RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-30
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06571162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female \>18 years of age
  2. 2. Receive follow-up care with Intermountain Health
  3. 3. Value-based patient (as defined in the EDW)
  4. 4. Documentation of an ASCVD diagnosis, by 1 of the following:
  5. * 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
  6. * Cerebrovascular accident (Primary inpatient ischemic stroke diagnosis during index encounter; Carotid endarterectomy during index encounter; or Carotid stent during index encounter)
  7. * Peripheral arterial disease (Bypass or percutaneous intervention during index encounter)
  1. 1. Patient age \<18 years.
  2. 2. Receipt of or expected receipt of palliative care, expected discharge to hospice, or long-term care facility (i.e., skilled nursing facility).
  3. 3. Pregnant or lactating women

Contacts and Locations

Study Contact

Kirk U Knowlton, MD
CONTACT
801-507-4757
kirk.knowlton@imail.org

Study Locations (Sites)

Intermountain Healthcare Hospitals and Clinics
Salt Lake City, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Intermountain Health Care, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-30
Study Completion Date2028-09

Study Record Updates

Study Start Date2025-01-30
Study Completion Date2028-09

Terms related to this study

Additional Relevant MeSH Terms

  • Atherosclerotic Cardiovascular Disease