Vermont Diabetes Information System

Diabetes Mellitus Clinical Trial

Official title:

Vermont Diabetes Information System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109369
• Other study ID #: 61167 (completed)
• Secondary ID: R01DK061167K24DK
• Status: Completed
• Phase: N/A
• First received: April 27, 2005
• Last updated: January 31, 2011
• Start date: June 2003
• Est. completion date: December 2007

Study information

• Verified date: January 2011
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7500
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult

• Diabetes confirmed by Primary Care provider

Exclusion Criteria:

• Severe dementia

• Nursing home resident

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Information and decision support for providers and patients
Laboratory-based decision support, reminders, and population report cards.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Vermont Program for Quality in Health Care

Country where clinical trial is conducted

United States, 

References & Publications (1)

MacLean CD, Littenberg B, Gagnon M, Reardon M, Turner PD, Jordan C. The Vermont Diabetes Information System (VDIS): study design and subject recruitment for a cluster randomized trial of a decision support system in a regional sample of primary care practices. Clin Trials. 2004;1(6):532-44. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control		2 years	No
Secondary	Processes of care		2 years	No
Secondary	Blood pressure control		2 years	No
Secondary	Hypercholesterolemia		2 years	No
Secondary	Adherence to Practice Guidelines		2 years	No
Secondary	Quality of life		2 years	No
Secondary	Healthcare utilization		2 years	No
Secondary	Patient satisfaction		2 years	No
Secondary	Medication use		2 years	No
Secondary	Functional status		2 years	No