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

532 Participants Needed

Trial Summary

What is the purpose of this trial?

Diagnosis rates of familial hypercholesterolemia (FH) are low in the United States, despite multiple guidelines and recommendations for screening and treatment of high cholesterol, to prevent heart attacks in those affected. Using a stepped-wedge design, the investigators plan to utilize tools from implementation science to improve uptake, acceptability, and sustainability of FH diagnostic programs in primary care settings. If successful, this study will provide tools generalizable to other health care systems to improve FH diagnosis rates.

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 data supports the effectiveness of this treatment for high cholesterol?

Research shows that using a comprehensive care approach, including lifestyle changes and education, can improve the management of familial hypercholesterolemia (a genetic high cholesterol condition). This approach helps in early diagnosis and better management, which can prevent heart disease. ^{1 2 3 4 5}

Is the Comprehensive Care Approach for High Cholesterol generally safe for humans?

The research articles do not provide specific safety data for the Comprehensive Care Approach for High Cholesterol or its components. However, they emphasize the importance of early diagnosis and management of familial hypercholesterolemia (FH) through lifestyle changes and medications, which are generally considered safe when monitored by healthcare professionals. ^{5 6 7 8 9}

How is the Comprehensive Care Approach for High Cholesterol treatment different from other treatments for familial hypercholesterolemia?

This treatment is unique because it uses a comprehensive care approach that includes early identification, cascade testing (testing family members), and management strategies to address gaps in care for familial hypercholesterolemia, aiming to prevent cardiovascular disease before it starts. ^{1 2 4 9 10}

Research Team

Laney K Jones, PharmD, MPH

Principal Investigator

Geisinger Clinic

Samuel S Gidding, MD

Principal Investigator

Geisinger Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Designing implementation strategies to improve identification, cascade testing, and management of families with familial hypercholesterolemia: An intervention mapping approach. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia: CARE-FH Protocol. [2023]

3. England pubmed.ncbi.nlm.nih.gov

International Atherosclerosis Society guidance for implementing best practice in the care of familial hypercholesterolaemia. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Applying implementation science to improve care for familial hypercholesterolemia. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Detection and management of familial hypercholesterolaemia in primary care in Australia: protocol for a pragmatic cluster intervention study with pre-post intervention comparisons. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Coronary heart disease mortality in severe vs. non-severe familial hypercholesterolaemia in the Simon Broome Register. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Improving identification and management of familial hypercholesterolaemia in primary care: Pre- and post-intervention study. [2019]

10. Japan pubmed.ncbi.nlm.nih.gov

International Developments in the Care of Familial Hypercholesterolemia: Where Now and Where to Next? [2017]