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Diabetes MellitusNCT00119535

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

A study testing Implementation of Proactive Diabetes Eye Care Program in people with Diabetes Mellitus and Diabetic Retinopathy, run by US Department of Veterans Affairs at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes Mellitus, Diabetic Retinopathy
What is being tested?
Implementation of Proactive Diabetes Eye Care Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
3 sitesUnited States
Study dates
Aug 2004to Dec 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 http://vaww.oqp.med.va.gov/oqpservices/performancemeasurement/techman.asp). 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.

Who cannot join

  • None if patient meets inclusion criteria

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073

Other trials in United States

About this study

Official title: An Evaluation of a Coordinated Proactive Diabetes Eye Care Program

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

Read the 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.

Being tested
Implementation of Proactive Diabetes Eye Care Program
Keywords
Diabetes mellitus, Diabetic retinopathy, Organizational change, Quality improvement, Quasi-experimental
Medical subject headings
Diabetes Mellitus, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation of Proactive Diabetes Eye Care ProgramBehavioural

Study groups in NCT00119535
Study groupRoleWhat they receive
Arm 1OtherNot described
Receives: Behavioral: Implementation of Proactive Diabetes Eye Care Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2005 (estimated)
  2. Study startAug 2004
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00119535
Sponsor's protocol ID
DIT 02-064
Status last verified
Apr 2006
First submitted
1 Jul 2005
Last updated
7 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Krein SL, Bernstein SJ, Fletcher CE, Makki F, Goldzweig CL, Watts B, Vijan S, Hayward RA. Improving eye care for veterans with diabetes: an example of using the QUERI steps to move from evidence to implementation: QUERI Series. Implement Sci. 2008 Mar 19;3:18. doi: 10.1186/1748-5908-3-18.

    PubMed 18353187

Questions about this trial

What is this clinical trial studying?

A study testing Implementation of Proactive Diabetes Eye Care Program in people with Diabetes Mellitus and Diabetic Retinopathy, run by US Department of Veterans Affairs at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

� Optimal timing of photocoagulation (prior to intervention and 12 months after interventions. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00119535, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.

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Clinical Trial NCT00119535 | AzTrials