Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057044
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2003-03-27
Brief Title:
From Research to Practice - Lipid Management for Low HDL-Cholesterol
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
From Research to Practice - Lipid Management for Low HDL-Cholesterol
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgdl and HDL-cholesterol 40 mgdl 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
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 mgdl and HDL-cholesterol 40 mgdl 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None