Back to resultsBest Practice Advisory to Initiate High-Intensity Statin Therapy in Patients With Peripheral Artery Disease
Primary Purpose
Peripheral Artery Disease
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice Advisory
Sponsored by
About this trial
This is an interventional other trial for Peripheral Artery Disease focused on measuring Peripheral Artery Disease, Statin, Electronic alert, Best Practice Advisory
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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Usual Care
Arm Description
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.
Patients randomized to the usual care arm will have the identical set of windows displayed in the discharge workflow minus the BPA window.
Outcomes
Primary Outcome Measures
Frequency of High-Intensity Statin Prescription at discharge
Frequency will be measured by identifying the number of high-intensity statin prescriptions at discharge
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05166187
First Posted
December 6, 2021
Last Updated
August 28, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05166187
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
August 13, 2023 (Actual)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
Peripheral Artery Disease, Statin, Electronic alert, Best Practice Advisory
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients randomized to the usual care arm will have the identical set of windows displayed in the discharge workflow minus the BPA window.
Intervention Type
Other
Intervention Name(s)
Best Practice Advisory
Intervention Description
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 Outcome Measure Information:
Title
Frequency of High-Intensity Statin Prescription at discharge
Description
Frequency will be measured by identifying the number of high-intensity statin prescriptions at discharge
Time Frame
Baseline, upon patient discharge through study completion, average of six months
Title
Frequency of High-Intensity Statin Prescription at 90 days post-discharge
Description
Frequency will be measured by identifying the number of high-intensity statin prescriptions at 90 days post-discharge.
Time Frame
90 days post-discharge
Secondary Outcome Measure Information:
Title
Frequency of a Composite of Cardiovascular Events
Description
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.
Time Frame
Baseline, upon patient discharge to 90 days post-discharge through study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron W Aday, MD, MSc
Organizational Affiliation
VUMC Cardiovascular Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Best Practice Advisory to Initiate High-Intensity Statin Therapy in Patients With Peripheral Artery Disease
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