[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06960655":3,"trial-entities:NCT06960655":92,"trial-summary:NCT06960655":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":14,"eligibility_criteria":60,"std_ages":73,"locations":76,"central_contacts":85,"overall_officials":86,"references":90,"see_also_links":91},"NCT06960655","2025P000910","Improving Lipid Optimization Quality and Treatment Options in ASCVD","ENROLLING_BY_INVITATION","2027-02-01","2026-02","2026-05-18","2025-10-14","Brigham and Women's Hospital","OTHER",false,"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).","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.",[18,19],"Hypercholesterolemia","ASCVD",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},300,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Referral to Pharmacist-Driven Medication Management Program","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.",[34],"Remote Pharmacist-Driven Medication Management Program",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Best-Practice Alert","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.",[39],"EHR-Based Provider Notification for Lipid Optimization",[41],{"measure":42,"description":43,"timeFrame":44},"Achieving Goal LDL-C","% of participants who achieve LDL-c goal (\\\u003C100 mg\u002FdL for high-risk primary prevention, \\\u003C70 mg\u002FdL for patients with established ASCVD)","6 months after notification",[46,50,51,54],{"measure":47,"description":48,"timeFrame":49},"Intensification lipid-lowering therapy","% of participants who receive any intensification lipid-lowering therapy","12 months after notification",{"measure":42,"description":43,"timeFrame":49},{"measure":52,"description":53,"timeFrame":49},"LDL- c reduction","Total and average LDL-c reduction compared to baseline",{"measure":55,"description":56,"timeFrame":49},"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)","ALL","18 Years","95 Years",{"inclusion":61,"exclusion":67,"raw_text":72},[62,63,64,65,66],"\\>18 years old and \\\u003C=95 years old","Established Atherosclerotic Cardiovascular Disease","Diabetes","Possible Familial Hypercholesterolemia (FH)","High-Risk Primary Prevention",[68,69,70,71],"No PCP, cardiologist, endocrinologist, or nephrologist at MGB","ESRD on dialysis","Enrolled in a hospice program","Advanced dementia","Inclusion Criteria:\n\n* \\>18 years old and \\\u003C=95 years old\n* Established Atherosclerotic Cardiovascular Disease\n* Diabetes\n* Possible Familial Hypercholesterolemia (FH)\n* High-Risk Primary Prevention\n\nExclusion Criteria:\n\n* No PCP, cardiologist, endocrinologist, or nephrologist at MGB\n* ESRD on dialysis\n* Enrolled in a hospice program\n* Advanced dementia",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":12,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Boston","Massachusetts","02115","United States",{"lat":83,"lon":84},42.35843,-71.05977,[],[87],{"name":88,"affiliation":12,"role":89},"Benjamin Scirica, M.D., MPH","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":93,"biomarkers":97},[94,95,18,96],"Atherosclerosis","Diabetes Mellitus","Hyperlipoproteinemia, Type IIa",[],{"nct_id":4,"found":14,"summary":99,"prompt_version":99},null]