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Completed

NCT Number: NCT05166187

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice Advisory

Other

Patients in this arm will have a Best Practice Advisory displayed in the Electronic Medical Record (EMR) as part of the discharge order workflow.

Primary outcomes

  1. Frequency of High-Intensity Statin Prescription at discharge

    Time frame: Baseline, upon patient discharge through study completion, average of six months

    Frequency will be measured by identifying the number of high-intensity statin prescriptions at discharge

  2. Frequency of High-Intensity Statin Prescription at 90 days post-discharge

    Time frame: 90 days post-discharge

    Frequency will be measured by identifying the number of high-intensity statin prescriptions at 90 days post-discharge.

Secondary outcomes

  1. Frequency of a Composite of Cardiovascular Events

    Time frame: Baseline, upon patient discharge to 90 days post-discharge through study completion

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2021
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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