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

NCT06571162 | Recruiting

• 1 other identifier: INC 1.0
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  1 year

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Clinical Pharmacy Team

EXPERIMENTAL

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

Other: Clinical Pharmacy Team

Interventions

Clinical Pharmacy Team OTHER

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

Clinical Pharmacy Team

Usual Care OTHER

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

Usual Care

Eligibility Criteria

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

You may qualify if:

• Male or female \>18 years of age
• Receive follow-up care with Intermountain Health
• Value-based patient (as defined in the EDW)
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Healthcare Hospitals and Clinics

Salt Lake City, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kirk U Knowlton, MD

CONTACT

801-507-4757; kirk.knowlton@imail.org

Study Design

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

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)