NCT05284513

Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 532 (estimated)
• Sponsor: Geisinger Clinic · Academic / Other
• Sex: All
• Age: 26 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Familial hypercholesterolemia (FH) is a common genetic disorder (prevalence 1 in 250) that requires lifelong sustained medical care. Evidence-based guidelines for screening and treatment for FH exist. These include universal screening of children ages 9-11, of adolescents ages 18-20, and of adults ages 40 and above; approved diagnostic tools including lipid panels and genetic testing; and recommendations for initiation of lipid lowering medication. FH diagnosis is currently made too late in life, often after a premature heart attack has occurred creating a care gap that results in excess cardiovascular morbidity and mortality. Diagnosing FH in the primary care setting would optimize treatment for individuals with FH and close this care gap. Utilizing tools from implementation science and human centered design, and by considering uptake, acceptability, and sustainability of programs related to FH care should improve earlier diagnosis. Implementation strategies that include insights from patients, clinicians, and healthcare systems are necessary. The long-term goal is to create an effective FH diagnosis program that is practical and sustainable in the real-world setting. The main objective of this project is to determine the uptake of an FH diagnosis program integrated into primary care practices to promote early identification of adult and pediatric patients that is generalizable to other healthcare settings. The research question is, does using a multi-level implementation strategy package, designed to address the specific needs of patients, clinicians, and healthcare systems, improve the diagnosis and activation of care management for individuals with FH. The specific aims are to: 1) to design a clinical trial to assess multi-level implementation strategies for improving FH diagnosis in an integrated health system, 2) compare FH diagnosis rates among primary care clinicians who receive the implementation strategy package versus those who do not, 3) to measure implementation success of an organized FH diagnosis program, and 4) to explore patient-related service and health outcomes related to an FH diagnosis program.

Conditions

• Familial Hypercholesterolemia

Interventions

Type	Name	Description
BEHAVIORAL	FH diagnosis program	Uptake of screening, diagnosis, and initiation of care management for FH
BEHAVIORAL	Implementation strategy package: Develop and implement tools for quality monitoring	EHR tools to order labs, record results, and document FH care
BEHAVIORAL	Implementation strategy package: Develop educational materials	Education regarding guidelines for identification and treatment of FH
BEHAVIORAL	Implementation strategy package: Conduct educational outreach visits	Continuing medical education (CME) material for FH that is presented to
BEHAVIORAL	Implementation strategy package: Intervene with clinicians and patients to enhance	Notify patients simultaneously with clinicians about the need for screening
BEHAVIORAL	Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions	Clinical lipid champions
BEHAVIORAL	Implementation strategy package: Audit and provide feedback	Provide aggregate level feedback to clinics on diagnosing FH
BEHAVIORAL	Implementation strategy package: Stage implementation scale up	Develop the timeline for the stepped-wedge rollout to primary care

Timeline

• Start date: 2022-09-09
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2022-03-17
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States