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

Not Applicable

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Other: Intervention A - Vascular Care + site 6MWT administration; Other: Intervention A - Vascular Care + CPC EQuIP 6MWT administration; Other: Intervention B - Standard Care + CPC EQuIP 6MWT administration; Other: Intervention B - Standard Care + site 6MWT administration

• Registration Number: NCT04400409
• Lead Sponsor: Colorado Prevention Center

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.

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-22
• Study Start: 2020-07-07
• Primary Completion: 2023-05-11
• Study Completion: 2023-05-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention A + site 6MWT administration	Intervention A - Vascular Care + site 6MWT administration	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.
Intervention A + CPC EQuIP 6MWT administration	Intervention A - Vascular Care + CPC EQuIP 6MWT administration	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.
Intervention B + CPC EQuIP 6MWT administration	Intervention B - Standard Care + CPC EQuIP 6MWT administration	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.
Intervention B + site 6MWT administration	Intervention B - Standard Care + site 6MWT administration	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.

Primary Outcome Measures

Name	Time	Method
Month 12 LDL-C	12 months	Percent change from baseline to month 12 in LDL-C

Secondary Outcome Measures

Name	Time	Method
Month 6 LDL-C	6 months	Percent change from baseline at 6 months in LDL-C

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States