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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06571162
Acronym
INCLUDE
Enrollment
400
Registered
2024-08-26
Start date
2025-01-30
Completion date
2028-09-30
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Cardiovascular Disease

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.

Interventions

OTHERClinical Pharmacy Team

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

OTHERUsual Care

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

Sponsors

Intermountain Health Care, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactKirk U Knowlton, MD
kirk.knowlton@imail.org801-507-4757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026