Clinical trial NCT04400409: Implementation of Vascular Care Team to Improve Medical Management of PAD Patients
Official title: Implementation of Vascular Care Team to Improve Medical Management of Peripheral Arterial Disease (PAD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Colorado Prevention Center
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study intends to evaluate the efficacy of a multidisciplinary vascular care team utilizing an intensive guideline-based lipid reduction program in improving risk factor modification as measured by LDL-C reduction at 12 months in patients with peripheral artery disease (PAD). An additional objective is to understand the potential reach and impact if this program were extended across the University of Colorado Healthcare (UC Health) System.

Detailed 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. In order to investigate the efficacy of the CPC Endpoint Quality Intervention Program (EQuIP), subjects will additionally be randomized 1:1 to an investigative site conducted Six-Minute Walk Test or an EQuIP team led Six-Minute Walk Test. Quality of Life data will be collected from all subjects. 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.

Eligibility criteria: Inclusion Criteria:

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 ≥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

Exclusion Criteria:

1. Unwilling or unlikely to remain in the UC Health system through 1 year follow up (12 months after randomization)
2. Life expectancy \< 12 months
3. Fasting triglycerides \>400 mg/ml at screening
4. End-stage renal disease (eGRF\<15 mL/min/1.73m2 and/or renal replacement therapy)
5. History of nephrotic syndrome
6. Clinical evidence of severe liver disease or another medical condition for which lipid lowering therapy may be contraindicated
7. Current enrollment in another investigational device or drug study with unapproved devices or therapies or with therapies that would impact lipid levels or lipid therapy
8. Any other condition that in the opinion of the investigator would make the subject unable to comply with the protocol

Primary outcomes:
measure: Month 12 LDL-C
timeFrame: 12 months
Secondary outcomes:
measure: Month 6 LDL-C
timeFrame: 6 months
Other outcomes:
measure: EQ-5D-5L Quality of Life questionnaire
timeFrame: 6 and 12 months
measure: Walking Impairment
timeFrame: 6 and 12 months
measure: Distance Walked
timeFrame: 6 and 12 months
measure: Medication adherence
timeFrame: 6 and 12 months
measure: Biomarker levels
timeFrame: 12 months
measure: Time to endpoint events
timeFrame: Time to event, up to 12 months
measure: Impact of CPC EQuIP process
timeFrame: 6 and 12 months
measure: Correlation between venipuncture and dried dried blood spots
timeFrame: 12 months
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: CPC Clinical Research
name: Connie Hess, MD
role: PRINCIPAL_INVESTIGATOR
References:
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