Vermont Diabetes Information System | NCT00109369

Studies
Vermont Diabetes Information System

NCT00109369

Sponsor

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

Status

Completed

Last Update Posted

Feb 1, 2011Estimated

Enrollment

7,500Estimated

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Information and decision support for providers and patients

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK061167	U.S. NIH Grant/Contract		View source
K24DK068380	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

Apr 27, 2005

First Submission Date that Met QC Criteria

Apr 26, 2005

First Posted Date

Apr 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2011

Last Update Posted Date

Feb 1, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

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

Collaborators

Name	Class
Vermont Program for Quality in Health Care	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

Diabetes Mellitus

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Information and decision support for providers and patients	Other	Laboratory-based decision support, reminders, and population report cards.	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycemic control		2 years

Secondary Outcomes

Measure	Description	Time Frame
Processes of care		2 years
Blood pressure control		2 years
Hypercholesterolemia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult
Diabetes confirmed by Primary Care provider

Exclusion Criteria:

Severe dementia
Nursing home resident

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin Littenberg, MD	University of Vermont	Principal Investigator
Charles D. MacLean, MDCM	University of Vermont	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Vermont		Burlington	Vermont	05401	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16279294	Background	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.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D003920	Diabetes Mellitus
D002908	Chronic Disease
D006937	Hypercholesterolemia
D006973	Hypertension
D006943	Hyperglycemia