Comprehensive Care Approach for High Cholesterol

(CARE-FH Trial)

Overseen By CARE-FH Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

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 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.

How Is the Trial Designed?

Group I: Phase 5 Experimental Treatment 8 Interventions

Phased rollout to clinic sites across the the Geisinger system using stepped wedge design

Group II: Phase 4 Experimental Treatment 8 Interventions

Phased rollout to clinic sites across the the Geisinger system using stepped wedge design

Group III: Phase 3 Experimental Treatment 8 Interventions

Phased rollout to clinic sites across the the Geisinger system using stepped wedge design

Group IV: Phase 2 Experimental Treatment 8 Interventions

Phased rollout to clinic sites across the the Geisinger system using stepped wedge design

Group V: Phase 1 Experimental Treatment 8 Interventions

Phased rollout to clinic sites across the the Geisinger system using stepped wedge design

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The CARE-FH study aims to enhance the diagnosis of Familial Hypercholesterolemia (FH) by integrating its evaluation into primary care, potentially identifying patients before serious cardiovascular issues arise.

The study will implement evidence-based guidelines across various medical specialties and analyze the effectiveness of these strategies in improving diagnostic rates and health outcomes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia: CARE-FH Protocol. Jones, LK., Williams, MS., Ladd, IG., et al.[2023]

Familial hypercholesterolemia (FH) is often underdiagnosed, leading to poor management due to knowledge gaps and misconceptions among both patients and healthcare providers, as identified through a needs assessment involving 22 individuals and 98 survey respondents.

The CARE-FH study implemented evidence-based strategies, such as multidisciplinary care teams and educational programs, to improve the identification and management of FH in primary care settings, highlighting the importance of addressing systemic barriers to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing implementation strategies to improve identification, cascade testing, and management of families with familial hypercholesterolemia: An intervention mapping approach. Jones, LK., Calvo, EM., Campbell-Salome, G., et al.[2023]

A review of 153 articles on improving care for familial hypercholesterolemia (FH) identified 37 studies that mapped to implementation strategies aimed at enhancing clinical care, highlighting the need for better translation of evidence into practice.

Only a small number of studies (8 out of 37) used established implementation science frameworks, indicating a gap in applying systematic approaches to address health disparities and improve FH care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying implementation science to improve care for familial hypercholesterolemia. Jones, LK., Brownson, RC., Williams, MS.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11606789/

Implementation outcomes from the IMPACT-FH Study - PMC Cascade testing can be highly effective in identifying individuals with familial hypercholesterolemia (FH) and help prevent atherosclerotic ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1933287423003148

A systematic review of cost-effectiveness analysis ... Diagnosis rate of familial hypercholesterolemia (FH) remained less than 10 % globally and the economic evaluation results of different FH screening ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9692978/

Familial Hypercholesterolemia and Its Current Diagnostics ... Familial hypercholesterolemia (FH) is a common, inherited disorder of cholesterol metabolism. This pathology is usually an autosomal dominant disorder.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X24004150

Implications of Diagnosis Through a Machine Learning ... To meet criteria for “likely FH,” patients were required to have a recorded LDL-C ≥190 mg/dL (while on no lipid-lowering therapies) or ≥125 mg/dL (while ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.119.013225

Diagnosis and Treatment of Heterozygous Familial ... At Week 24, an LDL‐C level <70 mg/dL (1.8 mmol/L) was achieved by 59.8% and 68.2% of patients in ODYSSEY FH I and FH II, respectively. LDL‐C ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6159470/

Familial Hypercholesterolaemia Diagnosis and Management This comprehensive review focuses on epidemiology, diagnosis and screening programmes, the goals of treatment and current lipid-lowering therapy in FH.

7. familyheart.org familyheart.org/research-circ-ce-data

FH Optimal Care in the US (FOCUS) Real-World Data ... The Family Heart Foundation's FOCUS Report quantifies gaps in diagnosis and treatment, and the unfortunate corresponding cardiovascular event rates.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8059332/

Management of Familial Hypercholesterolemia: Current ... The results of population-based studies of genetic screening for FH have demonstrated that there is no fixed LDL-C threshold for making the diagnosis of HoFH.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1098360022007845

A scoping review of interventions increasing screening and ... If left untreated, FH greatly increases risk for cardiovascular disease and premature death. Currently, FH is largely underdiagnosed and interventions are ...