Managing LDL cholesterol levels in patients with cardiovascular disease through a pharmacist-led program
A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients (The INCLUDE Trial)
This study is testing if a pharmacist-led program can help people with heart disease lower their LDL cholesterol levels better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Intermountain Health Care, Inc. Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06571162 on ClinicalTrials.gov |
What this trial studies
This initiative focuses on patients who have experienced an atherosclerotic cardiovascular disease (ASCVD) event and are receiving follow-up care at Intermountain Health. Eligible participants will be randomly assigned to receive either targeted LDL-C management by a clinical pharmacy team or usual care. The goal is to improve adherence to statin and lipid-lowering therapies and achieve guideline-recommended LDL-C levels of less than 70 mg/dL. Data will be collected for one year following randomization to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a documented diagnosis of ASCVD receiving follow-up care at Intermountain Health.
Not a fit: Patients under 18 years old, those receiving palliative care, or pregnant or lactating women may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve cholesterol management and reduce cardiovascular risks for patients with ASCVD.
How similar studies have performed: Other studies have shown that pharmacist-led interventions can effectively improve medication adherence and health outcomes in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Salt Lake City, Utah
- Intermountain Healthcare Hospitals and Clinics — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Kirk U Knowlton, MD
- Email: kirk.knowlton@imail.org
- Phone: 801-507-4757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.