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Best Practice Advisory for Peripheral Artery Disease
N/A
Waitlist Available
Led By Aaron W Aday, MD, MSc
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, upon patient discharge through study completion, average of six months
Awards & highlights
Study Summary
This trial will focus on understanding how well a Best Practice Advisory for high-intensity statin therapy works in patients with Peripheral Artery Disease.
Who is the study for?
This trial is for adult patients hospitalized with Peripheral Artery Disease (PAD) at Vanderbilt University Medical Center who are not currently on high-intensity statins. Excluded are those with a history of statin allergy, rhabdomyolysis, hepatitis A/B/C, certain liver enzyme elevations, comfort measures only status, pregnancy or recent acute myocardial infarction or stroke.Check my eligibility
What is being tested?
The study is examining the effect of a Best Practice Advisory alert system on how often doctors prescribe high-intensity statins to PAD patients. It aims to see if this reminder increases the prescription rates for appropriate treatment.See study design
What are the potential side effects?
While side effects aren't directly studied in this trial as it focuses on prescription practices rather than drug effects, common side effects of high-intensity statins include muscle pain, increased risk of diabetes and liver damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, upon patient discharge through study completion, average of six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, upon patient discharge through study completion, average of six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of High-Intensity Statin Prescription at 90 days post-discharge
Frequency of High-Intensity Statin Prescription at discharge
Secondary outcome measures
Frequency of a Composite of Cardiovascular Events
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
Patients randomized to the usual care arm will have the identical set of windows displayed in the discharge workflow minus the BPA window.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,040 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
655 Patients Enrolled for Peripheral Arterial Disease
Aaron W Aday, MD, MScPrincipal InvestigatorVUMC Cardiovascular Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of being allergic to or not tolerating statin medication, as documented in your medical records.You have a history of rhabdomyolysis as identified by specific medical codes.You have had hepatitis A, B, or C.Your alanine aminotransferase level is higher than 165 units/L within the last 30 days.You are not currently taking a strong dose of atorvastatin or rosuvastatin.Only receiving comfort care.Your aspartate aminotransferase (AST) levels are higher than 120 units/L in the past 30 days.You have been diagnosed with a heart attack at a hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots remaining in this study?
"Affirmative. The clinicaltrials.gov repository confirms that this medical trial began recruiting on April 20th 2022, and has since been edited November 8th of the same year. A total of 150 participants are sought from a single site for enrollment."
Answered by AI
How many candidates has this trial been able to accept thus far?
"Correct. Based on the clinicaltrials.gov database, this ongoing medical trial was first posted on April 20th 2022 and is currently recruiting 150 individuals from a single research site."
Answered by AI
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