Clinical trial NCT05166187: Best Practice Advisory to Initiate High-Intensity Statin Therapy in Patients With Peripheral Artery Disease
Official title: Best Practice Advisory to Initiate High-Intensity Statin Therapy in Patients With Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Peripheral Artery Disease
Statin
Electronic alert
Best Practice Advisory
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of High-Intensity Statin Prescription at discharge
timeFrame: Baseline, upon patient discharge through study completion, average of six months
measure: Frequency of High-Intensity Statin Prescription at 90 days post-discharge
timeFrame: 90 days post-discharge
Secondary outcomes:
measure: Frequency of a Composite of Cardiovascular Events
timeFrame: Baseline, upon patient discharge to 90 days post-discharge through study completion
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: VUMC Cardiovascular Medicine
name: Aaron W Aday, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: