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Study to Evaluate the Effectiveness of a Program Developed to Improve Eye Care for Veterans With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00119535
Recruitment Status : Completed
First Posted : July 13, 2005
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Brief Summary:
The study's primary objective is to determine whether the PRSS improves the optimal timing of photocoagulation in diabetic patients in VA. Secondary objectives include assessing if the program: (1) leads to improved compliance with retinopathy screening and surveillance visits; (2) improves patient and provider satisfaction with VA diabetic eye care; (3) reduces eye care visit rates among diabetics receiving eye care at VA; (4) decreases health care resource utilization; and (5) improves the cost-effectiveness of eye care for patients with diabetes

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Retinopathy Behavioral: Implementation of Proactive Diabetes Eye Care Program Not Applicable

Detailed Description:

Diabetes is a common cause of blindness and much of this blindness is preventable by early detection and treatment. Although VA and HEDIS quality criteria now allow some individuals with diabetes to have biannual examinations, current diabetes eye care policies continue to emphasize routine, annual eye exams for most diabetes patients. Strong evidence suggests that the current �one-size fits all� method wastes resources while ignoring an opportunity to substantially improve outcomes for high-risk patients.

Recent research shows that patients referred for screening examinations (i.e., those without retinopathy) require different follow-up then those referred for surveillance examinations (i.e., those with retinopathy). Using a more targeted, risk-based criteria for scheduling eye examinations together with system level interventions designed to assure their application may lead to improved healthcare outcomes. Although, the efficacy of such approaches have been demonstrated in other systems and organizational research, it has not yet been demonstrated for diabetes eye care.

Therefore, we propose to conduct and evaluate a prototype translational research project examining the impact of the Proactive Diabetes Eye Care Program, a coordinated and targeted system-level intervention, on: 1) the optimal timing of photocoagulation; 2) the optimal timing of eye care visits; 3) patient and provider satisfaction; 4) health care resource use; and 5) the overall cost-effectiveness of a targeted eye care program.

The primary intervention will involve the use of an innovative �Progressive Reminder and Scheduling System� in which intensity of the reminders is based on the patient�s degree of risk for developing proliferative diabetic retinopathy or macular edema. At the intervention sites, there will be separate clinics for screening (those whose last examination was normal) and surveillance (those with known retinopathy). This two-year prototype translational project will have a quasi-experimental design. Six facilities will be recruited: three will receive the intervention without the system design components. The control and intervention sites will be matched for comparability to baseline screening rates and similar patient populations. The intervention will be evaluated using historical controls (pre-post analyses) and by comparison to control sites.

Data will be collected from three sources. We will use the VISTA database to determine resource use, patients demographics, co-morbidities and medications. Trained medical personnel will conduct chart reviews on a random sample of patients undergoing photocoagulation to determine whether it was sub-optimally timed (i.e., the patient already had a major retinal hemorrhage or advanced macular edema at the time of the procedure). A random sample of patients will be surveyed, at baseline and after 12 months, about non-VA eye care services they received and their attitudes and satisfaction toward eye care. We will also survey health care providers regarding diabetic eye care services.

If successful, this program will serve as a model for disseminating diabetes eye care best practices throughout the VA system and could provide further information about the best approaches to managing other diseases in which patients may benefit from risk stratification rather than being treated according to a single standard.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Evaluation of a Coordinated Proactive Diabetes Eye Care Program
Study Start Date : August 2004
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Arm 1 Behavioral: Implementation of Proactive Diabetes Eye Care Program

Primary Outcome Measures :
  1. � Optimal timing of photocoagulation (prior to intervention and 12 months after interventions

Secondary Outcome Measures :
  1. � Meeting retinopathy screening and surveillance guidelines � Patient satisfaction with care � Resource utilization (during study and previous 12 months) � Intervention Costs (conclusion of study)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The population for the project will be all diabetic patients treated at the three VAMCs selected as intervention sites. Therefore, patient recruitment is not required for participation in the initial implementation activities nor in assessing compliance with recommendation for eye examination and treatment. Although the scheduling system will be redesigned and the clinical guidelines will be used to inform eye care clinical decision-making, the final decision about whom should receive diabetes eye care and at what interval will continue to be left to the best clinical judgment of the health care professionals and their patients at each study site. Nothing in this study will preclude a patient and their physician from seeking eye care more frequently or less frequently than recommended by the guidelines. In one regard, this study could be thought of as a study of usual care under two different management and organizational systems without any direct patient-level intervention.

For data analysis purposes, there will be two sets of inclusion criteria ? EPRP visit criteria and diabetes identification criteria. To be included in the primary data analyses a patient must meet the criteria of the Office of Quality & Performances quality monitoring program. This criteria includes at least one outpatient visit during the current fiscal year and at least one outpatient visit in the fiscal year prior to the current year (see The previous and current qualifying visits must be in any one of 8 clinics (Primary Care (301), General Medicine (323), Cardiology (303), Endocrinology/Metabolism (305), Diabetes (306), Hypertension (309), Pulmonary/Chest (312), or Women's Health (322)) per the West Virginia's Peer Review Organization's External Peer Review Program (EPRP) selection criteria. Eligible patients would be excluded if they had a life expectancy of 6 months or less (e.g., diagnosis of pancreatic cancer or in hospice). For epidemiological comparability, separate cohorts will be constructed for evaluating eye care at the beginning of the study period (for the pre-intervention analyses) and at end of the study period (for the post-intervention analyses). We will identify diabetics (for analytic purposes) by requiring them to meet one of the following criteria in the previous year: 1) one or more prescriptions filled for hypoglycemic medications or self-monitoring blood glucose supplies (as determined by VISTA records), 2) having a diagnosis of diabetes (ICD-9 250.x) recorded in at least 2 separate outpatient encounters, or 3) having a diagnosis of diabetes recorded for one or more inpatient stays.

Exclusion Criteria:

None if patient meets inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00119535

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United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: Steven J. Bernstein, MD MPH VA Ann Arbor Healthcare System, Ann Arbor, MI
Principal Investigator: Rodney A. Hayward, MD VA Ann Arbor Healthcare System, Ann Arbor, MI
Publications of Results:
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Responsible Party: US Department of Veterans Affairs Identifier: NCT00119535    
Other Study ID Numbers: DIT 02-064
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2006
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Diabetes mellitus
Diabetic retinopathy
Organizational change
Quality improvement
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications