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

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

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..

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Other: survey

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 Type: Observational
• Enrollment (Actual): 2422

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait, Kuwait
    • Sabah Hosptial
• Mexico
  • Qro
    • Querétaro, Qro, Mexico
      • Centro de Estudios Clínicos de Querétaro (CECLIQ)
• Saudi Arabia
  • Dhahran, Saudi Arabia, 31932
    • King Fahd Military Medical Complex
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

GOAL International enrolling approximately 2500 patients with clinical vascular disease or familial hypercholesterolemia (FH) and LDL-C > 2.0 mmol/L (77 mg/dl) despite maximally tolerated statin therapy. As part of an interactive knowledge translation component, physicians are asked to indicate their next steps in lowering of LDL-C and are then asked whether they will be following the guidelines and if not why not.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Anatoly Langer
• Collaborators: Amgen
• Investigators: Study Chair: Anatoly Langer, MD, M.Sc, FRCP(C,) FACC, Canadian Heart Rersearch Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: CHRC2019-GOAL INT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No