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Lipid Management Interventions for Cardiovascular Disease Risk

N/A

Recruiting

Led By Jacob A Udell, MD, MPH, FRCPC

Research Sponsored by Institute for Clinical Evaluative Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to increase the use of cholesterol-lowering statin drugs to prevent heart attack and stroke in high-risk health regions across Ontario using a 'toolbox' of interventions.

Who is the study for?

This trial is for communities in Ontario with higher-than-average cardiovascular disease rates, a certain number of family physicians, and specific population sizes of adults aged 40-75. It's not for patients who already have established heart conditions.

What is being tested?

The CHOICES study is testing how 'big data' can be used in clinical trials to improve cholesterol management using a toolbox of informational strategies aimed at both doctors and patients to prevent heart attacks and strokes.

What are the potential side effects?

Since the interventions involve informational strategies rather than medications or procedures, traditional side effects are not applicable. However, there may be indirect effects on healthcare practices within the community.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of 66 -75 year old patients who filled a statin prescription

Secondary study objectives

Incidence of Acute Myocardial Infarction (AMI), stroke or CVD death (major CVD outcome)

Incidence of Diabetes Mellitus (DM)

Cerebrovascular accident

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

The 14 communities that are in the intervention arm of the trial will receive a multicomponent intervention that provides both physicians and patients with access to a 'toolbox' of lipid management resources. The components planned for the 'toolbox' are all evidence-based interventions and chosen after consultations with Canadian family physicians and implementation science experts based on their potential for scalability to the entire population, cost and practicality. Online tools will be used and the trial will leverage pre-existing implementation initiatives (e.g., newsletters, listservs) wherever possible to minimize study costs and increase accessibility.

Group II: Control ArmActive Control1 Intervention

The 14 communities that are in the control arm of the trial will receive usual standard of care. The usual standard of care will follow clinical daily practice patterns provided by family physicians in Ontario for CVD prevention. This follows the periodic standard of care provided by Canadian cholesterol, hypertension, and diabetes best practice guideline recommendations utilized based on each physician's clinical judgement, physical assessment, and discretion. Patients also typically have access to existing cardiovascular prevention materials offered online through publicly available websites.

Do I qualify?Apply below to find out