- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00109369
Vermont Diabetes Information System
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vermont
-
Burlington, Vermont, United States, 05401
- University of Vermont
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult
- Diabetes confirmed by Primary Care provider
Exclusion Criteria:
- Severe dementia
- Nursing home resident
Study Plan
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
|
Laboratory-based decision support, reminders, and population report cards.
Other Names:
|
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
Collaborators
Investigators
- Study Director: Charles D. MacLean, MDCM, University of Vermont
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Hypertension
- Primary Health Care
- Hyperglycemia
- Hypercholesterolemia
- Chronic Disease
- Registries
- Clinical Decision Support Systems
- Guideline Adherence
- Quality of Healthcare
- Outcome and Process Assessment (Health Care)
- Reminder Systems
- Technology Assessment, Biomedical
- Multi-Hospital Information Systems
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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