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Partnership for Glaucoma
This study is currently recruiting participants.
Verified December 2009 by Duke University

First Received on May 4, 2008.   Last Updated on December 9, 2009   History of Changes
Sponsor: Duke University
Collaborator: University of Alabama at Birmingham
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00672048
  Purpose

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.


Condition Intervention
Glaucoma
Other: Computer Tablet
Other: Continuing Education Course
Other: Continuing education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Expanding Quality Care for Glaucoma Through a Provider-Patient Partnership

Resource links provided by NLM:


Further study details as provided by Duke University:

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. [ Time Frame: Baseline, Year 1 and Year 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: October 2007
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Other: Computer Tablet
A tablet computer based software application designed to collect structured clinical information from providers and patients at the point of care.
Other: Continuing Education Course
Annual standard continuing education
2
Control group to receive annual continuing education
Other: Continuing education
Annual standard continuing education materials

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Diagnosis of open angle glaucoma with documented visual field loss.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672048

Contacts
Contact: Shelley L Keatts, BS 919-684-4032 shelley.keatts@duke.edu
Contact: Kathy L Kimrey 919-681-1635 kathy.kimrey@duke.edu

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35204
Contact: Nicole Wasserman     205-325-8294     rnmoore@uab.edu    
Contact: Karen Searcey     (205) 325-8310     searcey@uab.edu    
Sub-Investigator: Gerald McGwinn, PHD            
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Shelley L Keatts, BS     919-684-4032     shelley.keatts@duke.edu    
Contact: Kathy L Kimrey     919-681-1635     kathy.kimrey@duke.edu    
Principal Investigator: Paul P Lee, MD, JD            
Sub-Investigator: William Rafferty, OD            
Sub-Investigator: David Lobach, MD, PHD, MS            
Sub-Investigator: Sanjay Asrani, MD            
Sponsors and Collaborators
Duke University
University of Alabama at Birmingham
Investigators
Principal Investigator: Paul Lee, MD, JD Duke University
  More Information

Publications:
Responsible Party: Paul Lee, MD, JD, Duke University Eye Center
ClinicalTrials.gov Identifier: NCT00672048     History of Changes
Other Study ID Numbers: 00002593, R01EY018405-01
Study First Received: May 4, 2008
Last Updated: December 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
glaucoma
optometrists

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012