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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Diabetes Mellitus Diabetic Retinopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type OTHER

Implementation of Proactive Diabetes Eye Care Program

Intervention Type BEHAVIORAL

Interventions

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Implementation of Proactive Diabetes Eye Care Program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No