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Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

Primary Purpose

Diabetic Retinopathy, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aim 3: Contract
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Retinopathy focused on measuring eye care utilization, ophthalmology, educational intervention, public health screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jefferson Pharmacy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aim 3: Contract

Aim 3: Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Aim 3: Rates of ocular disease
In Aim 3, the occurrence of diabetic retinopathy, glaucoma, cataracts, and other ocular diseases will be collected.

Full Information

First Posted
December 3, 2012
Last Updated
November 19, 2016
Sponsor
Wills Eye
Collaborators
Centers for Disease Control and Prevention, University of Alabama at Birmingham, University of Miami, Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01744132
Brief Title
Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes
Official Title
Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Centers for Disease Control and Prevention, University of Alabama at Birmingham, University of Miami, Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Diabetes Mellitus
Keywords
eye care utilization, ophthalmology, educational intervention, public health screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aim 3: Contract
Arm Type
Experimental
Arm Description
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.
Arm Title
Aim 3: Control
Arm Type
No Intervention
Arm Description
No contract is signed for half of the patients screened in Aim 3.
Intervention Type
Behavioral
Intervention Name(s)
Aim 3: Contract
Primary Outcome Measure Information:
Title
All Aims: DFE follow-up adherence rate
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Aim 3: Rates of ocular disease
Description
In Aim 3, the occurrence of diabetic retinopathy, glaucoma, cataracts, and other ocular diseases will be collected.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Aim 1: Age ≥ 18 years Type 2 diabetes mellitus 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: Age ≥ 18 years Type 2 diabetes mellitus Access to a telephone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Haller
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson Pharmacy
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27632231
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.
Results Reference
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PubMed Identifier
26949832
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. Epub 2016 Mar 7.
Results Reference
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PubMed Identifier
26656245
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. 2017 Jan/Feb;32(1):73-79. doi: 10.1177/1062860615616860. Epub 2016 Jul 10.
Results Reference
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PubMed Identifier
26119987
Citation
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.
Results Reference
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PubMed Identifier
26098386
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.
Results Reference
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Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

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