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

NCT05166187 | Completed

• 1 other identifier: 212294
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease; Statin; Electronic alert; Best Practice Advisory

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Frequency of a Composite of Cardiovascular Events

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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Patients randomized to the usual care arm will have the identical set of windows displayed in the discharge workflow minus the BPA window.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Aaron W Aday, MD, MSc

  VUMC Cardiovascular Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Cardiovascular Medicine

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 21, 2021
• Study Start: April 20, 2022
• Primary Completion: August 13, 2023
• Study Completion: November 13, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

US (1)