NCT00109369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,500

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2005

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2005

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

First QC Date

April 27, 2005

Last Update Submit

January 31, 2011

Conditions

Diabetes Mellitus

Keywords

Chronic DiseaseMulti-Hospital Information SystemsClinical Decision Support SystemsReminder SystemsRegistriesQuality of HealthcareGuideline AdherenceOutcome and Process Assessment (Health Care)Technology Assessment, BiomedicalPrimary Health CareHypercholesterolemiaHypertensionHyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    2 years

Secondary Outcomes (9)

  • Processes of care

    2 years

  • Blood pressure control

    2 years

  • Hypercholesterolemia

    2 years

  • Adherence to Practice Guidelines

    2 years

  • Quality of life

    2 years

  • +4 more secondary outcomes

Study Arms (2)

Active

EXPERIMENTAL

Provider and patient receive Diabetes Information System services

Other: Information and decision support for providers and patients

Control

NO INTERVENTION

Usual Care

Interventions

Information and decision support for providers and patientsOTHER

Laboratory-based decision support, reminders, and population report cards.

Also known as: Vermedx Diabetes Information System
Active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult
  • Diabetes confirmed by Primary Care provider

You may not qualify if:

  • Severe dementia
  • Nursing home resident

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related 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. doi: 10.1191/1740774504cn051oa.

    PMID: 16279294BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusChronic DiseaseHypercholesterolemiaHypertensionHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperlipidemiasDyslipidemiasLipid Metabolism DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Benjamin Littenberg, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

  • Charles D. MacLean, MDCM

    University of Vermont

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 27, 2005

First Posted

April 27, 2005

Study Start

June 1, 2003

Study Completion

December 1, 2007

Last Updated

February 1, 2011

Record last verified: 2011-01

Locations

US(1)