Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119535
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-07-01
Brief Title:
Study to Evaluate the Effectiveness of a Program Developed to Improve Eye Care for Veterans With Diabetes
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
An Evaluation of a Coordinated Proactive Diabetes Eye Care Program
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The studys 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
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 ie those without retinopathy require different follow-up then those referred for surveillance examinations ie 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 patients 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 ie 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
Recent research shows that patients referred for screening examinations ie those without retinopathy require different follow-up then those referred for surveillance examinations ie 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 patients 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None