GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL (GOAL QuERI)

Dr. Anatoly Langer

Status: Completed

Conditions: Dyslipidemia

Treatments: Other: survey

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03861533

CHRC2019-GOAL INT

Details and patient eligibility

About

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..

Full 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.

Enrollment: 2,422 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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