GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL

Study Overview
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Brief Summary
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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: Capture of data as reported by participating physician; Highlight (by providing feedback) where management may be optimized based on guidelines or recommendations; Identify challenges faced by physicians resulting in the care gap..

Detailed Description
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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.

Official Title
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Guidelines Oriented Approach to Lipid Lowering Quality Enhancement Research Initiative (GOAL QuERI) International

Conditions
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Dyslipidemia

Intervention / Treatment
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* Other: survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years old High risk for cardiovascular morbidity and mortality such as prior history of clinical cardiovascular disease and/or history of familial hypercholesterolemia LDL-C within the past 6 months above recommended level despite maximal tolerated statin therapy ± ezetimibe for the past 3 months. Exclusion Criteria: Current treatment with PCSK9 inhibitor Current participation in investigational study Prior participation in the GOAL program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: survey|Cross-Reference|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Relative and absolute reduction of LDL-C with lipid lowering medications added during the observation period. | the outcome variable, LDL-C, will be presented with mean and standard deviation | 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 | 
| 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 outcome variable, LDL-C, will be presented with mean and standard deviation | 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 | 
| 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 outcome variable, LDL-C, will be presented with mean and standard deviation | 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 | 
| Proportion of patients achieving LDL-C and non-HDL level across participating countries. | the outcome variable, LDL-C, will be presented with mean and standard deviation | 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 |