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Completed

NCT Number: NCT03861533

GOAL International QuERI - Protocol CHRC 2019 GOAL 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..

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sabah Hosptial, Kuwait City, Kuwait

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

Cross-Reference

Other names: cross-sectional study without specific intervention

Primary outcomes

  1. Proportion of patients achieving country specific guideline-recommended LDL-C levels after 18 month final visit or last available observation during follow up visits.

    Time frame: LDL-C target after 18 month final visit

    the outcome variable, LDL-C, will be presented with mean and standard deviation

Secondary outcomes

  1. 1. Relative and absolute reduction of LDL-C with lipid lowering medications added during the observation period.

    Time frame: 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

  2. 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.

    Time frame: 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

  3. 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.

    Time frame: 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

  4. Proportion of patients achieving LDL-C and non-HDL level across participating countries.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dr. Anatoly Langer

Other

Collaborators

  • Amgen

Registry information

Official study title

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

Acronym: GOAL QuERI

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2019
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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