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

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05166187
• Other study ID #: 212294
• Status: Completed
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: November 13, 2023

Study information

• Verified date: January 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: November 13, 2023
• Est. primary completion date: August 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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