The Vermont Diabetes Information System (VDIS) is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes. It will be evaluated by a randomized, controlled study in 60 Primary Care practices in Vermont and nearby New York.

Condition	Treatment or Intervention
Diabetes Mellitus	Procedure: Information and decision support for providers and patients

Further Study Details: 

Primary Outcomes: Glycemic control
Secondary Outcomes: Processes of care; Blood pressure control; Hypercholesterolemia; Adherence to Practice Guidelines; Quality of life; Healthcare utilization; Patient satisfaction; Medication use; Functional status
Expected Total Enrollment:  6000

The long-term goal of the Vermont Diabetes Information System is to reduce morbidity and mortality from diabetes mellitus. The project will implement and evaluate a state-wide system to support evidence-based disease management by primary care providers, their practices, and their patients in the community. The primary study question is: "What is the effect of a Diabetes Information System (including education, feedback and decision support) upon disease control measured by glycated hemoglobin?" Secondary questions address the effect of the system upon adherence to guideline recommendations, blood pressure control, patient satisfaction, medication use, and functional status. We hypothesize that the information system will result in improvements in the process and outcomes of clinical care. There are two specific aims:

Aim 1: Implement the Diabetes Information System. Objective 1.1: Develop a registry of patients with diabetes in primary care practices in Vermont; Objective 1.2: Provide education and feedback to providers regarding their patients with diabetes; Objective 1.3: Deliver decision support (flow sheets, alerts and reminders) based on the registry and targeted at primary care providers and patients, to prompt ideal management of diabetes.

Aim 2: Assess the Diabetes Information System. Objective 2.1: Assess disease control and guideline adherence by examining registry data in all subjects in a prospective, two-year, randomized, controlled trial in 60 primary care practices; Objective 2.2: Assess outcomes (blood pressure control, obesity, functional status, symptoms, medication use, and satisfaction) by interview and examination in a sub-sample of patients from the controlled trial.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Adult
• Diabetes confirmed by Primary Care provider

Exclusion Criteria:

• Severe dementia
• Nursing home resident

Vermont
      University of Vermont, Burlington,  Vermont,  05401,  United States

Study chairs or principal investigators

Benjamin Littenberg, MD,  Principal Investigator,  University of Vermont   
Charles D. MacLean, MDCM,  Study Director,  University of Vermont   

Study ID Numbers:  61167; R01 DK61167; K24 DK68380
Record last reviewed:  April 2005
Last Updated:  April 26, 2005
Record first received:  April 26, 2005
ClinicalTrials.gov Identifier:  NCT00109369
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03