Vermont Diabetes Information System

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Information and decision support for providers and patients

• Registration Number: NCT00109369
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

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.

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 Timeline

• Study Start: 2003-06
• Study First Submitted QC: 2005-04-26
• Study First Submitted: 2005-04-27
• Study First Posted: 2005-04-27
• Study Completion: 2007-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-31
• Last Update Posted: 2011-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7500

Inclusion Criteria

• Adult
• Diabetes confirmed by Primary Care provider

Exclusion Criteria

• Severe dementia
• Nursing home resident

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Information and decision support for providers and patients	Provider and patient receive Diabetes Information System services

Primary Outcome Measures

Name	Time	Method
Glycemic control	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Vermont; 🇺🇸 Burlington, Vermont, United States