Best Practice Advisory to Initiate High-Intensity Statin Therapy in Patients With Peripheral Artery Disease

The purpose of this study is to understand how a Best Practice Advisory (BPA) for high-intensity statin therapy in patients with Peripheral Artery Disease impacts prescription rates.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Other: Best Practice Advisory

Detailed Description

The central hypothesis is that an automated best practice advisory embedded within the electronic medical record (EMR) will improve prescription of high-intensity statins among hospitalized patients with Peripheral Artery Disease (PAD).

Aim 1: To assess the impact of an automated best practice advisory, deployed as part of the standard hospital discharge workflow within the electronic medical record, on high-intensity statin prescription among hospitalized patients with PAD.

Aim 2: To assess the impact of an automated best practice advisory, deployed as part of the standard hospital discharge workflow within the electronic medical record, on short-term cardiovascular outcomes among hospitalized patients with PAD.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary hospital diagnosis of PAD defined by ICD/CPT codes
• Inpatient status at the adult hospital at Vanderbilt University Medical Center
• Not currently prescribed a high-intensity statin (atorvastatin 40-80mg daily or rosuvastatin 20-40mg daily)

Exclusion Criteria:

• On comfort measures
• History of statin allergy or intolerance recorded in the EMR
• History of rhabdomyolysis defined by International Classification of Diseases/Current Procedural Terminology (ICD/CPT) codes
• History of hepatitis A, B, or C defined by ICD/CPT codes
• Pregnant
• Aspartate aminotransferase >120 units/L within 30 days of alert
• Alanine aminotransferase >165 units/L within 30 days of alert
• Primary hospital diagnosis of acute myocardial infarction defined by ICD/CPT codes
• Primary hospital diagnosis of acute stroke defined by ICD/CPT codes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients randomized to the intervention arm will have a Best Practice Advisory (BPA) displayed as part of the discharge order workflow. This BPA requires clinicians to choose an option before completing the discharge documentation. Options include ordering one of the appropriate statins or documenting that the medication is contraindicated, the patient declined, or the patient does not meet criteria for a high-intensity statin.	Other: Best Practice Advisory; Patients in this arm will have a Best Practice Advisory displayed in the Electronic Medical Record (EMR) as part of the discharge order workflow.
No Intervention: Usual Care; Patients randomized to the usual care arm will have the identical set of windows displayed in the discharge workflow minus the BPA window.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of High-Intensity Statin Prescription at discharge	Frequency will be measured by identifying the number of high-intensity statin prescriptions at discharge	Baseline, upon patient discharge through study completion, average of six months
Frequency of High-Intensity Statin Prescription at 90 days post-discharge	Frequency will be measured by identifying the number of high-intensity statin prescriptions at 90 days post-discharge.	90 days post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of a Composite of Cardiovascular Events	Frequency will be measured by identifying the number of cardiovascular events including myocardial infarction, coronary revascularization, stroke, lower extremity arterial revascularization, or all-cause mortality.	Baseline, upon patient discharge to 90 days post-discharge through study completion

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Aaron W Aday, MD, MSc, VUMC Cardiovascular Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): August 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; Statin; Electronic alert; Best Practice Advisory
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 212294

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No