From Research to Practice - Lipid Management for Low HDL-Cholesterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00057044
First received: March 27, 2003
Last updated: April 16, 2014
Last verified: April 2014

March 27, 2003
April 16, 2014
October 2001
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Proportion of target patients receiving guideline-concordant therapy
Complete list of historical versions of study NCT00057044 on ClinicalTrials.gov Archive Site
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From Research to Practice - Lipid Management for Low HDL-Cholesterol
From Research to Practice - Lipid Management for Low HDL-Cholesterol

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).

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Physicians' Practice Patterns
  • Coronary Heart Disease
Behavioral: education and reminder
Arm 1
Intervention: Behavioral: education and reminder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11700
September 2003
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Inclusion Criteria:

Subjects are primary care providers from participating VISN sites. Patients whose medical records are utilized are selected via an algorithm.

Exclusion Criteria:

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057044
TRX 01-083
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Hanna E. Bloomfield, MD MPH Minneapolis VA Health Care System, Minneapolis, MN
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP