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

NCT ID: NCT06571162

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2028-09-30

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.

Conditions

Atherosclerotic Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

Patients will receive usual care for their LDL-C management.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Patient will receive usual care for their LDL-C management.

Clinical Pharmacy Team

Patients will receive targeted care of their LDL-C through a pharmacist-driven management program.

Group Type: EXPERIMENTAL

Clinical Pharmacy Team

Intervention Type: OTHER

Patients will receive targeted care of their LDL-C through a pharmacist-driven management program.

Interventions

Clinical Pharmacy Team

Patients will receive targeted care of their LDL-C through a pharmacist-driven management program.

Intervention Type: OTHER

Usual Care

Patient will receive usual care for their LDL-C management.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Intermountain Healthcare Hospitals and Clinics

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kirk U Knowlton, MD

Role: CONTACT

kirk.knowlton@imail.org

801-507-4757

Facility Contacts

Kirk U Knowlton, MD

Role: primary

kirk.knowlton@imail.org

801.507.4701

Heidi T May, PhD, MSPH

Role: backup

heidi.may@imail.org

801-507-4700

Other Identifiers

INC 1.0

Identifier Type: -

Identifier Source: org_study_id