Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes
|ClinicalTrials.gov Identifier: NCT01744132|
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : November 22, 2016
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 or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy Diabetes Mellitus||Behavioral: Aim 3: Contract||Not Applicable|
Since its inception in October 2010 Collaborative Network Research Study at the Wills Eye Institute has aimed:
- 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;
- 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;
- 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 (Clinical Trial)|
|Actual Enrollment :||3000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744132
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Julia Haller||Wills Eye Hospital|