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

NCT ID: NCT00057044

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2003-09-30

Brief Summary

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).

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.

Conditions

Physicians' Practice Patterns; Coronary Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: OTHER

education and reminder

Intervention Type: BEHAVIORAL

Interventions

education and reminder

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanna E. Bloomfield, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Health Care System, Minneapolis, MN

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

TRX 01-083

Identifier Type: -

Identifier Source: org_study_id