Intervention Name(s)
No Financial Incentive
Other Intervention Name(s)
Standard of Care
Intervention Description
Standard of care eye health education
Intervention Type
Behavioral
Intervention Name(s)
Financial Incentive
Intervention Description
Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed.
Primary Outcome Measure Information:
Title
Percentage of participants that adhere to referral appointment
Description
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.
Time Frame
The time frame will be from baseline through 3 years of recruitment in the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay A Rhodes, MD, MSPH
Phone
2053258660
Email
lindsayrhodes@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay A Rhodes, MD, MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay A Rhodes, MD, MSPH
Phone
205-325-8660
Email
lindsayrhodes@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be determined at a later point.
Citations:
PubMed Identifier
33492893
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.
Results Reference
derived
Links:
URL
https://sightstudies.org/
Description
Website describing the research program as well as two other research programs funded by the same mechanism.

Learn more about this trial

Providing Financial Incentives to Improve Adherence to Referral Eye Care Visits

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