Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Diabetic Retinopathy

• Registration Number: NCT01744132
• Lead Sponsor: Wills Eye

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-19
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
All Aims: DFE follow-up adherence rate	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Aim 3: Rates of ocular disease	2 years	In Aim 3, the occurrence of diabetic retinopathy, glaucoma, cataracts, and other ocular diseases will be collected.

Trial Locations

Locations (1)

Jefferson Pharmacy; 🇺🇸 Philadelphia, Pennsylvania, United States