Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

Wills Eye

Status: Completed

Conditions: Diabetes Mellitus; Diabetic Retinopathy

Treatments: Behavioral: Aim 3: Contract

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01744132

U58DP002655

Details and patient eligibility

About

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.

Full description

Since its inception in October 2010 Collaborative Network Research Study at the Wills Eye Institute has aimed:

1. 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;
2. 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;
3. 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.

Enrollment: 3,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Aim 1:

1. Age ≥ 18 years
2. Type 2 diabetes mellitus
3. 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:

1. Age ≥ 18 years
2. Type 2 diabetes mellitus
3. Access to a telephone

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

Aim 3: Contract

Experimental group

Description:

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.

Treatment:

Behavioral: Aim 3: Contract

Aim 3: Control

No Intervention group

Description:

No contract is signed for half of the patients screened in Aim 3.