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.|
|ClinicalTrials.gov Identifier: NCT00119535|
Recruitment Status : Completed
First Posted : July 13, 2005
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Diabetic Retinopathy||Behavioral: Implementation of Proactive Diabetes Eye Care Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Evaluation of a Coordinated Proactive Diabetes Eye Care Program|
|Study Start Date :||August 2004|
|Actual Study Completion Date :||December 2005|
|Arm 1||Behavioral: Implementation of Proactive Diabetes Eye Care Program|
- � Optimal timing of photocoagulation (prior to intervention and 12 months after interventions
- � Meeting retinopathy screening and surveillance guidelines � Patient satisfaction with care � Resource utilization (during study and previous 12 months) � Intervention Costs (conclusion of study)
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 ClinicalTrials.gov identifier (NCT number): NCT00119535
|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|
|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|