Behavior, Health, Cataract, Diabetic Retinopathy, Glaucoma, Refractive Errors
Conditions
Keywords
telemedicine, teleophthalmology, telehealth, teleglaucoma, financial incentives
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.
Interventions
Standard of care eye health education
BEHAVIORALFinancial Incentive
Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed.
Sponsors
Centers for Disease Control and Prevention
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigators are masked as to which group the patient is in.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Adhere to Referral Appointment | The time frame will be whether they attended the referral appointment between the screening date until 6 months after the screening date. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Financial Incentive This group will receive standard of care eye health education alone and no financial incentive for completing a referral visit.
No Financial Incentive: Standard of care eye health education | 499 |
| 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.
Financial Incentive: Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed. | 401 |
| Total | 900 |
Baseline characteristics
| Characteristic | No Financial Incentive | Financial Incentive | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 227 Participants | 201 Participants | 428 Participants |
| Age, Categorical Between 18 and 65 years | 272 Participants | 200 Participants | 472 Participants |
| Age, Continuous | 58.49 years STANDARD_DEVIATION 13.5 | 59.58 years STANDARD_DEVIATION 11.99 | 58.97 years STANDARD_DEVIATION 12.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 496 Participants | 397 Participants | 893 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 228 Participants | 142 Participants | 370 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 9 Participants | 23 Participants |
| Race (NIH/OMB) White | 257 Participants | 250 Participants | 507 Participants |
| Region of Enrollment United States | 499 participants | 401 participants | 900 participants |
| Sex: Female, Male Female | 322 Participants | 258 Participants | 580 Participants |
| Sex: Female, Male Male | 177 Participants | 143 Participants | 320 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 499 | 0 / 401 |
| other Total, other adverse events | 0 / 499 | 0 / 401 |
| serious Total, serious adverse events | 0 / 499 | 0 / 401 |
Outcome results
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.
Time frame: The time frame will be whether they attended the referral appointment between the screening date until 6 months after the screening date.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Financial Incentive | Percentage of Participants That Adhere to Referral Appointment | 80 Participants |
| Financial Incentive | Percentage of Participants That Adhere to Referral Appointment | 92 Participants |