Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-01 @ 5:35 AM
Study NCT ID:
NCT03861533
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2019-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL
Sponsor:
Dr. Anatoly Langer
Organization:
Study Overview
Official Title:
Guidelines Oriented Approach to Lipid Lowering Quality Enhancement Research Initiative (GOAL QuERI) International
Status:
COMPLETED
Status Verified Date:
2024-08
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:
GOAL QuERI
Brief Summary:
This Quality Enhancement Research Initiative (QuERI) is a knowledge translation medical practice activity based on decision making support through feedback to physicians on their management of dyslipidemia in order to achieve guidelines recommended LDL-C levels in high risk patients. Physician interaction has three distinct components:
1. Capture of data as reported by participating physician;
2. Highlight (by providing feedback) where management may be optimized based on guidelines or recommendations;
3. Identify challenges faced by physicians resulting in the care gap..
1. Capture of data as reported by participating physician;
2. Highlight (by providing feedback) where management may be optimized based on guidelines or recommendations;
3. Identify challenges faced by physicians resulting in the care gap..
Detailed Description:
The GOAL QuERI International will engage approximately 115 health care practitioners (HCP) who will enroll up to 2500 patients with management observations based on four visits by the patients in an outpatient setting. The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture form (DCF). The DCF will be created and managed by the CHRC.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: