Familial HypercholesterolemiaBEAT FHNCT05746247
Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics
A study testing Testing centralized referral mechanism for PCPs and Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation in people with Familial Hypercholesterolemia, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- Testing centralized referral mechanism for PCPs and Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19146
About this study
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
Read the 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
- Conditions
- Familial Hypercholesterolemia
- Being tested
- Testing centralized referral mechanism for PCPs, Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation
- Keywords
- machine learning, FIND FH
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing centralized referral mechanism for PCPsBehavioural
For patients with a Penn PCP, we are testing a centralized referral mechanism to increase the number of referrals to preventive cardiology (default/opt out referrals)
For default/opt out: PCPs will receive a pended order for a referral for their patient to see a lipid specialist for a formal FH evaluation. Not interacting with the pended order or accepting the pended order will indicate that the referral to a lipid specialist should be placed.
Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluationBehavioural
All eligible patients will be informed that they have been identified by the FIND FH tool as potentially having familial hypercholesterolemia. All patients will be invited to schedule a telehealth appointment with a lipid specialist for a formal evaluation for FH.
| Study group | Role | What they receive |
|---|---|---|
| Patients without a primary care physician within the UPHS health system | Experimental | 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. Receives: 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 | 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. Receives: Behavioral: Testing centralized referral mechanism for PCPs; Behavioral: Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of flagged patients diagnosed with FH (familial hypercholesterolemia) as a result of the intervention
Patients will be evaluated for familial hypercholesterolemia (FH), an underdiagnosed genetic type of high cholesterol. An FH diagnosis will be defined using the Dutch Lipid Clinic Network Diagnostic (DLCN) Criteria for FH (Unlikely, Possible, Probable, Definite). The clinician will also make a clinical assessment of FH informed by the DLCN score and clinical expertise from the appointment.
Measured: Day 1 - post intervention study visit
Secondary outcomes (2)
Proportion of patients that have a change to their lipid management because of the intervention
Defined as the proportion of patients that start (or are prescribed) statins, ezetimibe, PCSK9 inhibitors, or have any intensification of any lipid lowering medications as a result of the visit with the lipid specialist for patients that qualify at the time of the appointment with the lipid specialist.
Measured: Day 1 - post intervention study visit
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
Defined as the proportion of patients that start (or are prescribed) statins, ezetimibe, PCSK9 inhibitors, or have any intensification of any lipid lowering medications as a result of the visit with the lipid specialist for patients that qualified and were not already optimally treated at the time of the appointment.
Measured: Day 1 - post intervention study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Mar 2022
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Family Heart Foundation, Northwestern University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746247
- Sponsor's protocol ID
- 849516
- Acronym
- BEAT FH
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diagnosis and Clinical Management of Familial Hypercholesterolemia Through Integrated Machine Learning, Implementation Science, and Behavioral Economics
- ClinicalTrials.gov ID
- NCT05746247
- Acronym / sponsor ID
- BEAT FH / 849516
- Conditions
- Familial Hypercholesterolemia
- Keywords
- machine learning, FIND FH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Family Heart Foundation, Northwestern University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients without a primary care physician within the UPHS health system | Experimental | Behavioral: Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluationPatients 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. |
| Patients with a primary care physician within the UPHS health system | Experimental | Behavioral: Testing centralized referral mechanism for PCPs, Behavioral: Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluationFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing centralized referral mechanism for PCPsFor patients with a Penn PCP, we are testing a centralized referral mechanism to increase the number of referrals to preventive cardiology (default/opt out referrals) For default/opt out: PCPs will receive a pended order for a referral for their patient to see a lipid specialist for a formal FH evaluation. Not interacting with the pended order or accepting the pended order will indicate that the referral to a lipid specialist should be placed. | Behavioural | Patients with a primary care physician within the UPHS health system |
| Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluationAll eligible patients will be informed that they have been identified by the FIND FH tool as potentially having familial hypercholesterolemia. All patients will be invited to schedule a telehealth appointment with a lipid specialist for a formal evaluation for FH. | Behavioural | Patients with a primary care physician within the UPHS health system, Patients without a primary care physician within the UPHS health system |
Primary outcome
Proportion of flagged patients diagnosed with FH (familial hypercholesterolemia) as a result of the intervention
Time frame: Day 1 - post intervention study visit
Patients will be evaluated for familial hypercholesterolemia (FH), an underdiagnosed genetic type of high cholesterol. An FH diagnosis will be defined using the Dutch Lipid Clinic Network Diagnostic (DLCN) Criteria for FH (Unlikely, Possible, Probable, Definite). The clinician will also make a clinical assessment of FH informed by the DLCN score and clinical expertise from the appointment.
2 secondary outcomes
Proportion of patients that have a change to their lipid management because of the intervention
Time frame: Day 1 - post intervention study visit
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
Time frame: Day 1 - post intervention study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing centralized referral mechanism for PCPs and Inviting patients to complete a telehealth appointment with a lipid specialist for an FH evaluation in people with Familial Hypercholesterolemia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of flagged patients diagnosed with FH (familial hypercholesterolemia) as a result of the intervention (time frame: Day 1 - post intervention study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.