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Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01744132
Enrollment
3000
Registered
2012-12-06
Start date
2012-10-31
Completion date
2016-10-31
Last updated
2016-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetic Retinopathy

Keywords

eye care utilization, ophthalmology, educational intervention, public health screening

Brief summary

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

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.

Interventions

BEHAVIORALAim 3: Contract

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
University of Alabama at Birmingham
CollaboratorOTHER
University of Miami
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
Wills Eye
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All Aims: DFE follow-up adherence rate2 yearsIn 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.

Secondary

MeasureTime frameDescription
Aim 3: Rates of ocular disease2 yearsIn Aim 3, the occurrence of diabetic retinopathy, glaucoma, cataracts, and other ocular diseases will be collected.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026