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Vermont Diabetes Information System

This study has been completed.
Sponsor:
Collaborator:
Vermont Program for Quality in Health Care
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00109369
First received: April 27, 2005
Last updated: January 31, 2011
Last verified: January 2011
History of Changes
  Purpose

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
Diabetes Mellitus
 Other: Information and decision support for providers and patients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vermont Diabetes Information System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Glycemic control [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Processes of care [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Blood pressure control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Hypercholesterolemia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Adherence to Practice Guidelines [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Healthcare utilization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Medication use [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Functional status [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 7500
Study Start Date: June 2003
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: Active
Provider and patient receive Diabetes Information System services
 Other: Information and decision support for providers and patients
Laboratory-based decision support, reminders, and population report cards.
Other Name: Vermedx Diabetes Information System
No Intervention: Control
Usual Care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult
  • Diabetes confirmed by Primary Care provider

Exclusion Criteria:

  • Severe dementia
  • Nursing home resident
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109369

Locations
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vermont Program for Quality in Health Care
Investigators
Principal Investigator: Benjamin Littenberg, MD University of Vermont
Study Director: Charles D. MacLean, MDCM University of Vermont
  More Information

Publications:

Responsible Party: Benjamin Littenberg, Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT00109369     History of Changes
Other Study ID Numbers: 61167 (completed), R01 DK61167, K24 DK68380
Study First Received: April 27, 2005
Last Updated: January 31, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013