Optimizing Non-statin Agents for ASCVD

ConditionASCVD Management

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Texas at Austin

About this trial

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Pharmacy Intern Counseling
Behavioral
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

Treatment groups

1,000 Participants

are divided into 1 treatment group

Group A: Enrolled Patients1 intervention

Trial outcomes

Primary outcomes

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

Time frame

6 months

Secondary outcomes

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

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas at Austin

Lead sponsor

Source ClinicalTrials.gov

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