HypercholesterolemiaNCT06960655
Improving Lipid Optimization Quality and Treatment Options in ASCVD
A study testing Referral to Pharmacist-Driven Medication Management Program and Best-Practice Alert in people with Hypercholesterolemia and ASCVD, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this project is to study different approaches to improve the utilization of guideline directed medicines to lower cholesterol in patients with or at high risk of atherosclerosis (cholesterol buildup in the arteries). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hypercholesterolemia, ASCVD
- What is being tested?
- Referral to Pharmacist-Driven Medication Management Program and Best-Practice Alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to 1 Feb 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old and <=95 years old
- Established Atherosclerotic Cardiovascular Disease
- Diabetes
- Possible Familial Hypercholesterolemia (FH)
- High-Risk Primary Prevention
Who cannot join
- No PCP, cardiologist, endocrinologist, or nephrologist at MGB
- ESRD on dialysis
- Enrolled in a hospice program
- Advanced dementia
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
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The goal of this project is to study different approaches to improve the utilization of guideline directed medicines to lower cholesterol in patients with or at high risk of atherosclerosis (cholesterol buildup in the arteries).
Read the detailed description
This project will include approximately 300 patients who, based on current guidelines, would benefit from optimized lipid management. The project is testing the most effective methods to notify providers and patients and inform them that their patients may benefit from further lipid optimization. It will utilize systematic allocation at the provider level in which clinicians are assigned to either the direct Provider Notification Strategy or the Pharmacist-Driven Medication Management Strategy, ensuring that all patients continue to receive guideline-based care while eliminating the risk of treatment selection bias. Approximately 100 providers to ensure a sufficient number of patients are included.
- Conditions
- Hypercholesterolemia, ASCVD
- Being tested
- Referral to Pharmacist-Driven Medication Management Program, Best-Practice Alert
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to Pharmacist-Driven Medication Management ProgramBehavioural
Medication initiations and titrations are based on an established drug-treatment algorithm that utilizes a statutory-defined Collaborative Drug Therapy Management Agreement (CDTM) approved by the BWH Pharmacy and Therapeutic Committee to initiate and titrate lipid-lowering medications. Scenarios outside the prescribed medication algorithm are routed to the supervising physician, and changes are signed off by a pharmacist and communicated to the patient and care team by a patient navigator under the supervision of physicians. After each change in medication, re-assessment and lab monitoring are collected in an iterative process until targets are achieved. Details of the programs can be found in the references.
Best-Practice AlertBehavioural
This strategy will employ automated, asynchronous, best-practice alerts (BPAs). Provider notifications via electronic health records (EHRs) are clinical tools designed to improve adherence to evidence-based guidelines by providing real-time alerts that have been widely implemented across healthcare systems to enhance patient safety, reduce clinical inertia, and standardize care delivery. However, their effectiveness depends on factors such as alert fatigue, provider engagement, and integration into existing workflows. BPAs are one of the most common types of automated EHR-based provider notifications.
| Study group | Role | What they receive |
|---|---|---|
| EHR-Based Provider Notification for Lipid Optimization | Active comparator | Not described Receives: Behavioral: Best-Practice Alert |
| Remote Pharmacist-Driven Medication Management Program | Active comparator | Not described Receives: Behavioral: Referral to Pharmacist-Driven Medication Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving Goal LDL-C
% of participants who achieve LDL-c goal (<100 mg/dL for high-risk primary prevention, <70 mg/dL for patients with established ASCVD)
Measured: 6 months after notification
Secondary outcomes (4)
Intensification lipid-lowering therapy
% of participants who receive any intensification lipid-lowering therapy
Measured: 12 months after notification
Achieving Goal LDL-C
% of participants who achieve LDL-c goal (<100 mg/dL for high-risk primary prevention, <70 mg/dL for patients with established ASCVD)
Measured: 12 months after notification
LDL- c reduction
Total and average LDL-c reduction compared to baseline
Measured: 12 months after notification
Lipid testing and prescriptions
Number of lipid-related lab testing or prescriptions for lipid-lowering therapy (by provider or remote disease management program; process related outcomes (responses to provider notifications)
Measured: 12 months after notification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start14 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Provider Notification Strategy Procedures: The provider notification recommendations are based on current professional society guidelines with FDA-approved therapeutics. Providers may follow, modify, or reject those recommendations as they deem clinically most appropriate. Remote Pharmacist-driven Medication Management Strategy Procedures: Treatment recommendations in this program are based on current professional society guidelines with FDA-approved therapeutics. This program is based on a statutory-defined Collaborative Drug Therapy Management agreement approved by the BWH Pharmacy and Therapeutic Committee to initiate and titrate lipid-lowering medications.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Benjamin M. Scirica, MD, Brigham and Women's Hospital
- Investigators
- Benjamin Scirica, M.D., MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960655
- Sponsor's protocol ID
- 2025P000910
- Status last verified
- Feb 2026
- First submitted
- 29 Apr 2025
- Last updated
- 18 May 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Lipid Optimization Quality and Treatment Options in ASCVD
- ClinicalTrials.gov ID
- NCT06960655
- Acronym / sponsor ID
- 2025P000910
- Conditions
- Hypercholesterolemia, ASCVD
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 7 May 2025 (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 project is to study different approaches to improve the utilization of guideline directed medicines to lower cholesterol in patients with or at high risk of atherosclerosis (cholesterol buildup in the arteries).
Detailed description
This project will include approximately 300 patients who, based on current guidelines, would benefit from optimized lipid management. The project is testing the most effective methods to notify providers and patients and inform them that their patients may benefit from further lipid optimization. It will utilize systematic allocation at the provider level in which clinicians are assigned to either the direct Provider Notification Strategy or the Pharmacist-Driven Medication Management Strategy, ensuring that all patients continue to receive guideline-based care while eliminating the risk of treatment selection bias. Approximately 100 providers to ensure a sufficient number of patients are included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Provider Notification Strategy Procedures: The provider notification recommendations are based on current professional society guidelines with FDA-approved therapeutics. Providers may follow, modify, or reject those recommendations as they deem clinically most appropriate. Remote Pharmacist-driven Medication Management Strategy Procedures: Treatment recommendations in this program are based on current professional society guidelines with FDA-approved therapeutics. This program is based on a statutory-defined Collaborative Drug Therapy Management agreement approved by the BWH Pharmacy and Therapeutic Committee to initiate and titrate lipid-lowering medications.
| Arm | Type | Receives |
|---|---|---|
| EHR-Based Provider Notification for Lipid Optimization | Active comparator | Behavioral: Best-Practice Alert |
| Remote Pharmacist-Driven Medication Management Program | Active comparator | Behavioral: Referral to Pharmacist-Driven Medication Management Program |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years old and <=95 years old
- Established Atherosclerotic Cardiovascular Disease
- Diabetes
- Possible Familial Hypercholesterolemia (FH)
- High-Risk Primary Prevention
Key exclusion criteria (4 listed)
- No PCP, cardiologist, endocrinologist, or nephrologist at MGB
- ESRD on dialysis
- Enrolled in a hospice program
- Advanced dementia
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 |
|---|---|---|
| Referral to Pharmacist-Driven Medication Management ProgramMedication initiations and titrations are based on an established drug-treatment algorithm that utilizes a statutory-defined Collaborative Drug Therapy Management Agreement (CDTM) approved by the BWH Pharmacy and Therapeutic Committee to initiate and titrate lipid-lowering medications. Scenarios outside the prescribed medication algorithm are routed to the supervising physician, and changes are signed off by a pharmacist and communicated to the patient and care team by a patient navigator under the supervision of physicians. After each change in medication, re-assessment and lab monitoring are collected in an iterative process until targets are achieved. Details of the programs can be found in the references. | Behavioural | Remote Pharmacist-Driven Medication Management Program |
| Best-Practice AlertThis strategy will employ automated, asynchronous, best-practice alerts (BPAs). Provider notifications via electronic health records (EHRs) are clinical tools designed to improve adherence to evidence-based guidelines by providing real-time alerts that have been widely implemented across healthcare systems to enhance patient safety, reduce clinical inertia, and standardize care delivery. However, their effectiveness depends on factors such as alert fatigue, provider engagement, and integration into existing workflows. BPAs are one of the most common types of automated EHR-based provider notifications. | Behavioural | EHR-Based Provider Notification for Lipid Optimization |
Primary outcome
Achieving Goal LDL-C
Time frame: 6 months after notification
% of participants who achieve LDL-c goal (<100 mg/dL for high-risk primary prevention, <70 mg/dL for patients with established ASCVD)
4 secondary outcomes
Intensification lipid-lowering therapy
Time frame: 12 months after notification
Achieving Goal LDL-C
Time frame: 12 months after notification
LDL- c reduction
Time frame: 12 months after notification
Lipid testing and prescriptions
Time frame: 12 months after notification
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 18 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
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Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
RecruitingPhase 3
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
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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.
Benjamin Scirica, M.D., MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral to Pharmacist-Driven Medication Management Program and Best-Practice Alert in people with Hypercholesterolemia and ASCVD, 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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 18 May 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?
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?
Achieving Goal LDL-C (time frame: 6 months after notification). 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 18 May 2026.