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

Dyslipidemias Clinical Trial

— PAD-ALERT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300450
• Other study ID #: 2022P002171
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: March 2024
• Source: Brigham and Women's Hospital
• Contact: Gregory Piazza
• Phone: 6177326984
• Email: gpiazza[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Esperion Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of all-cause mortality	The frequency will be assessed using a report from the medical record	6 months
Other	Frequency of major adverse cardiovascular events	The frequency of major adverse cardiovascular events (including myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization) will be assessed using a report from the medical record	6 months
Other	Frequency of major adverse limb events	The frequency of major adverse limb events (including amputation and peripheral artery revascularization) will be assessed using a report from the medical record	6 months
Other	Frequency of all-cause hospitalization	The frequency of all-cause hospitalization will be assessed using a report from the medical record	6 months
Primary	Frequency of prescription of oral LDL-C-lowering therapy	The frequency of prescription of oral LDL-C-lowering therapy will be assessed using a report from the medical record	90 days
Secondary	Change in LDL-C level	Change in LDL-C level will be assessed via the medical record	6 months