GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL

Completed

• Conditions: Dyslipidemia

• Registration Number: NCT03861533
• Lead Sponsor: Dr. Anatoly Langer

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..

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 Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-04
• Study Start: 2019-04-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2422

Inclusion Criteria

1. Adults ≥ 18 years old
2. High risk for cardiovascular morbidity and mortality such as prior history of clinical cardiovascular disease and/or history of familial hypercholesterolemia
3. LDL-C within the past 6 months above recommended level despite maximal tolerated statin therapy ± ezetimibe for the past 3 months.

Exclusion Criteria

1. Current treatment with PCSK9 inhibitor
2. Current participation in investigational study
3. Prior participation in the GOAL program

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving country specific guideline-recommended LDL-C levels after 18 month final visit or last available observation during follow up visits.	LDL-C target after 18 month final visit	the outcome variable, LDL-C, will be presented with mean and standard deviation

Secondary Outcome Measures

Name	Time	Method
Proportion of patients not achieving recommended LDL-C level based on high risk inclusion sub-group (e.g. FH), co-morbid conditions (diabetes mellitus), baseline treatment or baseline lipid profile.	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	the outcome variable, LDL-C, will be presented with mean and standard deviation
Proportion of patients achieving LDL-C and non-HDL level across participating countries.	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	the outcome variable, LDL-C, will be presented with mean and standard deviation
Proportion of patients not achieving recommended LDL-C level at each of the follow up visits according to physician responses as to why country specific recommendation for LDL-C lowering opportunities was not followed.	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	the outcome variable, LDL-C, will be presented with mean and standard deviation
1. Relative and absolute reduction of LDL-C with lipid lowering medications added during the observation period.	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	the outcome variable, LDL-C, will be presented with mean and standard deviation

Trial Locations

Locations (4)

Cleveland Clinic; 🇦🇪 Abu Dhabi, United Arab Emirates

Sabah Hosptial; 🇰🇼 Kuwait, Kuwait

Centro de Estudios Clínicos de Querétaro (CECLIQ); 🇲🇽 Querétaro, Qro, Mexico

King Fahd Military Medical Complex; 🇸🇦 Dhahran, Saudi Arabia