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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Other: Best Practice Advisory


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Patients in this arm will have a Best Practice Advisory displayed in the Electronic Medical Record (EMR) as part of the discharge order workflow.<br>|
| No Intervention: Usual Care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Artery Disease, Statin, Electronic alert, Best Practice Advisory