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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by (Responsible Party): | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00057044 |
Purpose
The overall purpose of this project is to improve the clinical outcomes of veterans with ischemic heart disease (IHD) through implementation of evidence-based lipid management, with a particular focus on veterans whose primary lipid abnormality is a low level of HDL-cholesterol (the �good� cholesterol).
| Condition | Intervention |
|---|---|
|
Physicians' Practice Patterns Coronary Heart Disease |
Behavioral: education and reminder |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | From Research to Practice - Lipid Management for Low HDL-Cholesterol |
| Estimated Enrollment: | 11700 |
| Study Start Date: | October 2001 |
| Study Completion Date: | September 2003 |
| Arms | Assigned Interventions |
|---|---|
| 1 | Behavioral: education and reminder |
Background:
The overall purpose of this project is to improve the clinical outcomes of veterans with ischemic heart disease (IHD) through implementation of evidence-based lipid management, with a particular focus on veterans whose primary lipid abnormality is a low level of HDL-cholesterol (the �good� cholesterol).
Objectives:
The major objectives are 1. to determine whether a multifaceted intervention results in improved guideline-concordant lipid management for patients with low HDL-cholesterol; and 2. to test the relative effectiveness of three different reminder systems on physician prescribing behavior.
Methods:
The primary care clinic at each of the six VISN 13 facilities will serve as intervention sites. Within those sites we will randomize providers to one of three reminder systems. Control sites will consist of twelve other facilities matched to the intervention sites on the basis of facility characteristics. We will use a modified �pre-post� nested cohort design that allows us to evaluate the effect of the intervention controlling for secular trends. Target patients will be identified based on the following: 1. an IHD diagnosis within the past 5 years; 2. regular follow-up in a primary care clinic; 3. most recent LDL-cholesterol < 130 mg/dl and HDL-cholesterol < 40 mg/dl; 4. No lipid therapy within prior 6 months. The intervention will consist of: a. an on-site interactive educational workshop for providers; b. reminders (either patient-directed mailed reminders, computer-chart reminders at the time of visit, or automatic consults); c. opinion leader recruitment and �activation�. The primary outcome is proportion of target patients receiving guideline-concordant therapy. For objective 1, the outcome will be compared between intervention and control sites. For objective 2, the outcome will be compared between the three groups randomized to the different reminder systems. In addition, providers will be surveyed with a written questionnaire to determine their reaction to the educational workshop and the different reminder systems.
Status:
Intervention and data collection are completed. Data analysis is being undertaken, final report will soon follow.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects are primary care providers from participating VISN sites. Patients whose medical records are utilized are selected via an algorithm.
Exclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| Academy Health Center Departments | |
| Minneapolis, Minnesota, United States, 55417 | |
| Principal Investigator: | Hanna E. Bloomfield, MD MPH | Department of Veterans Affairs |
More Information
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00057044 History of Changes |
| Other Study ID Numbers: | TRX 01-083 |
| Study First Received: | March 27, 2003 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Federal Government |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |