Vermont Diabetes Information System

January 31, 2011 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

7500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult
  • Diabetes confirmed by Primary Care provider

Exclusion Criteria:

  • Severe dementia
  • Nursing home resident

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual Care
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 Names:
  • Vermedx Diabetes Information System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycemic control
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 2 years
2 years
Processes of care
Time Frame: 2 years
2 years
Blood pressure control
Time Frame: 2 years
2 years
Hypercholesterolemia
Time Frame: 2 years
2 years
Adherence to Practice Guidelines
Time Frame: 2 years
2 years
Healthcare utilization
Time Frame: 2 years
2 years
Patient satisfaction
Time Frame: 2 years
2 years
Medication use
Time Frame: 2 years
2 years
Functional status
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators

Vermont Program for Quality in Health Care

Investigators

  • Study Director: Charles D. MacLean, MDCM, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 27, 2005

First Submitted That Met QC Criteria

April 26, 2005

First Posted (Estimate)

April 27, 2005

Study Record Updates

Last Update Posted (Estimate)

February 1, 2011

Last Update Submitted That Met QC Criteria

January 31, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61167 (completed)
  • R01DK061167 (U.S. NIH Grant/Contract)
  • K24DK068380 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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