Dyslipidemia
Conditions
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.
Interventions
OTHERsurvey
Cross-Reference
Sponsors
Amgen
Dr. Anatoly Langer
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
Countries
Kuwait, Mexico, Saudi Arabia, United Arab Emirates
Outcome results
None listed