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

Familial Hypercholesterolemia Clinical Trial

— BEAT FH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05746247
• Other study ID #: 849516
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Already have been clinically diagnosed with FH using the proper ICD-10 code

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Behavioral:
• Testing centralized referral mechanisms for PCPs
For patients with a Penn PCP, we are testing the two different centralized referral mechanisms to increase the number of referrals to preventive cardiology (active choice vs default/opt out referrals) For active choice: A non-interruptive In Basket alert will be delivered to PCPs that have patients that have been screened as positive with the FIND FH tool and recommends a referral to a lipid specialist. PCPs will have the choice of either accepting the referral or declining the referral. If they do not take action on the In Basket alert, the referral will stay in their In Basket. For default/opt out: A non-interruptive In Basket alert will be delivered to PCPs that have patients that have been screened as positive with the FIND FH tool and recommends a referral to a lipid specialist. Not interacting with the BPA or accepting the BPA will indicate that the referral to a lipid specialist should be placed.
• Testing out patient outreach methods
Testing health care system mediated outreach vs Family Heart Foundation mediated outreach to see which type of outreach might be most effective at getting patients to schedule an appointment with a lipid specialist

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Family Heart Foundation, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of referrals to preventive cardiology	For patients with a PCP within the UPHS health system, we want to see which centralized referral options leads to a greater rate of referrals to preventive cardiology.	6 months
Primary	Rate of actual patient visits with a lipid specialist	For all patients, we want to increase the # of scheduled appointments and examine the rate of actual patient visits with a lipid specialist for their formal evaluation of FH.	6 months