From Research to Practice - Lipid Management for Low HDL-Cholesterol
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|ClinicalTrials.gov Identifier: NCT00057044|
Recruitment Status : Completed
First Posted : March 28, 2003
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Physicians' Practice Patterns Coronary Heart Disease||Behavioral: education and reminder||Not Applicable|
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).
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.
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.
Intervention and data collection are completed. Data analysis is being undertaken, final report will soon follow.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||11700 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||From Research to Practice - Lipid Management for Low HDL-Cholesterol|
|Study Start Date :||October 2001|
|Actual Study Completion Date :||September 2003|
|Arm 1||Behavioral: education and reminder|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057044
|United States, Minnesota|
|Minneapolis VA Health Care System, Minneapolis, MN|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Hanna E. Bloomfield, MD MPH||Minneapolis VA Health Care System, Minneapolis, MN|