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

April 6, 2015 updated by: US Department of Veterans Affairs
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

11700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System, Minneapolis, MN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Behavioral: education and reminder

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Hanna E. Bloomfield, MD MPH, Minneapolis VA Health Care System, Minneapolis, MN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

March 27, 2003

First Submitted That Met QC Criteria

March 27, 2003

First Posted (Estimate)

March 28, 2003

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRX 01-083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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