Clinical trial NCT05746247: Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics
Official title: Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Familial Hypercholesterolemia
Keywords: machine learning
FIND FH
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Family Heart Foundation
name: Northwestern University
First posted: 2023-02-27
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 Phase 3: There will be 2 arms. Arm 1) Penn PCP: For patients with a Penn PCP, we will use a default centralized referral model to engage PCPs to sign a referral for their patients to see a lipid specialist. Arm 2) Direct to Patient: For patients without a PCP at Penn, we will conduct direct outreach to the patients to invite them to schedule a free telehealth appointment with a lipid specialist.
Primary purpose: DIAGNOSTIC

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

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
* 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

Primary outcomes:
measure: Proportion of flagged patients diagnosed with FH (familial hypercholesterolemia) as a result of the intervention
timeFrame: Day 1 - post intervention study visit
Secondary outcomes:
measure: Proportion of patients that have a change to their lipid management because of the intervention
timeFrame: Day 1 - post intervention study visit
measure: Proportion of patients that have a change to their lipid management among patients that were candidates for a change to their lipid management because of the intervention
timeFrame: Day 1 - post intervention study visit
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
References: