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

Intermountain Health Care, Inc.

Status: Enrolling

Conditions: Atherosclerotic Cardiovascular Disease

Treatments: Other: Usual Care; Other: Clinical Pharmacy Team

Study type: Interventional

Funder types: Other

Identifiers

NCT06571162

INC 1.0

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care

Clinical Pharmacy Team

Experimental group

Description:

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

Treatment:

Other: Clinical Pharmacy Team