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

Sponsor

University of Pennsylvania (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05746247

Collaborator

Family Heart Foundation (Other), Northwestern University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Familial Hypercholesterolemia	Behavioral: Testing centralized referral mechanisms for PCPs Behavioral: Testing out patient outreach methods	N/A

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

For the pilots, for patients with a PCP within the healthcare system, we are testing 2 different centralized referral models to increase the # of patients that see a lipid specialist (active choice vs default). For patients without a PCP within the health system, we are testing out health system mediated outreach vs Family Heart Foundation mediated outreach in order to increase the number of patients who make an appointment with a lipid specialist.For the pilots, for patients with a PCP within the healthcare system, we are testing 2 different centralized referral models to increase the # of patients that see a lipid specialist (active choice vs default). For patients without a PCP within the health system, we are testing out health system mediated outreach vs Family Heart Foundation mediated outreach in order to increase the number of patients who make an appointment with a lipid specialist.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patients without a primary care physician within the UPHS health system Pilot 1 is examining ways to get patients without a primary care physician within the UPHS health system to schedule a visit with a lipid specialist for a formal evaluation of FH.	Behavioral: 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
Active Comparator: Patients with a primary care physician within the UPHS health system Pilot 2 is examining ways to increase physician referrals to preventive cardiology, and increase patient visits with a lipid specialist for a formal evaluation of FH.	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. Behavioral: 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

Arm

Intervention/Treatment

Active Comparator: Patients without a primary care physician within the UPHS health system

Pilot 1 is examining ways to get patients without a primary care physician within the UPHS health system to schedule a visit with a lipid specialist for a formal evaluation of FH.

Behavioral: 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

Active Comparator: Patients with a primary care physician within the UPHS health system

Pilot 2 is examining ways to increase physician referrals to preventive cardiology, and increase patient visits with a lipid specialist for a formal evaluation of FH.

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.

Behavioral: Testing out patient outreach methods

Outcome Measures

Primary Outcome Measures

Rate of referrals to preventive cardiology [6 months]
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.
Rate of actual patient visits with a lipid specialist [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19146

Sponsors and Collaborators

University of Pennsylvania
Family Heart Foundation
Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT05746247

Other Study ID Numbers:

849516

First Posted:

Feb 27, 2023

Last Update Posted:

Feb 27, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Pennsylvania

machine learning

FIND FH

Additional relevant MeSH terms:

Hyperlipoproteinemia Type II

Hypercholesterolemia

Study Results

No Results Posted as of Feb 27, 2023