Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

Study Overview
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Brief Summary
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The goal of this project is to implement a Collaborative Translational Research Center (TRC) Network Study which aims to assure optimal two-way communication between ophthalmologists and their patients' primary care physicians (PCP). The Collaborative TRC Network Study will have 2 objectives: To design and develop common research protocols to develop a 4-year retrospective database (2007-2010) that compiles electronic billing and medical chart information that can be used to study individual-level, clinical-level and system-level factors that impact access to and quality of vision care; To evaluate adherence to dilated fundus exams (DFEs) follow-up as the primary measureable quality indicator, and its relationship to the patients' demographics, ethnicity, socioeconomic status (SES), severity of diabetic retinopathy (DR), other ocular and medical co-morbidities, presence of HA1C, and primary care provider (PCP) communication. By enhancing communication and strengthening the clinical information exchanged between PCPs and eye care professionals, this Collaborative TRC Network study will help to overcome barriers to obtaining ongoing DFEs and reduce disparities in vision care utilization.

Detailed Description
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Since its inception in October 2010 Collaborative Network Research Study at the Wills Eye Institute has aimed: to establish a retrospective analysis of existing ophthalmic data sets to assess and evaluate system-level and individual-level factors that impact access to and quality of vision care in patients with diabetes; to implement telephone-based and educational interventions to improve DFE follow-up adherence in African Americans with diabetes utilizing a prospective, cluster-based, randomized cohort design; to determine the feasibility and effectiveness of using a non-invasive, non-mydriatic fundus camera (Nidek) in a community-based pharmacy setting to screen and detect diabetic retinopathy and other ocular diseases among individuals with diabetes.

Official Title
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Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

Conditions
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Diabetic Retinopathy, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Aim 3: Contract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Aim 1: Age ≥ 18 years Type 2 diabetes mellitus Had a dilated fundus exam (DFE) within the past four years (2007-2010). Exclusion Criteria for Aim 1: 1) Pregnant women Inclusion Criteria for Aim 2 and 3: Age ≥ 18 years Type 2 diabetes mellitus Access to a telephone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aim 3: Contract<br>Half of patients screened in the pharmacy are selected to a contract group, which encourages patients to review the results of the screen, share the results with their PCP, and schedule and attend a follow-up appointment with an ophthalmologist if the results are abnormal. | Behavioral: Aim 3: Contract<br> <br> |
| No Intervention: Aim 3: Control<br>No contract is signed for half of the patients screened in Aim 3. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Aims: DFE follow-up adherence rate | In Aim 1 and Aim 2 specifically the influence patients' ethnicity and severity of diabetic retinopathy will be examined with the rate of dilated fundus examine (DFE) follow-up adherence. In Aim 3, the rate of DFE follow-up adherence will be examined for both patients in the contract and the no contract group. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aim 3: Rates of ocular disease | In Aim 3, the occurrence of diabetic retinopathy, glaucoma, cataracts, and other ocular diseases will be collected. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eye care utilization, ophthalmology, educational intervention, public health screening