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

Overview

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 Title of Study: “Implementation of Vascular Care Team to Improve Medical Management of Peripheral Arterial Disease (PAD) Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2021

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.

Interventions

  • Other: Intervention A – Vascular Care + site 6MWT administration
    • Implementation of multiple strategies related to improving lipid management, starting with a referral to the vascular care team. The subject will undergo a visit with a vascular care team, including a Vascular Medicine specialist who will obtain a patient history and prescribe a lipid lowering therapy regimen. The subject will also meet with a pharmacist to answer questions related to access to medications, drug side effects, and potential interactions with the subject’s other medications. Additionally, the site staff will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
  • Other: Intervention B – Standard Care + site 6MWT administration
    • Consists of provision of the treating provider with a copy of the 2018 ACC/AHA Guidelines on the Management of Blood Cholesterol. Subjects will return at 6 and 12 months for lab draws and endpoint event assessments but will not meet with vascular care team. Additionally, the site staff will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
  • Other: Intervention A – Vascular Care + CPC EQuIP 6MWT administration
    • Implementation of multiple strategies related to improving lipid management, starting with a referral to the vascular care team. The subject will undergo a visit with a vascular care team, including a Vascular Medicine specialist who will obtain a patient history and prescribe a lipid lowering therapy regimen. The subject will also meet with a pharmacist to answer questions related to access to medications, drug side effects, and potential interactions with the subject’s other medications. Additionally, the CPC EQuIP team will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
  • Other: Intervention B – Standard Care + CPC EQuIP 6MWT administration
    • Consists of provision of the treating provider with a copy of the 2018 ACC/AHA Guidelines on the Management of Blood Cholesterol. Subjects will return at 6 and 12 months for lab draws and endpoint event assessments but will not meet with vascular care team. Additionally, the CPC EQuIP team will conduct and guide the subjects through 6MWTs at protocol-dictated time points.

Arms, Groups and Cohorts

  • Active Comparator: Intervention A + 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.
  • Active Comparator: Intervention B + 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.
  • Active Comparator: Intervention A + 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.
  • Active Comparator: Intervention B + 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.

Clinical Trial Outcome Measures

Primary Measures

  • Month 12 LDL-C
    • Time Frame: 12 months
    • Percent change from baseline to month 12 in LDL-C

Secondary Measures

  • Month 6 LDL-C
    • Time Frame: 6 months
    • Percent change from baseline at 6 months in LDL-C

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Colorado Prevention Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Connie Hess, MD, 303-860-9900, connie.hess@cpcmed.org

References

Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):3168-3209. doi: 10.1016/j.jacc.2018.11.002. Epub 2018 Nov 10. Erratum in: J Am Coll Cardiol. 2019 Jun 25;73(24):3234-3237.

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Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.

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Rehring TF, Stolcpart RS, Sandhoff BG, Merenich JA, Hollis HW Jr. Effect of a clinical pharmacy service on lipid control in patients with peripheral arterial disease. J Vasc Surg. 2006 Jun;43(6):1205-10.

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