Clinical trial NCT06300450: Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy
Official title: Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Peripheral Vascular Diseases
Dyslipidemias
Keywords: Dyslipidemia
Peripheral Artery Disease
Peripheral Vascular Disease
Computerized Decision Support
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Esperion Therapeutics, Inc.
First posted: 2024-03-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of prescription of oral LDL-C-lowering therapy
timeFrame: 90 days
Secondary outcomes:
measure: Change in LDL-C level
timeFrame: 6 months
Other outcomes:
measure: Frequency of all-cause mortality
timeFrame: 6 months
measure: Frequency of major adverse cardiovascular events
timeFrame: 6 months
measure: Frequency of major adverse limb events
timeFrame: 6 months
measure: Frequency of all-cause hospitalization
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: BWH
name: Gregory Piazza
role: PRINCIPAL_INVESTIGATOR
References: