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Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of Miami
Johns Hopkins University
Information provided by (Responsible Party):
Julia Haller, Wills Eye
ClinicalTrials.gov Identifier:
NCT01744132
First received: December 3, 2012
Last updated: November 26, 2013
Last verified: November 2013

December 3, 2012
November 26, 2013
October 2012
October 2015   (final data collection date for primary outcome measure)
All Aims: DFE follow-up adherence rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01744132 on ClinicalTrials.gov Archive Site
Aim 3: Rates of ocular disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
In Aim 3, the occurrence of diabetic retinopathy, glaucoma, cataracts, and other ocular diseases will be collected.
Same as current
Not Provided
Not Provided
 
Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes
Not Provided

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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diabetic Retinopathy
  • Diabetes Mellitus
  • Dilated Eye Examinations
Behavioral: Aim 3: Contract
  • 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.
    Intervention: Behavioral: Aim 3: Contract
  • No Intervention: Aim 3: Control
    No contract is signed for half of the patients screened in Aim 3.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
Not Provided
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01744132
U58DP002655
Yes
Julia Haller, Wills Eye
Wills Eye
  • Centers for Disease Control and Prevention
  • University of Alabama at Birmingham
  • University of Miami
  • Johns Hopkins University
Not Provided
Wills Eye
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP