Implementation of Vascular Care Team to Improve Medical Management of PAD Patients

Colorado Prevention Center Clinical Research

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Other: Intervention A - Vascular Care + CPC EQuIP 6MWT administration; Other: Intervention B - Standard Care + site 6MWT administration; Other: Intervention B - Standard Care + CPC EQuIP 6MWT administration; Other: Intervention A - Vascular Care + site 6MWT administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04400409

OPTIMIZE PAD-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 4 patient groups

Intervention A + site 6MWT administration

Active Comparator group

Description:

Intervention A subjects will receive a vascular care team approach to care including pharmacy and healthcare provider assistance with medication adherence. 6-Minute Walk Test (6MWT) will be administered by site staff.

Treatment:

Other: Intervention A - Vascular Care + site 6MWT administration

Intervention B + site 6MWT administration

Active Comparator group

Description:

Intervention B will receive 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. 6-Minute Walk Test (6MWT) will be administered by site staff.

Treatment:

Other: Intervention B - Standard Care + site 6MWT administration

Intervention A + CPC EQuIP 6MWT administration

Active Comparator group

Description:

Intervention A subjects will receive a vascular care team approach to care including pharmacy and healthcare provider assistance with medication adherence. 6-Minute Walk Test (6MWT) will be administered by CPC EQuIP staff.

Treatment:

Other: Intervention A - Vascular Care + CPC EQuIP 6MWT administration

Intervention B + CPC EQuIP 6MWT administration

Active Comparator group

Description:

Intervention B will receive 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. 6-Minute Walk Test (6MWT) will be administered by CPC EQuIP staff.

Treatment:

Other: Intervention B - Standard Care + CPC EQuIP 6MWT administration