Familial HypercholesterolaemiaFH-ALERTNCT06743659
Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia
A study testing Alert-based computerized decision support in people with Familial Hypercholesterolaemia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a computer alert can aid clinicians in identifying patients with a genetic type of high cholesterol, called Familial Hypercholesterolemia. The main question it aims to answer is whether the computer alert increases recognition of this high cholesterol disorder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Familial Hypercholesterolaemia
- What is being tested?
- Alert-based computerized decision support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥ 18 years old
- seen in the BWH Endocrinology, Cardiovascular Medicine, and Primary Care Clinics
- Dutch Lipid Clinic Network score of at least 3 points
Who cannot join
- a Familial Hypercholesterolemia diagnosis already documented in the EHR medical history, visit history, or problem list
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Gregory Piazza, MD, MS, 617-732-6984, gpiazza@partners.org
Gregory Piazza, MD, MS
About this study
Official title: Alert-Based Computerized Decision Support for Identification and Management of Patients With Familial Hypercholesterolemia (FH-ALERT Trial)
The goal of this clinical trial is to learn if a computer alert can aid clinicians in identifying patients with a genetic type of high cholesterol, called Familial Hypercholesterolemia. The main question it aims to answer is whether the computer alert increases recognition of this high cholesterol disorder.
Read the detailed description
FH-ALERT is a single-center, time-series trial of a patient- and provider-facing EPIC BPA (alert-based CDS tool) to increase diagnosis, LDL-C lowering, and guideline-based therapy of outpatients with presentations consistent with FH. For the first 6 months, the BPA will run in "silent mode", identifying patients with presentations consistent with FH, but not alerting the clinician of record. Following this initial "pre-alert" 6-month period, the BPA will switch to "alert mode" for 18 months, which will provide the on-screen notification to the clinician of record. In other words, consecutive outpatients with presentations consistent with FH will be enrolled over two years: "pre-alert" (silent mode) for 6 months and "alert mode" for 18 months.
- Conditions
- Familial Hypercholesterolaemia
- Being tested
- Alert-based computerized decision support
- Keywords
- Familial Hypercholesterolemia, Computerized Decision Support, Electronic Alerts, High Cholesterol
- Medical subject headings
- Hyperlipoproteinemia Type II, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alert-based computerized decision supportDevice
Also called Best Practice Advisory, Computer Alert
A program will be designed to run within the Electronic Health Record (EHR) that will identify outpatients with "definite," "probable," or "possible" diagnosis of FH. The BPA will calculate the Dutch Lipid Clinic Network score using the following EHR data:
- Maximum LDL-C level in the laboratory results
- Abnormal genetic testing for FH in the laboratory results
- Medical history or problem list entry for tendinous xanthomata or arcus cornealis
- Medical history, visit diagnosis, or problem list entry of premature CAD, cerebrovascular disease, or PAD
- Family history of premature CAD, cerebrovascular disease, or PAD
In the Alert phase, an on-screen alert will notify the ambulatory care clinician of record that the patient has a "definite," "probable," or "possible" diagnosis of FH. ambulatory care clinician will have the opportunity to proceed to an order template through which a referral for specialty care focused on evaluation and management of FH can be made.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Alert | No intervention | In the Pre-Alert phase of 6 months, patients meeting enrollment criteria will be identified but the clinician will not be notified regarding the possible diagnosis of Familial Hypercholesterolemia. |
| Alert | Experimental | In the Alert phase of 18 months, an on-screen alert through the Electronic Health Record will notify the ambulatory care clinician of record that the patient has a "definite," "probable," or "possible" diagnosis of FH but has not been recognized as such. Receives: Device: Alert-based computerized decision support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of documented FH diagnosis
We will review the medical history, visit diagnosis, and problem list sections of the Electronic Health Record (EPIC) to make this determination of diagnosis of Familial Hypercholesterolemia.
Measured: 6 Months
Secondary outcomes (1)
Mean Change in LDL-C
Mean change in LDL-C levels within 6 months following triggering of the BPA compared with the most recent LDL-C prior to the clinic visit in outpatients with presentations consistent with FH ("definite," "probable," or "possible" Dutch Lipid Clinic Network score).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Apr 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolaemiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- During the first 6 months, the BPA will run in "silent mode" and will not provide notification to the clinician of record about the potential diagnosis of FH. For the following 18 months, the BPA will run in "alert mode" during which an on-screen alert will notify the ambulatory care clinician of record that the patient has a "definite," "probable," or "possible" diagnosis of FH but has not been recognized as such.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Piazza, MD, MS, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743659
- Sponsor's protocol ID
- 2024P001619
- Acronym
- FH-ALERT
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will provide data upon reasonable request after publication of study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alert-Based Computerized Decision Support for Identification and Management of Patients With Familial Hypercholesterolemia (FH-ALERT Trial)
- ClinicalTrials.gov ID
- NCT06743659
- Acronym / sponsor ID
- FH-ALERT / 2024P001619
- Conditions
- Familial Hypercholesterolaemia
- Keywords
- Familial Hypercholesterolemia, Computerized Decision Support, Electronic Alerts, High Cholesterol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 20 Dec 2024 (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 clinical trial is to learn if a computer alert can aid clinicians in identifying patients with a genetic type of high cholesterol, called Familial Hypercholesterolemia. The main question it aims to answer is whether the computer alert increases recognition of this high cholesterol disorder.
Detailed description
FH-ALERT is a single-center, time-series trial of a patient- and provider-facing EPIC BPA (alert-based CDS tool) to increase diagnosis, LDL-C lowering, and guideline-based therapy of outpatients with presentations consistent with FH. For the first 6 months, the BPA will run in "silent mode", identifying patients with presentations consistent with FH, but not alerting the clinician of record. Following this initial "pre-alert" 6-month period, the BPA will switch to "alert mode" for 18 months, which will provide the on-screen notification to the clinician of record. In other words, consecutive outpatients with presentations consistent with FH will be enrolled over two years: "pre-alert" (silent mode) for 6 months and "alert mode" for 18 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- During the first 6 months, the BPA will run in "silent mode" and will not provide notification to the clinician of record about the potential diagnosis of FH. For the following 18 months, the BPA will run in "alert mode" during which an on-screen alert will notify the ambulatory care clinician of record that the patient has a "definite," "probable," or "possible" diagnosis of FH but has not been recognized as such.
| Arm | Type | Receives |
|---|---|---|
| Pre-Alert | No intervention | –In the Pre-Alert phase of 6 months, patients meeting enrollment criteria will be identified but the clinician will not be notified regarding the possible diagnosis of Familial Hypercholesterolemia. |
| Alert | Experimental | Device: Alert-based computerized decision supportIn the Alert phase of 18 months, an on-screen alert through the Electronic Health Record will notify the ambulatory care clinician of record that the patient has a "definite," "probable," or "possible" diagnosis of FH but has not been recognized as such. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- seen in the BWH Endocrinology, Cardiovascular Medicine, and Primary Care Clinics
- Dutch Lipid Clinic Network score of at least 3 points
Key exclusion criteria (1 listed)
- a Familial Hypercholesterolemia diagnosis already documented in the EHR medical history, visit history, or problem list
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 |
|---|---|---|
| Alert-based computerized decision supportAlso: Best Practice Advisory, Computer AlertA program will be designed to run within the Electronic Health Record (EHR) that will identify outpatients with "definite," "probable," or "possible" diagnosis of FH. The BPA will calculate the Dutch Lipid Clinic Network score using the following EHR data: 1. Maximum LDL-C level in the laboratory results 2. Abnormal genetic testing for FH in the laboratory results 3. Medical history or problem list entry for tendinous xanthomata or arcus cornealis 4. Medical history, visit diagnosis, or problem list entry of premature CAD, cerebrovascular disease, or PAD 5. Family history of premature CAD, cerebrovascular disease, or PAD In the Alert phase, an on-screen alert will notify the ambulatory care clinician of record that the patient has a "definite," "probable," or "possible" diagnosis of FH. ambulatory care clinician will have the opportunity to proceed to an order template through which a referral for specialty care focused on evaluation and management of FH can be made. | Device | Alert |
Primary outcome
Frequency of documented FH diagnosis
Time frame: 6 Months
We will review the medical history, visit diagnosis, and problem list sections of the Electronic Health Record (EPIC) to make this determination of diagnosis of Familial Hypercholesterolemia.
1 secondary outcome
Mean Change in LDL-C
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. Will provide data upon reasonable request after publication of study.
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Clinical Decision Support for Familial Hypercholesterolemia
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alert-based computerized decision support in people with Familial Hypercholesterolaemia, run by Brigham and Women's Hospital 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Piazza, MD, MS (6177326984, gpiazza@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of documented FH diagnosis (time frame: 6 Months). 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 29 Sep 2026.