Pharmacist Intervention for High Cholesterol

Overseen By Lyndsi Roland, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Women of childbearing age, Hospice, End-stage liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare pharmacist-led care with usual care in managing high cholesterol for individuals with heart disease. The focus is on improving the use of cholesterol-lowering medications to prevent further heart problems. In the experimental group, a pharmacist will review participants' medical records and adjust treatments as needed. Individuals diagnosed with coronary artery disease and high LDL cholesterol levels may be suitable for this trial if they receive care at one of the specified clinics. As an unphased trial, this study offers participants the chance to contribute to innovative care approaches that could enhance heart disease treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that pharmacist intervention in lipid therapy is safe?

Research has shown that pharmacist involvement in cholesterol management is both safe and effective. Studies have found that pharmacist-led programs can greatly improve cholesterol levels, reducing the risk of heart problems. A review of 26 studies involving over 22,000 patients demonstrated that pharmacists significantly reduced cholesterol levels. Additionally, the number of people adhering to cholesterol guidelines increased from 60% to over 92% with pharmacists' assistance. These results suggest that pharmacist involvement is well-received and enhances cholesterol management without safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pharmacist intervention for high cholesterol because it offers a personalized approach to managing lipid levels. Unlike standard treatments, which typically involve medications like statins, this method involves a pharmacist reviewing patient charts and conducting follow-up visits to tailor lipid therapy specifically to each individual's needs. This personalized care could potentially enhance the effectiveness of treatment by ensuring that patients receive the most appropriate therapy for their condition. By involving pharmacists directly in patient care, this intervention also adds an extra layer of professional oversight, which may improve adherence to treatment and overall outcomes.

What evidence suggests that pharmacist intervention is effective for high cholesterol?

This trial will compare a Pharmacist Intervention with a Control group. Studies have shown that pharmacists can help lower LDL cholesterol, often called "bad" cholesterol. One study demonstrated a significant drop in LDL levels, from 140 mg/dL to 70 mg/dL. Research also shows that pharmacists can help manage other heart disease risks. In this trial, the Pharmacist Intervention arm involves pharmacists reviewing patient charts and conducting follow-up visits to prescribe appropriate therapy for hyperlipidemia. These actions can lead to better heart health by ensuring patients receive the right treatment for high cholesterol. ^{6 7 8 9 10}

Who Is on the Research Team?

Kayla Marvin, PharmD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for patients with coronary artery disease and high LDL cholesterol levels (>55), who are currently seeing a primary care physician at one of six specific clinics. It excludes women who could become pregnant, those managed by other practices, hospice or long-term care residents, and individuals with end-stage liver disease.

Inclusion Criteria

LDL > 55

Primary Care Physician at 1 of 6 identified clinics

I have been diagnosed with coronary artery disease.

Exclusion Criteria

Patients residing in hospice/Long Term Care facilities

Patients who are no longer an active patient of one of the internal medicine practices

Patients whose cholesterol is managed by another practice

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pharmacist review of patient chart and follow-up visits to prescribe appropriate therapy for hyperlipidemia

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacist Intervention in lipid therapy

Trial Overview The study aims to compare the effectiveness of pharmacist-led interventions in managing cholesterol using guideline-directed therapies versus usual care without this specialized intervention for secondary prevention in very high-risk patients.

How Is the Trial Designed?

Group I: Pharmacist Intervention Experimental Treatment 1 Intervention

Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia.

Group II: Control Active Control 1 Intervention

Chart review only

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S193328742030074X

Effect of pharmacist interventions on reducing low-density ... Pharmacist interventions significantly reduced LDL-C levels compared with usual care. Further research is warranted to determine the optimal pharmacist ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6983518/

Impact of the pharmacist‐led intervention on the control ... The findings of this review suggest that pharmacist‐led interventions in general practice can significantly reduce the medical risk factors of cardiovascular ...

3. cardio.jmir.org cardio.jmir.org/2025/1/e58837/PDF

Pharmacist-Initiated Team-Based Intervention for Optimizing Feasibility of an effective pharmacist-initiated intervention for improvement of lipid management was demonstrated by entry of recommendations ...

4. tctmd.com tctmd.com/news/pharmacist-led-intervention-slashes-ldl-and-bp-10000-patients

Pharmacist-Led Intervention Slashes LDL and BP in 10000 ... For the 2,753 patients in maintenance, LDL cholesterol declined from 140 mg/dL to 70 mg/dL (P < 0.001). In the maintenance arm, these reductions ...

5. jmcp.org jmcp.org/doi/10.18553/jmcp.2020.26.8.1010

Optimization of Lipid-Lowering Therapy for High ... The pharmacist recommended to intensify statin therapy for 16 patients (47.1%), initiate nonstatin therapy for 9 patients (26.5%), and initiate ...

6. academic.oup.com academic.oup.com/ajhp/article/81/Supplement_4/S152/7639561

Pharmacist optimization of lipid therapy in patients with ... Lipid optimization studies in the primary care setting have shown that pharmacist-based interventions can increase statin prescribing and the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11711772/

Learnings from Implementation Strategies to Improve Lipid ... A systematic review and meta-analysis of 26 randomised trials (22,095 patients) found that pharmacist-led interventions significantly reduced ...

8. pharmacytimes.com pharmacytimes.com/view/pharmacist-led-clinic-optimizes-lipid-therapy-for-postacute-coronary-syndromes

Pharmacist-Led Clinic Optimizes Lipid Therapy for ... Pharmacist-led interventions can significantly improve cholesterol levels, reducing the risk of further cardiovascular events. A case study ...

9. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0283369

Value of the clinical pharmacist interventions in the application ... Adherence with guideline recommendations was significantly improved from 60.3% to 92.6% (X2 = 79.1, p = 0.0001) after clinical pharmacist interventions. Among ...

10. bmccardiovascdisord.biomedcentral.com bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-021-02178-0

Effects of a pharmaceutical care intervention on clinical ... This was a prospective, randomized, controlled, outcomes-blinded trial designed to compare pharmaceutical care follow-up with standard care.