Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

NCT01744132 | Completed DMC

• 1 other identifier: U58DP002655
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Keywords

eye care utilization; ophthalmology; educational intervention; public health screening

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Aim 3: Rates of ocular disease

  2 years

Study Arms (2)

Aim 3: Contract

EXPERIMENTAL

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

Aim 3: Control

NO INTERVENTION

No contract is signed for half of the patients screened in Aim 3.

Interventions

Aim 3: Contract BEHAVIORAL

Aim 3: Contract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Type 2 diabetes mellitus
• Had a dilated fundus exam (DFE) within the past four years (2007-2010).

You may not qualify if:

• \) Pregnant women
• Age ≥ 18 years
• Type 2 diabetes mellitus
• Access to a telephone

Sponsors & Collaborators

• Wills Eye: lead
• Centers for Disease Control and Prevention: collaborator
• University of Alabama at Birmingham: collaborator
• University of Miami: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Jefferson Pharmacy

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (5)

• 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.

  PMID: 27632231 BACKGROUND

• 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. Epub 2016 Mar 7.

  PMID: 26949832 BACKGROUND

• 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. 2017 Jan/Feb;32(1):73-79. doi: 10.1177/1062860615616860. Epub 2016 Jul 10.

  PMID: 26656245 BACKGROUND

• 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. Epub 2015 Jun 25.

  PMID: 26119987 BACKGROUND

• 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.

  PMID: 26098386 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Julia Haller

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinipal Investigator, Ophthalmologist-in-Chief

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 6, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)