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Integrated Machine Learning Approach for High Cholesterol (BEAT FH Trial)

N/A

Waitlist Available

Research Sponsored by University of Pennsylvania

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 day 1 - post intervention study visit

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find those at high risk of familial hypercholesterolemia and encourage diagnosis and treatment. Three phases will help make it happen.

Who is the study for?

This trial is for patients at Penn Medicine who are identified by the FIND FH tool as likely having Familial Hypercholesterolemia (FH), but have not been clinically diagnosed with it. It's aimed at those who may be at high risk of this condition, which involves very high cholesterol levels.

What is being tested?

The study tests new ways to find and manage FH using a machine learning tool within electronic health records. It includes refining referral processes for primary care providers and exploring patient outreach methods across three phases: data gathering, pilot development, and a large-scale pragmatic trial.

What are the potential side effects?

Since this trial focuses on diagnosis and management strategies rather than medication or medical procedures, traditional side effects are not applicable. However, there might be indirect consequences related to changes in clinical management practices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 - post intervention study visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 - post intervention study visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 - post intervention study visit for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of flagged patients diagnosed with FH (familial hypercholesterolemia) as a result of the intervention

Secondary study objectives

Proportion of patients that have a change to their lipid management among patients that were candidates for a change to their lipid management because of the intervention

Proportion of patients that have a change to their lipid management because of the intervention

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

Group I: Patients without a primary care physician within the UPHS health systemExperimental Treatment1 Intervention

Patients without a primary care physician within the UPHS health system will receive direct outreach from the study team to invite them to schedule a visit with a lipid specialist for a formal evaluation of FH.

Group II: Patients with a primary care physician within the UPHS health systemExperimental Treatment2 Interventions

For patients with a primary care physician within the UPHS health system, their primary care physicians will be asked to review and sign physician referrals to a lipid specialist and invite patients to schedule a visit with a lipid specialist for a formal evaluation of FH.

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