Optimizing Non-statin Agents for ASCVD

Using Pharmacy Extenders to Optimize Non-statin Agents for Secondary ASCVD Prevention Outcomes in a Federally Qualified Health Center

• The purpose of the study is to improve care for patients with high cholesterol.
• If you choose to join the study, you will be asked to answer a phone call from study personnel. They will help you coordinate follow up appointments, review your medications and lab with you, and answer any questions you have about your medications. You will also continue to be seen by a clinical pharmacy team member. Your cholesterol medications may change to better lower your cholesterol. We will collect information about your visits, medicines, and cholesterol levels for 6 months.
• If you choose not to participate, you will receive the same information and treatment at your next scheduled visit. You will receive the same care regardless of choosing to participate in the study.
• Participation might involve a very low risk of some loss of privacy. There is low risk that someone outside the research study could see information about you.
• A possible benefit is lower cholesterol.
• Taking part in this research study is your choice. You do not have to participate, and you can stop at any time without any penalty.

Study Overview

• Status: Recruiting
• Conditions: ASCVD Management
• Intervention / Treatment: Behavioral: Pharmacy Intern Counseling

Detailed Description

In this prospective study, approximately 1,000 patients with a documented history of clinical ASCVD will be identified from Part 1 of the Zetia Project and a new report, generated after IRB approval, to capture newly diagnosed patients with ASCVD who may benefit from therapy optimization. This population health initiative will occur regardless of the proposed research in this protocol.

CommUnityCare Standard Procedure - Standard of Care As part of routine population health care at CuC, clinical pharmacists assess and evaluate for the optimization of LDL-lowering medications according to the 2018 AHA/ACC Guideline on the Management of Blood Cholesterol and the 2022 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of ASCVD. Clinical pharmacists will review lipid panels drawn within the past 12 months. If there are no recent lab history available, patients will be scheduled for standard of care fasting lipid panel. Labs will be collected by CuC phlebotomists, nurses, or other trained healthcare professionals outside of the research team. Clinical pharmacists will review, assess, and analyze lipid panel lab results. If LDL levels are at goal, the patient will continue their standard lipid-lowering therapy and continue routine follow-up with the clinical pharmacy team. This standard of care follow-up may occur either in-person or through telehealth visits conducted by the clinical pharmacists. The purpose of this routine call of clinical management and patient education as part of standard of care is to ensure medication adherence, safety, and efficacy per established guidelines. For patients not at goal, clinical pharmacists will provide guideline-directed therapy adjustments at a scheduled clinic visit. This may involve adjusting the intensity of the statin therapy or adding a non-statin agent, such as ezetimibe or a PCSK9 inhibitor, if the patient is not already on the maximally tolerated statin therapy. Intensification of statin dose will occur if: (1) LDL is not at goal for respective risk category (LDL ≥ 70 mg/dL for very high-risk ASCVD patients and LDL ≥55 mg/dL for high-risk patients) and (2) Patient is not on maximally tolerated statin therapy. Patients who are on maximally tolerated statins and who are not at respective LDL goals will be considered for the initiation of ezetimibe and/or PCSK9 inhibitors. A follow-up lipid panel will be ordered for 4-12 weeks after therapy adjustments and a follow-up clinical pharmacy appointment will also be scheduled within the same timeframe. Regardless of participation status in the study, all patients will continue to receive the routine care and follow-up from CuC clinical pharmacists described above.

Alterations to Standard Procedure - Intervention The research intervention consists of outreach conducted by a Texas-licensed pharmacist intern under the supervision of CuC-employed pharmacists. Eligible patients will be contacted by a student pharmacist after the clinical pharmacists' appointment (described above in the standard of care) using CuC's RingCentral telehealth system. During this outreach, student pharmacists will review current lipid-lowering therapies, medication adherence, education about lipid-lowering therapies, and review of labs. Student pharmacists will not make independent prescribing or care decisions. All prescribing authority and therapeutic adjustments remain under the direction of CuC-employed pharmacists in accordance with the standard operating procedures. Patients will be informed about the research project during the outreach call or during a separate call dedicated to recruitment prior to the outreach call. Informed consent will be sent and obtained via either the EHR messaging system (MyChart) or text message through the Ring Central application.

Only data from patients who provide informed consent will be included in the research dataset and subsequent chart review. For patients who decline participation after being contacted through the telehealth outreach, any information collected during the call will remain part of their standard clinical documentation in the EHR and will not be included in the research dataset. These patients will continue to receive standard clinical pharmacy care, and no data will be abstracted or analyzed for research purposes. Enrolled patients will then be followed through prospective chart review to evaluate outcomes at 3-6 months after consent and student pharmacist outreach.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Morgan Stewart, PharmD; Phone Number: 5129789096; Email: morgan.stewart@austin.utexas.edu
• Study Contact Backup: Name: Kathryn Lin, PharmD; Phone Number: 512-978-8593; Email: kathryn.lin@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78741
      • Recruiting
      • CommUnityCare Health Centers
      • Contact: Morgan Stewart, PharmD; Phone Number: 512-978-9096; Email: morgan.stewart@austin.utexas.edu
      • Sub-Investigator: Madison Tran
      • Sub-Investigator: Khue (Chloe) Dao
      • Sub-Investigator: Kathryn Lin, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria are appropriate for this study as this population would have benefit from a pharmacist/student pharmacist intervention of add-on non-statin therapy for secondary ASCVD prevention according to clinical guidelines. Exclusion criteria are appropriate for this study as patients either do not require intervention (i.e. they are already at goal an therapy does not need to be changed or initiation of therapy is not appropriate due to lack of documented history of ASCVD), do not receive cholesterol management at CommUnityCare, and/or may have a drug safety concern due to pregnancy status.

Description

Inclusion Criteria:

• Adult patients (>18 years) who have seen a CommUnityCare provider in the previous 12 months at time of enrollment, who have a documented history of clinical ASCVD, and are not achieving LDL targets (either <55 or <70 mg/dL based on risk factors)

Exclusion Criteria:

• Patients will be excluded if they do not have a clearly documented history clinical ASCVD, are already achieving LDL targets (either <55 or <70 mg/dL based on risk factors), having cholesterol managed by outside provider (e.g. outside cardiologist/lipid specialist), current pregnancy, have not seen a CUC provider in the previous 12 months, or otherwise do not qualify for clinical pharmacy intervention

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Enrolled Patients; Adult patients (>18 years) who have seen a CommUnityCare provider in the previous 12 months at time of enrollment, who have a documented history of clinical ASCVD, and are not achieving LDL targets (either <55 or <70 mg/dL based on risk factors)

Behavioral: Pharmacy Intern Counseling; The research intervention consists of outreach conducted by a Texas-licensed pharmacist intern under the supervision of CuC-employed pharmacists. Eligible patients will be contacted by a student pharmacist after the clinical pharmacists' appointment (described above in the standard of care) using CuC's RingCentral telehealth system. During this outreach, student pharmacists will review current lipid-lowering therapies, medication adherence, education about lipid-lowering therapies, and review of labs. Student pharmacists will not make independent prescribing or care decisions. All prescribing authority and therapeutic adjustments remain under the direction of CuC-employed pharmacists in accordance with the standard operating procedures. Patients will be informed about the research project during the outreach call or during a separate call dedicated to recruitment prior to the outreach call. Informed consent will be sent and obtained via either the EHR messaging system (MyChart) or text

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients at LDL target	To determine if pharmacy extenders' targeted outreach to patients with clinical ASCVD can result in a higher percentage of patients who are meeting LDL targets after 6 months of intervention	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage LDL lowering of ezetimibe and PCSK9i	To assess the real world % LDL lowering of add-on ezetimibe and/or PCSK9i's therapy for patients with clinical ASCVD who are not meeting LDL targets with maximally tolerated statin	6 months

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: non-statin
• Other Study ID Numbers: STUDY00006924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No