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

University of Pennsylvania

Status: Invitation-only

Conditions: Familial Hypercholesterolemia

Treatments: Behavioral: Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation; Behavioral: Testing centralized referral mechanism for PCPs

Study type: Interventional

Funder types: Other

Identifiers

NCT05746247

849516

Details and patient eligibility

About

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

Full description

Phase 1:

Aim 1: Adjusting and refining the application of the FIND FH tool to the UPHS EHR database Aim 2: Identifying the barriers and facilitators to making a diagnosis of FH and initiating or intensifying therapy for individuals with FH through qualitative interviews with clinicians and patients and creating a behavioral roadmap to inform the implementation approaches to test in the pilots

Phase 2:

Aim 1: Co-design implementation strategies using behavioral economics in partnership with the Family Heart Foundation Aim 2: Pilot implementation strategies with an enrollment goal of 80 patients total (40 per pilot) who have been flagged by the FIND FH tool as having probable FH to ascertain feasibility, acceptability, and appropriateness

Phase 3: Conduct a large-scale pragmatic trial consistent with recommendations and learnings from the pilots in Phase 2

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be a patient at Penn Medicine
• Must have been flagged by the FIND FH tool as having a high probability of FH
• First language is English
• Resides in PA or NJ

Exclusion criteria

• Already have been clinically diagnosed with FH using the proper ICD-10 code
• Currently see a lipid specialist at Penn Medicine
• Pass study clinician's Study Validity Check

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Patients without a primary care physician within the UPHS health system

Experimental group

Description:

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.

Treatment:

Behavioral: Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation

Patients with a primary care physician within the UPHS health system

Experimental group

Description:

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.

Treatment:

Behavioral: Testing centralized referral mechanism for PCPs

Behavioral: Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation