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

Part of paid clinical trials in Multiple Locations, Pennsylvania.

Sponsor
Geisinger Clinic
Study ID
NCT05284513
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
26 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 9, 2022
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
532 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Other: Phase 1
    Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
  • Other: Phase 2
    Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
  • Other: Phase 3
    Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
  • Other: Phase 4
    Phased rollout to clinic sites across the the Geisinger system using stepped wedge design
  • Other: Phase 5
    Phased rollout to clinic sites across the the Geisinger system using stepped wedge design

Primary Outcome Measure

FH diagnosis rate (Aim 2) [ Time Frame: Up to 45 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Geisinger ClinicMultiple LocationsPennsylvania00000-

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Geisinger Clinic· Multiple Locations, PA

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