Clinical Trial: From Research to Practice - Lipid Management for Low HDL-Cholesterol

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

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). 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.

Condition Treatment or Intervention
Coronary Heart Disease
 Behavior: education and reminder

MedlinePlus related topics:  Coronary Disease

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  11700

Study start: October 2001;  Study completion: September 2003

Eligibility

Genders Eligible for Study:  Both

Criteria

Subjects are primary care providers from participating VISN (Veteran Affairs Healthcare Network) sites. Patients whose medical records are utilized are selected via an algorithm.

Location Information


Minnesota
      Minneapolis VA Medical Center, Minneapolis,  Minnesota,  55417,  United States

      VA Medical Center, Minneapolis,  Minnesota,  55417,  United States

      VA Medical Center, Minneapolis,  Minnesota,  55417,  United States

More Information

Study ID Numbers:  TRX 01-083
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  March 27, 2003
ClinicalTrials.gov Identifier:  NCT00057044
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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