Vermont Diabetes Information System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vermont Diabetes Information System

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Information and decision support for providers and patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Diabetes confirmed by Primary Care provider Exclusion Criteria: Severe dementia Nursing home resident

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Provider and patient receive Diabetes Information System services | Other: Information and decision support for providers and patients<br>* Laboratory-based decision support, reminders, and population report cards.<br>* Other names: Vermedx Diabetes Information System;|
| No Intervention: Control<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Processes of care |  | 2 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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