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NCT Number: NCT06571162

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

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.

Recruiting

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Healthcare Hospitals and Clinics

Salt Lake City, Utah, 84107, United States

Location status: Recruiting

Location contact

Heidi T May, PhD, MSPH

CONTACT

[email protected]

801-507-4700

Kirk U Knowlton, MD

CONTACT

[email protected]

801.507.4701

Kirk U Knowlton, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female >18 years of age
  • Receive follow-up care with Intermountain Health
  • Value-based patient (as defined in the EDW)
  • 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

  • Patient age <18 years.
  • Receipt of or expected receipt of palliative care, expected discharge to hospice, or long-term care facility (i.e., skilled nursing facility).
  • Pregnant or lactating women

Treatment and study plan

Clinical Pharmacy Team

Other

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

Usual Care

Other

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

Primary outcomes

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

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Kirk U Knowlton, MD

CONTACT

[email protected]

801-507-4757

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Official study title

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

Acronym: INCLUDE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 26, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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