A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients

Not Applicable

Recruiting

• Conditions: Atherosclerotic Cardiovascular Disease
• Interventions: Other: Clinical Pharmacy Team; Other: Usual Care

• Registration Number: NCT06571162
• Lead Sponsor: Intermountain Health Care, Inc.

Brief Summary

Patients who had an ASCVD event at an Intermountain hospital will be screened for eligibility to be randomized. Subjects who meet eligibility criteria will be randomized 1:1 to receive targeted care of their LDL-C through a pharmacist-driven management program or not. Patients may opt-out of receiving LDL-C management by the pharmacy team at any time. The purpose of this program is to increase the proportion of patients who achieve guideline-based recommendations of LDL-C levels of \<70 mg/dL by increasing statin and/or LLT adherence and LDL-C testing. Data collection as part of the study will continue until the last person randomized has had 1-year of follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Study Start: 2025-01-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Primary Completion: 2028-01
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Male or female >18 years of age

2. Receive follow-up care with Intermountain Health

3. Value-based patient (as defined in the EDW)

4. Documentation of an ASCVD diagnosis, by 1 of the following:

   • Coronary artery disease (Primary inpatient CAD diagnosis during index encounter; Primary inpatient MI diagnosis during index encounter; PCI during index encounter; or CABG during index encounter
   • Cerebrovascular accident (Primary inpatient ischemic stroke diagnosis during index encounter; Carotid endarterectomy during index encounter; or Carotid stent during index encounter)
   • Peripheral arterial disease (Bypass or percutaneous intervention during index encounter)

Exclusion Criteria

1. Patient age <18 years.
2. Receipt of or expected receipt of palliative care, expected discharge to hospice, or long-term care facility (i.e., skilled nursing facility).
3. Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical Pharmacy Team	Clinical Pharmacy Team	Patients will receive targeted care of their LDL-C through a pharmacist-driven management program.
Usual Care	Usual Care	Patients will receive usual care for their LDL-C management.

Primary Outcome Measures

Name	Time	Method
Proportion of patients who achieve an LDL-C <70 mg/dL by 1-year.	1 year

Trial Locations

Locations (1)

Intermountain Healthcare Hospitals and Clinics; 🇺🇸 Salt Lake City, Utah, United States