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

NCT ID: NCT05284513

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

532 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-09

Study Completion Date

2027-01-31

Brief Summary

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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

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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

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Familial Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped-wedge design
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Phase 1

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

Group Type OTHER

FH diagnosis program

Intervention Type BEHAVIORAL

Uptake of screening, diagnosis, and initiation of care management for FH

Implementation strategy package: Develop and implement tools for quality monitoring

Intervention Type BEHAVIORAL

EHR tools to order labs, record results, and document FH care

Implementation strategy package: Develop educational materials

Intervention Type BEHAVIORAL

Education regarding guidelines for identification and treatment of FH

Implementation strategy package: Conduct educational outreach visits

Intervention Type BEHAVIORAL

Continuing medical education (CME) material for FH that is presented to

Implementation strategy package: Intervene with clinicians and patients to enhance

Intervention Type BEHAVIORAL

Notify patients simultaneously with clinicians about the need for screening

Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions

Intervention Type BEHAVIORAL

Clinical lipid champions

Implementation strategy package: Audit and provide feedback

Intervention Type BEHAVIORAL

Provide aggregate level feedback to clinics on diagnosing FH

Implementation strategy package: Stage implementation scale up

Intervention Type BEHAVIORAL

Develop the timeline for the stepped-wedge rollout to primary care

Phase 2

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

Group Type OTHER

FH diagnosis program

Intervention Type BEHAVIORAL

Uptake of screening, diagnosis, and initiation of care management for FH

Implementation strategy package: Develop and implement tools for quality monitoring

Intervention Type BEHAVIORAL

EHR tools to order labs, record results, and document FH care

Implementation strategy package: Develop educational materials

Intervention Type BEHAVIORAL

Education regarding guidelines for identification and treatment of FH

Implementation strategy package: Conduct educational outreach visits

Intervention Type BEHAVIORAL

Continuing medical education (CME) material for FH that is presented to

Implementation strategy package: Intervene with clinicians and patients to enhance

Intervention Type BEHAVIORAL

Notify patients simultaneously with clinicians about the need for screening

Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions

Intervention Type BEHAVIORAL

Clinical lipid champions

Implementation strategy package: Audit and provide feedback

Intervention Type BEHAVIORAL

Provide aggregate level feedback to clinics on diagnosing FH

Implementation strategy package: Stage implementation scale up

Intervention Type BEHAVIORAL

Develop the timeline for the stepped-wedge rollout to primary care

Phase 3

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

Group Type OTHER

FH diagnosis program

Intervention Type BEHAVIORAL

Uptake of screening, diagnosis, and initiation of care management for FH

Implementation strategy package: Develop and implement tools for quality monitoring

Intervention Type BEHAVIORAL

EHR tools to order labs, record results, and document FH care

Implementation strategy package: Develop educational materials

Intervention Type BEHAVIORAL

Education regarding guidelines for identification and treatment of FH

Implementation strategy package: Conduct educational outreach visits

Intervention Type BEHAVIORAL

Continuing medical education (CME) material for FH that is presented to

Implementation strategy package: Intervene with clinicians and patients to enhance

Intervention Type BEHAVIORAL

Notify patients simultaneously with clinicians about the need for screening

Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions

Intervention Type BEHAVIORAL

Clinical lipid champions

Implementation strategy package: Audit and provide feedback

Intervention Type BEHAVIORAL

Provide aggregate level feedback to clinics on diagnosing FH

Implementation strategy package: Stage implementation scale up

Intervention Type BEHAVIORAL

Develop the timeline for the stepped-wedge rollout to primary care

Phase 4

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

Group Type OTHER

FH diagnosis program

Intervention Type BEHAVIORAL

Uptake of screening, diagnosis, and initiation of care management for FH

Implementation strategy package: Develop and implement tools for quality monitoring

Intervention Type BEHAVIORAL

EHR tools to order labs, record results, and document FH care

Implementation strategy package: Develop educational materials

Intervention Type BEHAVIORAL

Education regarding guidelines for identification and treatment of FH

Implementation strategy package: Conduct educational outreach visits

Intervention Type BEHAVIORAL

Continuing medical education (CME) material for FH that is presented to

Implementation strategy package: Intervene with clinicians and patients to enhance

Intervention Type BEHAVIORAL

Notify patients simultaneously with clinicians about the need for screening

Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions

Intervention Type BEHAVIORAL

Clinical lipid champions

Implementation strategy package: Audit and provide feedback

Intervention Type BEHAVIORAL

Provide aggregate level feedback to clinics on diagnosing FH

Implementation strategy package: Stage implementation scale up

Intervention Type BEHAVIORAL

Develop the timeline for the stepped-wedge rollout to primary care

Phase 5

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

Group Type OTHER

FH diagnosis program

Intervention Type BEHAVIORAL

Uptake of screening, diagnosis, and initiation of care management for FH

Implementation strategy package: Develop and implement tools for quality monitoring

Intervention Type BEHAVIORAL

EHR tools to order labs, record results, and document FH care

Implementation strategy package: Develop educational materials

Intervention Type BEHAVIORAL

Education regarding guidelines for identification and treatment of FH

Implementation strategy package: Conduct educational outreach visits

Intervention Type BEHAVIORAL

Continuing medical education (CME) material for FH that is presented to

Implementation strategy package: Intervene with clinicians and patients to enhance

Intervention Type BEHAVIORAL

Notify patients simultaneously with clinicians about the need for screening

Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions

Intervention Type BEHAVIORAL

Clinical lipid champions

Implementation strategy package: Audit and provide feedback

Intervention Type BEHAVIORAL

Provide aggregate level feedback to clinics on diagnosing FH

Implementation strategy package: Stage implementation scale up

Intervention Type BEHAVIORAL

Develop the timeline for the stepped-wedge rollout to primary care

Interventions

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FH diagnosis program

Uptake of screening, diagnosis, and initiation of care management for FH

Intervention Type BEHAVIORAL

Implementation strategy package: Develop and implement tools for quality monitoring

EHR tools to order labs, record results, and document FH care

Intervention Type BEHAVIORAL

Implementation strategy package: Develop educational materials

Education regarding guidelines for identification and treatment of FH

Intervention Type BEHAVIORAL

Implementation strategy package: Conduct educational outreach visits

Continuing medical education (CME) material for FH that is presented to

Intervention Type BEHAVIORAL

Implementation strategy package: Intervene with clinicians and patients to enhance

Notify patients simultaneously with clinicians about the need for screening

Intervention Type BEHAVIORAL

Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions

Clinical lipid champions

Intervention Type BEHAVIORAL

Implementation strategy package: Audit and provide feedback

Provide aggregate level feedback to clinics on diagnosing FH

Intervention Type BEHAVIORAL

Implementation strategy package: Stage implementation scale up

Develop the timeline for the stepped-wedge rollout to primary care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Geisinger Clinic

OTHER

Sponsor Role lead

Responsible Party

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Samuel Gidding

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laney K Jones, PharmD, MPH

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Samuel S Gidding, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

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Geisinger Clinic

Multiple Locations, Pennsylvania, United States

Site Status

Countries

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United States

References

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Jones LK, Romagnoli KM, Schubert TJ, Clegg K, Kirchner HL, Hu Y, Cawley D, Norelli V, Williams MS, Gidding SS, Rahm AK. Using implementation science to develop a familial hypercholesterolemia screening program in primary care: The CARE-FH study. J Clin Lipidol. 2024 Mar-Apr;18(2):e176-e188. doi: 10.1016/j.jacl.2024.01.001. Epub 2024 Jan 4.

Reference Type DERIVED
PMID: 38228467 (View on PubMed)

Other Identifiers

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1R61HL161775

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021-0927

Identifier Type: -

Identifier Source: org_study_id