Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

November 19, 2016 updated by: Julia Haller, Wills Eye

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aim 3: Contract
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
No Intervention: Aim 3: Control
No contract is signed for half of the patients screened in Aim 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Aims: DFE follow-up adherence rate
Time Frame: 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.
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Collaborators

Johns Hopkins University
University of Miami
University of Alabama at Birmingham
Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Julia Haller, Wills Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 19, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U58DP002655 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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