Actively Recruiting
A Pragmatic Initiative for LDL-C Management by a Clinical Pharmacist-Led Team Among Atherosclerotic Cardiovascular Disease Patients (The INCLUDE Trial)
Led by Intermountain Health Care, Inc. · Updated on 2025-05-06
400
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to improve the management of LDL cholesterol (LDL-C) levels in patients with atherosclerotic cardiovascular disease (ASCVD) who have been treated at Intermountain hospitals. It compares usual care with a pharmacist-led program focused on managing LDL-C to help more patients reach guideline-recommended LDL-C levels below 70 mg/dL. The goal is to enhance adherence to statin or lipid-lowering therapy and increase LDL-C testing. Participants will be randomly assigned to one of two groups: one receiving usual LDL-C care and the other receiving targeted LDL-C management by a clinical pharmacy team. Patients can opt out of the pharmacist-driven program if they wish. The study will follow participants for one year after randomization to track LDL-C levels and treatment adherence. Throughout the study, researchers will collect data on LDL-C levels and medication adherence over one year. The main outcome is the proportion of patients achieving LDL-C levels below 70 mg/dL at one year. Patient care will continue with their regular providers during the study, and data collection will last until the final participant completes one year of follow-up.
CONDITIONS
Brief Title
A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female over 18 years of age
- Receive follow-up care with Intermountain Health
- Be a value-based patient as defined in the electronic data warehouse
- Have documented atherosclerotic cardiovascular disease diagnosed by one of the following: coronary artery disease, cerebrovascular accident, or peripheral arterial disease
You will not qualify if you...
- Patient age under 18 years
- Receiving or expected to receive palliative care, discharge to hospice, or long-term care facility
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 year
Participants receive LDL-C management either through a clinical pharmacist-led program or usual care to manage their LDL cholesterol levels.
Trial Site Locations
Total: 1 location
1
Intermountain Healthcare Hospitals and Clinics
Salt Lake City, Utah, United States, 84107
Actively Recruiting
Research Team
K
Kirk U Knowlton, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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