Actively Recruiting
Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy
Led by Brigham and Women's Hospital · Updated on 2025-09-16
400
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
E
Esperion Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an alert-based computerized decision support tool aimed at improving the use of recommended cholesterol-lowering therapies in patients with peripheral artery disease (PAD) who are not currently prescribed such treatments. The study highlights that many patients with PAD do not receive guideline-directed statin or alternative LDL-C lowering therapies, partly due to clinician knowledge gaps, provider inertia, and patient intolerance or hesitancy. This trial seeks to address these challenges by increasing appropriate use of LDL-C-lowering medications. The trial compares two groups: one where clinicians receive an on-screen electronic alert during patient visits highlighting the need for LDL-C-lowering therapy, along with options to prescribe medication or review evidence-based guidelines; and a control group where no such alert is provided. This randomized controlled trial involves 400 patients and assesses the impact of this alert system on prescribing patterns. The intervention is integrated into the EPIC electronic medical records system as a Best Practice Advisory (BPA). Participants will be followed for at least 90 days to measure how frequently oral LDL-C-lowering therapies are prescribed, with additional assessment of changes in LDL-C levels at 6 months. Researchers will monitor prescriptions and cholesterol levels through medical record review. This study will provide insights into whether computerized alerts can improve adherence to cholesterol treatment guidelines in patients with PAD. The total study duration extends until mid-2026, allowing for comprehensive data collection and analysis.
CONDITIONS
Brief Title
Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients 18 years or older
- Seen in Cardiovascular Medicine Clinic, Primary Care, Podiatry, Vascular Surgery, or Diabetology
- Medical history, visit diagnosis, or problem list entry of peripheral artery disease (PAD)
- Not currently prescribed LDL-C-lowering therapy
You will not qualify if you...
- Taking any statin, ezetimibe, bempedoic acid, PCSK9 inhibitor, inclisiran, or combination therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants receive either an alert-based computerized decision support tool to assist clinicians in prescribing LDL-C-lowering therapy or no alert, to evaluate the impact on guideline-directed therapy use in peripheral artery disease.
Visits occur as part of routine clinical care; no additional visits are required for the intervention.
Duration - 6 months
Participants are monitored for changes in their LDL-C levels to assess the effectiveness of lipid-lowering therapy.
Follow-up visits are conducted according to routine healthcare schedules.
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
G
Gregory Piazza
C
Candrika D Kharaini
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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