Partnership for Glaucoma
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer Tablet
Continuing Education Course
Continuing education
Sponsored by
About this trial
This is an interventional supportive care trial for Glaucoma focused on measuring glaucoma, optometrists
Eligibility Criteria
Inclusion Criteria:
-Diagnosis of open angle glaucoma with documented visual field loss.
Sites / Locations
- University of Alabama
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Control group to receive annual continuing education
Outcomes
Primary Outcome Measures
To determine if innovative technology will improve process quality of care & important outcomes of care by optometrists in a cost-efficient manner while simultaneously empowering & including patients as part of the care process.
Secondary Outcome Measures
Full Information
NCT ID
NCT00672048
First Posted
May 4, 2008
Last Updated
January 3, 2014
Sponsor
Duke University
Collaborators
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00672048
Brief Title
Partnership for Glaucoma
Official Title
Expanding Quality Care for Glaucoma Through a Provider-Patient Partnership
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to develop new ways of assisting patients with glaucoma and their eye doctors in using the recommendations from practice guidelines.
Detailed Description
Glaucoma is a leading cause of blindness and visual impairment in the United States, particularly among disadvantaged populations. Despite the presence of therapies proven in NEI, randomized controlled trials that can be delivered by more than 18,000 ophthalmologists and 34,000 optometrists, almost nothing is known about the content and quality of glaucoma care delivered by non-MD providers such as optometrists. With the numbers of people with glaucoma expected to more than double in the next twenty years in the face of no more than a 15% increase in the supply of eye care providers, methods to better support appropriate and high-quality care for chronic eye diseases such as glaucoma delivered by optometrists will become as critical, if not more so, as techniques to enhance quality care among ophthalmologists.
Our study is a community-based, randomized, controlled trial that evaluates the suitability and effectiveness of a technology-based (tablet computer) intervention within the context of a novel partnership between optometrists and patients with glaucoma to improve the process quality of care and ultimately outcomes of care. By using successfully implemented technology in novel applications,and by building on the success of ongoing community-based quality improvement projects in our region, the study provides a means for rapid translation into community care if the intervention is successful.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, optometrists
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
721 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Title
2
Arm Type
Other
Arm Description
Control group to receive annual continuing education
Intervention Type
Other
Intervention Name(s)
Computer Tablet
Intervention Description
A tablet computer based software application designed to collect structured clinical information from providers and patients at the point of care.
Intervention Type
Other
Intervention Name(s)
Continuing Education Course
Intervention Description
Annual standard continuing education
Intervention Type
Other
Intervention Name(s)
Continuing education
Intervention Description
Annual standard continuing education materials
Primary Outcome Measure Information:
Title
To determine if innovative technology will improve process quality of care & important outcomes of care by optometrists in a cost-efficient manner while simultaneously empowering & including patients as part of the care process.
Time Frame
Baseline, Year 1 and Year 2
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Diagnosis of open angle glaucoma with documented visual field loss.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Lee, MD, JD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35204
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17238715
Citation
Silvey GM, Lobach DF, Macri JM, Hunt M, Kacmaz RO, Lee PP. User interface considerations for collecting data at the point of care in the tablet PC computing environment. AMIA Annu Symp Proc. 2006;2006:1096.
Results Reference
background
PubMed Identifier
16779403
Citation
Silvey GM, Lobach DF, Macri JM, Hunt M, Kacmaz RO, Lee PP. Overcoming obstacles to collecting narrative data from eye care professionals at the point-of-care. AMIA Annu Symp Proc. 2005;2005:1116.
Results Reference
background
PubMed Identifier
16779288
Citation
Kacmaz RO, Arbanas JM, Lee PP, Lobach DF. Assessment of relative importance of tablet computer features in supporting direct electronic documentation of encounters by eye care professionals. AMIA Annu Symp Proc. 2005;2005:1001.
Results Reference
background
PubMed Identifier
16779083
Citation
Lobach DF, Silvey GM, Macri JM, Hunt M, Kacmaz RO, Lee PP. Identifying and overcoming obstacles to point-of-care data collection for eye care professionals. AMIA Annu Symp Proc. 2005;2005:465-9.
Results Reference
background
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Partnership for Glaucoma
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