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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Vermont Program for Quality in Health Care |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00109369 |
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 | Intervention |
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Diabetes Mellitus |
Other: Information and decision support for providers and patients |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Vermont Diabetes Information System |
Estimated Enrollment: | 7500 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | December 2007 |
Arms | Assigned Interventions |
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Active: Experimental
Provider and patient receive Diabetes Information System services
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Other: Information and decision support for providers and patients
Laboratory-based decision support, reminders, and population report cards.
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Control: No Intervention
Usual Care
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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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Vermont | |
University of Vermont | |
Burlington, Vermont, United States, 05401 |
Principal Investigator: | Benjamin Littenberg, MD | University of Vermont |
Study Director: | Charles D. MacLean, MDCM | University of Vermont |
Responsible Party: | University of Vermont ( Benjamin Littenberg, Professor ) |
Study ID Numbers: | 61167, R01 DK61167, K24 DK68380 |
Study First Received: | April 27, 2005 |
Last Updated: | December 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00109369 History of Changes |
Health Authority: | United States: Federal Government |
Chronic Disease Multi-Hospital Information Systems Clinical Decision Support Systems Reminder Systems Registries Quality of Healthcare Guideline Adherence |
Outcome and Process Assessment (Health Care) Technology Assessment, Biomedical Primary Health Care Hypercholesterolemia Hypertension Hyperglycemia |
Metabolic Diseases Hyperglycemia Diabetes Mellitus Endocrine System Diseases Chronic Disease |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Hypercholesterolemia Hypertension |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |