Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744132
• Other study ID #: U58DP002655
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: November 19, 2016
• Start date: October 2012
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy

Intervention

Behavioral:
• Aim 3: Contract

Locations

Country	Name	City	State
United States	Jefferson Pharmacy	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Wills Eye	Centers for Disease Control and Prevention, Johns Hopkins University, University of Alabama at Birmingham, University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (5)

Aleo CL, Murchison AP, Dai Y, Hark LA, Mayro EL, Collymore B, Haller JA. Improving eye care follow-up adherence in diabetic patients with ocular abnormalities: the effectiveness of patient contracts in a free, pharmacy-based eye screening. Public Health. 2015 Jul;129(7):996-9. doi: 10.1016/j.puhe.2015.05.012. — View Citation

Callinan CE, Kenney B, Hark LA, Murchison AP, Dai Y, Leiby BE, Mayro EL, Bilson J, Haller JA. Improving Follow-Up Adherence in a Primary Eye Care Setting. Am J Med Qual. 2015 Dec 11. pii: 1062860615616860. [Epub ahead of print] — View Citation

Keenum Z, McGwin G Jr, Witherspoon CD, Haller JA, Clark ME, Owsley C. Patients' Adherence to Recommended Follow-up Eye Care After Diabetic Retinopathy Screening in a Publicly Funded County Clinic and Factors Associated With Follow-up Eye Care Use. JAMA Ophthalmol. 2016 Nov 1;134(11):1221-1228. doi: 10.1001/jamaophthalmol.2016.3081. — View Citation

Murchison AP, Friedman DS, Gower EW, Haller JA, Lam BL, Lee DJ, McGwin G Jr, Owsley C, Saaddine J, Insight Study Group. A Multi-Center Diabetes Eye Screening Study in Community Settings: Study Design and Methodology. Ophthalmic Epidemiol. 2016;23(2):109-15. doi: 10.3109/09286586.2015.1099682. — View Citation

Storey PP, Murchison AP, Pizzi LT, Hark LA, Dai Y, Leiby BE, Haller JA. IMPACT OF PHYSICIAN COMMUNICATION ON DIABETIC EYE EXAMINATION ADHERENCE: Results From a Retrospective Cohort Analysis. Retina. 2016 Jan;36(1):20-7. doi: 10.1097/IAE.0000000000000652. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Aims: DFE follow-up adherence rate	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	No
Secondary	Aim 3: Rates of ocular disease	In Aim 3, the occurrence of diabetic retinopathy, glaucoma, cataracts, and other ocular diseases will be collected.	2 years	No