Integrated Machine Learning Approach for High Cholesterol

(BEAT FH Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Diagnosed FH, Lipid specialist, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the diagnosis and treatment of familial hypercholesterolemia (FH), a genetic condition causing high cholesterol levels, by using new strategies to identify individuals at high risk. Researchers are testing how primary care physicians and direct patient outreach can connect patients to specialists for proper evaluation. Participants should be Penn Medicine patients flagged by a tool as likely having FH, speak English as a first language, and live in Pennsylvania or New Jersey. As an unphased trial, this study offers participants the chance to contribute to innovative strategies that could enhance patient care and diagnosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these methods are safe for identifying and treating individuals at high risk of FH?

Research has shown that a central system for referring patients from primary care doctors to specialists is generally well-accepted. This system aids patients with familial hypercholesterolemia (FH), a genetic condition that can lead to high cholesterol, in receiving better diagnosis and treatment. Reports have not indicated any problems with this referral process, suggesting it is safe for patients.

Studies have found that patients respond well to targeted phone calls and personalized information about their health risks. These methods effectively encourage patients to explore treatment options, and no safety issues have been reported with these outreach methods.

In summary, both the referral and outreach strategies aim to improve patient care by connecting them with necessary medical help. Evidence suggests these methods are safe and do not add extra risks for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance cholesterol management through better patient referrals and outreach. Traditional treatments for high cholesterol often focus on medications like statins, but this trial is testing how improving communication and referrals can optimize care. By integrating primary care physicians into a centralized referral system and using direct outreach for patients without a primary care provider, the trial aims to streamline access to lipid specialists. This could lead to more timely and personalized care, potentially improving outcomes for patients with high cholesterol.

What evidence suggests that this trial's treatments could be effective for high cholesterol?

This trial will compare two approaches for managing high cholesterol related to familial hypercholesterolemia (FH). One arm will test a centralized referral mechanism for patients with a primary care physician within the UPHS health system. Research has shown that a central system for referring patients to primary care doctors can greatly improve FH management. Specifically, one study found that an automated referral system led to six times more correct statin prescriptions than traditional methods. Additionally, primary care doctors who received direct contact were more proactive in checking for FH.

The other arm will focus on patients without a primary care physician within the UPHS health system, testing patient outreach methods. Studies have found that targeted phone calls and communication can effectively identify FH, leading to better health outcomes. In one study, patients who received personalized outreach were more likely to discuss cholesterol medication with their doctors. These methods help ensure that people at high risk for FH receive necessary check-ups and treatments. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have been identified as having a high chance of having familial hypercholesterolemia (FH) by a special screening tool.

Must be a patient at Penn Medicine

Exclusion Criteria

Already have been clinically diagnosed with FH using the proper ICD-10 code

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Data Gathering

Applying the FIND FH tool to the health system EHR and gathering data for pilot development

8 weeks

Phase 2: Pilot Development and Implementation

Co-design and pilot implementation strategies using behavioral economics with an enrollment goal of 80 patients

12 weeks

Phase 3: Large-scale Pragmatic Trial

Conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in Phase 2

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Testing centralized referral mechanisms for PCPs
• Testing out patient outreach methods

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients without a primary care physician within the UPHS health system Experimental Treatment 1 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 system Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Family Heart Foundation

Collaborator

Trials

3

Recruited

1,600+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

The pharmacist-led SMASH intervention significantly reduced potentially hazardous prescribing rates by 40.7% after 12 months in 43 general practices serving over 235,000 people, demonstrating its efficacy in improving medication safety.

While the intervention also led to a 22.0% reduction in inadequate blood-test monitoring at 24 weeks, this improvement was not sustained at 12 months, indicating a need for ongoing monitoring in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a pharmacist-led actionable audit and feedback intervention for improving medication safety in UK primary care: An interrupted time series analysis. Peek, N., Gude, WT., Keers, RN., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11338952/

Primary care clinician engagement in implementing a ... We developed a comprehensive, multi-pronged educational program for primary care clinicians (PCCs) on screening, diagnosis, and management of Familial ...

2. pennmedicine.org pennmedicine.org/news/appropriate-statin-prescriptions-increase-with-automated-referral

Proper statin prescriptions rise with automated referrals Penn researchers found appropriate statin prescriptions increased sixfold with an automated referral process compared to traditional ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11795838/

Two Randomized Controlled Trials of Nudges to Encourage ... Two randomized controlled trials of nudges to encourage referrals to centralized pharmacy services for evidence-based statin initiation in high-risk patients.

4. researchgate.net researchgate.net/publication/382480558_Primary_care_clinician_engagement_in_implementing_a_machine-learning_algorithm_for_targeted_screening_of_Familial_Hypercholesterolemia

(PDF) Primary care clinician engagement in implementing ... Despite the fact that 87 % identified PCC's as most effective for early detection of FH, 100 % of PCCs who received direct outreach chose to ...

5. lipidworld.biomedcentral.com lipidworld.biomedcentral.com/articles/10.1186/s12944-025-02435-7

Automated process assessment of primary healthcare for ... Primary healthcare (PHC) plays a key role in hyperlipidemia (HL) management yet lacks adequate monitoring and feedback.

6. ajmc.com ajmc.com/view/patient-and-physician-perceptions-of-a-hypercholesterolemia-safety-net-program

Patient and Physician Perceptions of a ... PCPs were asked to describe their familiarity with the safety-net program and perceived patient barriers to filling a new statin prescription ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12035916/

Implementation strategies for improving the care of familial ... Central coordination has particular importance during the cascade testing of family members, allowing for the linkage of FH cases to a clinical ...

8. lipidworld.biomedcentral.com lipidworld.biomedcentral.com/articles/10.1186/s12944-023-01815-1

Referral rate, profile and degree of control of patients with ... This study explored the need, based on referral rate and cardiovascular (CV) risk factor control in patients evaluated for familial ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0021915024001084

Enhanced identification of familial hypercholesterolemia ... This study highlights how a laboratory-based approach can effectively identify and optimize treatment for FH patients.