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OPTIMIZE PAD-1: Implementation of Vascular Care Team to Improve Medical Management of PAD Patients

Study category: Heart and Blood Conditions

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Description

Patients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood. 1 There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study.

Details
Age

Adult

Eligibility

1. Documented lower extremity atherosclerotic PAD with recommended goal LDL-C <70 mg/dL by the ACC/AHA Management of Blood Cholesterol Guidelines 2. Receiving care at CU Anschutz 3. Screening/baseline LDL-C &#8805;70 mg/dL without change in lipid lowering therapy within the last 30 days prior to LDL-C draw. 4. Able to provide informed consent and willing to participate

Phase

IV - Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.

Type of Study

Outcomes Research

Location

University of Colorado Hospital

Principal Investigator
Connie Hess

Connie Hess

Study ID

Protocol Number: 20-0288

More information available at ClinicalTrials.gov: NCT04400409

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