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

Geisinger Health logo

Geisinger Health

Status

Invitation-only

Conditions

Familial Hypercholesterolemia

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05284513
2021-0927
1R61HL161775 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

532 estimated patients

Sex

All

Ages

26+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Primary care clinicians (pediatrician, community medicine, internal medicine) in the Geisinger Healthcare System

Exclusion criteria

  • None

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

532 participants in 5 patient groups

Phase 1
Other group
Description:
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Treatment:
Behavioral: FH diagnosis program
Behavioral: Implementation strategy package: Stage implementation scale up
Behavioral: Implementation strategy package: Audit and provide feedback
Behavioral: Implementation strategy package: Develop educational materials
Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions
Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance
Behavioral: Implementation strategy package: Conduct educational outreach visits
Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring
Phase 2
Other group
Description:
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Treatment:
Behavioral: FH diagnosis program
Behavioral: Implementation strategy package: Stage implementation scale up
Behavioral: Implementation strategy package: Audit and provide feedback
Behavioral: Implementation strategy package: Develop educational materials
Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions
Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance
Behavioral: Implementation strategy package: Conduct educational outreach visits
Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring
Phase 3
Other group
Description:
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Treatment:
Behavioral: FH diagnosis program
Behavioral: Implementation strategy package: Stage implementation scale up
Behavioral: Implementation strategy package: Audit and provide feedback
Behavioral: Implementation strategy package: Develop educational materials
Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions
Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance
Behavioral: Implementation strategy package: Conduct educational outreach visits
Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring
Phase 4
Other group
Description:
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Treatment:
Behavioral: FH diagnosis program
Behavioral: Implementation strategy package: Stage implementation scale up
Behavioral: Implementation strategy package: Audit and provide feedback
Behavioral: Implementation strategy package: Develop educational materials
Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions
Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance
Behavioral: Implementation strategy package: Conduct educational outreach visits
Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring
Phase 5
Other group
Description:
Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
Treatment:
Behavioral: FH diagnosis program
Behavioral: Implementation strategy package: Stage implementation scale up
Behavioral: Implementation strategy package: Audit and provide feedback
Behavioral: Implementation strategy package: Develop educational materials
Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions
Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance
Behavioral: Implementation strategy package: Conduct educational outreach visits
Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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