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

NCT05284513 | Enrolling By Invitation DMC

• 2 other identifiers: 2021-09271R61HL161775
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• FH diagnosis rate (Aim 2)

  FH diagnosis rate, is achieving both the scheduling of a clinic visit and evidence the clinician, at that visit, has completed evidence-based FH diagnostic evaluation, defined as completing one of: using the FH clinic note to document care, adding FH diagnosis on the problem list, using the FH smart-set (or ordered a genetic test for FH), making a referral to the lipid clinic, or starting a statin for an evidence-based indication

  Up to 45 months

• Acceptability (Aim 3)

  Clinician and patient satisfaction and self-efficacy with the FH diagnosis program

  Month 9, 12, 18, 24, 30, 36, 42

• Timeliness (Aim 4)

  Time to FH screen, time to diagnostic evaluation, time to statin initiation

  Up to 45 months

Secondary Outcomes (12)

• Initiation medication use (Aim 2)

  Up to 45 months

• Lipid measurement (Aim 2)

  Up to 45 months

• Genetic testing (Aim 2)

  Month 9, 12, 18, 24, 30, 36, 42

• Problem list diagnosis of FH (Aim 2)

  Up to 45 months

• FH smartset (Aim 2)

  Month 9, 12, 18, 24, 30, 36, 42

Study Arms (5)

Phase 1

OTHER

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

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

Phase 2

OTHER

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

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

Phase 3

OTHER

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

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

Phase 4

OTHER

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

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

Phase 5

OTHER

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

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

Interventions

FH diagnosis program BEHAVIORAL

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

Phase 1; Phase 2; Phase 3; Phase 4; Phase 5

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

Clinical lipid champions

Phase 1; Phase 2; Phase 3; Phase 4; Phase 5

Implementation strategy package: Develop and implement tools for quality monitoring BEHAVIORAL

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

Phase 1; Phase 2; Phase 3; Phase 4; Phase 5

Implementation strategy package: Develop educational materials BEHAVIORAL

Education regarding guidelines for identification and treatment of FH

Phase 1; Phase 2; Phase 3; Phase 4; Phase 5

Implementation strategy package: Conduct educational outreach visits BEHAVIORAL

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

Phase 1; Phase 2; Phase 3; Phase 4; Phase 5

Implementation strategy package: Intervene with clinicians and patients to enhance BEHAVIORAL

Notify patients simultaneously with clinicians about the need for screening

Phase 1; Phase 2; Phase 3; Phase 4; Phase 5

Implementation strategy package: Audit and provide feedback BEHAVIORAL

Provide aggregate level feedback to clinics on diagnosing FH

Phase 1; Phase 2; Phase 3; Phase 4; Phase 5

Implementation strategy package: Stage implementation scale up BEHAVIORAL

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

Phase 1; Phase 2; Phase 3; Phase 4; Phase 5

Eligibility Criteria

• Age: 26 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Geisinger Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Geisinger Clinic

Multiple Locations, Pennsylvania, 00000, United States

Location

Related Publications (1)

• 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.

  PMID: 38228467 DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Laney K Jones, PharmD, MPH

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

• Samuel S Gidding, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stepped-wedge design

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: March 17, 2022
• Study Start: September 9, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)