Comprehensive Care Approach for High Cholesterol
(CARE-FH Trial)

Overseen ByCARE-FH Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase the diagnosis rate of familial hypercholesterolemia (FH), a genetic condition causing high cholesterol, in primary care settings. Researchers are testing a new FH diagnosis program to help doctors identify and treat individuals with FH more effectively. This study could simplify and increase the frequency of FH diagnosis, reducing heart attack risk for those with the condition. Individuals who regularly visit their primary care doctors within the Geisinger Healthcare System may participate in this study. As an unphased trial, it offers participants the chance to contribute to important research that could enhance early diagnosis and treatment for FH.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this FH diagnosis program is safe?

Research has shown that using a program to diagnose familial hypercholesterolemia (FH) is generally safe. FH is a genetic condition that causes high cholesterol levels, increasing the risk of heart problems. The program aims to identify individuals who might have FH through a structured diagnosis process.

Studies have found that screenings for FH can help identify those needing treatment, potentially preventing heart attacks. No reports of negative effects from the diagnostic process itself exist. This program is not a new drug or treatment with potential side effects; it simply detects a condition early.

Since this trial does not test a new medication, the focus is on the effectiveness of the diagnosis program. Overall, available evidence suggests it is a well-tolerated approach with no known safety concerns.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Researchers are excited about the FH diagnosis program for high cholesterol because it focuses on identifying familial hypercholesterolemia (FH) early on. Unlike current treatments that primarily aim to manage cholesterol levels with medications like statins, this approach targets the root cause by detecting genetic predispositions in families. By catching FH early, it allows for more personalized and effective management strategies, potentially reducing the risk of heart disease before symptoms even appear.

What evidence suggests that this trial's treatments could be effective for improving FH diagnosis rates?

Research shows that a special program for diagnosing familial hypercholesterolemia (FH) can effectively identify individuals with this condition. FH is an inherited disorder where families pass down high cholesterol, increasing heart attack risk. Studies have found that less than 10% of people with FH receive a diagnosis worldwide, leaving many unaware of their condition. Tools like cascade testing, which involves checking the family members of someone with FH, have proven helpful in finding more cases. This trial will implement a comprehensive care approach, including the FH diagnosis program, to enhance FH diagnosis. Improving FH diagnosis enables more people to receive treatment to lower cholesterol and reduce heart risks.³ ⁶ ⁷ ⁸ ⁹

Who Is on the Research Team?

Laney K Jones, PharmD, MPH

Principal Investigator

Geisinger Clinic

Samuel S Gidding, MD

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

This trial is for primary care clinicians within the Geisinger Healthcare System. It aims to involve doctors who practice in pediatrics, community medicine, or internal medicine. There are no specific exclusion criteria mentioned, so it appears open to all clinicians in these fields.

Inclusion Criteria

This criterion specifies that only primary care clinicians within the Geisinger Healthcare System, such as pediatricians, community medicine doctors, and internal medicine doctors, are eligible to participate in the study.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Strategy Rollout

Phased rollout of the FH diagnosis program using a stepped-wedge design across clinic sites

45 months

Multiple visits as per phased rollout schedule

Follow-up

Participants are monitored for the effectiveness of the FH diagnosis program and initiation of lipid-lowering medication

45 months

Regular follow-up visits as per clinic schedule

What Are the Treatments Tested in This Trial?

Interventions

Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions
FH diagnosis program
Implementation strategy package: Audit and provide feedback
Implementation strategy package: Conduct educational outreach visits
Implementation strategy package: Develop and implement tools for quality monitoring
Implementation strategy package: Develop educational materials
Implementation strategy package: Intervene with clinicians and patients to enhance
Implementation strategy package: Stage implementation scale up

Trial Overview

The CARE-FH trial is testing a series of strategies designed to improve diagnosis rates of familial hypercholesterolemia (FH) in primary care settings. These include educational materials and outreach, quality monitoring tools, interventions with clinicians and patients, identifying clinical champions for lipids management, and providing feedback on performance.