Recruiting

LDL-C Management

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT06571162

Conditions

Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinical Pharmacy Team

Usual Care

Study Details

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 ID

NCT06571162

Start date

Jan 30, 2025

Status verified date

Apr, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Usual Care

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

experimental: Clinical Pharmacy Team

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.

Usual Care

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

Primary outcome measure

  • Proportion of patients who achieve an LDL-C <70 mg/dL by 1-year. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kirk U Knowlton, MD

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

Locations

Intermountain Healthcare Hospitals and Clinics

Recruiting

Salt Lake City, Utah, United States, 84107

Contacts

Kirk U Knowlton, MD

801.507.4701kirk.knowlton@imail.org

Heidi T May, PhD, MSPH

801-507-4700heidi.may@imail.org

Principal Investigator:

Kirk U Knowlton, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

May 6, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2025-05-06.