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

NCT ID: NCT06300450

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-07-30

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.

Conditions

Peripheral Artery Disease; Peripheral Vascular Diseases; Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Alert

Alert-based CDS will consist of an on-screen electronic alert that will notify the clinician that the patient has an indication for LDL-C-lowering therapy but is not prescribed any. The clinician will have the opportunity to proceed to an order template through which appropriate lipid-lowering can be prescribed. The clinician could also elect to learn more about current evidence-based recommendations for LDL-C lowering in the PAD population. Finally, the clinician could elect to proceed without ordering oral LDL-C-lowering therapy or reading evidence-based recommendations for LDL-C lowering but would have to provide a rationale for not doing so.

Group Type: EXPERIMENTAL

Computer Alert

Intervention Type: BEHAVIORAL

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

No Alert

No on-screen notification will be issued to the clinician

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Computer Alert

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

Intervention Type: BEHAVIORAL

Other Intervention Names

EPIC Best Practice Advisory

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Esperion Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gregory Piazza, MD, MS

Associate Director, Thrombosis Research Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory Piazza

Role: PRINCIPAL_INVESTIGATOR

BWH

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gregory Piazza

Role: CONTACT

gpiazza@bwh.harvard.edu

6177326984

Candrika D Kharaini

Role: CONTACT

cdkhairani@@bwh.harvard.edu

6177326984

Facility Contacts

Gregory Piazza, MD, MS

Role: primary

gpiazza@bwh.harvard.edu

617-732-6984

Role: backup

gpiazza@bwh.harvard.edu

Other Identifiers

2022P002171

Identifier Type: -

Identifier Source: org_study_id