Evaluation of Pharmacist Interventions in Lipid Management for Secondary Prevention

NCT06647238 | Completed Results

• 1 other identifier: IRB00118029
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this research project is to compare the effect of pharmacist interventions versus usual care in the implementation of guideline directed lipid lowering therapies for secondary prevention.

Conditions

Hyperlipidemia; Coronary Artery Disease

Keywords

Pharmacist intervention; Hyperlipidemia treatment; secondary prevention of cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55)

  patients with LDL within goal (\<55) (yes/no)

  Month 5

Secondary Outcomes (3)

• Percent Change in Low-density Lipoprotein (LDL)

  Baseline to end of study period up to Month 5

• Number of Participants With Medications Initiated or Titrated

  Baseline to end of study period up to Month 5

• Prevalence of Elevated Lipoprotein(a)

  Baseline to end of study period up to Month 5

Study Arms (2)

Pharmacist Intervention

EXPERIMENTAL

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

Other: Pharmacist Intervention in lipid therapy

Control

NO INTERVENTION

Chart review only

Interventions

Pharmacist Intervention in lipid therapy OTHER

Pharmacist intervention may include but is not limited to prescribing (statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, etc.), patient education, and medication access.

Pharmacist Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of coronary artery disease
• low-density lipoprotein (LDL) \> 55
• Primary Care Physician at 1 of 6 identified clinics

You may not qualify if:

• Patients who are no longer an active patient of one of the internal medicine practices
• Patients whose cholesterol is managed by another practice
• Women of childbearing age/potential
• Patients residing in hospice/Long Term Care facilities
• End-stage liver disease

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Cabarrus

Concord, North Carolina, 28025, United States

Location

MeSH Terms

Conditions

Hyperlipidemias; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Lyndsi Roland
• Organization: Atrium Health

lyndsi.roland@advocatehealth.org

828-434-5434

Study Officials

• Kayla Marvin, PharmD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control group will not directly interact with investigators. Will perform retrospective chart review only.

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: November 5, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 27, 2025
• Last Updated: July 22, 2025
• Results First Posted: July 22, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)