Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05746247
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

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

Interventions

  • Testing centralized referral mechanism for PCPs — BEHAVIORAL
    For patients with a Penn PCP, we are testing a centralized referral mechanism to increase the number of referrals to preventive cardiology (default/opt out referrals) For default/opt out: PCPs will receive a pended order for a referral for their patient to see a lipid specialist for a formal FH evaluation. Not interacting with the pended order or accepting the pended order will indicate that the referral to a lipid specialist should be placed.
  • Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation — BEHAVIORAL
    All eligible patients will be informed that they have been identified by the FIND FH tool as potentially having familial hypercholesterolemia. All patients will be invited to schedule a telehealth appointment with a lipid specialist for a formal evaluation for FH.

Study Details

The goal of this study is to identify individuals at high risk of FH, and to encourage the appropriate diagnosis and treatment of individuals at high risk of FH through the use of implementation science and behavioral economics principles. Phase 1: Applying the FIND FH tool to the health system EHR and gathering data for pilot development; Phase 2: Pilot development and implementation; Phase 3: Conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in Phase 2

Key Dates

Start date
Mar 1, 2022
Status verified
Mar 2026
Primary completion
Jan 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients without a primary care physician within the UPHS health system
    Patients without a primary care physician within the UPHS health system will receive direct outreach from the study team to invite them to schedule a visit with a lipid specialist for a formal evaluation of FH.
  • Experimental: Patients with a primary care physician within the UPHS health system
    For patients with a primary care physician within the UPHS health system, their primary care physicians will be asked to review and sign physician referrals to a lipid specialist and invite patients to schedule a visit with a lipid specialist for a formal evaluation of FH.

Primary Outcome Measure

Proportion of flagged patients diagnosed with FH (familial hypercholesterolemia) as a result of the intervention [ Time Frame: Day 1 - post intervention study visit ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania Health SystemPhiladelphiaPennsylvania19146-

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By research site
University of Pennsylvania Health System· Philadelphia, PA

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