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Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy

Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06300450
Acronym
PAD-ALERT
Enrollment
400
Registered
2024-03-08
Start date
2023-03-01
Completion date
2026-12-30
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, Peripheral Artery Disease, Peripheral Vascular Diseases

Keywords

Dyslipidemia, Peripheral Artery Disease, Peripheral Vascular Disease, Computerized Decision Support

Brief summary

This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy.

Detailed description

A Joint Task Force from the European Atherosclerosis Society and the European Society of Vascular Medicine recommends a low-density lipoprotein cholesterol (LDL-C) goal reduction of greater than 50% from baseline and a target of 55 mg/dL in patients with peripheral artery disease (PAD). An analysis of 1982 provider visits of patients with PAD in national outpatient databases in the U.S. between 2005-2012 showed that a statin was prescribed in only 33.1% of patients (Berger JS, Ladapo JA. J Am Coll Cardiol. 2017;69:2293-2300). Data from Europe demonstrates marginally better adherence to guidelines with 40% of patients with PAD prescribed a statin (Subherwal S, et al. Circulation. 2012;126:1345). Explanations for underutilization of LDL-C-lowering therapy in patients with PAD include clinician knowledge gaps regarding evidence-based clinical practice guideline recommendations, provider inertia, the need for prior authorization for some agents, statin intolerance, and statin hesitancy. Statin intolerance is defined as the inability to tolerate a dose of statin required to sufficiently reduce cardiovascular risk and has been estimated to affect up to 15% of patients treated with statins (Banach M, et al. Arch Med Sci 2015;11:1-23 and Banach M, et al. Expert Opin Drug Saf 2015;14:935-55). While numerous statin options exist and non-statin oral options for LDL-C lowering, such as ezetimibe and bempedoic acid, are widely available, lack of awareness and inconsistent implementation contribute to underutilization in patients at high-risk for cardiovascular events, such as those with PAD. Bempedoic acid, with or without ezetimibe, is a newer option for LDL-C lowering that offers a lower prevalence of musculoskeletal side effects than statins (Diabetes Ther. 2021 Jul;12(7):1779-1789). However, familiarity with this option remains limited outside of Preventive Cardiology and Lipid Clinics. The failure to achieve guideline-directed LDL-C targets due to clinician knowledge gaps, provider inertia, the need for prior authorization, statin intolerance, and statin hesitancy in the PAD population demonstrates similar clinical obstacles to other areas of cardiovascular medicine in which quality of care was impacted by provider and patient knowledge gaps. An alert-based computerized decision support (CDS) approach has been shown to be effective in such circumstances and could be similarly effective for optimizing lipid management in patients with PAD. This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy.

Interventions

BEHAVIORALComputer Alert

On-screen alert-based decision support raising awareness of need for lipid-lowering therapy in patients with peripheral artery disease

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER
Esperion Therapeutics, Inc.
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Participants, investigators and outcomes assessors will be blinded to the assignment of the clinician to the computer alert or control (non-alert) group.

Intervention model description

400-patient U.S.-based single-center Quality Improvement Initiative in the form of a randomized controlled trial focused on the feasibility of implementation of this patient- and provider-facing alert-based CDS (EPIC BPA)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients ≥ 18 years old * Seen in Cardiovascular Medicine Clinic, Primary Care, Podiatry, Vascular Surgery, and Diabetology * Medical history entry, visit diagnosis, or problem list entry of PAD * Not prescribed LDL-C-lowering therapy

Exclusion criteria

* Patients taking a statin, ezetimibe, bempedoic acid, a PCSK9 inhibitor, inclisiran or a combination will be excluded

Design outcomes

Primary

MeasureTime frameDescription
Frequency of prescription of oral LDL-C-lowering therapy90 daysThe frequency of prescription of oral LDL-C-lowering therapy will be assessed using a report from the medical record

Secondary

MeasureTime frameDescription
Change in LDL-C level6 monthsChange in LDL-C level will be assessed via the medical record

Countries

United States

Contacts

CONTACTGregory Piazza
gpiazza@bwh.harvard.edu6177326984
CONTACTCandrika D Kharaini
cdkhairani@@bwh.harvard.edu6177326984
PRINCIPAL_INVESTIGATORGregory Piazza

BWH

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026