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Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

This study is currently recruiting participants.
Verified December 2012 by Wills Eye
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
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: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetic Retinopathy
Diabetes Mellitus
Dilated Eye Examinations
 Behavioral: Aim 3: Contract

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 3000
Study Start Date: October 2012
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744132

Contacts
Contact: Lisa Hark, PhD 215-928-3045 lhark@willseye.org

Locations
United States, Pennsylvania
Jefferson Pharmacy Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Bianca Collymore, MS     215-440-3158        
Principal Investigator: Julia Haller, MD            
Sponsors and Collaborators
Wills Eye
Centers for Disease Control and Prevention
University of Alabama at Birmingham
University of Miami
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Julia Haller, Prinipal Investigator, Ophthalmologist-in-Chief, Wills Eye
ClinicalTrials.gov Identifier: NCT01744132     History of Changes
Other Study ID Numbers: U58DP002655
Study First Received: December 3, 2012
Last Updated: December 4, 2012
Health Authority: United States: Federal Government

Keywords provided by Wills Eye:
eye care utilization
ophthalmology
educational intervention
public health screening

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Retinopathy
Retinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on May 19, 2013