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

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.

Conditions

• Familial Hypercholesterolemia

Interventions

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Geisinger Clinic

  lead OTHER

Principal Investigators

• Laney K Jones, PharmD, MPH · Geisinger Clinic

• Samuel S Gidding, MD · Geisinger Clinic

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

26 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-09

Primary Completion

2027-01-31

Completion

2027-01-31

Countries

• United States