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

Primary Purpose

Familial Hypercholesterolemia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testing centralized referral mechanisms for PCPs
Testing out patient outreach methods
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Familial Hypercholesterolemia focused on measuring machine learning, FIND FH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Pennsylvania Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients without a primary care physician within the UPHS health system

Patients with a primary care physician within the UPHS health system

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2023
Last Updated
March 17, 2023
Sponsor
University of Pennsylvania
Collaborators
Family Heart Foundation, Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05746247
Brief Title
Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics
Acronym
BEAT FH
Official Title
Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Family Heart Foundation, Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypercholesterolemia
Keywords
machine learning, FIND FH

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients without a primary care physician within the UPHS health system
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patients with a primary care physician within the UPHS health system
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Testing centralized referral mechanisms for PCPs
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Testing out patient outreach methods
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of referrals to preventive cardiology
Description
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.
Time Frame
6 months
Title
Rate of actual patient visits with a lipid specialist
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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