Clinical trial NCT00109369: Vermont Diabetes Information System
Official title: Vermont Diabetes Information System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Vermont Program for Quality in Health Care
First posted: 2005-04-27
Enrollment: 7500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Adult
* Diabetes confirmed by Primary Care provider

Exclusion Criteria:

* Severe dementia
* Nursing home resident

Primary outcomes:
measure: Glycemic control
timeFrame: 2 years
Secondary outcomes:
measure: Processes of care
timeFrame: 2 years
measure: Blood pressure control
timeFrame: 2 years
measure: Hypercholesterolemia
timeFrame: 2 years
measure: Adherence to Practice Guidelines
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
measure: Healthcare utilization
timeFrame: 2 years
measure: Patient satisfaction
timeFrame: 2 years
measure: Medication use
timeFrame: 2 years
measure: Functional status
timeFrame: 2 years
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Benjamin Littenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Charles D. MacLean, MDCM
role: STUDY_DIRECTOR
References:
citation: 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.